NOTE:    The following Minutes are provided for informational purposes only.

If you would like to obtain an official copy of these Minutes, please contact the

State Board of Pharmacy at 614/466-4143 for instructions and fee.

 

 

 

Minutes Of The Meeting

Ohio State Board of Pharmacy

Columbus, Ohio

December 11, 12, 13, 2000

 

MONDAY, DECEMBER 11, 2000

 

  8:10 a.m.     ROLL CALL

 

The State Board of Pharmacy convened in Room 1914, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with the following members present:

 

Suzanne L. Neuber, R.Ph. (President); Diane C. Adelman, R.Ph. (Vice-President); Ann D. Abele, R.Ph.; Suzanne R. Eastman, R.Ph.; Robert P. Giacalone, R.Ph.; Lawrence J. Kost, R.Ph.; Dorothy Teater, Public Member; and James E. Turner, R.Ph.

 

Also present were William T. Winsley, Executive Director; Timothy Benedict, Assistant Executive Director; Mark Keeley, Legislative Affairs Administrator; David Rowland, Legal Affairs Administrator; and Sally Ann Steuk, Assistant Attorney General.

  8:21 a.m.

RES. 2001-075  After a brief discussion of the proposed rules that were the subject of the Public Hearing held during the November Board meeting, Ms. Abele moved that the Board implement the following rules with an effective date of January 1, 2001 and that Board staff be instructed to file the rules with the appropriate State agencies as soon as possible.

 

4729-5-30  Manner of issuance of prescription.

 

(A)  A prescription, to be effective, must be issued for a legitimate medical purpose by an individual prescriber acting in the usual course of his/her professional practice.  The responsibility for the proper prescribing is upon the prescriber, but a corresponding responsibility rests with the pharmacist who dispenses the prescription.  An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription and the person knowingly dispensing such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law.

 

(B)  All prescriptions shall be dated as of and signed on the day when issued, and shall bear the full name and address of the patient.

 

(C)  All written prescriptions issued by a prescriber shall bear the full name and address of the prescriber and shall be manually signed by the prescriber in the same manner as he/she would sign a check or legal document.

 

(D)  An original signed prescription (for other than a schedule II controlled substance except as noted in paragraph (N) of this rule and rules 4729-17-09 and 4729-19-02 of the Administrative Code) may be transmitted as an "other means of communication" to a pharmacy by the use of a facsimile machine only by a prescriber or the prescriber's agent.  Such a facsimile shall only be valid as a prescription if a system is in place that will allow the pharmacist to maintain the facsimile as a part of the prescription record including the positive identification of the prescriber and his/her agent as well as positive identification of the origin of the facsimile.  The pharmacist must record the prescription in writing pursuant to section 4729.37 of the Revised Code or store the facsimile copy in such a manner that will allow retention of the prescription record for three years from the date of the last transaction.  The original signed prescription from which the facsimile is produced shall not be issued to the patient.  The original signed prescription must remain with the patient’s records at the prescriber’s office or the institutional facility where it was issued.  If a board-approved electronic prescription transmission system is used to fax the prescription, the computer data must be retained for a period of three years at the prescriber's office.  A facsimile of a prescription received by a pharmacy in any manner other than transmission directly from the prescriber or the prescriber’s agent shall not be considered a valid prescription, except as a copy of a prescription pursuant to rule 4729-5-24 of the Administrative Code.

 

(E)  All prescriptions shall specify the number of times or the period of time for which the prescription may be refilled.  A prescription marked "Refill P.R.N." or some similar designation is not considered a valid refill authorization.

 

(F)  Prescriptions for dangerous drugs may not be dispensed for the first time beyond six months from the date of issuance by a prescriber.

 

(G)  Prescriptions for dangerous drugs and controlled substances in schedule V may not be authorized for refill beyond one year from the date of issuance.  Prescriptions for controlled substances in schedules III and IV shall be authorized for refill only as permitted by section 3719.05 of the Revised Code.  Prescriptions for controlled substances in schedule II may not be refilled.

 

(H)  A prescription may be refilled only as expressly authorized by the prescriber, either in writing or orally.  If no such authorization is given, the prescription may not be refilled except in accordance with section 4729.281 of the Revised Code.

 

(I)  The drug(s) in a compounded prescription or drug product shall be identified by the product trade name or generic name.

 

(J)  No prescription shall be coded in such a manner that it cannot be dispensed by any pharmacy of the patient's choice.  A "coded prescription" is one which THAT bears letters, numbers, words or symbols, or any other device used in lieu of the name, quantity, strength and directions for its use, other than those normal letters, numbers, words, symbols, or other media recognized by the profession of pharmacy as a means of conveying information by prescription.  No symbol, word, or any other device shall be used in lieu of the name of said preparation.

 

(K)  (1)  The agent of a prescriber who transfers a facsimile of THE PRESCRIBER'S AUTHORIZATION FOR an original prescription or transmits an oral prescription or authorization of a refill for a dangerous drug must identify themselves HIMSELF/HERSELF by full name and the pharmacist shall make a record of the prescriber's agent on the original prescription and, if used, on the alternate system of recordkeeping.  A pharmacist who modifies a patient's drug therapy, pursuant to a consult agreement, must personally transmit the facsimile or oral order to another pharmacist, if the drug is not dispensed by the pharmacist who modified the drug order.

 

(2)  A LICENSED PHARMACY INTERN MAY RECEIVE TELEPHONE AUTHORIZATION OF AN ORAL ORIGINAL PRESCRIPTION OR A REFILL FROM A PRESCRIBER OR THE PRESCRIBER'S AGENT PURSUANT TO THE FOLLOWING:

 

(a)  THE PHARMACIST ON DUTY WHO IS SUPERVISING THE ACTIVITY OF THE INTERN IS RESPONSIBLE FOR THE ACCURACY OF THE PRESCRIPTION.

 

(b)  THE PHARMACIST ON DUTY WHO IS SUPERVISING THE ACTIVITY OF THE INTERN WILL DETERMINE IF THE INTERN IS COMPETENT TO RECEIVE TELEPHONE PRESCRIPTIONS.

 

(c)  THE SUPERVISING PHARMACIST MUST BE IMMEDIATELY AVAILABLE TO ANSWER QUESTIONS OR DISCUSS THE PRESCRIPTION WITH THE CALLER.

 

(d)  THE INTERN SHALL IMMEDIATELY REDUCE THE PRESCRIPTION TO WRITING AND SHALL REVIEW THE PRESCRIPTION WITH THE SUPERVISING PHARMACIST.  PRIOR TO DISPENSING, POSITIVE IDENTIFICATION OF THE INTERN AND THE SUPERVISING PHARMACIST SHALL BE MADE ON THE PRESCRIPTION TO IDENTIFY THE RESPONSIBILITY FOR THE RECEIPT OF THE ORAL ORDER.

 

(L)  When forms are used that create multiple copies of a prescription issued to a patient by a prescriber, the original prescription which THAT also bears the actual signature of the prescriber must be issued to the patient for dispensing by a pharmacist.

 

(M)  A pharmacist may accept, without further verification of the prescriber’s identity required, a prescription that has been transmitted by means of a board-approved automated paperless system.  The system shall require positive identification of the prescriber as defined in rule 4729-5-01 of the Administrative Code as well as the full name of any authorized agent of the prescriber who transmits the prescription.

 

(N)  A schedule II controlled substance prescription for a narcotic substance issued for a patient enrolled in a hospice may be transmitted by the prescriber or the prescriber's agent to the pharmacy by facsimile.  The original prescription must indicate that the patient is a hospice patient.  The facsimile transmission must meet all of the requirements in paragraph (D) of this rule for such a prescription.

 

(O)  When a pharmacist, acting as an agent of the physician, modifies a patient's drug therapy pursuant to a consult agreement, the pharmacist must comply with this rule in the same manner as a prescriber and include the name of the physician who originally prescribed the drug and sign the pharmacist's full name.

 

(P)  A prescription orally transmitted by telephone to a pharmacy by a prescriber or the prescriber's agent may be placed on a recording device at the pharmacy if the pharmacist is unavailable.  The prescriber or prescriber's agent must provide his/her complete name.  The pharmacist must remove the prescription from the recorder and reduce it to writing.  The pharmacist is responsible for assuring the validity of the prescription removed from the recorder.

 

 

4729-5-31  Criteria for licensure by examination.

 

(A)  Pursuant to section 4729.07 of the Revised Code:

 

(1)  The examination shall consist of the “North American Pharmacist Licensure Examination (NAPLEX)” and a jurisprudence examination compiled by the state board of pharmacy or the “National Association of Boards of Pharmacy (NABP)."

 

(2)  (a)  The minimum passing grade SCORE for the NAPLEX is seventy-five.  Any candidate failing to attain a grade SCORE of seventy-five on the NAPLEX examination will be required to repeat the NAPLEX examination and remit the fee established by the state board of pharmacy for re-examination.

 

(b)  PURSUANT TO THE PROCEDURES ESTABLISHED BY THE NABP, A CANDIDATE MAY TRANSFER HIS/HER NAPLEX SCORE TO OHIO ONLY AFTER THE CANDIDATE HAS MET ALL OF THE REQUIREMENTS SET BY THE BOARD FOR EXAMINATION AND LICENSURE IN OHIO.

 

(3)  The minimum passing grade SCORE for the jurisprudence examination is seventy-five.  Any candidate who fails to receive a grade SCORE of seventy-five on the jurisprudence examination will be required to repeat the jurisprudence examination and remit the fee established by the state board of pharmacy for re-examination.

 

(B)  Pursuant to section 4729.13 of the Revised Code:

 

(1)  The examination shall consist of the "North American Pharmacist Licensure Examination (NAPLEX)" and a jurisprudence examination compiled by the state board of pharmacy or the "National Association of Boards of Pharmacy (NABP)."

 

(2)  The minimum passing grades SCORES for renewal of the pharmacist's identification card is a seventy-five on each exam.

 

(a)  Any candidate for renewal of an identification card who fails to receive a grade SCORE of seventy-five on the jurisprudence examination shall make application and remit the fee established by the state board of pharmacy for re-examination.

 

(b)  Any candidate for renewal of an identification card who fails to receive a grade SCORE of seventy-five on the NAPLEX examination shall make application and remit the fee established by the state board of pharmacy for re-examination.

 

(C)  Pursuant to section 4729.08 of the Revised Code:

 

Applicants for examination and registration as a pharmacist who are graduates of schools or colleges of pharmacy located outside the United States and who are using an approved examination to establish equiva­lency of their education shall:

 

(1)  Obtain a grade SCORE no lower than seventy-five on the "Foreign Pharmacy Graduate Equivalency Examination (FPGEE)"; and

 

(2)  Show oral proficiency in English by successful completion of the "Test of Spoken English (TSE)" or its equivalent, pursuant to rule 4729-5-34 of the Administrative Code.

 

 

4729-5-35  Automated drug delivery systems.

 

All automated drug delivery systems intended for use by a terminal distributor of dangerous drugs pursuant to rule 4729-17-01 or 4729-17-05 of the Administrative Code must meet the following requirements:

 

(A)  Each automated drug delivery system must be approved by the board of pharmacy prior to its implementation by the terminal distributor of dangerous drugs;

 

(B)  The automated drug delivery system shall have a documented and on-going quality assurance program that monitors total system performance and includes the requirement for one hundred per cent accuracy in drug and strength delivered;

 

(C)  The automated drug delivery system shall have adequate security to prevent unauthorized individuals from accessing or obtaining dangerous drugs;

 

(D)  The records kept by the automated drug delivery system shall comply with all board requirements.

 

 

4729-9-01  Definitions.

 

(A)  "Dangerous drug," as defined in section 4729.01 of the Revised Code, means any drug or drug product whose commercial package bears a label containing the symbol "Rx only", the legend "Caution:  Federal Law Prohibits Dispensing Without Prescription" or "Caution:  Federal Law Restricts This Drug To Use By Or On The Order Of A Licensed Veterinarian", or any similar restrictive statement.

 

(B)  A dangerous drug is adulterated if beyond the expiration date as stated by the manufacturer, packer, or distributor in its labeling or if it is not stored or dispensed according to the requirement of the federal act as indicated in the product labeling.

 

(C)  "Psychiatric outpatient facility" means a facility where psychiatric evaluation and treatment is provided on an outpatient basis.

 

(D)  As used in Chapters 3719. and 4729. of the Revised Code, "registered" and "licensed" mean that an individual or facility has met the initial qualifications for registration and licensure with the state board of pharmacy and, if they are still actively practicing pharmacy or distributing drugs, have complied with annual renewal procedures, including payment of applicable fees.

 

(E)  "Revoke", as used in Chapters 3719. and 4729. of the Revised Code, means to take action against a license which renders RENDERING such license void and such license may not be reissued.  "Revoke" is an action which THAT is permanent against the license and licensee.

 

(F)  "Suspend", as used in Chapters 3719. and 4729. of the Revised Code, means to take action against a license which renders RENDERING such license without force and effect for a period of time as determined by the state board of pharmacy.  The board may require that an individual whose license has been suspended may not be employed by or work in a facility licensed by the state board of pharmacy to possess or distribute dangerous drugs during such period of suspension.

 

(G)  "Place on probation", as used in Chapter 4729. of the Revised Code, means to take action against a license which suspends SUSPENDING SOME OR ALL OF the sanctions imposed by the state board of pharmacy during a period of good behavior for a AGAINST THAT LICENSE.  THE TERMS OF THE PROBATION SHALL STATE THE period of time and under such COVERED BY THE PROBATION AND MAY INCLUDE OTHER conditions as determined by the state board of pharmacy.

 

(H)   "Refuse to grant or renew", as used in Chapter 4729. of the Revised Code, means to deny original or continued licensure for a period of at least twelve months.  After twelve months or such period of time as the individual board order may require, a pharmacist, a pharmacy intern, a terminal distributor of dangerous drugs, a wholesale distributor of dangerous drugs, a wholesaler of controlled substances, a manufacturer of controlled substances, or an individual or facility who desires to attain such status by licensure, and whose license the state board of pharmacy has refused to grant or renew, may make application to the board for issuance of a new license.  A pharmacist, or an individual who desires to attain such status by licensure, whose license the state board of pharmacy has refused to grant or renew must meet any requirements established by the board or must pass any examination required by the board.

 

(I)  "Campus", as used to describe a type of terminal distributor of dangerous drugs license issued pursuant to division (E) of section 4729.51 of the Revised Code, means an establishment or place consisting of multiple buildings where dangerous drugs are stored that are located on a con­tiguous plot of land.  All such buildings and stocks of dangerous drugs shall be under common ownership and control.

 

(J)  "Certified diabetes educator", as used in Chapters 3719. and 4729. of the Revised Code, means a person who has been certified to conduct diabetes education by the "National Certification Board for Diabetes Educators (NCBDE)".

 

 

4729-9-07  Procedure for discontinuing business as a wholesale or a terminal distributor of dangerous drugs.

 

(A)  A wholesale or terminal distributor of dangerous drugs who plans to discontinue business activities shall file a written notice with the board of pharmacy.  The written notice shall be submitted to the board of pharmacy in person, BY VERIFIED FACSIMILE, or by registered or certified mail, return receipt requested, at least fourteen days in advance of the proposed date of discontinuing business, UNLESS THE BOARD WAIVES THIS TIME LIMITATION IN INDIVIDUAL INSTANCES.  This notice shall include the following information:

 

(1)  The name, address, and wholesale or terminal distributor of dangerous drugs number of the registrant discontinuing business;.

 

(2)  The name, address, and wholesale or terminal distributor of dangerous drugs number to whom the dangerous drugs will be transferred;.

 

(3)  The name and address of the SECURED location at which WHERE the records of purchase and dispensing will be kept in accordance with section 4729.37 of the Revised Code; and.  THE STORAGE OF DISPENSING RECORDS MUST COMPLY WITH THE CONFIDENTIALITY REQUIREMENTS OF RULE 4729-5-29 OF THE ADMINISTRATIVE CODE.

 

(4)  The proposed date of discontinuing business.

 

(B)  Unless the registrant is informed by the executive director before the proposed date of discontinuing business that the transfer of dangerous drugs and records may not occur, the registrant discontinuing business may transfer the dangerous drugs and records in accordance with the following:

 

(1)  On the date of discontinuing business, a complete inventory of all controlled substances being transferred, or disposed of according to rule 4729-9-06 of the Administrative Code, shall be made.  The inventory shall list the name and quantity of all controlled substances transferred or disposed of.

 

(2)  This inventory shall serve as the final inventory of the registrant discontinuing business and the initial inventory of the registrant to whom the controlled substances are being transferred.  A copy of the inventory shall be included in the records of each registrant involved in the transfer.

 

(C)  Upon discontinuing business, the registrant shall return to the board of pharmacy, in person or by registered or certified mail, return receipt requested, the wholesale distributor of dangerous drugs license or the terminal distributor of dangerous drugs license for cancellation.

 

 

4729-9-11  Security and control of dangerous drugs.

 

A pharmacist, prescriber, or responsible person pursuant to paragraph (C) of rule 4729-13-01 or paragraph (C) of rule 4729-14-01 of the Administrative Code, who has signed as being responsible for a terminal distributor of dangerous drugs license, shall provide "supervision and control" of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, and "adequate safeguards" to assure that dangerous drugs are being distributed in accordance with all state and federal laws as required in section 4729.55 of the Revised Code, by the following procedures:

 

(A)  In a pharmacy.

 

(1)  Personal supervision by a pharmacist of the dangerous drugs at all times to deter and detect theft or diversion; except,

 

(2)  Whenever personal supervision of the dangerous drugs is not provided by a pharmacist, physical or electronic security of the dangerous drugs must be provided according to the following requirements:

 

(a)  The prescription department or stock of dangerous drugs must be secured by either a physical barrier with suitable locks and/or an electronic barrier to detect entry at a time the pharmacist is not present.  Such a barrier, before being put into use, must be approved by the state board of pharmacy.

 

(b)  The prescription department must contain all dangerous drugs, exempt narcotics, hypodermics, poisons, and every other item or product which THAT requires the personal supervision or sale by a pharmacist.

 

(c)  No item, product, record, or equipment which THAT must be accessible to anyone other than a pharmacist may be stored in the prescription department.

 

(d)  Only EXCEPT AS PROVIDED IN RULE 4729-17-03 OF THE ADMINISTRATIVE CODE, ONLY a pharmacist may have access to the prescription department or stock of dangerous drugs or assume responsibility for the security of dangerous drugs, exempt narcotics, hypodermics, poisons, and any other item or product which THAT requires the personal supervision or sale by a pharmacist.

 

(e)  No prescription, dangerous drug, exempt narcotic, hypodermic, nor any other item or product which THAT requires the personal supervision or sale by a pharmacist may be sold, given away, or disposed of at any time the prescription department is closed.

 

(f)  New prescriptions received from the patient or by mail, or refill prescription orders received from the patient or by phone or by mail, may be dropped into the prescription department by slot DEPOSITED INTO A SECURED AREA WITHIN THE BUILDING WHERE THE PHARMACY IS LOCATED when a pharmacist is not present.  ONLY A PHARMACIST MAY HAVE ACCESS TO THIS SECURED AREA.

 

(g)  Notice to the public of operating hours of the prescription department must be posted.

 

(3)  Areas designated for the dispensing, compounding, and storage of dangerous drugs shall meet the security requirements in rule 4729-9-05 of the Administrative Code.  No person may be within the physical confines of the area designated for the dispensing, compounding, and storage of dangerous drugs unless under the personal supervision of a pharmacist.

 

(B)  In other terminal distributors of dangerous drugs, including but not limited to, emergency medical services pursuant to division (C) of section 4729.54 of the Revised Code, first-aid departments pursuant to rule 4729-9-04 of the Administrative Code, approved laboratories pursuant to paragraph (A) of rule 4729-13-01 of the Administrative Code, and animal shelters pursuant to paragraph (A) of rule 4729-14-01 of the Administrative Code, dangerous drugs must be stored in an area secured by either a physical barrier with suitable locks and/or an electronic barrier to deter and detect unauthorized access.

 

(C)  A pharmacist, prescriber, or responsible person for a terminal distributor of dangerous drugs license pursuant to paragraph (C) of rule 4729-13-01 or paragraph (C) of rule 4729-14-01 of the Administrative Code who has signed as being responsible for a terminal distributor of dangerous drugs license is responsible to monitor for suspicious orders, unusual usage, or questionable disposition of dangerous drugs.

 

The motion was seconded by Mrs. Adelman and approved by the Board (Aye-7/Nay-0).

  8:25 a.m.

Mr. Winsley distributed a draft copy of a proposal from DEA regarding controlled substances in long-term-care facilities.  Discussion on this issue was postponed until later to allow the Board members an opportunity to review the document.

  8:30 a.m.

Ms. Abele moved that the Board go into Executive Session for the purpose of the investigation of complaints regarding licensees and registrants pursuant to Section 121.22(G)(1) of the Revised Code and for the purpose of conferring with an attorney for the Board regarding pending or imminent court action pursuant to Section 121.22(G)(3) of the Revised Code.  The motion was seconded by Mr. Giacalone and a roll call vote was conducted by President Neuber as follows: Abele-Yes, Adelman-Yes, Eastman-Yes, Giacalone-Yes, Kost-Yes, Teater-Yes, and Turner-Yes.

  9:35 a.m.

Mr. Littlejohn arrived and joined the Executive Session in progress.

10:00 a.m.

RES. 2001-076  The Executive Session ended and the meeting was opened to the public.  Ms. Abele moved that the Board accept the following Settlement Agreement in the matter of Randolph A. Mosier, R.Ph. (03-1-20467).

 

(1)     Randolph D. Mosier, during the relevant time periods stated in the allegations or charges, was the responsible pharmacist at Walgreens #5473, pursuant to Sections 4729.27 and 4729.55 of the Ohio Revised Code and Rule 4729-5-11 of the Ohio Administrative Code.

 

(2)     Randolph D. Mosier is addicted to liquor or drugs or impaired physically or mentally to such a degree as to render him unfit to practice pharmacy, to wit: Randolph D. Mosier has admitted stealing controlled substances from his employer, Walgreens #5473, and that he has a “psychological addiction” to Adderall; Randolph D. Mosier has practiced pharmacy while being impaired, and he has recently entered into a drug treatment program.  Such conduct indicates that Randolph D. Mosier falls within the ambit of Sections 3719.121 and 4729.16(A)(3) of the Ohio Revised Code.

 

(3)     Randolph D. Mosier did, on or about March 30, 2000, knowingly obtain or possess a controlled substance when not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: Randolph D. Mosier voluntarily surrendered to an agent of the Board 21 unit-doses of Adderall which he possessed in his home without prescription.  Such conduct is in violation of Section 2925.11 of the Ohio Revised Code.

 

(4)     Randolph D. Mosier did, on or about June 9, 1998, knowingly make a false statement in a report or record required by Chapter 3719. or 4729. of the Revised Code, to wit: while working at Walgreen’s #3312, 22401 Lakeshore Blvd., Euclid, Ohio, Randolph D. Mosier falsely recorded the DEA Inventory Record of Controlled Substances to cover for his theft of drugs:

 

Drug/Strength

Quantity Recorded

 

Actual Inventory

Ativan .5 mg

120

 

150

Darvocet-N 100 mg

280

 

313

Propoxyphene-N 100 mg

1,030

 

1,892

Diazepam 10 mg

0

 

453

Chlordiazepoxide 5 mg

120

 

180

Alprazolam 1 mg

700

 

835

Xanax 1 mg

115

 

140

Hycodan

75

 

80

Vicoprofen 7.5/200 mg

105

 

149

Hydrocodone 10/650 mg

205

 

260

Vicodin ES

0

 

205

Vicodin HP

90

 

190

Hydrocodone 7.5/500 mg

150

 

185

 

Such conduct is in violation of Section 2925.23(A) of the Ohio Revised Code.

 

(5)     Randolph D. Mosier did, as the Responsible Pharmacist, from on or about June 9, 1998, through January 20, 2000, with purpose to deprive, knowingly obtain or exert control over dangerous drugs, the property of Walgreen’s #3312, beyond the express or implied consent of the owner, to wit: Randolph D. Mosier or someone under his supervision and control stole the following drugs from his employer:

 

Drug/Strength

 

Shortage

Adderall 5 mg

 

16

Adderall 10 mg

 

426

Adderall 20 mg

 

430

Oxycontin 20 mg

 

197

Oxycontin 40 mg

 

87

Methylphenidate 5 mg

 

15

Methylphenidate 10 mg

 

253

Methylphenidate 20 mg

 

90

Ritalin 20 mg

 

122

Alprazolam 1 mg

 

672

Alprazolam 2 mg

 

151

Ambien [Zolpidem] 10 mg

 

3,256

Chlordiazepoxide 5 mg

 

150

Chlordiazepoxide 10 mg

 

368

Clonazepam 2 mg

 

478

Lorazepam .5 mg

 

1,611

Lorazepam 1 mg

 

364

Lorazepam 2 mg

 

135

Vicoprofen 7.5/ 200 mg

 

297

Hydrocodone 7.5/500 mg

 

91

Lortab 7.5/500 mg

 

20

Hydrocodone 7.5/650 mg

 

133

Hydrocodone 7.5/750 mg

 

259

Vicodin ES 7.5/750 mg

 

110

Norco 10/325 mg

 

1,132

Hydrocodone 10/500 mg

 

5,397

Lortab 10/500 mg

 

972

Hydrocodone 10/650 mg

 

619

Lorcet 10/650 mg

 

142

Vicodin HP 10/650 mg

 

165

 

Such conduct is in violation of Section 2913.02 of the Ohio Revised Code.

 

(6)     Randolph D. Mosier did, as the Responsible Pharmacist, from on or about June 9, 1998, through January 20, 2000, with purpose to deprive, knowingly obtain or exert control over dangerous drugs, the property of Walgreen’s #5473, beyond the express or implied consent of the owner, to wit: Randolph D. Mosier or someone under his supervision or control stole the following drugs from his employer:

 

Drug/Strength

 

Shortage

Adderall 20 mg

 

60

Oxycontin 40 mg

 

130

Hydrocodone 10/500 mg

 

161

Norco

 

570

Ambien 10 mg

 

74

Sonata 10 mg

 

70

 

Such conduct is in violation of Section 2913.02 of the Ohio Revised Code.

 

(A)     Randolph D. Mosier knowingly and voluntarily agrees to the REVOCATION of his license to practice pharmacy in the state of Ohio as of the effective date of this agreement.

 

(B)     The Summary Suspension Order issued by the Board on April 5, 2000, is removed as of the effective date of this agreement.

 

 

The motion was seconded by Mrs. Teater and approved by the Board (Aye-7/Nay-0/Abstain-1[Littlejohn]).

10:05 a.m.

Dorothy Teater left the meeting for personal reasons.  Ms. Abele moved that the Board go into Executive Session for the purpose of the investigation of complaints regarding licensees and registrants pursuant to Revised Code Section 121.22(G)(1) and for the purpose of conferring with an attorney for the Board regarding pending or imminent court action pursuant to Revised Code Section 121.22(G)(3).  The motion was seconded by Mr. Giacalone and a roll call vote was conducted by President Neuber as follows: Abele-Yes, Adelman-Yes, Eastman-Yes, Giacalone-Yes, Kost-Yes, and Turner-Yes.

10:52 a.m.

The Executive Session ended and the meeting was opened to the public.  The Board was joined by representatives of Merck-Medco for a presentation regarding a new prescrip-tion scanning program soon to be implemented.  After the presentation, the Board members indicated that they would discuss this matter further and respond after that discussion.

11:38 a.m.

The Board recessed for lunch.

  1:02 p.m.

The Board reconvened with all members present in Room 1914, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio to continue the Board meeting.

  1:05 p.m.

RES. 2001-077  Mr. Winsley presented a request from Amanda Kochert, R.Ph. that she be permitted to attend the Reciprocity Hearing on Tuesday, December 12, 2000 even though her reciprocity application was not yet complete.  Ms. Eastman moved that the Board allow her to attend the reciprocity hearing and that Board staff be instructed to issue her pharmacist identification card upon successful completion of her reciprocity application.  The motion was seconded by Mr. Giacalone and approved by the Board (Aye-8/Nay-0).

  1:10 p.m.

RES. 2001-078  Mr. Benedict then presented a request from Capital Returns, a reverse distributor, that they be permitted to document the dangerous drugs returned from a Terminal Distributor’s site by means of a tape recording left on site in lieu of a written list.  As an alternative, they asked that Capital Returns be permitted to transcribe the tape and return a written list of the surrendered drugs to the Terminal Distributor’s site.  After discussion, the consensus of the Board was that the first alternative, leaving a tape-recorded list in lieu of a written list would be acceptable.  However, the Board members were not willing to accept the second alternative, sending the tape to Capital Returns for transcription.  Board staff was instructed to notify Capital Returns of the Board’s opinion.

  1:20 p.m.

The Board was joined by Assistant Attorney General Sally Ann Steuk for the purpose of conducting an adjudication hearing in accordance with Ohio Revised Code Chapters 119. and 4729. in the matter of Katherine Marie Blair, R.Ph., Canton.

  4:33 p.m.

The hearing ended and the record was closed.

  4:37 p.m.

Ms. Abele moved that the Board go into Executive Session for the purpose of the investigation of complaints regarding licensees and registrants pursuant to Section 121.22(G)(1) of the Revised Code.  The motion was seconded by Mr. Littlejohn and a roll call vote was conducted by President Neuber as follows: Abele-Yes, Adelman-Yes, Eastman-Yes, Giacalone-Yes, Kost-Yes, Littlejohn-Yes, Teater-Yes, and Turner-Yes.

  4:50 p.m.

RES. 2001-079  The Executive Session ended and the meeting was opened to the public.  Mr. Kost moved that the Board adopt the following Order in the matter of Katherine Marie Blair, R.Ph.:

 

(A)     Testimony

 

State's Witnesses:

 

(1)     David Gallagher, Ohio State Board of Pharmacy

 

Respondent's Witnesses:

 

(1)     Katherine Marie Blair, R.Ph., Respondent

 

(B)     Exhibits

 

State's Exhibits:

 

(1)     Exhibit 1--Copy of six-page Summary Suspension Order/Notice of Opportunity for Hearing letter dated April 4, 2000.

(2)     Exhibit 1A--Hearing Request letter dated April 23, 2000.

(3)     Exhibit 1B--Copy of Hearing Schedule letter dated April 27, 2000.

(4)     Exhibit 1C--Notification of Legal Representation letter dated May 10, 2000.

(5)     Exhibit 1D--Copy of four-page Addendum Notice letter dated May 15, 2000.

(6)     Exhibit 1E--Copy of Pharmacist File Front Sheet of Katherine Marie Blair showing original date of registration as June 23, 1987; and two-page copy of Renewal Application for Pharmacist License, No. 03-2-16954, for a license to practice pharmacy in Ohio from September 15, 1999, through September 15, 2000, of Katherine Marie Blair dated July 31, 1999.

(7)     Exhibit 2--VCR tape from Acme Pharmacy security camera.

(8)     Exhibit 3--Copy of two-page Statement of Katherine Marie Blair dated March 17, 2000.

(9)     Exhibit 4A--Twenty tablets of Watson's hydrocodone/APAP 7.5/750mg voluntarily surrendered to Agent David Gallagher by Katherine Marie Blair on March 17, 2000.

(10)   Exhibit 4B--Two tablets of Vicodin 7.5/750mg ES voluntarily surrendered to Agent David Gallagher by Katherine Marie Blair on March 17, 2000.

(11)   Exhibit 4C--Three capsules of Dexedrine 15mg voluntarily surrendered to Agent David Gallagher by Katherine Marie Blair on March 17, 2000.

(12)   Exhibit 4D--Three tablets of phentermine 37.5mg voluntarily surrendered to Agent David Gallagher by Katherine Marie Blair on March 17, 2000.

(13)   Exhibit 4E--Two tablets of methylphenidate with MD/562 imprint voluntarily surrendered to Agent David Gallagher by Katherine Marie Blair on March 17, 2000.

(14)   Exhibit 4F--One tablet of Lasix 40mg and two capsules of deconamine SR voluntarily surrendered to Agent David Gallagher by Katherine Marie Blair on March 17, 2000.

(15)   Exhibit 5--Copy of three-page Receipt for Drugs voluntarily surrendered to Agent David Gallagher by Katherine Marie Blair on March 17, 2000.

(16)   Exhibit 6--Copy of Prescription No. 4447857.

(17)   Exhibit 7--Acme Pharmacy prescription bag and dispensing container with an Acme Pharmacy #59 dispensing label affixed containing 72 tablets of hydrocodone/APAP 7.5/750mg.

(18)   Exhibit 8--Dispensing container with an Acme Pharmacy #59 dispensing label affixed containing 23 tablets of Lorazepam 1mg and one tablet of Cyclobenzaprine 10mg.

(19)   Exhibit 9--Dispensing container with an Acme Pharmacy #59 dispensing label affixed containing two tablets of Claritin-D.

(20)   Exhibit 10--Dispensing container with an Acme Pharmacy #59 dispensing label affixed containing nine tablets of Orphenadrine Citrate ER 100mg.

(21)   Exhibit 11--Dispensing container with an Acme Pharmacy #59 dispensing label affixed containing 10 tablets of hydrocodone/APAP 5/500mg.

(22)   Exhibit 12--Dispensing container with an Acme Pharmacy #59 dispensing label affixed containing 52 capsules of Fiorinal and Codeine 30mg.

(23)   Exhibit 13--One Acme Pharmacy prescription bag and pharmacy-type dispensing container with no dispensing label affixed containing 14 tablets of hydro-codone/APAP 7.5/750mg.

(24)   Exhibit 14--One pre-packed "Z-Pak" of Zithromax 250mg with two of the six tablets remaining.

(25)   Exhibit 15--One empty dispensing container with an Acme Pharmacy #59 dispensing label affixed with no Prescription Number listed.

(26)   Exhibits 16 through 16G--Prescriptions numbered 4444665, 6861131, 4446967, 4447116, 4447358, 4447429, 4447460, and 4447849.

(27)   Exhibit 17--Copy of two-page Medical Expenses report of James Skelton at Acme Pharmacy #59 covering January 1, 1997, through March 17, 2000.

(28)   Exhibit 18--Copy of Medical Expenses report of Charles Blair at Acme Pharmacy #59 covering November 1, 1997, through March 21, 2000.

(29)   Exhibit 19--Copy of Statement of Harry McDonnell, D.O. dated March 22, 2000.

(30)   Exhibit 20--Copy of Statement of Robert Bussan, M.D. dated March 23, 2000.

(31)   Exhibit 21--Copy of Pharmacy Daily Log Page Number 14097 for prescription tags dated January 2, 1999, through January 3, 1999.

(32)   Exhibit 22--Copy of Pharmacy Daily Log Page Number 18491 with prescription tags dated January 23, 1999, through January 26, 1999.

(33)   Exhibit 23--Copy of Pharmacy Daily Log Page Number 18445 with prescription tags dated December 30, 1999, through December 31, 1999.

(34)   Exhibit 24--Copy of Pharmacy Daily Log Page Number 18455 with prescription tags dated January 15, 2000, through January 17, 2000.

(35)   Exhibit 25--Copy of Pharmacy Daily Log Page Number 18464 with prescription tags dated January 29, 2000, through January 31, 2000.

(36)   Exhibit 26--Copy of Pharmacy Daily Log Page Number 15256 with prescription tags dated February 22, 2000, through February 23, 2000.

(37)   Exhibit 27--Copy of Pharmacy Daily Log Page Number 15258 with prescription tags dated February 25, 2000, through February 27, 2000.

(38)   Exhibit 28--Copy of Pharmacy Daily Log Page Number 15263 with prescription tags dated March 3, 2000, through March 5, 2000.

(39)   Exhibit 29--Copy of Pharmacy Daily Log Page Number 15267 with prescription tags dated March 7, 2000, through March 11, 2000.

(40)   Exhibit 30--Copy of Ohio State Board of Pharmacy Drug Audit Accountability Sheet of Acme #59 for Fastin 30mg dated April 17, 2000.

(41)   Exhibit 31--Copy of Ohio State Board of Pharmacy Drug Audit Accountability Sheet of Acme #59 for Phentermine 30mg dated April 17, 2000.

(42)   Exhibit 32--Copy of Ohio State Board of Pharmacy Drug Audit Accountability Sheet of Acme #59 for Adipex-P 37.5mg dated April 17, 2000.

(43)   Exhibit 33--Copy of Ohio State Board of Pharmacy Drug Audit Accountability Sheet of Acme #59 for Phentermine 37.5mg dated April 17, 2000.

(44)   Exhibit 34--Copy of Ohio State Board of Pharmacy Drug Audit Accountability Sheet of Acme #59 for Dexedrine Spansules 15mg dated April 17, 2000.

(45)   Exhibit 35--Copy of Ohio State Board of Pharmacy Drug Audit Accountability Sheet of Acme #59 for Vicodin 5/500mg dated April 17, 2000.

(46)   Exhibit 36--Copy of Ohio State Board of Pharmacy Drug Audit Accountability Sheet of Acme #59 for Hydrocodone/APAP 5/500mg dated April 17, 2000.

(47)   Exhibit 37--Copy of Ohio State Board of Pharmacy Drug Audit Accountability Sheet of Acme #59 for Lortab 10/500mg dated April 17, 2000.

(48)   Exhibit 38--Copy of Ohio State Board of Pharmacy Drug Audit Accountability Sheet of Acme #59 for Hydrocodone/APAP 10/500mg dated April 17, 2000.

(49)   Exhibit 39--Copy of Ohio State Board of Pharmacy Drug Audit Accountability Sheet of Acme #59 for Percocet 5/325mg dated April 17, 2000.

(50)   Exhibit 40--Copy of Ohio State Board of Pharmacy Drug Audit Accountability Sheet of Acme #59 for Endocet 5/325mg dated April 17, 2000.

(51)   Exhibit 41--Copy of Ohio State Board of Pharmacy Drug Audit Accountability Sheet of Acme #59 for Oxycodone/APAP 5/325mg dated April 17, 2000.

(52)   Exhibit 42--Copy of Ohio State Board of Pharmacy Drug Audit Accountability Sheet of Acme #59 for Vicodin ES 7.5/750mg dated April 17, 2000.

(53)   Exhibit 43--Copy of Ohio State Board of Pharmacy Drug Audit Accountability Sheet of Acme #59 for Hydrocodone/APAP 7.5/750mg dated April 17, 2000.

(54)   Exhibit 44--Copy of eight-page Indictment of Katherine Marie Blair, Case No. 2000CR0631, in the Stark County Common Pleas Court dated June 2, 2000.

(55)   Exhibit 45--Certified copies from the Stark County Court of Common Pleas of the following: Change of Plea In Open Court of Katherine Marie Blair, Case No. 00CR0631, dated July 10, 2000; two-page Judgment Entry, Change of Plea, and Pre-Sentence Investigation of Katherine Marie Blair, Case No. 2000CR0631, dated July 13, 2000; and six-page Plea of Guilty of Katherine Marie Blair, Case No. 2000CR0631, dated July 10, 2000.

(56)   Exhibit 46--Copy of six-page Judgment Entry and Sentence in the Stark County Common Pleas Court, Case No. 2000CR0631, State of Ohio vs. Katherine Blair, dated August 11, 2000.

(57)   Exhibit 47--Copy of letter from Joseph M. Lahovich dated April 21, 2000.

 

Respondent's Exhibits:

 

(1)     Exhibit A--Letter from Bernadette Charles dated December 4, 2000, with copies of 18 pages of drug test reports with specimen dates from May 2, 2000, through December 4, 2000.

(2)     Exhibit B--Copy of letter from Bernadette Charles dated July 6, 2000.

(3)     Exhibit C--Copy of two-page letter from Bernadette Charles dated July 5, 2000.

(4)     Exhibit D--Copy of letter from Bernadette Charles dated June 20, 2000.

(5)     Exhibit E--Copy of four-page Cumulative Subject Report of Quest Recovery Services for Katherine Blair dated December 5, 2000.

(6)     Exhibit F--Copy of letter from James Mallory dated July 12, 2000.

(7)     Exhibit G--Copy of two-page letter from Albert Weinstein dated December 4, 2000.

(8)     Exhibit H--Copy of Certificate of Participation in Continuing Pharmacy Education for P.R.O. Annual Conference-2000 of Katharine M. Blair dated May 21, 2000.

(9)     Exhibit I--Two-page copy of Pharmacists Rehabilitation Organization Pharma-cist's Recovery Contract of Katharine Blair dated November 20, 2000.

(10)   Exhibit J--Copy of Skyland Pines Inc. Statement of Earnings and Deductions of Katharine M. Blair for two-week pay period ending November 18, 2000.

(11)   Exhibit K--Copies of six AA Meetings Attendance Sheets and letter from Diane K. Moot dated December 10, 2000.

 

(1)     Records of the State Board of Pharmacy indicate that Katherine Marie Blair was originally licensed in the state of Ohio on June 23, 1987, pursuant to reciprocity, and on April 4, 2000, Katherine Marie Blair’s license was summarily suspended in accordance with Divisions (A) and (B) of Section 3719.121 of the Ohio Revised Code.

 

(2)     Katherine Marie Blair is addicted to liquor or drugs or impaired physically or mentally to such a degree as to render her unfit to practice pharmacy, to wit: Katherine Marie Blair admitted to an agent of the Board that she has a “serious addiction” to controlled substances; Katherine Marie Blair has been abusing drugs since the mid-1980’s; Katherine Marie Blair has abused approximately five tablets of hydrocodone products per day during the past two years, which has increased to approximately twenty tablets per day; and, Katherine Marie Blair has consumed drugs while practicing pharmacy.  During Katherine Marie Blair's own attempts to stop her abuse, Katherine Marie Blair admitted experiencing withdrawal symptoms.  Further, Katherine Marie Blair has admitted stealing the controlled substances she has abused, and Katherine Marie Blair voluntarily surrendered the following drugs from her purse that Katherine Marie Blair kept as a daily “stash”:

 

Drug

 

Quantity

Hydrocodone 7.5mg/APAP 750mg

 

20

Vicodin ES

 

2

Dexedrine 15mg

 

3

Phentermine 37.5mg

 

3

Methylphenidate ER 20mg

 

2

Lasix 40mg

 

1

Generic Deconamine SR

 

2

 

Such conduct indicates that Katherine Marie Blair falls within the ambit of Sections 3719.121 and 4729.16(A)(3) of the Ohio Revised Code.

 

(3)     Katherine Marie Blair did, from on or about March 9, 2000, through March 15, 2000, with purpose to deprive, knowingly obtain or exert control over controlled substances, the property of Acme Pharmacy #59, beyond the express or implied consent of the owner, to-wit: Katherine Marie Blair was observed and has admitted to stealing 36 unit doses of Vicodin ES and 123 unit doses of hydrocodone 7.5mg/APAP 750mg, Schedule III controlled substances, from her employer.  Such conduct is in violation of Section 2913.02 of the Ohio Revised Code.

 

(4)     Katherine Marie Blair did, from on or about August 17, 1998, through March 5, 2000, with purpose to deprive, knowingly obtain or exert control over dangerous drugs, the property of Acme Pharmacy #59, beyond the express or implied consent of the owner, to wit: Katherine Marie Blair was observed and has admitted to stealing the following dangerous drugs which were obtained from Katherine Marie Blair's residence:

 

Drug

 

Quantity

Lorazepam 1mg

 

23

Cyclobenzaprine 10mg

 

1

Claritin-D

 

2

Orphenadrine Citrate ER 100mg

 

9

Hydrocodone 5mg/APAP 500mg

 

10

Fiorinal & Codeine 30mg

 

52

Hydrocodone 7.5mg/APAP 750mg

 

14

Zithromax 250mg Z-Pak

 

1 pack containing 2 of 6

 

Such conduct is in violation of Section 2913.02 of the Ohio Revised Code.

 

(5)     Katherine Marie Blair did, on or about the following dates, knowingly affix a false or forged label to a package or receptacle containing dangerous drugs when the conduct was not in accordance with Chapters 3719. and 4729. of the Ohio Revised Code, to wit: when stealing drugs, Katherine Marie Blair created the following false labels and placed them on prescription drug vials:

 

Rx No.

 

Date

 

Drug

Quantity

4447857

 

03-10-00

 

Hydrocodone 7.5mg/APAP 750mg

120

none

 

08-14-99

 

Claritin-D 12 hour tabs

30

6879149

 

01-18-00

 

Claritin-D 10/240

14

6854382

 

08-17-98

 

Norflex 100mg tabs

30

4447854

 

02-15-00

 

Hydrocodone 5mg/APAP 500mg

20

 

Such conduct is in violation of Section 2925.23(D) of the Ohio Revised Code.

 

(6)     Katherine Marie Blair did, on or about December 30, 1998, through February 14, 2000, intentionally make, utter, or sell, or knowingly possess false or forged prescriptions, to wit: when stealing drugs and/or trafficking in drugs, Katherine Marie Blair created the following prescriptions to cover for her theft of drugs:

 

Rx No.

 

Date

 

Drug

Quantity.

4444665

 

12/30/98

 

Propoxyphene 100mg/APAP 650mg

20

6861131

 

12/30/98

 

Daypro 600mg

10

4446977

 

10/19/99

 

Hydrocodone 7.5mg/APAP 750mg

50

4447116

 

11/08/99

 

Hydrocodone 7.5mg/APAP 750mg

50

4447358

 

12/10/99

 

Hydrocodone 7.5mg/APAP 750mg

50

4447429

 

12/18/99

 

Hydrocodone 7.5mg/APAP 750mg

50

4447460

 

12/21/99

 

Hydrocodone 10mg/APAP 500mg

50

4447849

 

02/14/00

 

Hydrocodone 10mg/APAP 500mg

50

 

Such conduct is in violation of Section 2925.23(B) of the Ohio Revised Code.

 

(7)     Katherine Marie Blair did, from on or about January 3, 1999, through March 10, 2000, knowingly make a false statement in a prescription order, report, or record required by Chapter 3719. or 4729. of the Revised Code, to wit: when stealing drugs and/or trafficking in drugs, Katherine Marie Blair created the following prescription refills and maintained them on file at Acme Pharmacy #59 to cover for her theft of drugs:

 

Rx No.

 

Date

 

Drug

Quantity

4444665

 

01/03/99

 

Propoxyphene 100mg/APAP 650mg

20

6861131

 

01/03/99

 

Daypro 600mg

10

6861131

 

01/25/99

 

Daypro 600mg

10

4447460

 

12/31/99

 

Hydrocodone 10mg/APAP 500mg

50

4447460

 

01/16/00

 

Hydrocodone 10mg/APAP 500mg

50

4447460

 

01/29/00

 

Hydrocodone 10mg/APAP 500mg

50

4447849

 

02/22/00

 

Hydrocodone 10mg/APAP 500mg

50

4447849

 

02/26/00

 

Hydrocodone 10mg/APAP 500mg

50

4447849

 

03/03/00

 

Hydrocodone 10mg/APAP 500mg

50

4447849

 

03/10/00

 

Hydrocodone 10mg/APAP 500mg

50

 

Such conduct is in violation of Section 2925.23(A) of the Ohio Revised Code.

 

(8)     Katherine Marie Blair did, from on or about October 19, 1999, through December 18, 1999, knowingly sell a controlled substance in an amount exceeding five times the bulk amount but does not exceed fifty times the bulk amount when not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: Katherine Marie Blair sold the following Schedule III controlled substances pursuant to prescriptions which were not written by a licensed health professional authorized to prescribe drugs:

 

Rx No.

 

Date

 

Drug

 

Quantity

4446977

 

10/19/99

 

Hydrocodone 7.5mg/APAP 750mg

 

50

4447116

 

11/08/99

 

Hydrocodone 7.5mg/APAP 750mg

 

50

4447358

 

12/10/99

 

Hydrocodone 7.5mg/APAP 750mg

 

50

4447429

 

12/18/99

 

Hydrocodone 7.5mg/APAP 750mg

 

50

 

Such conduct is in violation of Section 2925.03(A) of the Ohio Revised Code.

 

(9)     Katherine Marie Blair did, on or about December 21, 1999, through March 10, 2000, knowingly sell a controlled substance in an amount exceeding five times the bulk amount but does not exceed fifty times the bulk amount when not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: Katherine Marie Blair sold the following Schedule III controlled substances pursuant to prescriptions which were not written by a licensed health professional authorized to prescribe drugs:

 

Rx No.

 

Date

 

Drug

 

Quantity

4447460

 

12/21/99

 

Hydrocodone 10mg/APAP 500mg

 

50

4447460

 

12/31/99

 

Hydrocodone 10mg/APAP 500mg

 

50

4447460

 

01/16/00

 

Hydrocodone 10mg/APAP 500mg

 

50

4447460

 

01/29/00

 

Hydrocodone 10mg/APAP 500mg

 

50

4447849

 

02/14/00

 

Hydrocodone 10mg/APAP 500mg

 

50

4447849

 

02/22/00

 

Hydrocodone 10mg/APAP 500mg

 

50

4447849

 

02/26/00

 

Hydrocodone 10mg/APAP 500mg

 

50

4447849

 

03/03/00

 

Hydrocodone 10mg/APAP 500mg

 

50

4447849

 

03/10/00

 

Hydrocodone 10mg/APAP 500mg

 

50

 

Such conduct is in violation of Section 2925.03(A) of the Ohio Revised Code.

 

(10)   Katherine Marie Blair did, on or about December 30, 1998, and again on or about January 3, 1999, knowingly sell a controlled substance in an amount exceeding the bulk amount but does not exceed five times the bulk amount when not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: on each occasion Katherine Marie Blair sold 20 unit doses of Propoxyphene 100mg/APAP 650mg, a Schedule III controlled substance, pursuant to prescription number 4444665 which was not written by a licensed health professional authorized to prescribe drugs.  Such conduct is in violation of Section 2925.03(A) of the Ohio Revised Code.

 

(11)   Katherine Marie Blair did, on or about the following dates, sell at retail danger-ous drugs, to wit: on each occasion Katherine Marie Blair created prescriptions and/or sold dangerous drugs which were not written by a licensed health professional authorized to prescribe drugs.

 

Rx No.

 

Date

 

Drug

 

Quantity

6861131

 

12/30/98

 

Daypro 600mg

 

10

6861131

 

01/03/99

 

Daypro 600mg

 

10

6861131

 

01/25/99

 

Daypro 600mg

 

10

 

Such conduct is in violation of Section 4729.51(C)(1) of the Ohio Revised Code.

 

(12)   Katherine Marie Blair did, from on or about July 5, 1998, through March 17, 2000, with purpose to deprive, knowingly obtain or exert control over controlled substances, the property of Acme Pharmacy #59, beyond the express or implied consent of the owner, to wit: Katherine Marie Blair stole the following controlled substances from her employer:

 

Drug

 

Quantity

Phentermine 30mg capsules

 

22

Phentermine 37.5mg tablets

 

161

Dexedrine 15mg capsules

 

165

hydrocodone 5mg/APAP 500mg tablets

 

1,635

hydrocodone 10mg/APAP 500mg tablets

 

1,854

oxycodone 5.325mg/APAP tablets

 

3,787

hydrocodone 7.5mg/APAP 750mg tablets

 

10,651

 

Such conduct is in violation of Section 2913.02 of the Ohio Revised Code.

 

(13)   Katherine Marie Blair did, from on or about July 5, 1998, through March 17, 2000, knowingly sell a controlled substance in an amount exceeding five times the bulk amount but does not exceed fifty times the bulk amount when not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: Katherine Marie Blair supplied Patient (A), a family member, with 161 unit doses of Phentermine 37.5mg tablets, a Schedule IV controlled substance, without authorization from a licensed health professional authorized to prescribe drugs and without a legitimate medical purpose.  Such conduct is in violation of Section 2925.03(A) of the Ohio Revised Code.

 

(14)   Katherine Marie Blair did, from on or about July 5, 1998, through March 17, 2000, knowingly sell a controlled substance in an amount exceeding five times the bulk amount but does not exceed fifty times the bulk amount when not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: Katherine Marie Blair supplied Patient (A), a family member, with 165 unit doses of Dexedrine 15mg capsules, a Schedule II controlled substance without authorization from a licensed health professional authorized to prescribe drugs and without a legitimate medical purpose.  Such conduct is in violation of Section 2925.03(A) of the Ohio Revised Code.

 

(15)   Katherine Marie Blair did, from on or about July 5, 1998, through March 17, 2000, knowingly sell a controlled substance in an amount exceeding fifty times the bulk amount when not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: Katherine Marie Blair supplied Patient (B) with 1,854 unit doses of hydrocodone 10mg/APAP 500mg tablets, a Schedule III controlled substance, without authorization from a licensed health professional authorized to prescribe drugs and without a legitimate medical purpose.  Such conduct is in violation of Section 2925.03(A) of the Ohio Revised Code.

 

(16)   Katherine Marie Blair did, from on or about July 5, 1998, through March 17, 2000, knowingly sell a controlled substance in an amount exceeding one hundred times the bulk amount and when not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: Katherine Marie Blair supplied Patient (B) with 3,787 unit doses of oxycodone 5mg/APAP 325mg tablets, a Schedule II controlled substance, without authorization from a licensed health professional authorized to prescribe drugs and without a legitimate medical purpose.  Such conduct is in violation of Section 2925.03(A) of the Ohio Revised Code.

 

(1)     Upon consideration of the record as a whole, the State Board of Pharmacy concludes that paragraphs (3) through (10) and (12) through (16) of the Findings of Fact constitutes being guilty of a felony and gross immorality as provided in Division (A)(1) of Section 4729.16 of the Ohio Revised Code.

 

(2)     Upon consideration of the record as a whole, the State Board of Pharmacy concludes that paragraphs (3) through (16) of the Findings of Fact constitute being guilty of dishonesty and unprofessional conduct in the practice of pharmacy as provided in Division (A)(2) of Section 4729.16 of the Ohio Revised Code.

 

(3)     Upon consideration of the record as a whole, the State Board of Pharmacy concludes that paragraph (2) of the Findings of Fact constitutes being addicted to or abusing liquor or drugs or impaired physically or mentally to such a degree as to render her unfit to practice pharmacy as provided in Division (A)(3) of Section 4729.16 of the Ohio Revised Code.

 

(4)     Upon consideration of the record as a whole, the State Board of Pharmacy concludes that paragraphs (5) through (11) and (13) through (16) of the Findings of Fact constitute being guilty of willfully violating, conspiring to violate, attempting to violate, or aiding and abetting the violation of provisions of Chapter 2925., 3719., or 4729. of the Revised Code as provided in Division (A)(5) of Section 4729.16 of the Ohio Revised Code.

 

(A)     On the basis of the Findings of Fact and paragraph (1) of the Conclusions of Law set forth above, the State Board of Pharmacy hereby revokes the pharma-cist identification card, No. 03-2-16954, held by Katherine Marie Blair effective as of the date of the mailing of this Order.

 

(B)     On the basis of the Findings of Fact and paragraph (2) of the Conclusions of Law set forth above, the State Board of Pharmacy hereby revokes the pharmacist identification card, No. 03-2-16954, held by Katherine Marie Blair effective as of the date of the mailing of this Order.

 

(C)     On the basis of the Findings of Fact and paragraph (3) of the Conclusions of Law set forth above, the State Board of Pharmacy hereby revokes the pharma-cist identification card, No. 03-2-16954, held by Katherine Marie Blair effective as of the date of the mailing of this Order.

 

(D)     On the basis of the Findings of Fact and paragraph (4) of the Conclusions of Law set forth above, the State Board of Pharmacy hereby revokes the pharma-cist identification card, No. 03-2-16954, held by Katherine Marie Blair effective as of the date of the mailing of this Order.

 

 

The motion was seconded by Ms. Abele and approved by the Board (Aye-5/Nay-4).

  4:56 p.m.

Mrs. Adelman moved that the minutes of the November 6, 7, 8, 2000 Board meeting be approved as amended.  The motion was seconded by Mr. Littlejohn and approved by the Board (Aye-7/Nay-0/Abstain-1[Abele]).

  5:10 p.m.

RES. 2001-080  Mr. Winsley presented requests from James H. Wise, R.Ph. and John Castanza, R.Ph. that, due to the length of time they have been absent from any state in which they hold a current pharmacist license, they be allowed to have the moral character vouchers on their reciprocity applications signed by pharmacists in Ohio who are familiar with them rather than being held to the requirement on the application that the voucher be signed by a pharmacist from a state in which they are currently licensed.  After discussion of this issue, Mr. Turner moved that these applicants’ requests be approved by the Board.  The motion was seconded by Mrs. Teater and approved by the Board (Aye-8/Nay-0).

  5:15 p.m.

RES. 2001-081  After discussion by the Board members regarding the need for a special rules committee to deal with the requirements of S.B. 248 which was awaiting the Governor’s signature, the following individuals were appointed by the Board to an Ad Hoc Committee on Medication Administration by Pharmacists:

 

James Turner R.Ph. (Chair) and Diane Adelman, R.Ph., Board Members; Marialice Bennett, R.Ph., Don Bennett, R.Ph., Max Peoples, R.Ph., Philip Black, R.Ph., Gayle Kamm, Pharm.D., and Lee Savino, Pharm.D.

 

In addition, Board staff was instructed to invite the participation of physicians and nurses on the committee by seeking recommendations from the appropriate licensing boards and professional societies.

  5:22 p.m.

The Board meeting recessed until Tuesday, December 12, 2000.

 

 

tuesday, december 12, 2000

 

  8:45 a.m.     ROLL CALL

 

The State Board of Pharmacy convened in Room 1948, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with the following members present:

 

Suzanne L. Neuber, R.Ph. (President); Diane C. Adelman, R.Ph. (Vice-President); Ann D. Abele, R.Ph.; Suzanne R. Eastman, R.Ph.; Robert P. Giacalone, R.Ph.; Lawrence J. Kost, R.Ph.; Amonte B. Littlejohn, R.Ph.; Dorothy Teater, Public Member; and James E. Turner, R.Ph.

  8:50 a.m.

The Board reviewed a report of those pharmacists who have held an active Ohio Pharmacist license for fifty years.  The Board directed staff to publish the following names of the pharmacists receiving Certificates of Appreciation for their service to the public in the Minutes:

 

CHARLES W. AGUE

J. LYNN ANDERSON

GEORGE A. ANDROS

JULIUS  BARRON

BENTON J. BERNSTECKER

JAMES D. BLACK

JOSEPH W. BLUMENTHAL

JOHN L. BOGGS

DONALD P. BOOKATZ

BERNICE  BUETTNER

PATRICIA A. BURNS

HAROLD B. BUSHMAN

EVERETT L. DANIELS

WILLIAM S. DERRY

ROBERT J. DEWEES

NORMAN I. DOUGLASS

STEPHEN  DUBOS

DONALD C. DUGAN

GOODWIN W. DUNCAN

JOHN A. DZIECH

IRVING S. FEUER

PETER WAYNE FOX

CARA LOU FREY

HARRY  FRIEDMAN

MELVILLE S. FRYER

JOE H. HALL

JOHN R. HECK

RALPH C. HEUERMAN

CHARLES R. HOUSER

JOAN DIPANGRAZ JACOBS

EDYTHE R. JAFFEE

GILBERT  KIRSCHENBAUM

ERNEST J. LAMATRICE

KARL F. LEUPOLD

JOHN W. LYNN

JAY J. MARK

WILLIAM D. MARTINEAU

MATTHEW R. MATTMULLER

THOMAS C. McCABE

JOSEPH  NICHOL

RICHARD L. NIST

ALFRED G. PENNONI

DON E. REPP

ROBERT W. REYNOLDS

JULIOUS E. ROLLERSON

JERRY H. RYMER

RUDOLPH  SCHOR

ISADORE A. SCHWARTZ

JOHN P. SEVASTOS

NATHAN  SHAGRIN

MARVIN W. SNYDER

YVONNE L. SNYDER

JOHN RAYMOND SPECKER

ROBERT L. STAHLER

EILEEN H. STRASBAUGH

ROSE MARIE THOMPSON

WILLIAM L. THOMPSON

RAY H. VAUGHN

GARCON  WEISS

ROBERT M. WHITAKER

ALDA W. WRIGHT

JACQUELINE  YOUNG

STANLEY S. ZEIDMAN

JOSEPH J. ZUPIC

  8:55 a.m.

The Board was joined by Assistant Attorney General Sally Ann Steuk for the purpose of conducting an adjudication hearing in accordance with Ohio Revised Code Chapters 119. and 4729. in the matter of John Paul Tekulve, R.Ph., Columbus.

  9:50 a.m.

RES. 2001-082  The hearing was terminated and the record was closed.  Mr. Tekulve was notified by the Board that he did not have sufficient material to proceed with his reinstatement petition and that he would receive a letter from the Board defining the steps he would need to follow before being able to proceed further.  The Board took a brief recess.

10:07 a.m.

The Board discussed the DEA draft proposal regarding controlled substances in long-term-care facilities.  Board staff was instructed to prepare a draft response to be distri-buted to Board members for their review.

10:26 a.m.

Mr. Kost reported on the activities of the Nursing Board’s Committee on Prescriptive Governance.  Mr. Benedict reported on his recent meeting with the Medical Board’s Prescribing Committee.  There were no items in either report requiring official action by the Board.

10:32 a.m.

RES. 2001-083  Mr. Kost then moved that the Board approve the following as an Approved Provider of Continuing Pharmacy Education:

 

AdvancePCS, Inc. (Ohio); Powell, Ohio

 

The motion was seconded by Mr. Turner and approved by the Board (Aye-8/Nay-0).

10:37 a.m.

The Board was joined by Mark Keeley, Legislative Affairs Administrator, who discussed the legislative report with the Board.

11:00 a.m.

RES. 2001-084  The Board discussed the prescription scanning program presented by Merck-Medco during Monday’s meeting.  The consensus of the members was that this program would be approvable subject to a satisfactory final inspection by Board staff.

11:02 a.m.

The Board meeting recessed for lunch.

12:39 p.m.

The meeting reconvened in Room 1914, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio, with all members present except Mrs. Teater.

12:44 p.m.

RES. 2001-085  After discussion, Ms. Abele moved that a letter regarding reinstatement be sent to John Paul Tekulve, R.Ph. pursuant to the adjudication hearing on Monday that was terminated due to his lack of compliance with his previous Board Order.  The letter is to state that eighteen months continuous compliance with the Board's Order are required before proceeding with a new hearing.  Further, that as of his hearing date, the Board determined that he had only met ten months of continuous compliance.  The motion was seconded by Mr. Littlejohn and approved by the Board (Aye-7/Nay-0).

12:46 p.m.

The members held a brief discussion regarding the stocking of the computerized floor stock machines being used in hospitals and long-term-care facilities.  The discussion was tabled until a later date to allow the Board’s office staff to gather more information.

  1:00 p.m.

The Board then moved the meeting to Room 1919, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio, for the purpose of meeting with the candidates for licensure by reciprocity.

 

RES. 2001-086  Following presentations by Board members and self-introductions by the candidates for licensure by reciprocity, Ms. Eastman moved that the Board approve the following candidates for licensure.  The motion was seconded by Mrs. Adelman and approved by the Board (Aye-7/Nay-0).

 

JASON RYAN FRANCISCO

03-1-24461

WEST VIRGINIA

TRISHA SUE HARTMAN

03-1-24448

NEW HAMPSHIRE

MARK DOUGLAS MCGRANAHAN

03-1-24466

INDIANA

CANDI DEE NICHTER

03-1-24455

MICHIGAN

MARK JOHN OBUHANYCH

03-1-24462

MASSACHUSETTS

HERCHEL PORTMAN

03-1-24439

ILLINOIS

JULI MARIE RICHTER

03-1-24451

GEORGIA

  1:21 p.m.

Mr. Turner left the meeting for personal reasons.

  1:51 p.m.

The Board was joined by Assistant Attorney General Sally Ann Steuk for the purpose of conducting an adjudication hearing in accordance with Ohio Revised Code Chapters 119. and 4729. in the matter of Parmjit Kaur Rai, Pharmacy Intern, Valleyview.

  5:23 p.m.

The hearing ended and the record was closed.

  5:26 p.m.

Ms. Abele moved that the Board go into Executive Session for the purpose of the investigation of complaints regarding licensees and registrants pursuant to Section 121.22(G)(1) of the Revised Code.  The motion was seconded by Mr. Littlejohn and a roll call vote was conducted by President Neuber as follows: Abele-Yes, Adelman-Yes, Eastman-Yes, Giacalone-Yes, Kost-Yes, and Littlejohn-Yes.

  5:50 p.m.

RES. 2001-087  The Executive Session ended and the meeting was opened to the public.  Ms. Eastman moved that the Board adopt the following Order in the matter of Parmjit Kaur Rai, Pharmacy Intern:

 

(A)     Testimony

 

State's Witnesses:

 

(1)     Joann Predina, R.Ph., Ohio State Board of Pharmacy

(2)     Lori Indriolo

 

Respondent's Witnesses:

 

(1)     Parmjit Kaur Rai, Respondent

 

(B)     Exhibits

 

State's Exhibits:

 

(1)     Exhibit 1--Copy of three-page Notice of Opportunity for Hearing letter dated August 25, 2000.

(2)     Exhibit 1A--Hearing Request letter dated September 5, 2000.

(3)     Exhibit 1B--Copy of Hearing Schedule letter dated September 8, 2000.

(4)     Exhibit 2--Certified copy of Indictment, Hardin County Common Pleas Court, of Parmjit K. Rai dated January 20, 2000.

(5)     Exhibit 3--Certified copy of three-page Entry in the Hardin County Common Pleas Court, Case No. 20002006-CRI, of Parmjit K. Rai dated April 18, 2000.

(6)     Exhibit 4--Certified copy of two-page Withdrawal of Former Plea of Not Guilty and Written Plea of Guilty in the Hardin County Common Pleas Court, Case No. 20002006-CRI, of Parmjit K. Rai dated April 17, 2000.

(7)     Exhibit 5--Copy of Ada Police Department Offense Report of Victim Julie Riley, Report No. 1032-99, dated December 9, 1999, with the following attachments: five narrative reports by Ptl. Scott Holbrook of the Ada Police Department dated December 9, 1999 (two pages), December 15, 1999, January 2, 2000, January 4, 2000 (three pages), and January 24, 2000.

(8)     Exhibit 6--Copy of Statement of Account, No. 237294, at the First National Bank of Dennison of Julia A. Riley for the period of November 11, 1999, through December 12, 1999.

(9)     Exhibit 7--Copy of three-page Ada Police Department Witness Statement Under Oath of Julie Riley dated December 11, 1999.

(10)   Exhibit 8--Copy of four-page Ada Police Department Witness Statement Under Oath of Parmjit Rai dated January 4, 2000.

(11)   Exhibit 9--Copy of two-page Ada Police Department Witness Statement Under Oath of Stephanie Elder dated December 11, 1999.

(12)   Exhibit 10--Copy of letter from Rhonda K. Eck dated May 31, 2000.

(13)   Exhibit 11--Statement of Parmjit Rai dated June 5, 2000.

(14)   Exhibit 12--Five-page Statement of Howard Quincy Miller dated August 3, 2000, and copy of SNPhA & Habitat for Humanity Care Raffle time schedule covering April 24 through April 29, and Hardin Co. Community Corrections Time sheet of Parmjit K. Rai covering April 24, 2000, through May 3, 2000, signed by Howard "Quincy" Miller and dated May 4, 2000.

(15)   Exhibit 13--Copy of Hardin Co. Community Corrections Time sheet of Parmjit K. Rai covering April 24, 2000, through May 3, 2000, signed by Howard "Quincy" Miller and dated May 4, 2000., and copy of SNPhA & Habitat for Humanity Care Raffle time schedule covering April 24 through April 29.

(16)   Exhibit 14--Letter from Raymond J. Marvar dated November 30, 2000.

(17)   Exhibit 15--Letter from Lori M. Rose dated November 21, 2000.

(18)   Exhibit 16--Five-page letter from Lori Indriolo, not dated.

(19)   Exhibit 17--Memo from Karen L. Kier dated December 8, 2000, with copies of three e-mails between Parmjit Rai and Karen Kier dated November 4, 2000, November 20, 2000, and November 21, 2000.

(20)   Exhibit 18--Six-page statement of Julia A. Riley signed and notarized on November 27, 2000.

 

Respondent's Exhibits:

 

(1)     Exhibit A--Dean's List Certificate of Parmjit Rai dated November 28, 2000.

(2)     Exhibit B--Letter from Joan Amberik dated December 11, 2000.

(3)     Exhibit C--Letter from Noreen A. Wilson dated November 20, 2000.

(4)     Exhibit D--Letter from Larry Fligor dated November 24, 2000.

(5)     Exhibit E--Letter from Traci Bryant Adkins dated November 14, 2000.

(6)     Exhibit F--Letter from Lori M. Rose dated November 20, 2000.

(7)     Exhibit G--Copy of Entry, Case No. 20002006 CRI, in the Hardin County Common Pleas Court, of Parmjit K. Rai dated October 25, 2000.

(8)     Exhibit H--Letter from Tina M. Jacobs dated October 3, 2000.

 

(1)     Records of the State Board of Pharmacy indicate that Parmjit Kaur Rai was originally licensed to practice pharmacy as an intern in the state of Ohio on March 6, 1997, and Parmjit Kaur Rai is currently licensed to practice pharmacy as an intern.

 

(2)     Parmjit Kaur Rai did, on or about October 15, 1999, receive, retain, or dispose of property of another, knowing or having reasonable cause to believe it had been obtained through the commission of a theft offense, to wit: Parmjit Kaur Rai retained a stolen credit card.  Such conduct is in violation of Section 2913.51 of the Ohio Revised Code.

 

(3)     Parmjit Kaur Rai did, from October 15, 1999, through November 19, 1999, with purpose to deprive, knowingly obtain or exert control over the property of another without consent, to wit: Parmjit Kaur Rai used a stolen credit card at ATM machines to withdraw $84.00 in cash belonging to another without consent.  Such conduct is in violation of Section 2913.02 of the Ohio Revised Code.

 

(4)     Parmjit Kaur Rai was, on or about April 17, 2000, convicted of Misuse of Credit Cards in violation of Section 2913.21 of the Ohio Revised Code, a misdemeanor of the first degree.  State v Rai, Case No. 20002006-CRI, Hardin County Common Pleas Court.  Parmjit Kaur Rai was sentenced to one year of probation, fined $250.00, and sentenced to perform 40 hours of community service.

 

(1)     Upon consideration of the record as a whole, the State Board of Pharmacy concludes that paragraphs (2) through (4) of the Findings of Fact constitute being guilty of gross immorality as provided in Division (A)(1) of Section 4729.16 of the Ohio Revised Code.

 

 

The motion was seconded by Ms. Abele and approved by the Board (Aye-4/Nay-2).

 

RES. 2001-088  Ms. Abele then moved that Ms. Rai be notified of this action prior to the January, 2001 Board meeting.  The motion was seconded by Mr. Littlejohn and approved by the Board (Aye-6/Nay-0).

  5:55 p.m.

The Board recessed until Wednesday, December 13, 2000.

 

 

wednesday, december 13, 2000

 

  8:20 a.m.     ROLL CALL

 

The State Board of Pharmacy convened in Room 1914, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with the following members present:

 

Suzanne L. Neuber, R.Ph. (President); Diane C. Adelman, R.Ph. (Vice-President); Suzanne R. Eastman, R.Ph.; Robert P. Giacalone, R.Ph.; Lawrence J. Kost, R.Ph.; Amonte B. Littlejohn, R.Ph.; and Dorothy Teater, Public Member.

  8:23 a.m.

The Board was joined by Assistant Attorney General Sally Ann Steuk for the purpose of continuing the adjudication hearing from the November, 2000 meeting being held in accordance with Ohio Revised Code Chapters 119. and 4729. in the matters of Scarbrough’s Medical Arts Pharmacy, T.D., Findlay; Stanley Shaw Scarbrough, R.Ph., Findlay; and Sue G. Gratz, R.Ph., Pandora.

11:23 a.m.

The hearing recessed for lunch.

12:36 p.m.

The Board reconvened in Room 1914, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio to continue the hearing in the matters of Scarbrough’s Medical Arts Pharmacy, T.D.; Stanley Shaw Scarbrough, R.Ph.; and Sue G. Gratz, R.Ph.

  7:18 p.m.

The hearing ended and the record was closed.  Mrs. Teater moved that the Board go into Executive Session for the purpose of the investigation of complaints regarding licensees and registrants pursuant to Section 121.22(G)(1) of the Revised Code.  The motion was seconded by Mrs. Adelman and a roll call vote was conducted by President Neuber as follows: Adelman-Yes, Eastman-Yes, Giacalone-Yes, Kost-Yes, Littlejohn-Yes, and Teater-Yes.

  8:47 p.m.

RES. 2001-089  The Executive Session ended and the meeting was opened to the public.  Mr. Giacalone moved that the Board adopt the following Order in the matter of Sue G. Gratz, R.Ph.:

 

(A)     Testimony

 

State's Witnesses:

 

(1)     Mark Keeley, R.Ph., Ohio State Board of Pharmacy

 

Respondent's Witnesses:

 

(1)     Stanley Shaw Scarbrough, R.Ph.

(2)     Sue G. Gratz, R.Ph., Respondent

(3)     Alan Spreen, M.D.

 

(B)     Exhibits

 

State's Exhibits:

 

(1)       Exhibit 1--Copy of nineteen-page Notice of Opportunity for Hearing letter of Stanley Shaw Scarbrough dated May 31, 2000.

(2)       Exhibit 1A--Copy of fourteen-page Notice of Opportunity for Hearing letter of Sue G. Gratz dated May 31, 2000.

(3)       Exhibit 1B--Copy of eighteen-page Notice of Opportunity for Hearing letter of Scarbroughs Medical Arts Pharmacy dated May 31, 2000.

(4)       Exhibit 1C--Hearing Request letter of Stanley Shaw Scarbrough dated June 28, 2000.

(5)       Exhibit 1D--Hearing Request letter of Sue G. Gratz dated June 28, 2000.

(6)       Exhibit 1E--Hearing Request letter of Scarbroughs Medical Arts Pharmacy dated June 28, 2000.

(7)       Exhibit 1F--Copy of Hearing Schedule letter of Scarbrough's Medical Arts Pharmacy, Stanley Shaw Scarbrough, and Sue G. Gratz dated June 30, 2000.

(8)       Exhibit 1G--Copy of Pharmacist File Front Sheet of Stanley Shaw Scarbrough showing original date of registration as May 4, 1979; and two-page copy of Renewal Application for Pharmacist License, No. 03-2-12847, for a license to practice pharmacy in Ohio from September 15, 2000, through September 15, 2001, signed and dated June 27, 2000.

(9)       Exhibit 1H--Copy of Pharmacist File Front Sheet of Sue G. Gratz showing original date of registration as August 8, 1960; and two-page copy of Renewal Application for Pharmacist License, No. 03-3-07246, for a license to practice pharmacy in Ohio from September 15, 2000, through September 15, 2001, signed and dated July 28, 2000.

(10)     Exhibit 1I--Copy of Renewal Application for DDD License No. 02-0114850 for a Terminal Distributor of Dangerous Drugs license from January 1, 2000, through December 31, 2000, signed by Stan Scarbrough and dated September 9, 1999.

(11)     Exhibit 1J--Copy of two-page letter from James F. Flynn dated October 6, 2000.

(12)     Exhibit 1K--Copy of letter from David L. Rowland to James F. Flynn dated October 6, 2000.

(13)     Exhibit 1L--Two-page Request for Continuance letter from James F. Flynn dated November 2, 2000.

(14)     Exhibit 1M--Copy of Continuance Request Response letter dated November 6, 2000.

(15)     Exhibit 1N--Copy of Hearing Schedule letter dated November 9, 2000.

(16)     Exhibit 1O--Copy of Hearing Schedule letter dated November 15, 2000.

(17)     Exhibit 2--Copy of four-page Dangerous Drug Distributor Inspection Report of Scarbroughs Medical Arts Pharmacy, Terminal Distributor No. 02-0114850, dated March 26, 1997; and copy of response to inspection report violations signed by Stan Scarbrough, received in the Board office on March 31, 1997.

(18)     Exhibit 2A--Copy of eight-page Dangerous Drug Distributor Inspection Report of Scarbroughs Medical Arts Pharmacy, Terminal Distributor No. 02-0114850, dated April 22, 1997; and copy of response to inspection report violations signed by Stan Scarbrough, not dated.

(19)     Exhibit 2B--Copy of five-page Dangerous Drug Distributor Inspection Report of Scarbroughs Medical Arts Pharmacy, Terminal Distributor No. 02-0114850, dated May 4, 1998; and copy of three-page response to inspection report violations signed by Stan Scarbrough, dated May 20, 1998.

(20)     Exhibit 3--Copy of FDA forms FDA 481(E)-CG, FDA 481(A)-CG, and FDA 481(C)-CG completed during limited inspection at Scarbrough Medical Arts Pharmacy on April 22-29, 1997, FDA Central File No. 1528698; and copy of ten-page Summary of Findings (EI: 4/22-29/97 MPS) signed by Michael P. Sheehan, not dated.

(21)     Exhibit 3A--Copy of FDA forms FDA 481(E)-CG, FDA 481(A)-CG, and FDA 481(C)-CG completed during limited inspection at Scarbrough Medical Arts Pharmacy on July 8, 9, 1997, FDA Central File No. 1530500; and copy of seventeen-page Summary of Findings (EI: 7/8-9/97 MPS) signed by Michael P. Sheehan, not dated.

(22)     Exhibit 3B--Copy of two-page Response letter for July 8, 9, 1997 inspection results from Stan Scarbrough dated July 22, 1997.

(23)     Exhibit 3C--Copy of two-page FDA Memorandum (Re: Scarbrough Pharmacy's Response Letter to July, 1997 EI) dated August 5, 1997.

(24)     Exhibit 3D--Copy of Collection Report (Form FDA 464) and C/R Continuation Sheet (Form FDA 464a) for Sample No. 97-740-762, collected July 9, 1997, Central File No. 1530500, with the following attachments: copy of two-page e-mail regarding Non-Traditional Drug Bulletin #21 dated June 27, 1997; copy of two-page Warning Letter Draft, not dated.

(25)     Exhibit 4--Letter from Fred L. Dailey, Director of the Ohio Department of Agriculture, dated June 27, 2000.

(26)     Exhibit 5--Two-page letter from Bruce A. Bouts, M.D. signed and dated May 11, 1998, and re-signed and notarized on May 17, 2000.

(27)     Exhibit 5A--Two-page letter from Gary E. Hirschfield, M.D. signed and dated May 27, 1998, and re-signed and notarized on May 17, 2000.

(28)     Exhibit 5B--Letter from Rick D. Watson, M.D. signed and dated May 21, 1998, and re-signed and notarized on May 17, 2000.

(29)     Exhibit 5C--Letter from William H. Kose, M.D. signed and dated May 6, 1998, and re-signed and notarized on May 17, 2000.

(30)     Exhibit 5D--Letter from Sue Best and Seth Brownlee signed and dated July 10, 1997, and re-signed and notarized March 3, 2000.

(31)     Exhibit 5E--Statement of Heather Zehender signed and notarized April 11, 2000.

(32)     Exhibit 5G--Twenty-five-page transcript of interview with Jill Waldron and Heather Zehender by Compliance Agent Dale Fritz and Compliance Specialist Mark Keeley held on March 6, 2000.

(33)     Exhibit 5I--Seventy-six-page transcript of Tape #4-Interview with Stan Scarbrough  by Compliance Specialists Mark Keeley and Joann Predina and Compliance Agent Dale Fritz held on May 4, 1998.

(34)     Exhibit 6--Prescription vial containing 120 capsules of Enalapril 2.5mg.

(35)     Exhibit 7--Copy of Compounding Log for Enalapril 2.5mg capsules, Scarbrough Pharmacy Compound No. 167.

(36)     Exhibit 8--Prescription vial containing 30 capsules of Fenfluramine 20mg.

(37)     Exhibit 9--Copy of Compounding Log for Fenfluramine 20mg capsules, Scarbrough Pharmacy Compound No. 519.

(38)     Exhibit 10--Amber bottle labeled "Stock" containing 170ml of Hydrocortisone Lotion 2.5%.

(39)     Exhibit 11--Copy of Compounding Log for Hydrocortisone Lotion 2.5%, Scarbrough Pharmacy Compound No. 249.

(40)     Exhibit 12--Prescription vial containing 190 capsules of 5-Hydroxytryptophan 50mg.

(41)     Exhibit 13--Copy of Compounding Log for 5-Hydroxytryptophan 50mg, Scarbrough Pharmacy Compound No. 454.

(42)     Exhibit 14--Prescription vial containing 135 capsules of 5-Hydroxytryptophan 100mg.

(43)     Exhibit 15--Copy of Compounding Log for 5-Hydroxytryptophan 100mg, Scarbrough Pharmacy Compound No. 486.

(44)     Exhibit 16--Prescription vial containing 63 capsules of 5-Hydroxytryptophn 200mg.

(45)     Exhibit 17--Copy of Compounding Log for 5-Hydroxytryptophn 200mg, Scarbrough Pharmacy Compound No. 516.

(46)     Exhibit 18--White jar containing Lidocaine 2.5%/Prilocaine 2.5% cream.

(47)     Exhibit 19--Copy of Compounding Log for Lidocaine 2.5%/Prilocaine 2.5%, Scarbrough Pharmacy Compound No. 412.

(48)     Exhibit 20--Prescription vial containing 79 capsules of Extra Strength Met-Fuel

(49)     Exhibit 21--Copy of Compounding Log for Extra Strength Met-Fuel, Scarbrough Pharmacy Compound No. 394.

(50)     Exhibit 22--Prescription vial containing 80 capsules of Methyltestosterone 5mg

(51)     Exhibit 23--Copy of Compounding Log for Methyltestosterone 5mg, Scarbrough Pharmacy Compound No. 472.

(52)     Exhibit 24--Prescription vial containing 39 capsules of Pregnenolone 10mg.

(53)     Exhibit 25--Copy of Compounding Log for Pregnenolone 10mg, Scarbrough Pharmacy Compound No. 378.

(54)     Exhibit 26--Prescription vial containing 25 capsules of Progesterone 100mg with Prescription No. 489790 label.

(55)     Exhibit 27--Copy of Compounding Log for Progesterone 100mg, Scarbrough Pharmacy Compound No. 119.

(56)     Exhibit 28--Prescription vial containing 45 capsules of Progesterone 100mg

(57)     Exhibit 29--Prescription vial containing 60 capsules of Progesterone 20mg with Prescription No. 480637 label.

(58)     Exhibit 30--Copy of Compounding Log for Progesterone 20mg, Scarbrough Pharmacy Compound No. 322.

(59)     Exhibit 31--Prescription vial containing 35 capsules of Progesterone 200mg.

(60)     Exhibit 32--Copy of Compounding Log for Progesterone 200mg, Scarbrough Pharmacy Compound No. 506.

(61)     Exhibit 33--Prescription vial containing 70 capsules of Progesterone 100mg/Estriol 2.5mg.

(62)     Exhibit 34--Copy of Compounding Log for Progesterone 100mg/Estriol 2.5mg, Scarbrough Pharmacy Compound No. 483.

(63)     Exhibit 35--Prescription vial containing 14 capsules of Promethazine 25mg.

(64)     Exhibit 36--Copy of Compounding Log for Promethazine 25mg, Scarbrough Pharmacy Compound No. 417.

(65)     Exhibit 37--Amber bottle containing 30ml of Salicylic Acid 10%/Formalin 40% with Prescription No. 484034 label.

(66)     Exhibit 38--Copy of Compounding Log for Salicylic Acid 10%/Formalin 40%, Scarbrough Pharmacy Compound No. 26.

(67)     Exhibit 39--Prescription vial containing 20 capsules of Sertaline 50mg.

(68)     Exhibit 40--Copy of Compounding Log for Sertaline 50mg capsules, Scarbrough Pharmacy Compound No. 193.

(69)     Exhibit 41--Prescription vial containing 40 capsules of Simvastin 10mg.

(70)     Exhibit 42--Copy of Compounding Log for Simvastin 10mg capsules, Scarbrough Pharmacy Compound No. 517.

(71)     Exhibit 43--Prescription vial containing 40 capsules of Tri-Hormone.

(72)     Exhibit 44--Copy of Compounding Log for Tri-Hormone capsules, Scarbrough Pharmacy Compound No. 521.

(73)     Exhibit 45--Prescription vial containing 40 capsules of Tri-Hormone-2/50/.4 w/Cal Carb Filler.

(74)     Exhibit 46--Copy of Compounding Log for Tri-Hormone-2/50/.4 w/Cal Carb Filler, Scarbrough Pharmacy Compound No. 521.

(75)     Exhibit 47--Prescription vial containing 59 capsules of Tri-Hormone with Prescription No. 490498 label.

(76)     Exhibit 48--Prescription vial containing 50 capsules of Triest Plus Progesterone 200mg.

(77)     Exhibit 49--Copy of Compounding Log for Triest Plus Progesterone 200mg, Scarbrough Pharmacy Compound No. 566.

(78)     Exhibit 50--Prescription vial containing 25 capsules of Triest Plus Pro.

(79)     Exhibit 51--Prescription vial containing 50 capsules of Triest Plus Pro.

(80)     Exhibit 52--Copy of Compounding Log for Triest Plus Pro capsules, Scarbrough Pharmacy Compound No. 499.

(81)     Exhibit 53--White jar containing Urea 40% Ointment.

(82)     Exhibit 54--Copy of Compounding Log for Urea 40% Ointment, PCCA Compound No. 3244.

(83)     Exhibit 55--Sixty-one clear dosette vials containing Albuterol 0.083% Inhalant Solution with Lot No. 971203 label.

(84)     Exhibit 56--Fourteen clear dosette vials containing Albuterol 0.083% Inhalant Solution with Lot No. 970204 label.

(85)     Exhibit 57--Three clear dosette vials containing Albuterol 0.083% Inhalant Solution with Lot No. 961412 label.

(86)     Exhibit 58--Clear dosette vial containing Albuterol 0.083% Inhalant Solution with Lot No. 972402 label.

(87)     Exhibit 59--Copy of two-page Compounding Log for Albuterol 0.083% Inhalant Solution, PCCA Compound No. 0021.

(88)     Exhibit 60--Two copies of label for 4oz. of Colloidal Silver showing Lot No. 970201.

(89)     Exhibit 61--Copy of label for 1oz. of Colloidal Silver showing Lot No. 960409.

(90)     Exhibit 62--Copy of label for 2oz. of Colloidal Silver showing Lot No. 961511.

(91)     Exhibit 63--Label for 4oz. of Colloidal Silver showing Lot No. 972403.

(92)     Exhibit 64--Copy of label for 8oz. of Colloidal Silver showing Lot No. 971504.

(93)     Exhibit 65--Copy of label for 4oz. of Colloidal Silver showing Lot No. 971904.

(94)     Exhibit 66--Copy of Compounding Log for Colloidal Silver, no Compound No. listed.

(95)     Exhibit 67--Copy of label for 120 capsules of Met-Fuel showing Lot No. 962012.

(96)     Exhibit 68--Copy of Compounding Log for Met-Fuel capsule, Scarbrough Pharmacy Compound No. 219.

(97)     Exhibit 69--Prescription vial containing 100 capsules of Extra Strength Met-Fuel with Lot No. 972406 label.

(98)     Exhibit 71--Copy of label for DHEA 5mg Sublingual Tablets showing Lot No. 962407.

(99)     Exhibit 72--Copy of Compounding Log for DHEA 5mg sublingual tablets, Scarbrough Pharmacy Compound No. 253 and PCCA Compound No. 0907.

(100)   Exhibit 73--Copy of label for DHEA 25mg capsules showing Lot No. 970701.

(101)   Exhibit 74--Copy of Compounding Log for DHEA 25mg capsules, Scarbrough Pharmacy Compound No. 127.

(102)   Exhibit 75--Copy of label for DHEA 50mg capsules showing Lot No. 971703.

(103)   Exhibit 76--Copy of Compounding Log for DHEA 50mg capsules, Scarbrough Pharmacy Compound No. 218.

(104)   Exhibit 77--Copy of label for ADD Formula #529 showing Lot No. 972703.

(105)   Exhibit 78--Copy of Compounding Log for ADD Formula #529, Scarbrough Pharmacy Compound No. 529.

(106)   Exhibit 79--Copy of label for ADD Formula #468 showing Lot No. 970201.

(107)   Exhibit 80--Copy of Compounding Log for ADD Formula #468, Scarbrough Pharmacy Compound No. 468.

(108)   Exhibit 81--Copy of label for ADD Formula #438 (Modified) showing Lot No. 971501.

(109)   Exhibit 82--Copy of Compounding Log for ADD Formula #438, Scarbrough Pharmacy Compound No. 438.

(110)   Exhibit 83--Copy of label for ADD Formula #441 showing Lot No. 971004.

(111)   Exhibit 84--Copy of Compounding Log for ADD Formula #441, Scarbrough Pharmacy Compound No. 441.

(112)   Exhibit 85--Copy of label for 100cc of Chicken Collagen Solution showing Lot No. 971103.

(113)   Exhibit 86--Label for 500gm of Creatine Monohydrate Powder 99% showing Lot No. 971503; and label for 90 capsules of Herbal Smoke Eliminator showing Lot No. 971503.

(114)   Exhibit 87--Copy of label for 120cc of Creatine Syrup showing Lot No. 960612.

(115)   Exhibit 88--Copy of label for Scarbrough's Diaper Rash Ointment showing Lot No. 970904.

(116)   Exhibit 89--Copy of label for 2oz of Poison Ivy Gel showing Lot No. 960908.

(117)   Exhibit 90--Copy of label for 30 Co-Enzyme Q-10 60mg capsules showing Lot No. 971504.

(118)   Exhibit 91--Copy of Compounding Log for Herbal Smoke Eliminator, no Compound No. listed.

(119)   Exhibit 94--Twenty-page printout of Scarbrough Pharmacy Prescription Log for Albuterol for the period from January 1, 1996, to July 8, 1997.

(120)   Exhibit 95--Prescription No. 463904,dated 10/16/95, for Albuterol.

(121)   Exhibit 96--Prescription No. 464570, dated 12/04/1995, for Proventil.

(122)   Exhibit 97--Prescription No. 473954, dated 4/22/96, for Albuterol.

(123)   Exhibit 98--Prescription No. 476542, dated 6/4/96, for Albuterol.

(124)   Exhibit 101--Prescription No. 485351, dated 11-5-96, for Albuterol.

(125)   Exhibit 108--Two-page printout of Scarbrough Pharmacy Prescription Log for Sertraline for the period from January 1, 1996, to July 8, 1997.

(126)   Exhibit 108a--Two-page printout of Scarbrough Pharmacy Prescription Log for Zoloft for the period from January 1, 1996, to July 8, 1997.

(127)   Exhibit 109--Prescription No. 472590, dated 3-29-96, for Zoloft.

(128)   Exhibit 110--Prescription No. 470127, dated 2/23/96, for Albuterol.

(129)   Exhibit 111--Prescription No. 476809, dated 06/10/1996, for Proventil.

(130)   Exhibit 137--Exempt Narcotics Register from January 27, 1996, to July 5, 1997.

(131)   Exhibit 138--Three-page Section 3719.44 of the Ohio Revised Code (ORC) titled "Authority of board of pharmacy to change schedules".

(132)   Exhibit 139--Rule 4729-11-09 of the Ohio Administrative Code (OAC) titled "Sale of schedule V controlled substance products without a prescription".

(133)   Exhibit 140--Copy of Compounding Log for Morphine Sulfate SR 15mg capsules, Scarbrough Pharmacy Compound No. 406.

(134)   Exhibit 141--Copy of two-page Compounding Log for Phentermine SR 25mg capsules, Scarbrough Pharmacy Compound No. 192.

(135)   Exhibit 142--Copy of Compounding Log for Theophylline 300mg Slow Release capsules, Scarbrough Pharmacy Compound No. 582 and PCCA Compound No. 3183.

(136)   Exhibit 143--Copy of Compounding Log for Phentermine 15mg capsules, no Compound No. listed.

(137)   Exhibit 144--Copy of two-page Compounding Log for Triest 2.5mg, Scarbrough Pharmacy Compound No. 374 and PCCA Compound No. 2813.

(138)   Exhibit 145--Copy of Compounding Log for Morphine Sulfate SR 500mg capsules, Scarbrough Pharmacy Compound No. 203 and PCCA Compound No. 694.

(139)   Exhibit 146--Copy of Compounding Log for Testosterone 1mg/ml in Vanicream, Scarbrough Pharmacy Compound No. 923.

(140)   Exhibit 147--Copy of Compounding Log for Triest Plus Pro Test capsules, Scarbrough Pharmacy Compound No. 498.

(141)   Exhibit 148--Twenty-four-page Table3 product list dated September 24, 1998, and Page 22 of Table3 product list dated August 7, 1998.

(142)   Exhibit 149--Two-page Ohio State Board of Pharmacy Report of Investigation by William F. McMillen dated April 5, 1999.

(143)   Exhibit 150--Two-page printout of VitaminUSA web page titled "Welcome to VitaminUSA".

(144)   Exhibit 151--Two-page printout of VitaminUSA web page titled "Men's Health".

(145)   Exhibit 152--Printout of VitaminUSA web page titled "Testosterone".

(146)   Exhibit 153--Printout of VitaminUSA web page titled "Your Shopping Basket" completed for Testosterone.

(147)   Exhibit 154--Printout of VitaminUSA web page titled "Shipping Form" completed for Testosterone to Bill McMillen.

(148)   Exhibit 155--Two-page printout of VitaminUSA web page titled "Billing Form" to Bill McMillen and printout of VitaminUSA web page titled "Order Confirmation" to Bill McMillen.

(149)   Exhibit 156--VitaminUSA Invoice No. 0174 dated March 31, 1999 to Bill McMillen.

(150)   Exhibit 157--Stock bottle containing 60 tablets of Nurivention Targeted Dietary Supplement for Testosterone Plus Ester C.

(151)   Exhibit 158--Printout of three VitaminUSA web pages dated May 23, 2000, titled "Testosterone", "Men's Health", and "VitaminUSA.com", and printout of two-page Scarbrough Pharmacy web page dated May 23, 2000.

(152)   Exhibit 160--FDA letter with Summary of Enalapril analysis results from Steven P. Eastham dated August 12, 1997 with copies of twelve pages of selected analysis records attached.

(153)   Exhibit 161--Copy of FDA Memorandum from Charles S. Price dated August 25, 1997 regarding his conversation with Stan Scarbrough.

(154)   Exhibit 162--Copy of FDA Memorandum by Charles J. Ganley, M.D. dated September 16, 1997 regarding Enalapril potential health hazard.

(155)   Exhibit 163--Copy of e-mail from Bob Lamb to Bruce Bouts with analysis results of Colloidal Silver dated September 16, 1998.

(156)   Exhibit 164--Ketoprofen 2% Gel labeled "Sample-Not for Sale".

(157)   Exhibit 165--Two-page letter from Gary E. Hirschfeld, M.D. signed and dated October 29, 1999, and re-signed and notarized on May 17, 2000.

(158)   Exhibit 166--Letter from James R. Robertson, M.D. and Bruce A. Bouts, M.D. signed and dated October 26, 1999 and re-signed by Bruce A. Bouts and notarized on May 17, 2000.

(159)   Exhibit 167--Two-page letter regarding Wilson's Syndrome from Bruce Bouts, M.D., R.Ph. and the following attachments: copy of Scarbrough Pharmacy advertisement regarding Wilson's Syndrome in The Courier, Findlay, Ohio, December 22, 1999, issue; copy of two-page "The Mortar and Pestle" newsletter from Scarbrough Pharmacy dated November 1999; two-page copy of article titled "Naturopath Charged with Unprofessional Conduct" by Stephen Barrett, M.D. dated December 6, 1999; copy of pages 3 and 4 of web page http://www.quackwatch.com/01QuackeryRelatedTopics/fad.html dated December 6, 1999.

(160)   Exhibit 168--"Worst Pills Best Pills News", March 2000 Vol. 6 No. 3, pages 17 through 24.

(161)   Exhibit 169--Copy of Thyroid.org web page dated February 24, 2000, and copy of three-page American Thyroid Association Statement on "Wilson's Syndrome" dated February 24, 2000.

(162)   Exhibit 170--Stock bottle for MGP Promethazine w/Codeine Cough Syrup labeled with NDC 60432-606-16, but containing in part a different syrup with NDC 0472-1627-28.

(163)   Exhibit 172--Copy of Sections 4731.34 (Unauthorized practice of medicine, surgery or podiatry) and 4731.41 (Practice of medicine or surgery without certificate) of the Ohio Revised Code.

(164)   Exhibit 173--Eight-page copy of Section 321 (Definitions; generally) of Title 21, US Code.

(165)   Exhibit 174--Three-page copy of Section 3715.01 (Definitions) of the Ohio Revised Code.

 

Respondent's Exhibits:

 

(1)     Exhibit A--Copy of Dangerous Drug Distributor Inspection Report of Scarbrough's Medical Arts Pharmacy signed and dated July 17, 1996.

(2)     Exhibit B--Copy of Dangerous Drug Distributor Inspection Report of Scarbrough's Medical Arts Pharmacy signed and dated October 25, 2000.

(3)     Exhibit C--Copy of two-page letter to James R. Robertson, M.D. and Bruce A. Bouts, M.D. from Stanley S. Scarbrough dated December 20, 1999.

(4)     Exhibit D--Copy of eight-page Scarbrough Pharmacy Log of Scripts for prescrip-tions filled between February 1, 2000, and October 30, 2000, dated October 30, 2000.

(5)     Exhibit E--Copy of letter from Sharon A. Carlson dated October 26, 2000.

(6)     Exhibit F--Copy of letter from Mary Basinger dated November 6, 2000.

(7)     Exhibit G--Copy of two-page table sorted by Program and Program Date and two-page table sorted by person, both dated November 2, 2000.

(8)     Exhibit H--Copy of two-page letter from Judy Patton dated November 1, 2000.

(9)     Exhibit I--Copy of pages 2698, 2700, 2701, and 2702 of the First Supplement, USP-NF, not dated.

(10)   Exhibit J--Copy of letter from Susan Alger dated October 31, 2000.

(11)   Exhibit K--Copy of two-page letter from Carol J. Hicks, M.D. dated November 7, 2000.

(12)   Exhibit L--Copy of letter from Carol J. Hicks, M.D. dated December 18, 1998.

(13)   Exhibit M--Copy of pages 344 through 351 of International Journal of Pharmaceutical Compounding, Vol. 3 No. 5, September/October 1999.

(14)   Exhibit N--Copy of pages 180 and 181 of International Journal of Pharmaceutical Compounding, Vol. 4 No. 3, May/June 2000.

(15)   Exhibit O--Copy of letter to Bruce Bouts, M.D. from Stan Scarbrough, not dated.

(16)   Exhibit P--List of Scarbrough's Medical Arts Pharmacy Library Contents dated October, 2000.

(17)   Exhibit Q--Copy of six-page "Good Compounding Practices Applicable to State Licensed Pharmacies" dated November 7, 2000.

(18)   Exhibit R--Copy of letter from Gwynn Jelden, M.D. dated October 25, 2000.

(19)   Exhibit S--Copy of letter from Jeanne L. Ashworth, M.D. dated October 25, 2000.

(20)   Exhibit T--Copy of two PCCA Certificates of Completion for program titled "Primary Compounding Techniques" on June 24 & 25, 1996 issued to Sue Gratz, R.Ph. and Carole Gill, Technician.

(21)   Exhibit U--Copy of nine-page information paper about "Methocel E4MÒ Premium (Hydroxypropylmethylcellulose (HPMC))".

(22)   Exhibit V--Copy of prescription for 500cc of ADD #441 dated August 14; copy of Logged Formula Worksheet for ADD Formula Liq dated August 17, 2000; copy of prescription for 8oz.of Colloidal Silver 20 PPM; and copy of Logged Formula Worksheet for Colloidal Silver Liquid dated September 6, 2000.

(23)   Exhibit W--Copy of letter from Michael G. Scherer, D.O. dated December 6, 2000.

(24)   Exhibit X--Copy of letter from Lyle T. Calcamuggio, M.D. dated December 11, 2000.

(25)   Exhibit Y--Copy of letter from Jay W. Nielsen, M.D., not dated.

(26)   Exhibit Z--Copy of letter from Robert R. Summers, D.O. and Lorie A. Thomas, D.O. dated December 8, 2000.

(27)   Exhibit AA--Copy of letter from L. Terry Chappell, M.D. dated December 7, 2000.

(28)   Exhibit BB--Copy of two-page letter from James C. Roberts Jr., M.D. dated December 5, 2000.

(29)   Exhibit CC--Copy of letter from Gwynn Jelden, M.D. dated November 29, 2000.

(30)   Exhibit DD--Copy of letter from John C. Biery, D.O. dated December 4, 2000.

 

(1)     Records of the State Board of Pharmacy indicate that Sue G. Gratz was originally licensed in the state of Ohio on August 8, 1960, pursuant to examination, and is currently licensed to practice pharmacy in the state of Ohio.

 

(2)     Sue G. Gratz did, on or before April 22, 1997, manufacture, sell, hold for sale, or deliver a drug that was adulterated or misbranded, to wit: Sue G. Gratz and/or Stanley Scarbrough compounded or manufactured the following drugs which lacked required labeling information:

 

(a)     Enalapril 2.5mg capsules, #120 capsules: The label has no lot num-ber, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(b)     Fenfluramine 20mg capsules, #30 capsules: The label has a date that can be referenced to an entry on a compounding log; however, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(c)     Hydrocortisone Lotion 2.5% Stock, 170ml: The label has no lot num-ber, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(d)     5-Hydroxytryptophan 50mg capsules, #190 capsules: The label has a date that can be referenced to an entry on a compounding log; how-ever, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are referenced on the compound-ing log for the bulk medications used to compound or manufacture the drug product.

(e)     5-Hydroxytryptophan 100mg capsules, #135 capsules: The label has no lot number, no expiration date, no date of manufacture or com-pounding, and no method to refer to an entry on a compounding log.

(f)      5-Hydroxytryptophan 200mg capsules, #63 capsules: The label has a lot number that can be referenced to an entry on a compounding log; however, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(g)     Lidocaine 2.5%/Prilocaine 2.5% in emollient cream base: The label has no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(h)     Extra Strength Met-Fuel capsules, #79 capsules: The label has a date that can be referenced to an entry on a compounding log; however, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(i)      Methyltestosterone 5mg capsules, #80 capsules: The label has no lot number, no expiration date, no date of manufacture or compound-ing, and no method to refer to an entry on a compounding log.

(j)      Pregnenolone 10mg capsules, #39 capsules: The label has no lot number, no expiration date, no date of manufacture or compound-ing, and no method to refer to an entry on a compounding log.

(k)     Progesterone 100mg capsules, #25 capsules, Rx# 489790: The label has no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(l)      Progesterone 100mg capsules, #45 capsules: The label has no lot number, no expiration date, no date of manufacture or compound-ing, and no method to refer to an entry on a compounding log.

(m)     Progesterone 20mg capsules, #60 capsules, Rx# 480637: The label has a date that can be referenced to an entry on a compounding log; however, there is no expiration date on the bottle or on the com-pounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(n)     Progesterone 200mg capsules, #35 capsules: The label has a date that can be referenced to an entry on a compounding log; however, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(o)     Progesterone 100mg/Estriol 2.5mg capsules, #70 capsules: The label has no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(p)     Promethasine (sic Promethazine) 25mg capsules, #14 capsules: The label has no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a com-pounding log.

(q)     Salicylic Acid 10%/Formalin 40% in Alcohol, 30ml, Rx# 484034: The label has a date, but it cannot be referenced to an entry on a com-pounding log; therefore, there is no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(r)     Sertaline 50mg capsules, # 20 capsules: The label has no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(s)     Simvastin 10mg capsules, #40 capsules: The label has a lot number that can be referenced to an entry on a compounding log; however, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(t)      Tri-Hormone capsules, #40 capsules: The label has a date that cannot be referenced to an entry on a compounding log; therefore, there is no lot number, no expiration date, no date of manufacture or com-pounding, and no method to refer to an entry on a compounding log.

(u)     Tri-Hormone-2/50/.4 w/Cal Carb filler capsules, #40 capsules: The label has a date that cannot be referenced to an entry on a com-pounding log; therefore, there is no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(v)     Tri-Hormone capsules, #59 capsules, Rx# 490498: The label has a date, but it cannot be referenced to an entry on a compounding log; therefore, there is no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(w)     Triest Plus Progesterone 200mg capsules, #50 capsules: The label has no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(x)     Triest Plus Pro capsules, #25 capsules and #50 capsules: The label has a lot number that can be referenced to an entry on a compound-ing log; however, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(y)     Urea 40% ointment: The label has no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(z)     Albuterol 0.083% Inhalant Solution, #61 vials, lot # 971203, exp. date: 7/97:  The label has a lot number and an expiration date but does not indicate the volume per vial.  Additionally, the lot number cannot be referenced to an entry on a compounding log; therefore, no lot numbers can be referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(aa)    Albuterol 0.083% Inhalant Solution, #14 vials, lot # 970204, exp. date: 7/97: The label has a lot number and an expiration date but does not indicate the volume per vial.  Additionally, the lot number cannot be referenced to an entry on a compounding log; therefore, no lot numbers can be referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(bb)   Albuterol 0.083% Inhalant Solution, #3 vials, lot # 961412, exp. date: 5/97:  The label has a lot number and an expiration date but does not indicate the volume per vial.  Additionally, the lot number cannot be referenced to an entry on a compounding log; therefore, no lot numbers can be referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(cc)    Albuterol 0.083% Inhalant Solution, #1 vial, lot # 972402, exp. date: 8/97: The label has a lot number and an expiration date but does not indicate volume per vial.  Additionally, the lot number cannot be referenced to an entry on a compounding log; therefore, no lot numbers can be referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

 

Such conduct is in violation of Section 3715.52(A)(1) of the Ohio Revised Code, 21 USCA 331(b) of the United States Code, and 21 CFR 201.18.

 

(3)     Sue G. Gratz did, on or before April 22, 1997, manufacture, sell, hold for sale, or deliver a drug that was adulterated or misbranded, to wit: Sue G. Gratz and/or Stanley Scarbrough compounded or manufactured the following drugs which were labeled with false and misleading information:

 

(a)     Colloidal Silver Solution: The product is labeled without validation as a “Super Antibiotic” and as an “Antiseptic/Antibiotic”.  The contents of active and inactive ingredients are not listed on the label.  The strength was not initially listed on the label, but currently is listed as 3-5ppm.  5ppm, or 15mcgm silver/tsp. without documentation or validation; therefore, there is no basis for suggested use or dose on label.  There are no warning instructions on label.  Initially no expiration date assigned, then given 1 year expiration date, and finally a 3 month expiration date.  The expiration dates were assigned arbitrarily. (Log present)

(b)     Met-Fuel capsules, all combinations: The complete contents of active and inactive ingredients are not listed on the label.  The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  An expiration date of 1 year was arbitrarily assigned.

(c)     DHEA sublingual tablets, all strengths: The complete contents of active and inactive ingredients are not listed on the label.  The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 1 year arbitrarily assigned.

(d)     DHEA capsules, all strengths: Contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  Expiration dates are arbitrarily assigned.

(e)     ADD Formula, all combinations: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 3 to 6 months was arbitrarily assigned.  The name of ADD for the product falsely makes one conclude that it is for attention deficit disorder.

(f)      Chicken Collagen Solution: The complete contents of active and inactive ingredients are not listed on the label.  Contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has invalid and incomplete warning instructions.  An expiration date of 1 year was arbitrarily assigned.

(g)     Creatine Monohydrate Powder: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  No expiration date was assigned.

(h)     Creatine Syrup: The complete contents of active and inactive ingredients are not listed on the label.  Contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  No warning instructions on label.  An expiration date of 23 months was arbitrarily assigned.

(i)      Scarbrough’s Diaper Rash Ointment: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 22 months arbitrarily assigned.

(j)      Poison Ivy Gel: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 2 years was arbitrarily assigned.

(k)     Co-Enzyme Q-10 60mg capsules: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 1 year was arbitrarily assigned.

(l)      Herbal Smoke Eliminator capsules: The label was without validation as a “Healthy and Energizing Herbal Synergism to Combat Smoking Habit and Effects”.  The complete contents of active and inactive ingredients are not listed on the label.  The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 1 year was arbitrarily assigned.

 

Such conduct is in violation of Section 3715.52(A)(1) of the Ohio Revised Code and 21 USCA 331(b) of the United States Code.

 

(4)     Sue G. Gratz did, on or before April 22, 1997, sell, deliver, offer for sale, and/or hold for sale a new drug when not in accordance with Section 3715.65 of the Ohio Revised Code, to wit: the following drugs were not tested and found to be safe under the conditions recommended or suggested in its labeling, and prior to selling the drug or offering it for sale, Sue G. Gratz and/or Stanley Scarbrough failed to file an application for new drugs with the director of agriculture:

 

(a)     Colloidal Silver Solution: The product is labeled without validation as a “Super Antibiotic” and as an “Antiseptic/Antibiotic”.  The contents of active and inactive ingredients are not listed on the label.  The strength was not initially listed on the label, but currently is listed as 3-5ppm.  5ppm, or 15mcgm silver/tsp. without documentation or validation; therefore, there is no basis for suggested use or dose on label.  There are no warning instructions on label.  Initially no expiration date assigned, then given 1 year expiration date, and finally a 3 month expiration date.  The expiration dates were assigned arbitrarily. (Log present)

(b)     Met-Fuel capsules, all combinations: The complete contents of active and inactive ingredients are not listed on the label.  The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  An expiration date of 1 year was arbitrarily assigned. 

(c)     DHEA sublingual tablets, all strengths: The complete contents of active and inactive ingredients are not listed on the label.  The con-tents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 1 year arbitrarily assigned.

(d)     DHEA capsules, all strengths: The complete contents of active and inactive ingredients were not listed on the label; however, this was corrected as of 4-22-97 inspection.  Contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  Expiration dates are arbitrarily assigned.

(e)     ADD Formula, all combinations: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 3 to 6 months was arbitrarily assigned.  The name of ADD for the product falsely makes one conclude that it is for attention deficit disorder.

(f)      Chicken Collagen Solution: The complete contents of active and inactive ingredients are not listed on the label.  Contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has invalid and incomplete warning instructions.  An expiration date of 1 year was arbitrarily assigned.

(g)     Creatine Monohydrate Powder: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  No expiration date was assigned.

(h)     Creatine Syrup: The complete contents of active and inactive ingredients are not listed on the label.  Contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  No warning instructions on label.  An expiration date of 23 months was arbitrarily assigned.

(i)      Scarbrough’s Diaper Rash Ointment: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 22 months arbitrarily assigned.

(j)      Poison Ivy Gel: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 2 years was arbitrarily assigned.

(k)     Co-Enzyme Q-10 60mg capsules: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 1 year was arbitrarily assigned.

(l)      Herbal Smoke Eliminator capsules: The label was without validation as a “Healthy and Energizing Herbal Synergism to Combat Smoking Habit and Effects”.  The complete contents of active and inactive ingredients are not listed on the label.  The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 1 year was arbitrarily assigned.

 

Such conduct is in violation of Section 3715.65(A)(2) of the Ohio Revised Code.

 

(5)     Sue G. Gratz did, on or about the following dates, fail to assign a new serial number to prescriptions that were not refillable, to wit: Sue G. Gratz filled the following prescriptions and, upon refilling the prescriptions with newly compounded drugs which were not generically equivalent, failed to assign a new serial number to the compounded drug and vice versa:

 

Date of

Change

 

Rx. No.

Drug

Initially Dispensed

Second

Drug Dispensed

 

Qty.

07/02/96

463904

Albuterol UD

Compounded Albuterol Inhaler

360

09/25/96

470127

Albuterol UD

Compounded Albuterol Inhaler

360

10/21/96

476809

Proventil UD

Compounded Albuterol Inhaler

360

06/27/97

485351

Compounded

Albuterol Inhaler

Albuterol UD

180

 

Such conduct is in violation of Rules 4729-5-19, 4729-5-27, and 4729-5-30 of the Ohio Administrative Code, and Section 4729.38 of the Ohio Revised Code.

 

(6)     Sue G. Gratz did, from on or about June 21, 1996, through June 5, 1997, sell, deliver, offer for sale, and/or hold for sale a new drug when not in accordance with Section 3715.65 of the Ohio Revised Code, to wit: on 213 separate occasions, Sue G. Gratz and/or Stanley Scarbrough sold one of the following new drugs which were not tested and found to be safe under the conditions recommended or suggested in its labeling, and prior to selling the drug or offering it for sale, Sue G. Gratz and/or Stanley Scarbrough failed to file an application for new drugs with the director of agriculture:

 

(a)     Met-Fuel-Caffeine Free: Contents, in part--Ephedrine 1.0gm., L-Carnitine 5.0gm., Chromium Picolinate 0.010gm, and Ginger Root 1.0gm per 100 capsules.

(b)     Met-Fuel: Contents, in part--Ephedrine 1.0gm, Caffeine 10gm, L-Carnitine 5.0gms, Chromium Picolinate 0.010gms, and Ginger Root 1.0gm per 100 capsules.

(c)     Extra Strength Met-Fuel: Contents, in part--Ephedrine 1.0gm, Caffeine 10gm, L-Carnitine 5.0gm, Chromium Picolinate 0.010gm, Ginger Root 1.0gm, and Aspirin 4.05gm per 100 capsules.

 

Such conduct is in violation of Section 3715.65(A)(2) of the Ohio Revised Code.

 

(7)     Sue G. Gratz did, from on or about June 21, 1996, through July 5, 1997, sell a Schedule V controlled substance without a prescription in an amount exceeding fifty times the bulk amount, but in an amount less than one hundred times that amount when the conduct was not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: throughout this time period Scarbrough Medical Arts Pharmacy made 161 individual sales of Met Fuel.  Sue G. Gratz made 68 of those sales for a total of 8,160 unit doses; and, on each occasion, Sue G. Gratz dispensed to each patient over 100 unit doses in a 30-day time period without a legitimate medical purpose.  Such conduct is not in accordance with Rule 4729-11-09 of the Ohio Administrative Code and, therefore, is in violation of Section 2925.03(A) of the Ohio Revised Code.

 

(8)     Sue G. Gratz did, from on or about October 26, 1996, through June 25, 1997, sell a Schedule V controlled substance without a prescription in an amount exceeding five times the bulk amount, but in an amount less than fifty times that amount when the conduct was not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: throughout this time period Scarbrough Medical Arts Pharmacy made 40 individual sales of Extra Strength Met Fuel.  Sue G. Gratz made 18 of those sales for a total of 2,160 unit doses; and, on each occasion, Sue G. Gratz dispensed to each patient over 100 unit doses in a 30-day time period without a legitimate medical purpose.  Such conduct is not in accordance with Rule 4729-11-09 of the Ohio Administrative Code and, therefore, is in violation of Section 2925.03(A) of the Ohio Revised Code.

 

(9)     Sue G. Gratz did, on or about April 11, 1997, sell a Schedule V controlled substance without a prescription in an amount exceeding the bulk amount, but in an amount less than five times that amount when the conduct was not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: Sue G. Gratz sold 120 unit doses of Met Fuel w/ASA which allowed the patient over 100 unit doses in a 30-day time period and not for a legitimate medical purpose.  Such conduct is not in accordance with Rule 4729-11-09 of the Ohio Administrative Code and, therefore, is in violation of Section 2925.03(A) of the Ohio Revised Code.

 

(1)     Upon consideration of the record as a whole, the State Board of Pharmacy concludes that paragraphs (2) through (9) of the Findings of Fact constitute being guilty of unprofessional conduct in the practice of pharmacy as provided in Division (A)(2) of Section 4729.16 of the Ohio Revised Code.

 

(2)     Upon consideration of the record as a whole, the State Board of Pharmacy concludes that paragraphs (2) through (9) of the Findings of Fact constitute being guilty of willfully violating, conspiring to violate, attempting to violate, or aiding and abetting the violation of provisions of Sections 3715.52 to 3715.72 or Chapter 2925., 3719., or 4729. of the Revised Code as provided in Division (A)(5) of Section 4729.16 of the Ohio Revised Code.

 

(A)     On the basis of the Findings of Fact and paragraph (1) of the Conclusions of Law set forth above, the State Board of Pharmacy hereby suspends for six months the pharmacist identification card, No. 03-3-07246, held by Sue G. Gratz effective as of the date of the mailing of this Order.

 

(B)     On the basis of the Findings of Fact and paragraph (2) of the Conclusions of Law set forth above, the State Board of Pharmacy hereby imposes a monetary penalty of five thousand dollars ($5,000.00) on Sue G. Gratz effective as of the date of the mailing of this Order.

 

(C)     Further, the Board will suspend the suspension and fine imposed in paragraphs (A) and (B) provided that Sue G. Gratz successfully completes six hours of continuing pharmacy education in Board-approved Jurisprudence and submits the original certificates of completion to the Board within six months from the effective date of this Order.

 

 

The motion was seconded by Mr. Kost and approved by the Board (Aye-6/Nay-0).

 

RES. 2001-090  Ms. Eastman moved that the Board adopt the following Order in the matter of Scar-brough’s Medical Arts Pharmacy, T.D.:

 

(A)     Testimony

 

State's Witnesses:

 

(1)     Mark Keeley, R.Ph., Ohio State Board of Pharmacy

 

Respondent's Witnesses:

 

(1)     Stanley Shaw Scarbrough, R.Ph.

(2)     Sue G. Gratz, R.Ph., Respondent

(3)     Alan Spreen, M.D.

 

(B)     Exhibits

 

State's Exhibits:

 

(1)       Exhibit 1--Copy of nineteen-page Notice of Opportunity for Hearing letter of Stanley Shaw Scarbrough dated May 31, 2000.

(2)       Exhibit 1A--Copy of fourteen-page Notice of Opportunity for Hearing letter of Sue G. Gratz dated May 31, 2000.

(3)       Exhibit 1B--Copy of eighteen-page Notice of Opportunity for Hearing letter of Scarbroughs Medical Arts Pharmacy dated May 31, 2000.

(4)       Exhibit 1C--Hearing Request letter of Stanley Shaw Scarbrough dated June 28, 2000.

(5)       Exhibit 1D--Hearing Request letter of Sue G. Gratz dated June 28, 2000.

(6)       Exhibit 1E--Hearing Request letter of Scarbroughs Medical Arts Pharmacy dated June 28, 2000.

(7)       Exhibit 1F--Copy of Hearing Schedule letter of Scarbrough's Medical Arts Pharmacy, Stanley Shaw Scarbrough, and Sue G. Gratz dated June 30, 2000.

(8)       Exhibit 1G--Copy of Pharmacist File Front Sheet of Stanley Shaw Scarbrough showing original date of registration as May 4, 1979; and two-page copy of Renewal Application for Pharmacist License, No. 03-2-12847, for a license to practice pharmacy in Ohio from September 15, 2000, through September 15, 2001, signed and dated June 27, 2000.

(9)       Exhibit 1H--Copy of Pharmacist File Front Sheet of Sue G. Gratz showing original date of registration as August 8, 1960; and two-page copy of Renewal Application for Pharmacist License, No. 03-3-07246, for a license to practice pharmacy in Ohio from September 15, 2000, through September 15, 2001, signed and dated July 28, 2000.

(10)     Exhibit 1I--Copy of Renewal Application for DDD License No. 02-0114850 for a Terminal Distributor of Dangerous Drugs license from January 1, 2000, through December 31, 2000, signed by Stan Scarbrough and dated September 9, 1999.

(11)     Exhibit 1J--Copy of two-page letter from James F. Flynn dated October 6, 2000.

(12)     Exhibit 1K--Copy of letter from David L. Rowland to James F. Flynn dated October 6, 2000.

(13)     Exhibit 1L--Two-page Request for Continuance letter from James F. Flynn dated November 2, 2000.

(14)     Exhibit 1M--Copy of Continuance Request Response letter dated November 6, 2000.

(15)     Exhibit 1N--Copy of Hearing Schedule letter dated November 9, 2000.

(16)     Exhibit 1O--Copy of Hearing Schedule letter dated November 15, 2000.

(17)     Exhibit 2--Copy of four-page Dangerous Drug Distributor Inspection Report of Scarbroughs Medical Arts Pharmacy, Terminal Distributor No. 02-0114850, dated March 26, 1997; and copy of response to inspection report violations signed by Stan Scarbrough, received in the Board office on March 31, 1997.

(18)     Exhibit 2A--Copy of eight-page Dangerous Drug Distributor Inspection Report of Scarbroughs Medical Arts Pharmacy, Terminal Distributor No. 02-0114850, dated April 22, 1997; and copy of response to inspection report violations signed by Stan Scarbrough, not dated.

(19)     Exhibit 2B--Copy of five-page Dangerous Drug Distributor Inspection Report of Scarbroughs Medical Arts Pharmacy, Terminal Distributor No. 02-0114850, dated May 4, 1998; and copy of three-page response to inspection report violations signed by Stan Scarbrough, dated May 20, 1998.

(20)     Exhibit 3--Copy of FDA forms FDA 481(E)-CG, FDA 481(A)-CG, and FDA 481(C)-CG completed during limited inspection at Scarbrough Medical Arts Pharmacy on April 22-29, 1997, FDA Central File No. 1528698; and copy of ten-page Summary of Findings (EI: 4/22-29/97 MPS) signed by Michael P. Sheehan, not dated.

(21)     Exhibit 3A--Copy of FDA forms FDA 481(E)-CG, FDA 481(A)-CG, and FDA 481(C)-CG completed during limited inspection at Scarbrough Medical Arts Pharmacy on July 8, 9, 1997, FDA Central File No. 1530500; and copy of seventeen-page Summary of Findings (EI: 7/8-9/97 MPS) signed by Michael P. Sheehan, not dated.

(22)     Exhibit 3B--Copy of two-page Response letter for July 8, 9, 1997 inspection results from Stan Scarbrough dated July 22, 1997.

(23)     Exhibit 3C--Copy of two-page FDA Memorandum (Re: Scarbrough Pharmacy's Response Letter to July, 1997 EI) dated August 5, 1997.

(24)     Exhibit 3D--Copy of Collection Report (Form FDA 464) and C/R Continuation Sheet (Form FDA 464a) for Sample No. 97-740-762, collected July 9, 1997, Central File No. 1530500, with the following attachments: copy of two-page e-mail regarding Non-Traditional Drug Bulletin #21 dated June 27, 1997; copy of two-page Warning Letter Draft, not dated.

(25)     Exhibit 4--Letter from Fred L. Dailey, Director of the Ohio Department of Agriculture, dated June 27, 2000.

(26)     Exhibit 5--Two-page letter from Bruce A. Bouts, M.D. signed and dated May 11, 1998, and re-signed and notarized on May 17, 2000.

(27)     Exhibit 5A--Two-page letter from Gary E. Hirschfield, M.D. signed and dated May 27, 1998, and re-signed and notarized on May 17, 2000.

(28)     Exhibit 5B--Letter from Rick D. Watson, M.D. signed and dated May 21, 1998, and re-signed and notarized on May 17, 2000.

(29)     Exhibit 5C--Letter from William H. Kose, M.D. signed and dated May 6, 1998, and re-signed and notarized on May 17, 2000.

(30)     Exhibit 5D--Letter from Sue Best and Seth Brownlee signed and dated July 10, 1997, and re-signed and notarized March 3, 2000.

(31)     Exhibit 5E--Statement of Heather Zehender signed and notarized April 11, 2000.

(32)     Exhibit 5G--Twenty-five-page transcript of interview with Jill Waldron and Heather Zehender by Compliance Agent Dale Fritz and Compliance Specialist Mark Keeley held on March 6, 2000.

(33)     Exhibit 5I--Seventy-six-page transcript of Tape #4-Interview with Stan Scarbrough  by Compliance Specialists Mark Keeley and Joann Predina and Compliance Agent Dale Fritz held on May 4, 1998.

(34)     Exhibit 6--Prescription vial containing 120 capsules of Enalapril 2.5mg.

(35)     Exhibit 7--Copy of Compounding Log for Enalapril 2.5mg capsules, Scarbrough Pharmacy Compound No. 167.

(36)     Exhibit 8--Prescription vial containing 30 capsules of Fenfluramine 20mg.

(37)     Exhibit 9--Copy of Compounding Log for Fenfluramine 20mg capsules, Scarbrough Pharmacy Compound No. 519.

(38)     Exhibit 10--Amber bottle labeled "Stock" containing 170ml of Hydrocortisone Lotion 2.5%.

(39)     Exhibit 11--Copy of Compounding Log for Hydrocortisone Lotion 2.5%, Scarbrough Pharmacy Compound No. 249.

(40)     Exhibit 12--Prescription vial containing 190 capsules of 5-Hydroxytryptophan 50mg.

(41)     Exhibit 13--Copy of Compounding Log for 5-Hydroxytryptophan 50mg, Scarbrough Pharmacy Compound No. 454.

(42)     Exhibit 14--Prescription vial containing 135 capsules of 5-Hydroxytryptophan 100mg.

(43)     Exhibit 15--Copy of Compounding Log for 5-Hydroxytryptophan 100mg, Scarbrough Pharmacy Compound No. 486.

(44)     Exhibit 16--Prescription vial containing 63 capsules of 5-Hydroxytryptophn 200mg.

(45)     Exhibit 17--Copy of Compounding Log for 5-Hydroxytryptophn 200mg, Scarbrough Pharmacy Compound No. 516.

(46)     Exhibit 18--White jar containing Lidocaine 2.5%/Prilocaine 2.5% cream.

(47)     Exhibit 19--Copy of Compounding Log for Lidocaine 2.5%/Prilocaine 2.5%, Scarbrough Pharmacy Compound No. 412.

(48)     Exhibit 20--Prescription vial containing 79 capsules of Extra Strength Met-Fuel

(49)     Exhibit 21--Copy of Compounding Log for Extra Strength Met-Fuel, Scarbrough Pharmacy Compound No. 394.

(50)     Exhibit 22--Prescription vial containing 80 capsules of Methyltestosterone 5mg

(51)     Exhibit 23--Copy of Compounding Log for Methyltestosterone 5mg, Scarbrough Pharmacy Compound No. 472.

(52)     Exhibit 24--Prescription vial containing 39 capsules of Pregnenolone 10mg.

(53)     Exhibit 25--Copy of Compounding Log for Pregnenolone 10mg, Scarbrough Pharmacy Compound No. 378.

(54)     Exhibit 26--Prescription vial containing 25 capsules of Progesterone 100mg with Prescription No. 489790 label.

(55)     Exhibit 27--Copy of Compounding Log for Progesterone 100mg, Scarbrough Pharmacy Compound No. 119.

(56)     Exhibit 28--Prescription vial containing 45 capsules of Progesterone 100mg

(57)     Exhibit 29--Prescription vial containing 60 capsules of Progesterone 20mg with Prescription No. 480637 label.

(58)     Exhibit 30--Copy of Compounding Log for Progesterone 20mg, Scarbrough Pharmacy Compound No. 322.

(59)     Exhibit 31--Prescription vial containing 35 capsules of Progesterone 200mg.

(60)     Exhibit 32--Copy of Compounding Log for Progesterone 200mg, Scarbrough Pharmacy Compound No. 506.

(61)     Exhibit 33--Prescription vial containing 70 capsules of Progesterone 100mg/Estriol 2.5mg.

(62)     Exhibit 34--Copy of Compounding Log for Progesterone 100mg/Estriol 2.5mg, Scarbrough Pharmacy Compound No. 483.

(63)     Exhibit 35--Prescription vial containing 14 capsules of Promethazine 25mg.

(64)     Exhibit 36--Copy of Compounding Log for Promethazine 25mg, Scarbrough Pharmacy Compound No. 417.

(65)     Exhibit 37--Amber bottle containing 30ml of Salicylic Acid 10%/Formalin 40% with Prescription No. 484034 label.

(66)     Exhibit 38--Copy of Compounding Log for Salicylic Acid 10%/Formalin 40%, Scarbrough Pharmacy Compound No. 26.

(67)     Exhibit 39--Prescription vial containing 20 capsules of Sertaline 50mg.

(68)     Exhibit 40--Copy of Compounding Log for Sertaline 50mg capsules, Scarbrough Pharmacy Compound No. 193.

(69)     Exhibit 41--Prescription vial containing 40 capsules of Simvastin 10mg.

(70)     Exhibit 42--Copy of Compounding Log for Simvastin 10mg capsules, Scarbrough Pharmacy Compound No. 517.

(71)     Exhibit 43--Prescription vial containing 40 capsules of Tri-Hormone.

(72)     Exhibit 44--Copy of Compounding Log for Tri-Hormone capsules, Scarbrough Pharmacy Compound No. 521.

(73)     Exhibit 45--Prescription vial containing 40 capsules of Tri-Hormone-2/50/.4 w/Cal Carb Filler.

(74)     Exhibit 46--Copy of Compounding Log for Tri-Hormone-2/50/.4 w/Cal Carb Filler, Scarbrough Pharmacy Compound No. 521.

(75)     Exhibit 47--Prescription vial containing 59 capsules of Tri-Hormone with Prescription No. 490498 label.

(76)     Exhibit 48--Prescription vial containing 50 capsules of Triest Plus Progesterone 200mg.

(77)     Exhibit 49--Copy of Compounding Log for Triest Plus Progesterone 200mg, Scarbrough Pharmacy Compound No. 566.

(78)     Exhibit 50--Prescription vial containing 25 capsules of Triest Plus Pro.

(79)     Exhibit 51--Prescription vial containing 50 capsules of Triest Plus Pro.

(80)     Exhibit 52--Copy of Compounding Log for Triest Plus Pro capsules, Scarbrough Pharmacy Compound No. 499.

(81)     Exhibit 53--White jar containing Urea 40% Ointment.

(82)     Exhibit 54--Copy of Compounding Log for Urea 40% Ointment, PCCA Compound No. 3244.

(83)     Exhibit 55--Sixty-one clear dosette vials containing Albuterol 0.083% Inhalant Solution with Lot No. 971203 label.

(84)     Exhibit 56--Fourteen clear dosette vials containing Albuterol 0.083% Inhalant Solution with Lot No. 970204 label.

(85)     Exhibit 57--Three clear dosette vials containing Albuterol 0.083% Inhalant Solution with Lot No. 961412 label.

(86)     Exhibit 58--Clear dosette vial containing Albuterol 0.083% Inhalant Solution with Lot No. 972402 label.

(87)     Exhibit 59--Copy of two-page Compounding Log for Albuterol 0.083% Inhalant Solution, PCCA Compound No. 0021.

(88)     Exhibit 60--Two copies of label for 4oz. of Colloidal Silver showing Lot No. 970201.

(89)     Exhibit 61--Copy of label for 1oz. of Colloidal Silver showing Lot No. 960409.

(90)     Exhibit 62--Copy of label for 2oz. of Colloidal Silver showing Lot No. 961511.

(91)     Exhibit 63--Label for 4oz. of Colloidal Silver showing Lot No. 972403.

(92)     Exhibit 64--Copy of label for 8oz. of Colloidal Silver showing Lot No. 971504.

(93)     Exhibit 65--Copy of label for 4oz. of Colloidal Silver showing Lot No. 971904.

(94)     Exhibit 66--Copy of Compounding Log for Colloidal Silver, no Compound No. listed.

(95)     Exhibit 67--Copy of label for 120 capsules of Met-Fuel showing Lot No. 962012.

(96)     Exhibit 68--Copy of Compounding Log for Met-Fuel capsule, Scarbrough Pharmacy Compound No. 219.

(97)     Exhibit 69--Prescription vial containing 100 capsules of Extra Strength Met-Fuel with Lot No. 972406 label.

(98)     Exhibit 71--Copy of label for DHEA 5mg Sublingual Tablets showing Lot No. 962407.

(99)     Exhibit 72--Copy of Compounding Log for DHEA 5mg sublingual tablets, Scarbrough Pharmacy Compound No. 253 and PCCA Compound No. 0907.

(100)   Exhibit 73--Copy of label for DHEA 25mg capsules showing Lot No. 970701.

(101)   Exhibit 74--Copy of Compounding Log for DHEA 25mg capsules, Scarbrough Pharmacy Compound No. 127.

(102)   Exhibit 75--Copy of label for DHEA 50mg capsules showing Lot No. 971703.

(103)   Exhibit 76--Copy of Compounding Log for DHEA 50mg capsules, Scarbrough Pharmacy Compound No. 218.

(104)   Exhibit 77--Copy of label for ADD Formula #529 showing Lot No. 972703.

(105)   Exhibit 78--Copy of Compounding Log for ADD Formula #529, Scarbrough Pharmacy Compound No. 529.

(106)   Exhibit 79--Copy of label for ADD Formula #468 showing Lot No. 970201.

(107)   Exhibit 80--Copy of Compounding Log for ADD Formula #468, Scarbrough Pharmacy Compound No. 468.

(108)   Exhibit 81--Copy of label for ADD Formula #438 (Modified) showing Lot No. 971501.

(109)   Exhibit 82--Copy of Compounding Log for ADD Formula #438, Scarbrough Pharmacy Compound No. 438.

(110)   Exhibit 83--Copy of label for ADD Formula #441 showing Lot No. 971004.

(111)   Exhibit 84--Copy of Compounding Log for ADD Formula #441, Scarbrough Pharmacy Compound No. 441.

(112)   Exhibit 85--Copy of label for 100cc of Chicken Collagen Solution showing Lot No. 971103.

(113)   Exhibit 86--Label for 500gm of Creatine Monohydrate Powder 99% showing Lot No. 971503; and label for 90 capsules of Herbal Smoke Eliminator showing Lot No. 971503.

(114)   Exhibit 87--Copy of label for 120cc of Creatine Syrup showing Lot No. 960612.

(115)   Exhibit 88--Copy of label for Scarbrough's Diaper Rash Ointment showing Lot No. 970904.

(116)   Exhibit 89--Copy of label for 2oz of Poison Ivy Gel showing Lot No. 960908.

(117)   Exhibit 90--Copy of label for 30 Co-Enzyme Q-10 60mg capsules showing Lot No. 971504.

(118)   Exhibit 91--Copy of Compounding Log for Herbal Smoke Eliminator, no Compound No. listed.

(119)   Exhibit 94--Twenty-page printout of Scarbrough Pharmacy Prescription Log for Albuterol for the period from January 1, 1996, to July 8, 1997.

(120)   Exhibit 95--Prescription No. 463904,dated 10/16/95, for Albuterol.

(121)   Exhibit 96--Prescription No. 464570, dated 12/04/1995, for Proventil.

(122)   Exhibit 97--Prescription No. 473954, dated 4/22/96, for Albuterol.

(123)   Exhibit 98--Prescription No. 476542, dated 6/4/96, for Albuterol.

(124)   Exhibit 101--Prescription No. 485351, dated 11-5-96, for Albuterol.

(125)   Exhibit 108--Two-page printout of Scarbrough Pharmacy Prescription Log for Sertraline for the period from January 1, 1996, to July 8, 1997.

(126)   Exhibit 108a--Two-page printout of Scarbrough Pharmacy Prescription Log for Zoloft for the period from January 1, 1996, to July 8, 1997.

(127)   Exhibit 109--Prescription No. 472590, dated 3-29-96, for Zoloft.

(128)   Exhibit 110--Prescription No. 470127, dated 2/23/96, for Albuterol.

(129)   Exhibit 111--Prescription No. 476809, dated 06/10/1996, for Proventil.

(130)   Exhibit 137--Exempt Narcotics Register from January 27, 1996, to July 5, 1997.

(131)   Exhibit 138--Three-page Section 3719.44 of the Ohio Revised Code (ORC) titled "Authority of board of pharmacy to change schedules".

(132)   Exhibit 139--Rule 4729-11-09 of the Ohio Administrative Code (OAC) titled "Sale of schedule V controlled substance products without a prescription".

(133)   Exhibit 140--Copy of Compounding Log for Morphine Sulfate SR 15mg capsules, Scarbrough Pharmacy Compound No. 406.

(134)   Exhibit 141--Copy of two-page Compounding Log for Phentermine SR 25mg capsules, Scarbrough Pharmacy Compound No. 192.

(135)   Exhibit 142--Copy of Compounding Log for Theophylline 300mg Slow Release capsules, Scarbrough Pharmacy Compound No. 582 and PCCA Compound No. 3183.

(136)   Exhibit 143--Copy of Compounding Log for Phentermine 15mg capsules, no Compound No. listed.

(137)   Exhibit 144--Copy of two-page Compounding Log for Triest 2.5mg, Scarbrough Pharmacy Compound No. 374 and PCCA Compound No. 2813.

(138)   Exhibit 145--Copy of Compounding Log for Morphine Sulfate SR 500mg capsules, Scarbrough Pharmacy Compound No. 203 and PCCA Compound No. 694.

(139)   Exhibit 146--Copy of Compounding Log for Testosterone 1mg/ml in Vanicream, Scarbrough Pharmacy Compound No. 923.

(140)   Exhibit 147--Copy of Compounding Log for Triest Plus Pro Test capsules, Scarbrough Pharmacy Compound No. 498.

(141)   Exhibit 148--Twenty-four-page Table3 product list dated September 24, 1998, and Page 22 of Table3 product list dated August 7, 1998.

(142)   Exhibit 160--FDA letter with Summary of Enalapril analysis results from Steven P. Eastham dated August 12, 1997 with copies of twelve pages of selected analysis records attached.

(143)   Exhibit 161--Copy of FDA Memorandum from Charles S. Price dated August 25, 1997 regarding his conversation with Stan Scarbrough.

(144)   Exhibit 162--Copy of FDA Memorandum by Charles J. Ganley, M.D. dated September 16, 1997 regarding Enalapril potential health hazard.

(145)   Exhibit 163--Copy of e-mail from Bob Lamb to Bruce Bouts with analysis results of Colloidal Silver dated September 16, 1998.

(146)   Exhibit 164--Ketoprofen 2% Gel labeled "Sample-Not for Sale".

(147)   Exhibit 165--Two-page letter from Gary E. Hirschfeld, M.D. signed and dated October 29, 1999, and re-signed and notarized on May 17, 2000.

(148)   Exhibit 166--Letter from James R. Robertson, M.D. and Bruce A. Bouts, M.D. signed and dated October 26, 1999 and re-signed by Bruce A. Bouts and notarized on May 17, 2000.

(149)   Exhibit 167--Two-page letter regarding Wilson's Syndrome from Bruce Bouts, M.D., R.Ph. and the following attachments: copy of Scarbrough Pharmacy advertisement regarding Wilson's Syndrome in The Courier, Findlay, Ohio, December 22, 1999, issue; copy of two-page "The Mortar and Pestle" news-letter from Scarbrough Pharmacy dated November 1999; two-page copy of article titled "Naturopath Charged with Unprofessional Conduct" by Stephen Barrett, M.D. dated December 6, 1999; copy of pages 3 and 4 of web page http://www.quackwatch.com/01QuackeryRelatedTopics/fad.html dated December 6, 1999.

(150)   Exhibit 168--"Worst Pills Best Pills News", March 2000 Vol. 6 No. 3, pages 17 through 24.

(151)   Exhibit 169--Copy of Thyroid.org web page dated February 24, 2000, and copy of three-page American Thyroid Association Statement on "Wilson's Syndrome" dated February 24, 2000.

(152)   Exhibit 170--Stock bottle for MGP Promethazine w/Codeine Cough Syrup labeled with NDC 60432-606-16, but containing in part a different syrup with NDC 0472-1627-28.

(153)   Exhibit 172--Copy of Sections 4731.34 (Unauthorized practice of medicine, surgery or podiatry) and 4731.41 (Practice of medicine or surgery without certificate) of the Ohio Revised Code.

(154)   Exhibit 173--Eight-page copy of Section 321 (Definitions; generally) of Title 21, US Code.

(155)   Exhibit 174--Three-page copy of Section 3715.01 (Definitions) of the Ohio Revised Code.

(156)   Exhibit 176--Information Sheet showing "Suggested Formula for Albuterol Inhalant, 1 Liter", and "Suggested Compounding Procedure", dated August 17, 1993.

 

Respondent's Exhibits:

 

(1)     Exhibit A--Copy of Dangerous Drug Distributor Inspection Report of Scarbrough's Medical Arts Pharmacy signed and dated July 17, 1996.

(2)     Exhibit B--Copy of Dangerous Drug Distributor Inspection Report of Scarbrough's Medical Arts Pharmacy signed and dated October 25, 2000.

(3)     Exhibit C--Copy of two-page letter to James R. Robertson, M.D. and Bruce A. Bouts, M.D. from Stanley S. Scarbrough dated December 20, 1999.

(4)     Exhibit D--Copy of eight-page Scarbrough Pharmacy Log of Scripts for prescrip-tions filled between February 1, 2000, and October 30, 2000, dated October 30, 2000.

(5)     Exhibit E--Copy of letter from Sharon A. Carlson dated October 26, 2000.

(6)     Exhibit F--Copy of letter from Mary Basinger dated November 6, 2000.

(7)     Exhibit G--Copy of two-page table sorted by Program and Program Date and two-page table sorted by person, both dated November 2, 2000.

(8)     Exhibit H--Copy of two-page letter from Judy Patton dated November 1, 2000.

(9)     Exhibit I--Copy of pages 2698, 2700, 2701, and 2702 of the First Supplement, USP-NF, not dated.

(10)   Exhibit J--Copy of letter from Susan Alger dated October 31, 2000.

(11)   Exhibit K--Copy of two-page letter from Carol J. Hicks, M.D. dated November 7, 2000.

(12)   Exhibit L--Copy of letter from Carol J. Hicks, M.D. dated December 18, 1998.

(13)   Exhibit M--Copy of pages 344 through 351 of International Journal of Pharmaceutical Compounding, Vol. 3 No. 5, September/October 1999.

(14)   Exhibit N--Copy of pages 180 and 181 of International Journal of Pharmaceutical Compounding, Vol. 4 No. 3, May/June 2000.

(15)   Exhibit O--Copy of letter to Bruce Bouts, M.D. from Stan Scarbrough, not dated.

(16)   Exhibit P--List of Scarbrough's Medical Arts Pharmacy Library Contents dated October, 2000.

(17)   Exhibit Q--Copy of six-page "Good Compounding Practices Applicable to State Licensed Pharmacies" dated November 7, 2000.

(18)   Exhibit R--Copy of letter from Gwynn Jelden, M.D. dated October 25, 2000.

(19)   Exhibit S--Copy of letter from Jeanne L. Ashworth, M.D. dated October 25, 2000.

(20)   Exhibit T--Copy of two PCCA Certificates of Completion for program titled "Primary Compounding Techniques" on June 24 & 25, 1996 issued to Sue Gratz, R.Ph. and Carole Gill, Technician.

(21)   Exhibit U--Copy of nine-page information paper about "Methocel E4MÒ Premium (Hydroxypropylmethylcellulose (HPMC))".

(22)   Exhibit V--Copy of prescription for 500cc of ADD #441 dated August 14; copy of Logged Formula Worksheet for ADD Formula Liq dated August 17, 2000; copy of prescription for 8oz.of Colloidal Silver 20 PPM; and copy of Logged Formula Worksheet for Colloidal Silver Liquid dated September 6, 2000.

(23)   Exhibit W--Copy of letter from Michael G. Scherer, D.O. dated December 6, 2000.

(24)   Exhibit X--Copy of letter from Lyle T. Calcamuggio, M.D. dated December 11, 2000.

(25)   Exhibit Y--Copy of letter from Jay W. Nielsen, M.D., not dated.

(26)   Exhibit Z--Copy of letter from Robert R. Summers, D.O. and Lorie A. Thomas, D.O. dated December 8, 2000.

(27)   Exhibit AA--Copy of letter from L. Terry Chappell, M.D. dated December 7, 2000.

(28)   Exhibit BB--Copy of two-page letter from James C. Roberts Jr., M.D. dated December 5, 2000.

(29)   Exhibit CC--Copy of letter from Gwynn Jelden, M.D. dated November 29, 2000.

(30)   Exhibit DD--Copy of letter from John C. Biery, D.O. dated December 4, 2000.

 

(1)     Records of the State Board of Pharmacy indicate that Stanley Shaw Scarbrough is the Responsible Pharmacist at Scarbroughs Medical Arts Pharmacy pursuant to Sections 4729.27 and 4729.55 of the Ohio Revised Code and Rule 4729-5-11 of the Ohio Administrative Code.

 

(2)     Scarbroughs Medical Arts Pharmacy did, on or before April 22, 1997, manufacture, sell, hold for sale, or deliver a drug that was adulterated or misbranded, to wit: Scarbroughs Medical Arts Pharmacy compounded or manufactured the following drugs which lacked required labeling information:

 

(a)     Enalapril 2.5mg capsules, #120 capsules: The label has no lot num-ber, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(b)     Fenfluramine 20mg capsules, #30 capsules: The label has a date that can be referenced to an entry on a compounding log; however, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(c)     Hydrocortisone Lotion 2.5%- Stock, 170ml: The label has no lot num-ber, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(d)     5-Hydroxytryptophan 50mg capsules, #190 capsules: The label has a date that can be referenced to an entry on a compounding log; how-ever, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are referenced on the compound-ing log for the bulk medications used to compound or manufacture the drug product.

(e)     5-Hydroxytryptophan 100mg capsules, #135 capsules: The label has no lot number, no expiration date, no date of manufacture or com-pounding, and no method to refer to an entry on a compounding log.

(f)      5-Hydroxytryptophan 200mg capsules, #63 capsules: The label has a lot number that can be referenced to an entry on a compounding log; however, there is no expiration date on the bottle or on the com-pounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(g)     Lidocaine 2.5%/Prilocaine 2.5% in emollient cream base: The label has no lot number, no expiration date, no date of manufacture or com-pounding, and no method to refer to an entry on a compounding log.

(h)     Extra Strength Met-Fuel capsules, #79 capsules: The label has a date that can be referenced to an entry on a compounding log; however, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(i)      Methyltestosterone 5mg capsules, #80 capsules: The label has no lot number, no expiration date, no date of manufacture or compound-ing, and no method to refer to an entry on a compounding log.

(j)      Pregnenolone 10mg capsules, #39 capsules: The label has no lot number, no expiration date, no date of manufacture or compound-ing, and no method to refer to an entry on a compounding log.

(k)     Progesterone 100mg capsules, #25 capsules, Rx# 489790: The label has no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(l)      Progesterone 100mg capsules, #45 capsules: The label has no lot number, no expiration date, no date of manufacture or com-pounding, and no method to refer to an entry on a compounding log.

(m)     Progesterone 20mg capsules, #60 capsules, Rx# 480637: The label has a date that can be referenced to an entry on a compounding log; however, there is no expiration date on the bottle or on the com-pounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(n)     Progesterone 200mg capsules, #35 capsules: The label has a date that can be referenced to an entry on a compounding log; however, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(o)     Progesterone 100mg/Estriol 2.5mg capsules, #70 capsules: The label has no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(p)     Promethasine (sic Promethazine) 25mg capsules, #14 capsules: The label has no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a com-pounding log.

(q)     Salicylic Acid 10%/Formalin 40% in Alcohol, 30ml, Rx# 484034: The label has a date, but it cannot be referenced to an entry on a compounding log; therefore, there is no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(r)      Sertaline 50mg capsules, # 20 capsules: The label has no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(s)     Simvastin 10mg capsules, #40 capsules: The label has a lot number that can be referenced to an entry on a compounding log; however, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(t)      Tri-Hormone capsules, #40 capsules: The label has a date that cannot be referenced to an entry on a compounding log; therefore, there is no lot number, no expiration date, no date of manufacture or com-pounding, and no method to refer to an entry on a compounding log.

(u)     Tri-Hormone-2/50/.4 w/Cal Carb filler capsules, #40 capsules: The label has a date that cannot be referenced to an entry on a com-pounding log; therefore, there is no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(v)     Tri-Hormone capsules, #59 capsules, Rx# 490498: The label has a date, but it cannot be referenced to an entry on a compounding log; therefore, there is no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(w)     Triest Plus Progesterone 200mg capsules, #50 capsules: The label has no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(x)     Triest Plus Pro capsules, #25 capsules and #50 capsules: The label has a lot number that can be referenced to an entry on a com-pounding log; however, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are refer-enced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(y)     Urea 40% ointment: The label has no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(z)     Albuterol 0.083% Inhalant Solution, #61 vials, lot # 971203, exp. date: 7/97:  The label has a lot number and an expiration date but does not indicate the volume per vial.  Additionally, the lot number cannot be referenced to an entry on a compounding log; therefore, no lot numbers can be referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(aa)    Albuterol 0.083% Inhalant Solution, #14 vials, lot # 970204, exp. date: 7/97: The label has a lot number and an expiration date but does not indicate the volume per vial.  Additionally, the lot number cannot be referenced to an entry on a compounding log; therefore, no lot numbers can be referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(bb)   Albuterol 0.083% Inhalant Solution, #3 vials, lot # 961412, exp. date: 5/97:  The label has a lot number and an expiration date but does not indicate the volume per vial.  Additionally, the lot number cannot be referenced to an entry on a compounding log; therefore, no lot numbers can be referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(cc)    Albuterol 0.083% Inhalant Solution, #1 vial, lot # 972402, exp. date: 8/97: The label has a lot number and an expiration date but does not indicate volume per vial.  Additionally, the lot number cannot be ref-erenced to an entry on a compounding log; therefore, no lot numbers can be referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

 

Such conduct is in violation of Section 3715.52(A)(1) of the Ohio Revised Code, Section 331(b) of Title 21 of the United States Code, and Section 201.18 of Title 21 of the Code of Federal Regulations.

 

(3)     Scarbroughs Medical Arts Pharmacy did, on or before April 22, 1997, manufacture, sell, hold for sale, or deliver a drug that was adulterated or misbranded, to wit: Scarbroughs Medical Arts Pharmacy compounded or manufactured the following drugs which were labeled with false and misleading information:

 

(a)     Colloidal Silver Solution: The product is labeled without validation as a “Super Antibiotic” and as an “Antiseptic/Antibiotic”.  The contents of active and inactive ingredients are not listed on the label.  The strength was not initially listed on the label, but currently is listed as 3-5ppm.  5ppm, or 15mcgm silver/tsp. without documentation or validation; therefore, there is no basis for suggested use or dose on label.  There are no warning instructions on label.  Initially no expiration date assigned, then given 1 year expiration date, and finally a 3 month expiration date.  The expiration dates were assigned arbitrarily. (Log present)

(b)     Met-Fuel capsules, all combinations: The complete contents of active and inactive ingredients are not listed on the label.  The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  An expiration date of 1 year was arbitrarily assigned.

(c)     DHEA sublingual tablets, all strengths: The complete contents of active and inactive ingredients are not listed on the label.  The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 1 year arbitrarily assigned.

(d)     DHEA capsules, all strengths: Contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  Expiration dates are arbitrarily assigned. 

(e)     ADD Formula, all combinations: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 3 to 6 months was arbitrarily assigned.  The name of ADD for the product falsely makes one conclude that it is for attention deficit disorder.

(f)      Chicken Collagen Solution: The complete contents of active and inactive ingredients are not listed on the label.  Contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has invalid and incomplete warning instructions.  An expiration date of 1 year was arbitrarily assigned.

(g)     Creatine Monohydrate Powder: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  No expiration date was assigned.

(h)     Creatine Syrup: The complete contents of active and inactive ingredients are not listed on the label.  Contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  No warning instructions on label.  An expiration date of 23 months was arbitrarily assigned.

(i)      Scarbrough’s Diaper Rash Ointment: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 22 months arbitrarily assigned.

(j)      Poison Ivy Gel: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 2 years was arbitrarily assigned.

(k)     Co-Enzyme Q-10 60mg capsules: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 1 year was arbitrarily assigned.

(l)      Herbal Smoke Eliminator capsules: The label was without validation as a “Healthy and Energizing Herbal Synergism to Combat Smoking Habit and Effects”.  The complete contents of active and inactive ingredients are not listed on the label.  The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 1 year was arbitrarily assigned.

 

Such conduct is in violation of Section 3715.52(A)(1) of the Ohio Revised Code and Section 331(b) of Title 21 of the United States Code.

 

(4)     Scarbroughs Medical Arts Pharmacy did, on or before April 22, 1997, sell, deliver, offer for sale, and/or hold for sale a new drug when not in accordance with Section 3715.65 of the Ohio Revised Code, to wit: the following drugs were not tested and found to be safe under the conditions recommended or suggested in its labeling, and prior to selling the drug or offering it for sale, Scarbroughs Medical Arts Pharmacy failed to file an application for new drugs with the director of agriculture:

 

(a)     Colloidal Silver Solution: The product is labeled without validation as a “Super Antibiotic” and as an “Antiseptic/Antibiotic”.  The contents of active and inactive ingredients are not listed on the label.  The strength was not initially listed on the label, but currently is listed as 3-5ppm.  5ppm, or 15mcgm silver/tsp. without documentation or validation; therefore, there is no basis for suggested use or dose on label.  There are no warning instructions on label.  Initially no expiration date assigned, then given 1 year expiration date, and finally a 3 month expiration date.  The expiration dates were assigned arbitrarily. (Log present)  

(b)     Met-Fuel capsules, all combinations: The complete contents of active and inactive ingredients are not listed on the label.  The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  An expiration date of 1 year was arbitrarily assigned. 

(c)     DHEA sublingual tablets, all strengths: The complete contents of active and inactive ingredients are not listed on the label.  The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 1 year arbitrarily assigned.

(d)     DHEA capsules, all strengths Contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  Expiration dates are arbitrarily assigned. 

(e)      ADD Formula, all combinations: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 3 to 6 months was arbitrarily assigned.  The name of ADD for the product falsely makes one conclude that it is for attention deficit disorder.

(f)      Chicken Collagen Solution: The complete contents of active and inactive ingredients are not listed on the label.  Contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has invalid and incomplete warning instructions.  An expiration date of 1 year was arbitrarily assigned.

(g)     Creatine Monohydrate Powder: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  No expiration date was assigned.

(h)     Creatine Syrup: The complete contents of active and inactive ingredients are not listed on the label.  Contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  No warning instructions on label.  An expiration date of 23 months was arbitrarily assigned.

(i)      Scarbrough’s Diaper Rash Ointment: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 22 months arbitrarily assigned.

(j)      Poison Ivy Gel: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 2 years was arbitrarily assigned.

(k)     Co-Enzyme Q-10 60mg capsules: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 1 year was arbitrarily assigned.

(l)      Herbal Smoke Eliminator capsules: The label was without validation as a “Healthy and Energizing Herbal Synergism to Combat Smoking Habit and Effects”.  The complete contents of active and inactive ingredients are not listed on the label.  The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 1 year was arbitrarily assigned.

 

Such conduct is in violation of Section 3715.65(A)(2) of the Ohio Revised Code.

 

(5)     Scarbroughs Medical Arts Pharmacy did, on and prior to May 4, 1998, fail to meet the minimum standards for compounding parenteral or sterile product prescriptions, to wit: the pharmacy’s clean room and/or laminar flow hood had never been certified; thus, all drugs compounded or manufactured in the pharmacy’s laminar flow hood were adulterated.  Such conduct is in violation of Rule 4729-19-04 of the Ohio Administrative Code and Section 3715.63 of the Ohio Revised Code.

 

(6)     Scarbroughs Medical Arts Pharmacy did, on or about the following dates, fail to assign a new serial number to prescriptions that were not refillable, to wit: Scarbroughs Medical Arts Pharmacy filled the following prescriptions and, upon refilling the prescriptions with newly compounded drugs which were not generically equivalent, failed to assign a new serial number to the compounded drug and vice versa:

 

(a)     The following prescriptions were changed by Stanley Shaw Scarbrough:

 

Date of

Change

 

Rx No.

Drug

Initially Dispensed

Second

Drug Dispensed

 

Qty.

07/02/96

472590

Zoloft 50mg

Compounded Sertraline 50mg

30

07/05/96

473954

Albuterol UD

Compounded Albuterol Inhaler

360

07/08/96

464570

Proventil UD

Compounded Albuterol Inhaler

360

07/26/97

476542

Albuterol

Compounded Albuterol Inhaler

360

 

(b)     The following prescriptions were changed by Sue G. Gratz:

 

Date of

Change

 

Rx No.

Drug

Initially Dispensed

Second

Drug Dispensed

 

Qty.

07/02/96

463904

Albuterol UD

Compounded Albuterol Inhaler

360

09/25/96

470127

Albuterol UD

Compounded Albuterol Inhaler

360

10/21/96

476809

Proventil UD

Compounded Albuterol Inhaler

360

06/27/97

485351

Compounded

Albuterol Inhaler

Albuterol UD

180

 

Such conduct is in violation of Rules 4729-5-19, 4729-5-27, and 4729-5-30 of the Ohio Administrative Code, and Section 4729.38 of the Ohio Revised Code.

 

(7)     Scarbroughs Medical Arts Pharmacy did, from on or about June 21, 1996, through June 5, 1997, sell, deliver, offer for sale, and/or hold for sale a new drug when not in accordance with Section 3715.65 of the Ohio Revised Code, to wit: on 213 separate occasions, Stanley Shaw Scarbrough or someone under his supervision at Scarbroughs Medical Arts Pharmacy sold one of the following new drugs prior to being tested and found to be safe under the conditions recommended or suggested in its labeling, and prior to selling the drug or offering it for sale, Scarbroughs Medical Arts Pharmacy failed to file an application for new drugs with the director of agriculture.

 

(a)      Met-Fuel-Caffeine Free: Contents, in part--Ephedrine 1.0gm, L-Carnitine 5.0gm., Chromium Picolinate 0.010gm, and Ginger Root 1.0mg per 100 capsules.

(b)      Met-Fuel: Contents, in part--Ephedrine 1.0gm, Caffeine 10gm, L-Carnitine 5.0gm, Chromium Picolinate 0.010gms, and Ginger Root 1.0gm per 100 capsules.

(c)      Extra Strength Met-Fuel: Contents, in part--Ephedrine 1.0gm, Caffeine 10gm, L-Carnitine 5.0gm, Chromium Picolinate 0.010gm, Ginger Root 1.0gm, and Aspirin 4.05gm per 100 capsules.

 

Such conduct is in violation of Section 3715.65(A)(2) of the Ohio Revised Code.

 

(8)     Scarbroughs Medical Arts Pharmacy did, on or about July 11, 1997, fail to perform prospective drug utilization review and patient counseling, to wit: the pharmacy, when dispensing Extra Strength Met-Fuel to a patient, failed to review the log book for over-utilization, incorrect drug dosage and duration of drug treatment, and misuse; and pharmacists at Scarbroughs Medical Arts Pharmacy failed to offer, and maintain records of, patient counseling.  Such conduct is in violation of Rules 4729-5-20 and 4729-5-22 of the Ohio Administrative Code.

 

(9)     Scarbroughs Medical Arts Pharmacy did, on or about July 11, 1997, sell a schedule V controlled substance product without a prescription, failing to require patient identification and failing to maintain a record of transaction for the sale, to wit: the pharmacy sold Extra Strength Met-Fuel to a patient and failed to require identification to check for the patient’s age, name, address and signature, and failed to maintain a record of the transaction.  Such conduct is in violation of Rule 4729-11-09 of the Ohio Administrative Code.

 

(10)   Scarbroughs Medical Arts Pharmacy did, from on or about June 21, 1996, through July 5, 1997, sell a schedule V controlled substance without a prescrip-tion in an amount exceeding one hundred times the bulk amount when the conduct was not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: throughout this time period the pharmacy made 161 individual sales of Met Fuel for a total of 19,500 unit doses; and, on each occasion, the pharmacy dispensed to each patient over 100 unit doses in a 30-day time period without a legitimate medical purpose.  Such conduct is not in accordance with Rule 4729-11-09 of the Ohio Administrative Code and, therefore, is in violation of Section 2925.03(A) of the Ohio Revised Code.

 

(11)   Scarbroughs Medical Arts Pharmacy did, from on or about October 26, 1996, through June 25, 1997, sell a schedule V controlled substance without a pre-scription in an amount exceeding five times the bulk amount, but in an amount less than fifty times that amount when the conduct was not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: throughout this time period the pharmacy made 40 individual sales of Extra Strength Met Fuel for a total of 4,800 unit doses; and, on each occasion, the pharmacy dispensed to each patient over 100 unit doses in a 30-day time period without a legitimate medical purpose.  Such conduct is not in accordance with Rule 4729-11-09 of the Ohio Administrative Code and, therefore, is in violation of Section 2925.03(A) of the Ohio Revised Code.

 

(12)   Scarbroughs Medical Arts Pharmacy did, on or about April 11, 1997, sell a schedule V controlled substance without a prescription in an amount exceeding the bulk amount, but in an amount less than five times that amount when the conduct was not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: the pharmacy sold 120 unit doses of Met Fuel w/ASA, which allowed the patient to obtain over 100 unit doses in a 30-day time period and not for a legitimate medical purpose.  Such conduct is not in accordance with Rule 4729-11-09 of the Ohio Administrative Code and, there-fore, is in violation of Section 2925.03(A) of the Ohio Revised Code.

 

(13)   Scarbroughs Medical Arts Pharmacy did, prior to May 4, 1998, permit techni-cians to compound prescriptions, to wit: the pharmacy allowed technicians to compound drugs without the supervision of a pharmacist, placing them in a position that requires professional judgment.  The products were never checked for error, weight and content uniformity, drug absorption and/or sterility.  Further, pharmacists at Scarbroughs Medical Arts Pharmacy failed to perform the final check of the finished product.  The following list is an example of the drugs compounded in such a manner:

 

(a)      Albuterol Inhalant 0.83mg/ml: PCCA Compound Number 0021, with violation dates of 6-5-96, 6-13-96, 7-8-96,7-26-96, 8-9-96, 8-12-96, 8-30-96, 10-24-96, 11-12-96, 12-6-96 12-15-96, 12-26-96, 1-20-97, 2-13-97, 4-2-97, 4-11-97, 5-13-97, and 6-26-97 (two pages):  The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(b)     Morphine Sulfate SR 15mg Caps: Scarbrough Pharmacy Compound Number 406, with violation date of 2-19-98:  The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(c)     Phentermine SR 25mg Caps: Scarbrough Pharmacy Compound Number 192, with violation date of 7-2-97: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(d)     Phentermine 25mg SR Capsules: Scarbrough Pharmacy Compound Number 192, with violation dates of 7-24-96, 8-7-96, 8-20-96, 9-24-96, 10-22-96: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.  Additional violation dates of 4-7-97, 5-7-97, and 5-28-97:  The technician signed the pharmacist’s initials.

(e)     Theophylline Slow Release Caps 300mg with CaCO3 as Filler: Scarbrough Pharmacy Compound Number 582, PCCA Compound Number 3183, with violation date of 4-28-97: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist's initials.

(f)      Phentermine 15mg Caps: no Compound Number reference, with violation dates of 2-20-97 and 3-24-97: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist's initials.

(g)     Estriol/Estrone/Estradiol (Triest 2.5mg): Scarbrough Pharmacy Compound Number 374, PCCA Compound Number 2813, with violation dates of 9-20-96, 10-11-96, 11-25-96, 12-20-96, 1-14-97, 3-7-97, 3-31-97, 4-16-97, 5-29-97, 7-1-97, 7-25-97, 8-11-97, 8-22-97, 10-2-97, 10-21-97, 3-16-98, 4-6-98, and 4-29-98 (two pages): The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.  Additional violation dates of 12-5-97, 12-16-97, 1-12-98, 1-23-98, and 2-13-98: The technician signed the pharmacist’s initials.

(h)     Morphine Sulfate Sustained Release Caps 500mg: Scarbrough Pharmacy Compound Number 203, PCCA Compound Number 694, with violation dates of 6-7-96, 7-10-96, and 7-16-96: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist's initials.

(i)      Testosterone 1mg/ml in Vanicream: Compound Number 923, with violation dates of 2-24-98, 2-27-98, 3-2-98, 3-2-98, 3-2-98, 3-3-98, 3-3-98, 3-6-98, 3-26-98, 3-27-98, 3-30-98, 3-31-98, 4-2-98, 4-23-98, 4-27-98, 4-28-98, and 5-4-98 (two pages): The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.  Additional violation dates of 1-19-98, 2-6-98, and 2-24-98: The technician signed the pharmacist’s initials.

(j)      Fenfluramine 20mg Capsules: Scarbrough Pharmacy Compound Number 519, with violation dates of 2-19-97 and 4-1-97: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(k)     Ripped Fuel (Met Fuel) (Manufactured): Scarbrough Pharmacy Compound Number 219, with violation dates of 6-17-96, 6-17-96, 7-1-96, 7-2-96, 7-15-96, 7-16-96, 7-18-96, 7-24-96, 7-25-96, 8-6-96, 8-19-96, 9-6-96, 9-25-96, 10-4-96, 10-9-96, 10-24-96, 11-11-96, and 11-13-96 (two pages): The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(l)      Ex Strength Met-Fuel (Manufactured): Scarbrough Pharmacy Com-pound Number 394, with violation dates of 10-11-96, 11-13-96, and 12-20-96: The log does not indicate the drug lot numbers of the ingredients used, and there is no positive identification of the pharmacists.

(m)     Ex Strength Met-Fuel (Manufactured): Scarbrough Pharmacy Com-pound Number 394, with violation dates of 1-22-97, 2-7-97, 2-18-97, 2-24-97, 3-20-97, 4-2-97, 4-15-97, 5-7-97, 5-24-97, 6-4-97, 6-20-97, and 6-24-97: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.  

(n)     Lidocaine 2.5%/Prilocaine 2.5% in Emollient Cream Base: Scarbrough Pharmacy Compound Number 412, with violation date of 11-1-96: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(o)     Pregnenoline 10mg Capsules: Scarbrough Pharmacy Compound Number SP378, with violation dates of 9-26-96 and 9-27-96: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist's initials..

(p)     Progesterone 100mg Caps: Scarbrough Pharmacy Compound Number 119, with violation date of 7-17-97: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(q)     Progesterone Caps 20mg: Scarbrough Pharmacy Compound Number 322, with violation date of 8-15-96: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(r)     Progesterone 200mg Caps: Scarbrough Pharmacy Compound Number 506, with violation dates of 2-21-97 and 4-1-97: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(s)     Promethazine 25mg Capsule: Scarbrough Pharmacy Compound Number 417, with violation date of 11-8-96: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(t)      Salicylic Acid 10%/Formalin 40%/in Alcohol: Scarbrough Pharmacy Compound Number 26, with violation dates of 6-26-96 and 3-31-97: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(u)     Simvastin 10mg Capsules: Scarbrough Pharmacy Compound Number SP517, with violation date of 3-4-97: The log does not indicate the drug lot numbers of the ingredients used.

(v)     Triest Plus Pro Caps: Scarbrough Pharmacy Compound Number 499, PCCA Compound Number 2813, with violation date of 2-14-97. The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist's initials.

(w)     Triest Plus Pro Test Caps: Scarbrough Pharmacy Compound Number 498, with violation dates of 2-14-97, 3-17-97, and 4-1-97: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist's initials.

(x)     ADD Formula (Manufactured): Scarbrough Pharmacy Compound Number 438, with violation dates of 11-29-96, 12-3-96, and 1-15-97: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(y)     Colloidal Silver (Manufactured): no Compound Number reference, with violation dates  of 10-7-96, 11-16-96, 12-23-96, 12-24-96, 12-26-96, and 12-31-96: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist's initials.

(z)     Colloidal Silver (Manufactured): no Compound Number reference, with violation dates  of 2-5-97 and 3-24-97: The log does not indicate the drug lot numbers of the ingredients used, Scarbrough Pharmacy’s internal lot number, and there is no positive identification of the pharmacists or technicians.  Additional violation date of 1-13-97: The log does not indicate the drug lot numbers of the ingredients used, Scarbrough Pharmacy’s internal lot number, and there is no positive identification of the pharmacist.

 

Such conduct is in violation of Rules 4729-5-25 and 4729-9-21(C) of the Ohio Administrative Code and Section 4729.28 of the Ohio Revised Code.

 

(14)   Scarbroughs Medical Arts Pharmacy did, on or about April 22, 1997, and again on or about May 4, 1998, fail to maintain minimum standards for a pharmacy, to wit: the pharmacy was not equipped with a library containing current literature and references for compounding drugs.  Such conduct violates Rule 4729-9-02 of the Ohio Administrative Code.

 

(15)   Scarbroughs Medical Arts Pharmacy did, from on or about December 26, 1996, through April 22, 1997, sell a misbranded drug, to wit: the pharmacy com-pounded drugs which failed content uniformity, which contained incorrect amounts of ingredients as suggested in the labeling, and/or which contained fillers that had not been approved by the Food and Drug Administration, to wit: the pharmacy compounded Enalapril 5mg capsules dated December 26, 1996, which failed content uniformity.  Such conduct is in violation of Section 3715.52 of the Ohio Revised Code.

 

(16)   Scarbroughs Medical Arts Pharmacy did, on or before September 16, 1998, hold for sale a misbranded drug, to wit: the pharmacy manufactured drugs which failed content uniformity, which contained incorrect amounts of ingredients as suggested in the labeling, and/or which contained fillers that had not been approved by the Food and Drug Administration, to wit: the pharmacy manufactured Colloidal Silver Solution 3 to 5 ppm which failed content uniformity. Such conduct is in violation of Section 3715.52 of the Ohio Revised Code.

 

(17)   Scarbroughs Medical Arts Pharmacy did, on or before May 4, 1998, hold for distribution manufactured sample drugs and furnished manufactured sample drugs to physicians as a marketing tool, to wit: the pharmacy manufactured and distributed Ketoprofen 2% Gel labeled “Sample-Not For Sale”.  Such conduct is in violation of Section 3719.81 of the Ohio Revised Code.

 

(18)   Scarbroughs Medical Arts Pharmacy did, on or before May 4, 1998, fail to keep complete and accurate records in its automated data system, to wit: the pharmacy’s computer system, NDC Data Stat, does not allow a log to be created that documents necessary changes made to a prescription.  Such conduct is in violation of Rule 4729-5-27 of the Ohio Administrative Code and Section 4729.37 of the Ohio Revised Code.

 

(19)   Scarbroughs Medical Arts Pharmacy did, on or about April 22, 1997, manufac-ture, sell, hold for sale, or deliver a drug that was adulterated or misbranded, to wit: an agent of the Board witnessed a technician refill a one pint bottle of Promethazine with Codeine Cough Syrup having NDC 60432606-16 with another brand of a one gallon bottle of Promethazine with Codeine Cough Syrup having NDC 0472-1627-28.  The adulterated or misbranded Prometha-zine with Codeine Cough Syrup was then dispensed by the pharmacy with a label bearing a completely different NDC of  00182-1712-4.  Such conduct is in violation of Section 3715.52(A)(1) of the Ohio Revised Code; Section 331(b) of Title 21 of the United States Code, and Section 201.18 of Title 21 of the Code of Federal Regulations.

 

(1)     Upon consideration of the record as a whole, the State Board of Pharmacy concludes that paragraphs (5), (6), (8) through (14), and (18) of the Findings of Fact constitute violating rules of the Board as provided in Division (A)(2) of Section 4729.57 of the Ohio Revised Code.

 

(2)     Upon consideration of the record as a whole, the State Board of Pharmacy concludes that paragraphs (6), (13), and (18) of the Findings of Fact constitute violating provisions of Chapter 4729. of the Revised Code as provided in Division (A)(3) of Section 4729.57 of the Ohio Revised Code.

 

(3)     Upon consideration of the record as a whole, the State Board of Pharmacy concludes that paragraphs (2) through (5), (7), (15), (16), (17), and (19) of the Findings of Fact constitute violating provisions of the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301, or Chapter 3715. of the Revised Code as provided in Division (A)(4) of Section 4729.57 of the Ohio Revised Code.

 

(4)     Upon consideration of the record as a whole, the State Board of Pharmacy concludes that paragraphs (2), (3), (4), (7), (10), (11), (12), (17), and (19) of the Findings of Fact constitute violating provisions of the federal drug abuse control laws or Chapter 2925. or 3719. of the Revised Code as provided in Division (A)(5) of Section 4729.57 of the Ohio Revised Code.

 

(5)     Upon consideration of the record as a whole, the State Board of Pharmacy concludes that paragraph (3) of the Findings of Fact constitutes falsely or fraudulently promoting to the public a dangerous drug as provided in Division (A)(6) of Section 4729.57 of the Ohio Revised Code.

 

(A)     On the basis of the Findings of Fact and paragraphs (1) and (5) of the Conclusions of Law set forth above, the State Board of Pharmacy hereby suspends for five years the Terminal Distributor of Dangerous Drugs license, No. 02-0114850, held by Scarbroughs Medical Arts Pharmacy effective as of the date of the mailing of this Order.

 

(B)     On the basis of the Findings of Fact and paragraphs (2), (3), and (4) of the Conclusions of Law set forth above, the State Board of Pharmacy hereby imposes a monetary penalty of fifty thousand dollars ($50,000.00) on Scarbroughs Medical Arts Pharmacy effective as of the date of the mailing of this Order.

 

(C)     Further, the Board suspends the suspension imposed in paragraph (A) and forty-five thousand dollars ($45,000.00) of the monetary penalty imposed in paragraph (B), and places Scarbroughs Medical Arts Pharmacy on probation for five years effective as of the date of the mailing of this Order.  The terms of probation are as follows:

 

(1)     The five thousand dollars ($5,000.00) of the monetary penalty that was not suspended is due and owing within thirty days of the mailing of this Order.  The remittance should be made payable to the "Treasurer, State of Ohio" and mailed with the enclosed form to the State Board of Pharmacy, 77 South High Street, Room 1702, Columbus, Ohio 43215-6126.

 

(2)     Scarbroughs Medical Arts Pharmacy must not violate the drug laws of the state of Ohio, any other state, or the federal government.

 

(3)     Scarbroughs Medical Arts Pharmacy must abide by the rules of the State Board of Pharmacy.

 

(4)     Scarbroughs Medical Arts Pharmacy must comply with the terms of this Order.

 

Scarbroughs Medical Arts Pharmacy is hereby advised that the Board may at any time revoke probation for cause, modify the conditions of probation, and reduce or extend the period of probation.  At any time during this period of probation, the Board may revoke probation for a violation occurring during the probation period.

 

 

The motion was seconded by Mr. Kost and approved by the Board (Aye-4/Nay-2).

 

RES. 2001-091  Mr. Kost moved that the Board adopt the following Order in the matter of Stanley Shaw Scarbrough, R.Ph.:

 

(A)     Testimony

 

State's Witnesses:

 

(1)     Mark Keeley, R.Ph., Ohio State Board of Pharmacy

 

Respondent's Witnesses:

 

(1)     Stanley Shaw Scarbrough, R.Ph.

(2)     Sue G. Gratz, R.Ph., Respondent

(3)     Alan Spreen, M.D.

 

(B)     Exhibits

 

State's Exhibits:

 

(1)       Exhibit 1--Copy of nineteen-page Notice of Opportunity for Hearing letter of Stanley Shaw Scarbrough dated May 31, 2000.

(2)       Exhibit 1A--Copy of fourteen-page Notice of Opportunity for Hearing letter of Sue G. Gratz dated May 31, 2000.

(3)       Exhibit 1B--Copy of eighteen-page Notice of Opportunity for Hearing letter of Scarbroughs Medical Arts Pharmacy dated May 31, 2000.

(4)       Exhibit 1C--Hearing Request letter of Stanley Shaw Scarbrough dated June 28, 2000.

(5)       Exhibit 1D--Hearing Request letter of Sue G. Gratz dated June 28, 2000.

(6)       Exhibit 1E--Hearing Request letter of Scarbroughs Medical Arts Pharmacy dated June 28, 2000.

(7)       Exhibit 1F--Copy of Hearing Schedule letter of Scarbrough's Medical Arts Pharmacy, Stanley Shaw Scarbrough, and Sue G. Gratz dated June 30, 2000.

(8)       Exhibit 1G--Copy of Pharmacist File Front Sheet of Stanley Shaw Scarbrough showing original date of registration as May 4, 1979; and two-page copy of Renewal Application for Pharmacist License, No. 03-2-12847, for a license to practice pharmacy in Ohio from September 15, 2000, through September 15, 2001, signed and dated June 27, 2000.

(9)       Exhibit 1H--Copy of Pharmacist File Front Sheet of Sue G. Gratz showing original date of registration as August 8, 1960; and two-page copy of Renewal Application for Pharmacist License, No. 03-3-07246, for a license to practice pharmacy in Ohio from September 15, 2000, through September 15, 2001, signed and dated July 28, 2000.

(10)     Exhibit 1I--Copy of Renewal Application for DDD License No. 02-0114850 for a Terminal Distributor of Dangerous Drugs license from January 1, 2000, through December 31, 2000, signed by Stan Scarbrough and dated September 9, 1999.

(11)     Exhibit 1J--Copy of two-page letter from James F. Flynn dated October 6, 2000.

(12)     Exhibit 1K--Copy of letter from David L. Rowland to James F. Flynn dated October 6, 2000.

(13)     Exhibit 1L--Two-page Request for Continuance letter from James F. Flynn dated November 2, 2000.

(14)     Exhibit 1M--Copy of Continuance Request Response letter dated November 6, 2000.

(15)     Exhibit 1N--Copy of Hearing Schedule letter dated November 9, 2000.

(16)     Exhibit 1O--Copy of Hearing Schedule letter dated November 15, 2000.

(17)     Exhibit 2--Copy of four-page Dangerous Drug Distributor Inspection Report of Scarbroughs Medical Arts Pharmacy, Terminal Distributor No. 02-0114850, dated March 26, 1997; and copy of response to inspection report violations signed by Stan Scarbrough, received in the Board office on March 31, 1997.

(18)     Exhibit 2A--Copy of eight-page Dangerous Drug Distributor Inspection Report of Scarbroughs Medical Arts Pharmacy, Terminal Distributor No. 02-0114850, dated April 22, 1997; and copy of response to inspection report violations signed by Stan Scarbrough, not dated.

(19)     Exhibit 2B--Copy of five-page Dangerous Drug Distributor Inspection Report of Scarbroughs Medical Arts Pharmacy, Terminal Distributor No. 02-0114850, dated May 4, 1998; and copy of three-page response to inspection report violations signed by Stan Scarbrough, dated May 20, 1998.

(20)     Exhibit 3--Copy of FDA forms FDA 481(E)-CG, FDA 481(A)-CG, and FDA 481(C)-CG completed during limited inspection at Scarbrough Medical Arts Pharmacy on April 22-29, 1997, FDA Central File No. 1528698; and copy of ten-page Summary of Findings (EI: 4/22-29/97 MPS) signed by Michael P. Sheehan, not dated.

(21)     Exhibit 3A--Copy of FDA forms FDA 481(E)-CG, FDA 481(A)-CG, and FDA 481(C)-CG completed during limited inspection at Scarbrough Medical Arts Pharmacy on July 8, 9, 1997, FDA Central File No. 1530500; and copy of seventeen-page Summary of Findings (EI: 7/8-9/97 MPS) signed by Michael P. Sheehan, not dated.

(22)     Exhibit 3B--Copy of two-page Response letter for July 8, 9, 1997 inspection results from Stan Scarbrough dated July 22, 1997.

(23)     Exhibit 3C--Copy of two-page FDA Memorandum (Re: Scarbrough Pharmacy's Response Letter to July, 1997 EI) dated August 5, 1997.

(24)     Exhibit 3D--Copy of Collection Report (Form FDA 464) and C/R Continuation Sheet (Form FDA 464a) for Sample No. 97-740-762, collected July 9, 1997, Central File No. 1530500, with the following attachments: copy of two-page e-mail regarding Non-Traditional Drug Bulletin #21 dated June 27, 1997; copy of two-page Warning Letter Draft, not dated.

(25)     Exhibit 4--Letter from Fred L. Dailey, Director of the Ohio Department of Agriculture, dated June 27, 2000.

(26)     Exhibit 5--Two-page letter from Bruce A. Bouts, M.D. signed and dated May 11, 1998, and re-signed and notarized on May 17, 2000.

(27)     Exhibit 5A--Two-page letter from Gary E. Hirschfield, M.D. signed and dated May 27, 1998, and re-signed and notarized on May 17, 2000.

(28)     Exhibit 5B--Letter from Rick D. Watson, M.D. signed and dated May 21, 1998, and re-signed and notarized on May 17, 2000.

(29)     Exhibit 5C--Letter from William H. Kose, M.D. signed and dated May 6, 1998, and re-signed and notarized on May 17, 2000.

(30)     Exhibit 5D--Letter from Sue Best and Seth Brownlee signed and dated July 10, 1997, and re-signed and notarized March 3, 2000.

(31)     Exhibit 5E--Statement of Heather Zehender signed and notarized April 11, 2000.

(32)     Exhibit 5G--Twenty-five-page transcript of interview with Jill Waldron and Heather Zehender by Compliance Agent Dale Fritz and Compliance Specialist Mark Keeley held on March 6, 2000.

(33)     Exhibit 5I--Seventy-six-page transcript of Tape #4-Interview with Stan Scarbrough  by Compliance Specialists Mark Keeley and Joann Predina and Compliance Agent Dale Fritz held on May 4, 1998.

(34)     Exhibit 6--Prescription vial containing 120 capsules of Enalapril 2.5mg.

(35)     Exhibit 7--Copy of Compounding Log for Enalapril 2.5mg capsules, Scarbrough Pharmacy Compound No. 167.

(36)     Exhibit 8--Prescription vial containing 30 capsules of Fenfluramine 20mg.

(37)     Exhibit 9--Copy of Compounding Log for Fenfluramine 20mg capsules, Scarbrough Pharmacy Compound No. 519.

(38)     Exhibit 10--Amber bottle labeled "Stock" containing 170ml of Hydrocortisone Lotion 2.5%.

(39)     Exhibit 11--Copy of Compounding Log for Hydrocortisone Lotion 2.5%, Scarbrough Pharmacy Compound No. 249.

(40)     Exhibit 12--Prescription vial containing 190 capsules of 5-Hydroxytryptophan 50mg.

(41)     Exhibit 13--Copy of Compounding Log for 5-Hydroxytryptophan 50mg, Scarbrough Pharmacy Compound No. 454.

(42)     Exhibit 14--Prescription vial containing 135 capsules of 5-Hydroxytryptophan 100mg.

(43)     Exhibit 15--Copy of Compounding Log for 5-Hydroxytryptophan 100mg, Scarbrough Pharmacy Compound No. 486.

(44)     Exhibit 16--Prescription vial containing 63 capsules of 5-Hydroxytryptophn 200mg.

(45)     Exhibit 17--Copy of Compounding Log for 5-Hydroxytryptophn 200mg, Scarbrough Pharmacy Compound No. 516.

(46)     Exhibit 18--White jar containing Lidocaine 2.5%/Prilocaine 2.5% cream.

(47)     Exhibit 19--Copy of Compounding Log for Lidocaine 2.5%/Prilocaine 2.5%, Scarbrough Pharmacy Compound No. 412.

(48)     Exhibit 20--Prescription vial containing 79 capsules of Extra Strength Met-Fuel

(49)     Exhibit 21--Copy of Compounding Log for Extra Strength Met-Fuel, Scarbrough Pharmacy Compound No. 394.

(50)     Exhibit 22--Prescription vial containing 80 capsules of Methyltestosterone 5mg

(51)     Exhibit 23--Copy of Compounding Log for Methyltestosterone 5mg, Scarbrough Pharmacy Compound No. 472.

(52)     Exhibit 24--Prescription vial containing 39 capsules of Pregnenolone 10mg.

(53)     Exhibit 25--Copy of Compounding Log for Pregnenolone 10mg, Scarbrough Pharmacy Compound No. 378.

(54)     Exhibit 26--Prescription vial containing 25 capsules of Progesterone 100mg with Prescription No. 489790 label.

(55)     Exhibit 27--Copy of Compounding Log for Progesterone 100mg, Scarbrough Pharmacy Compound No. 119.

(56)     Exhibit 28--Prescription vial containing 45 capsules of Progesterone 100mg

(57)     Exhibit 29--Prescription vial containing 60 capsules of Progesterone 20mg with Prescription No. 480637 label.

(58)     Exhibit 30--Copy of Compounding Log for Progesterone 20mg, Scarbrough Pharmacy Compound No. 322.

(59)     Exhibit 31--Prescription vial containing 35 capsules of Progesterone 200mg.

(60)     Exhibit 32--Copy of Compounding Log for Progesterone 200mg, Scarbrough Pharmacy Compound No. 506.

(61)     Exhibit 33--Prescription vial containing 70 capsules of Progesterone 100mg/-Estriol 2.5mg.

(62)     Exhibit 34--Copy of Compounding Log for Progesterone 100mg/Estriol 2.5mg, Scarbrough Pharmacy Compound No. 483.

(63)     Exhibit 35--Prescription vial containing 14 capsules of Promethazine 25mg.

(64)     Exhibit 36--Copy of Compounding Log for Promethazine 25mg, Scarbrough Pharmacy Compound No. 417.

(65)     Exhibit 37--Amber bottle containing 30ml of Salicylic Acid 10%/Formalin 40% with Prescription No. 484034 label.

(66)     Exhibit 38--Copy of Compounding Log for Salicylic Acid 10%/Formalin 40%, Scarbrough Pharmacy Compound No. 26.

(67)     Exhibit 39--Prescription vial containing 20 capsules of Sertaline 50mg.

(68)     Exhibit 40--Copy of Compounding Log for Sertaline 50mg capsules, Scarbrough Pharmacy Compound No. 193.

(69)     Exhibit 41--Prescription vial containing 40 capsules of Simvastin 10mg.

(70)     Exhibit 42--Copy of Compounding Log for Simvastin 10mg capsules, Scarbrough Pharmacy Compound No. 517.

(71)     Exhibit 43--Prescription vial containing 40 capsules of Tri-Hormone.

(72)     Exhibit 44--Copy of Compounding Log for Tri-Hormone capsules, Scarbrough Pharmacy Compound No. 521.

(73)     Exhibit 45--Prescription vial containing 40 capsules of Tri-Hormone-2/50/.4 w/Cal Carb Filler.

(74)     Exhibit 46--Copy of Compounding Log for Tri-Hormone-2/50/.4 w/Cal Carb Filler, Scarbrough Pharmacy Compound No. 521.

(75)     Exhibit 47--Prescription vial containing 59 capsules of Tri-Hormone with Prescription No. 490498 label.

(76)     Exhibit 48--Prescription vial containing 50 capsules of Triest Plus Progesterone 200mg.

(77)     Exhibit 49--Copy of Compounding Log for Triest Plus Progesterone 200mg, Scarbrough Pharmacy Compound No. 566.

(78)     Exhibit 50--Prescription vial containing 25 capsules of Triest Plus Pro.

(79)     Exhibit 51--Prescription vial containing 50 capsules of Triest Plus Pro.

(80)     Exhibit 52--Copy of Compounding Log for Triest Plus Pro capsules, Scarbrough Pharmacy Compound No. 499.

(81)     Exhibit 53--White jar containing Urea 40% Ointment.

(82)     Exhibit 54--Copy of Compounding Log for Urea 40% Ointment, PCCA Com-pound No. 3244.

(83)     Exhibit 55--Sixty-one clear dosette vials containing Albuterol 0.083% Inhalant Solution with Lot No. 971203 label.

(84)     Exhibit 56--Fourteen clear dosette vials containing Albuterol 0.083% Inhalant Solution with Lot No. 970204 label.

(85)     Exhibit 57--Three clear dosette vials containing Albuterol 0.083% Inhalant Solution with Lot No. 961412 label.

(86)     Exhibit 58--Clear dosette vial containing Albuterol 0.083% Inhalant Solution with Lot No. 972402 label.

(87)     Exhibit 59--Copy of two-page Compounding Log for Albuterol 0.083% Inhalant Solution, PCCA Compound No. 0021.

(88)     Exhibit 60--Two copies of label for 4oz. of Colloidal Silver showing Lot No. 970201.

(89)     Exhibit 61--Copy of label for 1oz. of Colloidal Silver showing Lot No. 960409.

(90)     Exhibit 62--Copy of label for 2oz. of Colloidal Silver showing Lot No. 961511.

(91)     Exhibit 63--Label for 4oz. of Colloidal Silver showing Lot No. 972403.

(92)     Exhibit 64--Copy of label for 8oz. of Colloidal Silver showing Lot No. 971504.

(93)     Exhibit 65--Copy of label for 4oz. of Colloidal Silver showing Lot No. 971904.

(94)     Exhibit 66--Copy of Compounding Log for Colloidal Silver, no Compound No. listed.

(95)     Exhibit 67--Copy of label for 120 capsules of Met-Fuel showing Lot No. 962012.

(96)     Exhibit 68--Copy of Compounding Log for Met-Fuel capsule, Scarbrough Pharmacy Compound No. 219.

(97)     Exhibit 69--Prescription vial containing 100 capsules of Extra Strength Met-Fuel with Lot No. 972406 label.

(98)     Exhibit 71--Copy of label for DHEA 5mg Sublingual Tablets showing Lot No. 962407.

(99)     Exhibit 72--Copy of Compounding Log for DHEA 5mg sublingual tablets, Scarbrough Pharmacy Compound No. 253 and PCCA Compound No. 0907.

(100)   Exhibit 73--Copy of label for DHEA 25mg capsules showing Lot No. 970701.

(101)   Exhibit 74--Copy of Compounding Log for DHEA 25mg capsules, Scarbrough Pharmacy Compound No. 127.

(102)   Exhibit 75--Copy of label for DHEA 50mg capsules showing Lot No. 971703.

(103)   Exhibit 76--Copy of Compounding Log for DHEA 50mg capsules, Scarbrough Pharmacy Compound No. 218.

(104)   Exhibit 77--Copy of label for ADD Formula #529 showing Lot No. 972703.

(105)   Exhibit 78--Copy of Compounding Log for ADD Formula #529, Scarbrough Pharmacy Compound No. 529.

(106)   Exhibit 79--Copy of label for ADD Formula #468 showing Lot No. 970201.

(107)   Exhibit 80--Copy of Compounding Log for ADD Formula #468, Scarbrough Pharmacy Compound No. 468.

(108)   Exhibit 81--Copy of label for ADD Formula #438 (Modified) showing Lot No. 971501.

(109)   Exhibit 82--Copy of Compounding Log for ADD Formula #438, Scarbrough Pharmacy Compound No. 438.

(110)   Exhibit 83--Copy of label for ADD Formula #441 showing Lot No. 971004.

(111)   Exhibit 84--Copy of Compounding Log for ADD Formula #441, Scarbrough Pharmacy Compound No. 441.

(112)   Exhibit 85--Copy of label for 100cc of Chicken Collagen Solution showing Lot No. 971103.

(113)   Exhibit 86--Label for 500gm of Creatine Monohydrate Powder 99% showing Lot No. 971503; and label for 90 capsules of Herbal Smoke Eliminator showing Lot No. 971503.

(114)   Exhibit 87--Copy of label for 120cc of Creatine Syrup showing Lot No. 960612.

(115)   Exhibit 88--Copy of label for Scarbrough's Diaper Rash Ointment showing Lot No. 970904.

(116)   Exhibit 89--Copy of label for 2oz of Poison Ivy Gel showing Lot No. 960908.

(117)   Exhibit 90--Copy of label for 30 Co-Enzyme Q-10 60mg capsules showing Lot No. 971504.

(118)   Exhibit 91--Copy of Compounding Log for Herbal Smoke Eliminator, no Compound No. listed.

(119)   Exhibit 94--Twenty-page printout of Scarbrough Pharmacy Prescription Log for Albuterol for the period from January 1, 1996, to July 8, 1997.

(120)   Exhibit 95--Prescription No. 463904,dated 10/16/95, for Albuterol.

(121)   Exhibit 96--Prescription No. 464570, dated 12/04/1995, for Proventil.

(122)   Exhibit 97--Prescription No. 473954, dated 4/22/96, for Albuterol.

(123)   Exhibit 98--Prescription No. 476542, dated 6/4/96, for Albuterol.

(124)   Exhibit 101--Prescription No. 485351, dated 11-5-96, for Albuterol.

(125)   Exhibit 108--Two-page printout of Scarbrough Pharmacy Prescription Log for Sertraline for the period from January 1, 1996, to July 8, 1997.

(126)   Exhibit 108a--Two-page printout of Scarbrough Pharmacy Prescription Log for Zoloft for the period from January 1, 1996, to July 8, 1997.

(127)   Exhibit 109--Prescription No. 472590, dated 3-29-96, for Zoloft.

(128)   Exhibit 110--Prescription No. 470127, dated 2/23/96, for Albuterol.

(129)   Exhibit 111--Prescription No. 476809, dated 06/10/1996, for Proventil.

(130)   Exhibit 137--Exempt Narcotics Register from January 27, 1996, to July 5, 1997.

(131)   Exhibit 138--Three-page Section 3719.44 of the Ohio Revised Code (ORC) titled "Authority of board of pharmacy to change schedules".

(132)   Exhibit 139--Rule 4729-11-09 of the Ohio Administrative Code (OAC) titled "Sale of schedule V controlled substance products without a prescription".

(133)   Exhibit 140--Copy of Compounding Log for Morphine Sulfate SR 15mg capsules, Scarbrough Pharmacy Compound No. 406.

(134)   Exhibit 141--Copy of two-page Compounding Log for Phentermine SR 25mg capsules, Scarbrough Pharmacy Compound No. 192.

(135)   Exhibit 142--Copy of Compounding Log for Theophylline 300mg Slow Release capsules, Scarbrough Pharmacy Compound No. 582 and PCCA Compound No. 3183.

(136)   Exhibit 143--Copy of Compounding Log for Phentermine 15mg capsules, no Compound No. listed.

(137)   Exhibit 144--Copy of two-page Compounding Log for Triest 2.5mg, Scarbrough Pharmacy Compound No. 374 and PCCA Compound No. 2813.

(138)   Exhibit 145--Copy of Compounding Log for Morphine Sulfate SR 500mg capsules, Scarbrough Pharmacy Compound No. 203 and PCCA Compound No. 694.

(139)   Exhibit 146--Copy of Compounding Log for Testosterone 1mg/ml in Vanicream, Scarbrough Pharmacy Compound No. 923.

(140)   Exhibit 147--Copy of Compounding Log for Triest Plus Pro Test capsules, Scarbrough Pharmacy Compound No. 498.

(141)   Exhibit 148--Twenty-four-page Table3 product list dated September 24, 1998, and Page 22 of Table3 product list dated August 7, 1998.

(142)   Exhibit 149--Two-page Ohio State Board of Pharmacy Report of Investigation by William F. McMillen dated April 5, 1999.

(143)   Exhibit 150--Two-page printout of VitaminUSA web page titled "Welcome to VitaminUSA".

(144)   Exhibit 151--Two-page printout of VitaminUSA web page titled "Men's Health".

(145)   Exhibit 152--Printout of VitaminUSA web page titled "Testosterone".

(146)   Exhibit 153--Printout of VitaminUSA web page titled "Your Shopping Basket" completed for Testosterone.

(147)   Exhibit 154--Printout of VitaminUSA web page titled "Shipping Form" completed for Testosterone to Bill McMillen.

(148)   Exhibit 155--Two-page printout of VitaminUSA web page titled "Billing Form" to Bill McMillen and printout of VitaminUSA web page titled "Order Confirmation" to Bill McMillen.

(149)   Exhibit 156--VitaminUSA Invoice No. 0174 dated March 31, 1999 to Bill McMillen.

(150)   Exhibit 157--Stock bottle containing 60 tablets of Nurivention Targeted Dietary Supplement for Testosterone Plus Ester C.

(151)   Exhibit 158--Printout of three VitaminUSA web pages dated May 23, 2000, titled "Testosterone", "Men's Health", and "VitaminUSA.com", and printout of two-page Scarbrough Pharmacy web page dated May 23, 2000.

(152)   Exhibit 160--FDA letter with Summary of Enalapril analysis results from Steven P. Eastham dated August 12, 1997 with copies of twelve pages of selected analysis records attached.

(153)   Exhibit 161--Copy of FDA Memorandum from Charles S. Price dated August 25, 1997 regarding his conversation with Stan Scarbrough.

(154)   Exhibit 162--Copy of FDA Memorandum by Charles J. Ganley, M.D. dated September 16, 1997 regarding Enalapril potential health hazard.

(155)   Exhibit 163--Copy of e-mail from Bob Lamb to Bruce Bouts with analysis results of Colloidal Silver dated September 16, 1998.

(156)   Exhibit 164--Ketoprofen 2% Gel labeled "Sample-Not for Sale".

(157)   Exhibit 165--Two-page letter from Gary E. Hirschfeld, M.D. signed and dated October 29, 1999, and re-signed and notarized on May 17, 2000.

(158)   Exhibit 166--Letter from James R. Robertson, M.D. and Bruce A. Bouts, M.D. signed and dated October 26, 1999 and re-signed by Bruce A. Bouts and notarized on May 17, 2000.

(159)   Exhibit 167--Two-page letter regarding Wilson's Syndrome from Bruce Bouts, M.D., R.Ph. and the following attachments: copy of Scarbrough Pharmacy advertisement regarding Wilson's Syndrome in The Courier, Findlay, Ohio, December 22, 1999, issue; copy of two-page "The Mortar and Pestle" news-letter from Scarbrough Pharmacy dated November 1999; two-page copy of article titled "Naturopath Charged with Unprofessional Conduct" by Stephen Barrett, M.D. dated December 6, 1999; copy of pages 3 and 4 of web page http://www.quackwatch.com/01QuackeryRelatedTopics/fad.html dated December 6, 1999.

(160)   Exhibit 168--"Worst Pills Best Pills News", March 2000 Vol. 6 No. 3, pages 17 through 24.

(161)   Exhibit 169--Copy of Thyroid.org web page dated February 24, 2000, and copy of three-page American Thyroid Association Statement on "Wilson's Syndrome" dated February 24, 2000.

(162)   Exhibit 170--Stock bottle for MGP Promethazine w/Codeine Cough Syrup labeled with NDC 60432-606-16, but containing in part a different syrup with NDC 0472-1627-28.

(163)   Exhibit 172--Copy of Sections 4731.34 (Unauthorized practice of medicine, surgery or podiatry) and 4731.41 (Practice of medicine or surgery without certificate) of the Ohio Revised Code.

(164)   Exhibit 173--Eight-page copy of Section 321 (Definitions; generally) of Title 21, US Code.

(165)   Exhibit 174--Three-page copy of Section 3715.01 (Definitions) of the Ohio Revised Code.

(166)   Exhibit 176--Information Sheet showing "Suggested Formula for Albuterol Inhalant, 1 Liter", and "Suggested Compounding Procedure", dated August 17, 1993.

 

Respondent's Exhibits:

 

(1)     Exhibit A--Copy of Dangerous Drug Distributor Inspection Report of Scarbrough's Medical Arts Pharmacy signed and dated July 17, 1996.

(2)     Exhibit B--Copy of Dangerous Drug Distributor Inspection Report of Scarbrough's Medical Arts Pharmacy signed and dated October 25, 2000.

(3)     Exhibit C--Copy of two-page letter to James R. Robertson, M.D. and Bruce A. Bouts, M.D. from Stanley S. Scarbrough dated December 20, 1999.

(4)     Exhibit D--Copy of eight-page Scarbrough Pharmacy Log of Scripts for prescriptions filled between February 1, 2000, and October 30, 2000, dated October 30, 2000.

(5)     Exhibit E--Copy of letter from Sharon A. Carlson dated October 26, 2000.

(6)     Exhibit F--Copy of letter from Mary Basinger dated November 6, 2000.

(7)     Exhibit G--Copy of two-page table sorted by Program and Program Date and two-page table sorted by person, both dated November 2, 2000.

(8)     Exhibit H--Copy of two-page letter from Judy Patton dated November 1, 2000.

(9)     Exhibit I--Copy of pages 2698, 2700, 2701, and 2702 of the First Supplement, USP-NF, not dated.

(10)   Exhibit J--Copy of letter from Susan Alger dated October 31, 2000.

(11)   Exhibit K--Copy of two-page letter from Carol J. Hicks, M.D. dated November 7, 2000.

(12)   Exhibit L--Copy of letter from Carol J. Hicks, M.D. dated December 18, 1998.

(13)   Exhibit M--Copy of pages 344 through 351 of International Journal of Pharmaceutical Compounding, Vol. 3 No. 5, September/October 1999.

(14)   Exhibit N--Copy of pages 180 and 181 of International Journal of Pharmaceutical Compounding, Vol. 4 No. 3, May/June 2000.

(15)   Exhibit O--Copy of letter to Bruce Bouts, M.D. from Stan Scarbrough, not dated.

(16)   Exhibit P--List of Scarbrough's Medical Arts Pharmacy Library Contents dated October, 2000.

(17)   Exhibit Q--Copy of six-page "Good Compounding Practices Applicable to State Licensed Pharmacies" dated November 7, 2000.

(18)   Exhibit R--Copy of letter from Gwynn Jelden, M.D. dated October 25, 2000.

(19)   Exhibit S--Copy of letter from Jeanne L. Ashworth, M.D. dated October 25, 2000.

(20)   Exhibit T--Copy of two PCCA Certificates of Completion for program titled "Primary Compounding Techniques" on June 24 & 25, 1996 issued to Sue Gratz, R.Ph. and Carole Gill, Technician.

(21)   Exhibit U--Copy of nine-page information paper about "Methocel E4MÒ Premium (Hydroxypropylmethylcellulose (HPMC))".

(22)   Exhibit V--Copy of prescription for 500cc of ADD #441 dated August 14; copy of Logged Formula Worksheet for ADD Formula Liq dated August 17, 2000; copy of prescription for 8oz.of Colloidal Silver 20 PPM; and copy of Logged Formula Worksheet for Colloidal Silver Liquid dated September 6, 2000.

(23)   Exhibit W--Copy of letter from Michael G. Scherer, D.O. dated December 6, 2000.

(24)   Exhibit X--Copy of letter from Lyle T. Calcamuggio, M.D. dated December 11, 2000.

(25)   Exhibit Y--Copy of letter from Jay W. Nielsen, M.D., not dated.

(26)   Exhibit Z--Copy of letter from Robert R. Summers, D.O. and Lorie A. Thomas, D.O. dated December 8, 2000.

(27)   Exhibit AA--Copy of letter from L. Terry Chappell, M.D. dated December 7, 2000.

(28)   Exhibit BB--Copy of two-page letter from James C. Roberts Jr., M.D. dated December 5, 2000.

(29)   Exhibit CC--Copy of letter from Gwynn Jelden, M.D. dated November 29, 2000.

(30)   Exhibit DD--Copy of letter from John C. Biery, D.O. dated December 4, 2000.

 

(1)     Records of the State Board of Pharmacy indicate that Stanley Shaw Scarbrough was originally licensed in the state of Ohio on May 4, 1979, pursuant to examination, and is currently licensed to practice pharmacy in the state of Ohio.  Records further reflect that Stanley Shaw Scarbrough is the Responsible Pharmacist at Scarbroughs Medical Arts Pharmacy pursuant to Sections 4729.27 and 4729.55 of the Ohio Revised Code and Rule 4729-5-11 of the Ohio Administrative Code.

 

(2)     Stanley Shaw Scarbrough did, as the Responsible Pharmacist, on or before April 22, 1997, manufacture, sell, hold for sale, or deliver a drug that was adulterated or misbranded, to wit: Stanley Shaw Scarbrough and/or a phar-macist or technician under his supervision compounded or manufactured the following drugs which lacked required labeling information:

 

(a)     Enalapril 2.5mg capsules, #120 capsules: The label has no lot num-ber, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(b)     Fenfluramine 20mg capsules, #30 capsules: The label has a date that can be referenced to an entry on a compounding log; however, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(c)     Hydrocortisone Lotion 2.5%- Stock, 170ml: The label has no lot num-ber, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(d)     5-Hydroxytryptophan 50mg capsules, #190 capsules: The label has a date that can be referenced to an entry on a compounding log; however, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(e)     5-Hydroxytryptophan 100mg capsules, #135 capsules: The label has no lot number, no expiration date, no date of manufacture or com-pounding, and no method to refer to an entry on a compounding log.

(f)      5-Hydroxytryptophan 200mg capsules, #63 capsules: The label has a lot number that can be referenced to an entry on a compounding log; however, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(g)     Lidocaine 2.5%/Prilocaine 2.5% in emollient cream base: The label has no lot number, no expiration date, no date of manufacture or com-pounding, and no method to refer to an entry on a compounding log.

(h)     Extra Strength Met-Fuel capsules, #79 capsules: The label has a date that can be referenced to an entry on a compounding log; however, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(i)      Methyltestosterone 5mg capsules, #80 capsules: The label has no lot number, no expiration date, no date of manufacture or compound-ing, and no method to refer to an entry on a compounding log.

(j)      Pregnenolone 10mg capsules, #39 capsules: The label has no lot number, no expiration date, no date of manufacture or com-pounding, and no method to refer to an entry on a compounding log.

(k)     Progesterone 100mg capsules, #25 capsules, Rx# 489790: The label has no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(l)      Progesterone 100mg capsules, #45 capsules: The label has no lot number, no expiration date, no date of manufacture or compound-ing, and no method to refer to an entry on a compounding log.

(m)     Progesterone 20mg capsules, #60 capsules, Rx# 480637: The label has a date that can be referenced to an entry on a compounding log; however, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(n)     Progesterone 200mg capsules, #35 capsules: The label has a date that can be referenced to an entry on a compounding log; however, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(o)     Progesterone 100mg/Estriol 2.5mg capsules, #70 capsules: The label has no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(p)     Promethasine (sic Promethazine) 25mg capsules, #14 capsules: The label has no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a com-pounding log.

(q)     Salicylic Acid 10%/Formalin 40% in Alcohol, 30ml, Rx# 484034: The label has a date, but it cannot be referenced to an entry on a compounding log; therefore, there is no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(r)      Sertaline 50mg capsules, # 20 capsules: The label has no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(s)     Simvastin 10mg capsules, #40 capsules: The label has a lot number that can be referenced to an entry on a compounding log; however, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(t)      Tri-Hormone capsules, #40 capsules: The label has a date that cannot be referenced to an entry on a compounding log; therefore, there is no lot number, no expiration date, no date of manufacture or com-pounding, and no method to refer to an entry on a compounding log.

(u)     Tri-Hormone-2/50/.4 w/Cal Carb filler capsules, #40 capsules: The label has a date that cannot be referenced to an entry on a com-pounding log; therefore, there is no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(v)     Tri-Hormone capsules, #59 capsules, Rx# 490498: The label has a date, but it cannot be referenced to an entry on a compounding log; therefore, there is no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(w)     Triest Plus Progesterone 200mg capsules, #50 capsules: The label has no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(x)     Triest Plus Pro capsules, #25 capsules and #50 capsules: The label has a lot number that can be referenced to an entry on a compound-ing log; however, there is no expiration date on the bottle or on the compounding log.  Additionally, no lot numbers are referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(y)     Urea 40% ointment: The label has no lot number, no expiration date, no date of manufacture or compounding, and no method to refer to an entry on a compounding log.

(z)     Albuterol 0.083% Inhalant Solution, #61 vials, lot # 971203, exp. date: 7/97:  The label has a lot number and an expiration date but does not indicate the volume per vial.  Additionally, the lot number cannot be referenced to an entry on a compounding log; therefore, no lot numbers can be referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(aa)    Albuterol 0.083% Inhalant Solution, #14 vials, lot # 970204, exp. date: 7/97: The label has a lot number and an expiration date but does not indicate the volume per vial.  Additionally, the lot number cannot be referenced to an entry on a compounding log; therefore, no lot numbers can be referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(bb)   Albuterol 0.083% Inhalant Solution, #3 vials, lot # 961412, exp. date: 5/97:  The label has a lot number and an expiration date but does not indicate the volume per vial.  Additionally, the lot number cannot be referenced to an entry on a compounding log; therefore, no lot numbers can be referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

(cc)    Albuterol 0.083% Inhalant Solution, #1 vial, lot # 972402, exp. date: 8/97: The label has a lot number and an expiration date but does not indicate volume per vial.  Additionally, the lot number cannot be referenced to an entry on a compounding log; therefore, no lot numbers can be referenced on the compounding log for the bulk medications used to compound or manufacture the drug product.

 

Such conduct is in violation of Section 3715.52(A)(1) of the Ohio Revised Code, Section 331(b) of Title 21 of the United States Code, and Section 201.18 of Title 21 of the Code of Federal Regulations.

 

(3)     Stanley Shaw Scarbrough did, as the Responsible Pharmacist, on or before April 22, 1997, manufacture, sell, hold for sale, or deliver a drug that was adulter-ated or misbranded, to wit: Stanley Shaw Scarbrough and/or a pharmacist or technician under his supervision compounded or manufactured the following drugs which were labeled with false and misleading information:

 

(a)     Colloidal Silver Solution: The product is labeled without validation as a “Super Antibiotic” and as an “Antiseptic/Antibiotic”.  The contents of active and inactive ingredients are not listed on the label.  The strength was not initially listed on the label, but currently is listed as 3-5ppm.  5ppm, or 15mcgm silver/tsp. without documentation or validation; therefore, there is no basis for suggested use or dose on label.  There are no warning instructions on label.  Initially no ex-piration date assigned, then given 1 year expiration date, and finally a 3 month expiration date.  The expiration dates were assigned arbitrarily.  The manufacturer is not noted on log.

(b)     Met-Fuel capsules, all combinations: The complete contents of active and inactive ingredients are not listed on the label.  The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  An expiration date of 1 year was arbitrarily assigned.   The manufacturer is not noted on log or the log does not indicate the ingredients, lot number and valid expiration dates or positive identification of the pharmacist responsible for verification.

(c)      DHEA 5mg sublingual tablets: The complete contents of active and inactive ingredients are not listed on the label.  The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 1 year arbitrarily assigned.

(d)     DHEA 25mg and 50mg capsules: Contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  Expiration dates are arbitrarily assigned. The manufacturer is not noted on log or the log does not indicate the ingredients, lot number and valid expiration dates or positive identification of the pharmacist responsible for verification.

(e)     ADD Formula, all combinations: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 3 to 6 months was arbitrarily assigned.  The name of ADD for the product falsely makes one conclude that it is for attention deficit disorder. The manufacturer is not noted on log or the log does not indicate the ingredients, lot number and valid expiration dates or positive identification of the pharmacist responsible for verification.

(f)      Chicken Collagen Solution: The complete contents of active and inactive ingredients are not listed on the label.  Contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has invalid and incomplete warning instructions.  An expiration date of 1 year was arbitrarily assigned.

(g)     Creatine Monohydrate Powder: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  No expiration date was assigned.

(h)     Creatine Syrup: The complete contents of active and inactive ingredients are not listed on the label.  Contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  No warning instructions on label.  An expiration date of 23 months was arbitrarily assigned.

(i)      Scarbrough’s Diaper Rash Ointment: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 22 months arbitrarily assigned.

(j)      Poison Ivy Gel: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 2 years was arbitrarily assigned.

(k)     Co-Enzyme Q-10 60mg capsules: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 1 year was arbitrarily assigned.

(l)      Herbal Smoke Eliminator capsules: The label was without validation as a “Healthy and Energizing Herbal Synergism to Combat Smoking Habit and Effects”.  The complete contents of active and inactive ingredients are not listed on the label.  The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instruc-tions.  An expiration date of 1 year was arbitrarily assigned.  The manufacturer of the product is not listed on the log.

 

Such conduct is in violation of Section 3715.52(A)(1) of the Ohio Revised Code; and Section 331(b) of Title 21 of the United States Code.

 

(4)     Stanley Shaw Scarbrough did, as the Responsible Pharmacist, on or before April 22, 1997, sell, deliver, offer for sale, and/or hold for sale a new drug when not in accordance with Section 3715.65 of the Ohio Revised Code, to wit: the following drugs were not tested and found to be safe under the conditions recommended or suggested in its labeling, and prior to selling the drug or offering it for sale, Stanley Shaw Scarbrough failed to file an application for new drugs with the director of agriculture:

 

(a)     Colloidal Silver Solution: The product is labeled without validation as a “Super Antibiotic” and as an “Antiseptic/Antibiotic”.  The contents of active and inactive ingredients are not listed on the label.  The strength was not initially listed on the label, but currently is listed as 3-5ppm.  5ppm, or 15mcgm silver/tsp. without documentation or validation; therefore, there is no basis for suggested use or dose on label.  There are no warning instructions on label.  Initially no expiration date assigned, then given 1 year expiration date, and finally a 3 month expiration date.  The expiration dates were assigned arbitrarily.  The manufacturer is not noted on log.

(b)     Met-Fuel capsules, all combinations: The complete contents of active and inactive ingredients are not listed on the label.  The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  An expiration date of 1 year was arbitrarily assigned.   The manufacturer is not noted on log or the log does not indicate the ingredients, lot number and valid expiration dates or positive identification of the pharmacist responsible for verification.

(c)     DHEA 5mg sublingual tablets: The complete contents of active and inactive ingredients are not listed on the label.  The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 1 year arbitrarily assigned.

(d)     DHEA 25mg and 50mg capsules: Contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  Expiration dates are arbitrarily assigned. The manufacturer is not noted on log or the log does not indicate the ingredients, lot number and valid expiration dates or positive identification of the pharmacist responsible for verification.

(e)     ADD Formula, all combinations: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 3 to 6 months was arbitrarily assigned.  The name of ADD for the product falsely makes one conclude that it is for attention deficit disorder. The manufacturer is not noted on log or the log does not indicate the ingredients, lot number and valid expiration dates or positive identification of the pharmacist responsible for verification.

(f)      Chicken Collagen Solution: The complete contents of active and inactive ingredients are not listed on the label.  Contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has invalid and incomplete warning instructions.  An expiration date of 1 year was arbitrarily assigned.

(g)     Creatine Monohydrate Powder: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  No expiration date was assigned.

(h)     Creatine Syrup: The complete contents of active and inactive ingredients are not listed on the label.  Contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  No warning instructions on label.  An expiration date of 23 months was arbitrarily assigned.

(i)      Scarbrough’s Diaper Rash Ointment: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 22 months arbitrarily assigned.

(j)      Poison Ivy Gel: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 2 years was arbitrarily assigned.

(k)     Co-Enzyme Q-10 60mg capsules: The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instructions.  An expiration date of 1 year was arbitrarily assigned.

(l)      Herbal Smoke Eliminator capsules: The label was without validation as a “Healthy and Energizing Herbal Synergism to Combat Smoking Habit and Effects”.  The complete contents of active and inactive ingredients are not listed on the label.  The contents listed are invalid due to lack of end product testing; therefore, there is no basis for suggested use or dose on label.  The label has no warning instruc-tions.  An expiration date of 1 year was arbitrarily assigned.  The manufacturer of the product is not listed on the log.

 

Such conduct is in violation of Section 3715.65(A)(2) of the Ohio Revised Code.

 

(5)     Stanley Shaw Scarbrough did, as the Responsible Pharmacist, on and prior to May 4, 1998, fail to meet the minimum standards for compounding parenteral or sterile product prescriptions, to wit: the pharmacy’s clean room and/or laminar flow hood had never been certified; thus, all drugs compounded or manufactured in the pharmacy’s laminar flow hood were adulterated.  Such conduct is in violation of Rule 4729-19-04 of the Ohio Administrative Code and Section 3715.63 of the Ohio Revised Code.

 

(6)     Stanley Shaw Scarbrough did, as the responsible pharmacist, on or about the following dates, fail to assign a new serial number to prescriptions that were not refillable, to wit: Stanley Shaw Scarbrough or someone under his super-vision filled the following prescriptions and, upon refilling the prescriptions with newly compounded drugs which were not generically equivalent, failed to assign a new serial number to the compounded drug and vice versa:

 

(a)     The following prescriptions were changed by Stanley Shaw Scarbrough:

 

Date of

Change

 

Rx No.

Drug

Initially Dispensed

Second

Drug Dispensed

 

Qty.

07/02/96

472590

Zoloft 50mg

Compounded Sertaline 50mg

30

07/05/96

473954

Albuterol UD

Compounded Albuterol Inhaler

360

07/08/96

464570

Proventil UD

Compounded Albuterol Inhaler

360

07/26/97

476542

Albuterol

Compounded Albuterol Inhaler

360

 

(b)     The following prescriptions were changed by Sue G. Gratz:

 

Date of

Change

 

Rx No.

Drug

Initially Dispensed

Second

Drug Dispensed

 

Qty.

07/02/96

463904

Albuterol UD

Compounded Albuterol Inhaler

360

09/25/96

470127

Albuterol UD

Compounded Albuterol Inhaler

360

10/21/96

476809

Proventil UD

Compounded Albuterol Inhaler

360

06/27/97

485351

Compounded

Albuterol Inhaler

Albuterol UD

180

 

Such conduct is in violation of Rules 4729-5-19, 4729-5-27, and 4729-5-30 of the Ohio Administrative Code, and Section 4729.38 of the Ohio Revised Code.

 

(7)     Stanley Shaw Scarbrough did, as the Responsible Pharmacist, from on or about June 21, 1996, through June 5, 1997, sell, deliver, offer for sale, and/or hold for sale a new drug when not in accordance with Section 3715.65 of the Ohio Revised Code, to wit: on 213 separate occasions, Stanley Shaw Scarbrough or a pharmacist under his supervision sold one of the following new drugs which were not tested and found to be safe under the conditions recommended or suggested in its labeling, and prior to selling the drug or offering it for sale, Stanley Shaw Scarbrough and/or a pharmacist under his supervision failed to file an application for new drugs with the director of agriculture:

 

(a)     Met-Fuel-Caffeine Free: Contents, in part--Ephedrine 1.0gm, L-Carnitine 5.0gm, Chromium Picolinate 0.010gm, and Ginger Root 1.0mg per 100 capsules.

(b)     Met-Fuel: Contents, in part--Ephedrine 1.0gm, Caffeine 10gm, L-Carnitine 5.0gm, Chromium Picolinate 0.010gms, and Ginger Root 1.0gm per 100 capsules.

(c)     Extra Strength Met-Fuel: Contents, in part--Ephedrine 1.0gm, Caffeine 10gm, L-Carnitine 5.0gm, Chromium Picolinate 0.010gm, Ginger Root 1.0gm, and Aspirin 4.05gm per 100 capsules.

 

Such conduct is in violation of Section 3715.65(A)(2) of the Ohio Revised Code.

 

(8)     Stanley Shaw Scarbrough did, as the Responsible Pharmacist, on or about July 11, 1997, fail to perform prospective drug utilization review and patient counseling, to wit: Stanley Shaw Scarbrough and/or a pharmacist under his supervision, when dispensing Extra Strength Met-Fuel to a patient, failed to review the log book for over-utilization, incorrect drug dosage and duration of drug treatment, and misuse; and Stanley Shaw Scarbrough and/or someone under his supervision failed to offer, and maintain records of, patient counseling.  Such conduct is in violation of Rules 4729-5-20 and 4729-5-22 of the Ohio Administrative Code.

 

(9)     Stanley Shaw Scarbrough did, as the Responsible Pharmacist, on or about July 11, 1997, sell a schedule V controlled substance product without a pre-scription, failing to require patient identification and failing to maintain a record of transaction for the sale, to wit: Stanley Shaw Scarbrough and/or a pharmacist under his supervision, sold Extra Strength Met-Fuel to a patient and failed to require identification to check for the patient’s age, name, address and signature, and failed to maintain a record of the transaction.  Such conduct is in violation of Rules 4729-11-09 of the Ohio Administrative Code.

 

(10)   Stanley Shaw Scarbrough did, as the Responsible Pharmacist, from on or about June 21, 1996, through July 5, 1997, sell a schedule V controlled substance without a prescription in an amount exceeding one hundred times the bulk amount when the conduct was not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: throughout this time period Stanley Shaw Scarbrough and/or a pharmacist under his supervision made 161 individual sales of Met Fuel for a total of 19,500 unit doses; and, on each occasion, Stanley Shaw Scarbrough and/or a pharmacist under his supervision dispensed to each patient over 100 unit doses in a 30-day time period without a legitimate medical purpose.  Such conduct is not in accordance with Rule 4729-11-09 of the Ohio Administrative Code and, therefore, is in violation of Section 2925.03(A) of the Ohio Revised Code.

 

(11)   Stanley Shaw Scarbrough did, as the Responsible Pharmacist, from on or about October 26, 1996, through June 25, 1997, sell a schedule V controlled substance without a prescription in an amount exceeding five times the bulk amount, but in an amount less than fifty times that amount when the conduct was not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: throughout this time period Stanley Shaw Scarbrough and/or someone under his supervision made 40 individual sales of Extra Strength Met Fuel for a total of 4,800 unit doses; and, on each occasion, Stanley Shaw Scarbrough or someone under his control dispensed to each patient over 100 unit doses in a 30-day time period without a legitimate medical purpose.  Such conduct is not in accordance with Rule 4729-11-09 of the Ohio Administrative Code and, therefore, is in violation of Section 2925.03(A) of the Ohio Revised Code.

 

(12)   Stanley Shaw Scarbrough did, as the Responsible Pharmacist, on or about April 11, 1997, sell a schedule V controlled substance without a prescription in an amount exceeding the bulk amount, but in an amount less than five times that amount when the conduct was not in accordance with Chapters 3719., 4729., and 4731. of the Ohio Revised Code, to wit: Stanley Shaw Scarbrough and/or someone under his supervision sold 120 unit doses of Met Fuel w/ASA, which allowed the patient to obtain over 100 unit doses in a 30-day time period and not for a legitimate medical purpose.  Such conduct is not in accordance with Rule 4729-11-09 of the Ohio Administrative Code and, therefore, is in violation of Section 2925.03(A) of the Ohio Revised Code.

 

(13)   Stanley Shaw Scarbrough did, as the Responsible Pharmacist, prior to May 4, 1998, permit technicians to compound prescriptions, to wit: Stanley Shaw Scarbrough and/or a pharmacist under his supervision allowed technicians to compound drugs without the supervision of a pharmacist, placing them in a position that requires professional judgment.  The products were never checked for error, weight and content uniformity, drug absorption and/or sterility.  Further, pharmacists failed to perform the final check of the finished product.  The following list is an example of the drugs compounded in such a manner:

 

(a)     Albuterol Inhalant 0.83mg/ml: PCCA Compound Number 0021, with violation dates of 6-5-96, 6-13-96, 7-8-96,7-26-96, 8-9-96, 8-12-96, 8-30-96, 10-24-96, 11-12-96, 12-6-96 12-15-96, 12-26-96, 1-20-97, 2-13-97, 4-2-97, 4-11-97, 5-13-97, and 6-26-97 (two pages):  The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(b)     Morphine Sulfate SR 15mg Caps: Scarbrough Pharmacy Compound Number 406, with violation date of 2-19-98:  The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(c)     Phentermine SR 25mg Caps: Scarbrough Pharmacy Compound Number 192, with violation date of 7-2-97: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.  

(d)     Phentermine 25mg SR Capsules: Scarbrough Pharmacy Compound Number 192, with violation dates of 7-24-96, 8-7-96, 8-20-96, 9-24-96, 10-22-96: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.  Additional violation dates of 4-7-97, 5-7-97, and 5-28-97:  The technician signed the pharmacist’s initials.

(e)     Theophylline Slow Release Caps 300mg with CaCO3 as Filler: Scarbrough Pharmacy Compound Number 582, PCCA Compound Number 3183, with violation date of 4-28-97: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist's initials.

(f)      Phentermine 15mg Caps: no Compound Number reference, with violation dates of 2-20-97 and 3-24-97: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist's initials.

(g)     Estriol/Estrone/Estradiol (Triest 2.5mg): Scarbrough Pharmacy Compound Number 374, PCCA Compound Number 2813, with violation dates of 9-20-96, 10-11-96, 11-25-96, 12-20-96, 1-14-97, 3-7-97, 3-31-97, 4-16-97, 5-29-97, 7-1-97, 7-25-97, 8-11-97, 8-22-97, 10-2-97, 10-21-97, 3-16-98, 4-6-98, and 4-29-98 (two pages): The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.  Additional violation dates of 12-5-97, 12-16-97, 1-12-98, 1-23-98, and 2-13-98: The technician signed the pharmacist’s initials.

(h)     Morphine Sulfate Sustained Release Caps 500mg: Scarbrough Pharmacy Compound Number 203, PCCA Compound Number 694, with violation dates of 6-7-96, 7-10-96, and 7-16-96: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist's initials.

(i)      Testosterone 1mg/ml in Vanicream: Compound Number 923, with violation dates of 2-24-98, 2-27-98, 3-2-98, 3-2-98, 3-2-98, 3-3-98, 3-3-98, 3-6-98, 3-26-98, 3-27-98, 3-30-98, 3-31-98, 4-2-98, 4-23-98, 4-27-98, 4-28-98, and 5-4-98 (two pages): The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.  Additional violation dates of 1-19-98, 2-6-98, and 2-24-98: The technician signed the pharmacist’s initials.

(j)      Fenfluramine 20mg Capsules: Scarbrough Pharmacy Compound Number 519, with violation dates of 2-19-97 and 4-1-97: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(k)     Ripped Fuel (Met Fuel) (Manufactured): Scarbrough Pharmacy Compound Number 219, with violation dates of 6-17-96, 6-17-96, 7-1-96, 7-2-96, 7-15-96, 7-16-96, 7-18-96, 7-24-96, 7-25-96, 8-6-96, 8-19-96, 9-6-96, 9-25-96, 10-4-96, 10-9-96, 10-24-96, 11-11-96, and 11-13-96 (two pages): The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(l)      Ex Strength Met-Fuel (Manufactured): Scarbrough Pharmacy Com-pound Number 394, with violation dates of 10-11-96, 11-13-96, and 12-20-96: The log does not indicate the drug lot numbers of the ingredients used, and there is no positive identification of the pharmacists.

(m)     Ex Strength Met-Fuel (Manufactured): Scarbrough Pharmacy Com-pound Number 394, with violation dates of 1-22-97, 2-7-97, 2-18-97, 2-24-97, 3-20-97, 4-2-97, 4-15-97, 5-7-97, 5-24-97, 6-4-97, 6-20-97, and 6-24-97: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(n)     Lidocaine 2.5%/Prilocaine 2.5% in Emollient Cream Base: Scarbrough Pharmacy Compound Number 412, with violation date of 11-1-96: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(o)     Pregnenoline 10mg Capsules: Scarbrough Pharmacy Compound Number SP378, with violation dates of 9-26-96 and 9-27-96: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist's initials..

(p)     Progesterone 100mg Caps: Scarbrough Pharmacy Compound Number 119, with violation date of 7-17-97: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(q)     Progesterone Caps 20mg: Scarbrough Pharmacy Compound Number 322, with violation date of 8-15-96: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(r)     Progesterone 200mg Caps: Scarbrough Pharmacy Compound Number 506, with violation dates of 2-21-97 and 4-1-97: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(s)     Promethazine 25mg Capsule: Scarbrough Pharmacy Compound Number 417, with violation date of 11-8-96: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials. 

(t)      Salicylic Acid 10%/Formalin 40%/in Alcohol: Scarbrough Pharmacy Compound Number 26, with violation dates of 6-26-96 and 3-31-97: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(u)     Simvastin 10mg Capsules: Scarbrough Pharmacy Compound Number SP517, with violation date of 3-4-97: The log does not indicate the drug lot numbers of the ingredients used.

(v)     Triest Plus Pro Caps: Scarbrough Pharmacy Compound Number 499, PCCA Compound Number 2813, with violation date of 2-14-97.  The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist's initials.

(w)     Triest Plus Pro Test Caps: Scarbrough Pharmacy Compound Number 498, with violation dates of 2-14-97, 3-17-97, and 4-1-97: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist's initials.

(x)     ADD Formula (Manufactured): Scarbrough Pharmacy Compound Num-ber 438, with violation dates of 11-29-96, 12-3-96, and 1-15-97: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist’s initials.

(y)     Colloidal Silver (Manufactured): no Compound Number reference, with violation dates  of 10-7-96, 11-16-96, 12-23-96, 12-24-96, 12-26-96, and 12-31-96: The log does not indicate the drug lot numbers of the ingredients used, and the technician signed the pharmacist's initials.

(z)     Colloidal Silver (Manufactured): no Compound Number reference, with violation dates  of 2-5-97 and 3-24-97: The log does not indicate the drug lot numbers of the ingredients used, Scarbrough Pharmacy’s internal lot number, and there is no positive identification of the pharmacists or technicians.  Additional violation date of 1-13-97: The log does not indicate the drug lot numbers of the ingredients used, Scarbrough Pharmacy’s internal lot number, and there is no positive identification of the pharmacist.

 

Such conduct is in violation of Rules 4729-5-25 and 4729-9-21(C) of the Ohio Administrative Code and Section 4729.28 of the Ohio Revised Code.

 

(14)   Stanley Shaw Scarbrough did, as the Responsible Pharmacist, on or about April 22, 1997, and again on or about May 4, 1998, fail to maintain minimum standards for a pharmacy, to wit: the pharmacy was not equipped with a library containing current literature and references for compounding drugs.  Such conduct violates Rule 4729-9-02 of the Ohio Administrative Code.

 

(15)   Stanley Shaw Scarbrough did, on or about March 30, 1999, and again on May 23, 2000, directly or indirectly represent a counterfeit controlled substance as a controlled substance by describing its effects as the physical or psychological effects associated with use of a controlled substance, to wit: Stanley Shaw Scarbrough advertised the sale of testosterone using false and misleading information through an Internet site, VitaminUSA.com.  Such conduct is in violation of Section 2925.37(E) of the Ohio Revised Code.

 

(16)   Stanley Shaw Scarbrough did, from on or about December 26, 1996, through April 22, 1997, sell a misbranded drug, to wit: Stanley Shaw Scarbrough compounded drugs which failed content uniformity, which contained incorrect amounts of ingredients as suggested in the labeling, and/or which contained fillers that had not been approved by the Food and Drug Administration, to wit: Stanley Shaw Scarbrough compounded Enalapril 5mg capsules dated December 26, 1996, which failed content uniformity.  Such conduct is in violation of Section 3715.52 of the Ohio Revised Code.

 

(17)   Stanley Shaw Scarbrough did, on or before September 16, 1998, hold for sale a misbranded drug, to wit: Stanley Shaw Scarbrough manufactured drugs which failed content uniformity, which contained incorrect amounts of ingredients as suggested in the labeling, and/or which contained fillers that had not been approved by the Food and Drug Administration, to wit: Stanley Shaw Scarbrough manufactured Colloidal Silver Solution 3 to 5 ppm which failed content uniformity.  Such conduct is in violation of Section 3715.52 of the Ohio Revised Code.

 

(18)   Stanley Shaw Scarbrough did, on or before May 4, 1998, hold for distribution manufactured sample drugs and furnished manufactured sample drugs to physicians as a marketing tool, to wit: Stanley Shaw Scarbrough manufactured and distributed Ketoprofen 2% Gel labeled “Sample-Not For Sale”.  Such conduct is in violation of Section 3719.81 of the Ohio Revised Code.

 

(19)   Stanley Shaw Scarbrough did, as the Responsible Pharmacist, on or before May 4, 1998, fail to keep complete and accurate records in Scarbroughs Medical Arts Pharmacy’s automated data system, to wit: the pharmacy’s computer system, NDC Data Stat, does not allow a log to be created that documents necessary changes made to a prescription.  Such conduct is in violation of Rule 4729-5-27 of the Ohio Administrative Code and Section 4729.38 of the Ohio Revised Code.

 

(20)   Stanley Shaw Scarbrough did, as the Responsible Pharmacist, on or about April 22, 1997, manufacture, sell, hold for sale, or deliver a drug that was adul-terated or misbranded, to wit: an agent of the Board witnessed a technician, refill a one pint bottle of Promethazine with Codeine Cough Syrup having NDC 60432606-16 with another brand of a one gallon bottle of Promethazine with Codeine Cough Syrup having NDC 0472-1627-28.  The adulterated or mis-branded Promethazine with Codeine Cough Syrup was then dispensed by Stanley Shaw Scarbrough or a pharmacist under his supervision with a label bearing a completely different NDC of 00182-1712-4.  Such conduct is in violation of Section 3715.52(A)(1) of the Ohio Revised Code; Section 331(b) of Title 21 of the United States Code, and Section 201.18 of Title 21 of the Code of Federal Regulations.

 

(1)     Upon consideration of the record as a whole, the State Board of Pharmacy concludes that paragraphs (2) through (18) and (20) of the Findings of Fact constitute being guilty of dishonesty and unprofessional conduct in the practice of pharmacy as provided in Division (A)(2) of Section 4729.16 of the Ohio Revised Code.

 

(2)     Upon consideration of the record as a whole, the State Board of Pharmacy concludes that paragraphs (2) through (7), (10) through (13), and (15) through (20) of the Findings of Fact constitute being guilty of willfully violating, conspiring to violate, attempting to violate, or aiding and abetting the violation of provisions of Sections 3715.52 to 3715.72 or Chapter 2925., 3719., or 4729. of the Revised Code as provided in Division (A)(5) of Section 4729.16 of the Ohio Revised Code.

 

(3)     Upon consideration of the record as a whole, the State Board of Pharmacy concludes that paragraph (13) of the Findings of Fact constitutes being guilty of permitting anyone other than a pharmacist or pharmacy intern to practice pharmacy as provided in Division (A)(6) of Section 4729.16 of the Ohio Revised Code.

 

(A)     On the basis of the Findings of Fact and paragraphs (1) and (3) of the Conclu-sions of Law set forth above, the State Board of Pharmacy hereby suspends for five years the pharmacist identification card, No. 03-2-12847, held by Stanley Shaw Scarbrough effective as of the date of the mailing of this Order.

 

(B)     On the basis of the Findings of Fact and paragraph (2) of the Conclusions of Law set forth above, the State Board of Pharmacy hereby imposes a monetary penalty of five thousand dollars ($5,000.00) on Stanley Shaw Scarbrough effective as of the date of the mailing of this Order.  The monetary penalty is due and owing within thirty days of the mailing of this Order.  The remittance should be made payable to the "Treasurer, State of Ohio" and mailed with the enclosed form to the State Board of Pharmacy, 77 South High Street, Room 1702, Columbus, Ohio 43215-6126.

 

(C)     Further, the Board will suspend the suspension imposed in paragraph (A) above and place Stanley Shaw Scarbrough on probation for five years provided that he successfully completes six hours of continuing pharmacy education in Board-approved Jurisprudence and submits the original certificates of completion to the Board within six months from the effective date of this Order.  The terms of probation are as follows:

 

(1)     The State Board of Pharmacy hereby declares that Stanley Shaw Scarbrough's pharmacist identification card is not in good standing and thereby denies the privilege of being a preceptor and training pharmacy interns pursuant to paragraph (D)(1) of Rule 4729-3-01 of the Ohio Administrative Code.

 

(2)     Stanley Shaw Scarbrough must not violate the drug laws of the state of Ohio, any other state, or the federal government.

 

(3)     Stanley Shaw Scarbrough must abide by the rules of the State Board of Pharmacy.

 

(4)     Stanley Shaw Scarbrough must comply with the terms of this Order.

 

Stanley Shaw Scarbrough is hereby advised that the Board may at any time revoke probation for cause, modify the conditions of probation, and reduce or extend the period of probation.  At any time during this period of probation, the Board may revoke probation for a violation occurring during the probation period.

 

 

The motion was seconded by Mrs. Teater and approved by the Board (Aye-4/Nay-2).

  8:56 p.m.

Mr. Littlejohn moved that the Board receive Per Diem as follows:

 

PER DIEM

12/11