State Board of Pharmacy; 77 South High Street, Room 1702; Columbus, Ohio 43215-6126

Phone: 614/466-4143     <>     Email: exec@bop.state.oh.us     <>     Fax: 614/752-4836

 

 

RULES EFFECTIVE IN 2002 SHOWING CHANGES

[Ohio Administrative Code]

 

 

I N D E X

 

 

RULE NO.

 

RULE TITLE

 

EFFECTIVE

 

 

 

 

 

 

 

Administrative Procedures

 

 

 

 

 

 

 

4729-1-01

 

Public notice of hearing to consider proposed rule changes.

 

02/01/2002

4729-1-02

 

Notice of meetings.

 

02/01/2002

 

 

Internship

 

 

4729-3-01

 

Definitions.

 

02/01/2002

4729-3-02

 

Registration as a pharmacy intern.

 

02/01/2002

4729-3-03

 

Application for registration as a pharmacy intern.

 

02/01/2002

4729-3-04

 

Pharmacy intern identification card renewal.

 

02/01/2002

4729-3-05

 

Internship credit.

 

02/01/2002

 

 

Pharmacy Practice

 

 

 

4729-5-07

 

Recognized and approved colleges of pharmacy.

 

02/01/2002

4729-5-13

 

Prescription format.

 

02/01/2002

4729-5-24

 

Prescription copy.

 

02/01/2002

4729-5-27

 

Recordkeeping.

 

02/01/2002

4729-5-29

 

Confidentiality of patient records.

 

02/01/2002

4729-5-30

 

Manner of issuance of prescription.

 

02/01/2002

 

 

Impaired Pharmacists

 

 

 

4729-6-01

 

Definitions; impaired pharmacists.

 

02/01/2002

4729-6-02

 

Applicability.

 

02/01/2002

4729-6-08

 

Requirements for approved treatment providers and limited approved treatment providers.

 

02/01/2002

 

 

Continuing Pharmacy Education

 

 

4729-7-02

 

Requirements for renewal of a pharmacist identification card.

 

02/01/2002

 

 

Dangerous Drugs

 

 

4729-9-04

 

Returned drugs.

 

02/01/2002

 

 

Nonresidential Terminal Distributor of Dangerous Drugs

 

 

 

4729-10-02

 

Licensure.

 

02/01/2002

 

 

 

F U L L   T E X T

 

 

ALL CAPS = Add Language                  Strike Through = Remove Language

Bolding = Added to text to aid in locating changes

(if entire rule is new, only the rule number and title will be bolded)

 

 

4729-1-01  Public notice of hearing to consider proposed rule changes.  [OAC: 02/01/2002]

 

(A)  Reasonable public notice, as required by section 119.03 of the Revised Code, shall be given at least thirty days prior to the date set for the public hearing as follows:

 

(1)  By advertising placing such notice in the register of Ohio.  The board may also advertise such notice, one time, in at least one newspaper of general circulation in the state of Ohio at least thirty days prior to the date set for the public hearing.

 

(2)  By mailing, e-mailing, or faxing such notice, one time, to all sub­scribers on the board's sunshine notice mailing list at least thirty days prior to the date set for the public hearing.

 

(3)  By mailing, e-mailing, or faxing such notice, one time, to all persons who have requested the board to provide notification of any proposed rule changes at least thirty days prior to the date set for the public hearing.

 

(4)  By placing such notice on the board's world wide web home page at least thirty days prior to the date set for the public hearing, and remaining there until the public hearing record is closed.

 

(B)  The board shall furnish the full text of the proposed rules as follows:

 

(1)  By mailing to any person who requests such in writing and who pays the cost of copying and mailing.

 

(2)  By e-mailing to any person upon request.

 

(2)(3)  By posting on the board's world wide web home page and remaining there until the public hearing record is closed.

 

 

4729-1-02  Notice of meetings.  [OAC: 02/01/2002]

 

Any person may determine the time and place of all regularly scheduled meetings and the time, place, and purpose of all special meetings of the state board of pharmacy, as required by division (F) of section 121.22 of the Revised Code, by:

 

(A)  Written request to the state board of pharmacy.

 

(1)  Written requests shall include the name, mailing address, and telephone number of the person making the request.

 

(2)  Written requests shall be accompanied by a service fee of twenty-five dollars which shall be valid for the fiscal year of July first through June thirtieth.

 

(3)  Notice for the annual renewal of this request will be sent by the board of pharmacy by June first of each year and shall be due no later than July thirty-first of each year.

 

(B)  Calling the telephone number of the state board of pharmacy between the nor­mal business hours of eight a.m. to four-thirty p.m., Monday through Friday, legal holidays excepted.

 

(C)  Consulting the official record of all board of pharmacy regularly scheduled and special meetings located at office of the state board of pharmacy.

 

(D)  Viewing the state board of pharmacy's world wide web home page.

 

 

4729-3-01  Definitions.  [OAC: 02/01/2002]

 

As used in Chapter 4729-3 of the Administrative Code:

 

(A)  "Pharmacy internship" means the supervised practical experience required for licensure as a registered pharmacist.  The purpose of the pharmacy internship program is to provide those individuals, who intend to become registered pharmacists, with the knowledge and practical experience necessary for func­tioning competently and effectively upon licensure.

 

(B)  "Supervised practical experience" is the experience obtained at an internship site and which is conducted in accordance with the "National Association of Boards of Pharmacy - American Association of Colleges of Pharmacy" publica­tion "The Internship Experience," or a similar outline and/or manual approved by the board of pharmacy.

 

(C)  "Internship site" means a pharmacy licensed as a terminal distributor of dan­gerous drugs pursuant to Chapter 4729. of the Revised Code, except as pro­vided in paragraph (C) or (D) of rule 4729-3-05 of the Administrative Code, and whose license is in good standing.

 

(D)  "Preceptor" is the individual responsible for seeing that the intern is prop­erly supervised and exposed to all aspects of the internship program defined as the supervised practical experience.

 

(1)  A "preceptor" is a pharmacist who holds a current identification card which is in good standing; or, is a person who is of good moral char­acter and is qualified to direct the approved experience in the area approved by the director of internship pursuant to rule 4729-3-05 of
the Administrative Code.

 

(2)  A person may serve as the preceptor for more than one intern.  The number of interns engaged in the practice of pharmacy at any time
is limited to not more than two for each pharmacist on duty.

 

(3)  A preceptor must report to the board on the progress and aptitude of an intern when requested by the director of internship.

 

(E)  "Director of internship" has the same meaning as provided in section 4729.11 of the Revised Code.

 

(F)  "In good standing" means that the licensee or registrant has not been denied the privilege of supervising interns by the board.

 

(G)  "Statement of Preceptor" is the form which must be received by the board of pharmacy for each pharmacy intern within thirty days of beginning internship under a preceptor's supervision.

 

(1)  No credit will be given for practical experience obtained prior to thirty days of the date that the "Statement of Preceptor" form is re­ceived by the board office; except, that in the event of extraordinary circumstances and when due to no fault of the intern, the board may accept a retroactive date of filing for the "Statement of Preceptor."

 

(2)  The intern must file a "Statement of Preceptor" form whenever he/she changes internship sites and/or preceptors.

 

(H)  "Practical experience affidavit" is the form which must be used to submit practical experience for internship credit.

 

(1)  Practical experience must be itemized to the nearest half hour on the affidavit by the total number of hours obtained each week.  The hours reported must be able to be documented by payroll or other records
which may be examined by the board of pharmacy upon reasonable notice.

 

(2)  Practical experience affidavits must be signed by the preceptor on file with the board of pharmacy.  In the event of the unavailability of the preceptor's signature due to extraordinary circumstances and due to no fault of the intern, the board may accept an alternative method for verification of a practical experience affidavit.

 

(3)  Practical experience affidavits for a calendar year may be filed at
any time, except that they must be received in the board office or postmarked no later than the first day of March of the following year.

 

(I)  "School of pharmacy" has the same meaning as a college of pharmacy or a department of pharmacy of a university, which has been recognized and approved by the state board of pharmacy.

 

 

4729-3-02  Registration as a pharmacy intern.  [OAC: 02/01/2002]

 

(A)  A certificate of registration as a pharmacy intern shall only be issued for the purpose of allowing those individuals who intend to become registered pharmacists the opportunity to obtain the practical experience required for examination and registration as a pharmacist.

 

(B)  If a person desires to work as a pharmacy intern in Ohio, he/she must:

 

(1)  Have successfully completed forty-eight semester or seventy-two quarter hours of college and have been accepted into a school or college of pharmacy or a department of pharmacy of a university recognized and approved by the state board of pharmacy; or

 

(2)  Have obtained a first professional degree in pharmacy from a program which has been recognized and approved by the state board of pharmacy; or

 

(3)  Have established educational equivalency by obtaining a Foreign Pharmacy Graduate Examination Commission (FPGEC) certificate, and have estab­lished proficiency in spoken English by successfully completing the Test of Spoken English (TSE) or its equivalent;

 

(4)  Apply to the state board of pharmacy for registration as a pharmacy intern.

 

 

4729-3-03  Application for registration as a pharmacy intern.  [OAC: 02/01/2002]

 

(A)  Every person desiring to register as a pharmacy intern shall submit the following to the state board of pharmacy:

 

(1)  A completed application form as provided by the board;

 

(2)  A three- by four-inch head and shoulders photograph taken within the previous six months;

 

(3)  Fee;

 

(4)  A transcript certifying that the applicant has in fact successfully completed a minimum of forty-eight semester or seventy-two quarter hours of college work; and

 

(5)  A certificate of acceptance into a school or college of pharmacy or a department of pharmacy of a university recognized and approved by the state board of pharmacy.

 

or

 

(6)  All items listed in paragraphs (A)(1) to (A)(3) of this rule and cer­tification of having obtained a first professional degree in pharmacy from a program which has been recognized and approved by the state
board of pharmacy; or certification of having established educational equivalency by obtaining a “Foreign Pharmacy Graduate Examination Com­mission (FPGEC)” certificate, and evidence of successful completion of the “Test of Spoken English (TSE)” or its equivalent.

 

(B)  The state board of pharmacy may register an applicant as a pharmacy intern as soon as the state board of pharmacy receives all the required items set forth in paragraphs (A)(1) to (A)(5) or paragraph (A)(6) of this rule.

 

(C)  The state board of pharmacy may, pursuant to rule 4729-5-04 of the Admini­strative Code, deny the issuance of a certificate of registration or an identification card to practice as a pharmacy intern.

 

 

4729-3-04  Pharmacy intern identification card renewal.  [OAC: 02/01/2002]

 

A pharmacy intern may renew his/her identification card each year provided he/she is actively working toward the requirements for licensure as a pharmacist and otherwise meets the requirements and rules of the state board of pharmacy.  The state board of pharmacy may, pursuant to rule 4729-5-04 of the Administrative Code, deny the issuance of an identification card to practice pharmacy as an intern.

 

(A)  An intern shall be considered to be actively working towards licensure as a pharmacist if he/she has complied with all of the statutes and rules regard­ing internship since registration as a pharmacy intern, and:

 

(1)  He/she is enrolled in a college school of pharmacy or is able to provide evidence that he/she has been, or will be, accepted for enrollment or re-enrollment in a college school of pharmacy; or

 

(2)  He/she is a member of the armed forces and can provide evidence that he/she has been, or will be, accepted for enrollment or re-enrollment in a college school of pharmacy upon his/her release from the armed forces; or

 

(3)  He/she is able to provide evidence of obtaining a first professional degree in pharmacy from a school or college of pharmacy or a department of pharmacy of a university recognized and approved by the state board of pharmacy; or

 

(4)  He/she is able to provide evidence of obtaining a “Foreign Pharmacy Graduate Examination Commission (FPGEC)” certificate, and can provide evidence of successful completion of the “Test of Spoken English (TSE)” or its equivalent.

 

(B)  An intern who has obtained a first professional degree in pharmacy from a school or college of pharmacy or a department of pharmacy of a university recognized and approved by the state board of pharmacy, or who has estab­lished equivalency by obtaining a “Foreign Pharmacy Graduate Examination Commission (FPGEC)” certificate, may renew his/her license only once.  In
the event of extraordinary circumstances and when due to no fault of the intern, the board may approve additional renewals.

 

 

4729-3-05  Internship credit.  [OAC: 02/01/2002]

 

(A)  No internship credit shall be granted by the board for practical experience obtained before registration as an intern or during a period when the intern's registration has lapsed.

 

(B)  Internship credit may be granted for practical experience obtained when the intern is registered and attending classes in the academic program of a school of pharmacy, other than the structured academic program as provided for in paragraph (C) of this rule.

 

(C)  Internship credit may be gained for practical experience obtained in a struc­tured program for which academic credit is awarded (e.g., externship, clerk­ship).  Such credit shall be limited to the number of hours for which the structured program has been approved by the state board of pharmacy.  Intern­ship credit shall be granted only when the intern obtains a passing grade
for the course involved.  A school or college of pharmacy which desires to conduct such structured programs eligible for approval shall make a written request on forms provided by the board.

 

(D)  Up to five hundred hours of internship credit may be obtained at a site other than a pharmacy licensed as a terminal distributor of dangerous drugs (e.g., manufacturing, research, consulting, drug information, and drug utilization review).  To receive credit for such experience, a formal request must be submitted to the director of internship for approval prior to beginning the experience in these areas.  The request shall include a detailed description of the contemplated internship with respect to time, place, duties, respon­sibilities, professional supervision, and the person supervising the experi­ence.

 

(E)  Internship credit may be denied for the practical experience accumulated when an intern is found to be guilty of violation(s) pursuant to section 4729.16 of the Revised Code.

 

(F)  The pharmacy internship requirement for the licensure examination shall be deemed satisfactorily completed when the intern has filed affidavits certi­fying that he/she has obtained a total of one thousand five hundred hours of supervised practical experience and such affidavits have been accepted by the board of pharmacy.

 

 

4729-5-07  Recognized and approved colleges schools of pharmacy.  [OAC: 02/01/2002]

 

(A)  To be recognized and approved by the state board of pharmacy, a school or college of pharmacy or a department of pharmacy of a university shall meet the requirements as set forth by the board.  The board may utilize the reports, requirements, and recommendations of any recognized accrediting organization or higher education governing board in determining the require­ments.  The board of pharmacy shall take into consideration, but not be bound by, accreditation standards established by the "American Council on Pharma­ceutical Education".

 

(B)  For the purpose of satisfying the requirements of division (C) of section 4729.08 of the Revised Code, graduates of a school or college of pharmacy or a department of pharmacy of a university located outside the United States shall establish educational equivalency by obtaining a "Foreign Pharmacy Graduate Examination Commission (FPGEC)" certificate, and by establishing proficiency in spoken English by obtaining the score required by rule
4729-5-34 of the Administrative Code on the "Test of Spoken English (TSE)".

 

(C)  The term "United States," as used in paragraph (B) of this rule, shall be deemed to include all states of the United States, the District of Columbia, and all territories and any commonwealths.

 

 

4729-5-13  Prescription format.  [OAC: 02/01/2002]

 

Except as provided in rule 4729-5-14 of the Administrative Code:

 

(A)  No pharmacist shall dispense dangerous drugs pursuant to a written outpatient prescription unless the following conditions are met:

 

(1)  The prescription is issued in compliance with rule 4729-5-30 of the Administrative Code.

 

(2)  If preprinted with multiple drug name and strength combinations:

 

(a)  There are no controlled substances among the choices;

 

(b)  There is only one prescription order selected per form.

 

(B)  No prescriber shall write and no pharmacist shall dispense controlled sub­stances pursuant to a written outpatient prescription unless the following conditions are met:

 

(1)  The prescription has been issued in compliance with rule 4729-5-30 of the Administrative Code.

 

(2)  The prescription contains only one prescription order per prescription form, whether handwritten or preprinted.

 

(3)  The quantity has been written both numerically and alphabetically.

 

(4)  If preprinted, there is only one drug and strength combination printed on the form.

 

(C)  A prescription issued by a medical intern, resident, or fellow as defined in paragraph (B) of rule 4729-5-15 of the Administrative Code may not be dis­pensed unless the prescription is issued in compliance with this rule and rule 4729-17-13 of the Administrative Code and unless it bears the identifi­cation number issued by the employing hospital or institution pursuant to rule 4729-17-13 of the Administrative Code.

 

(D)  A prescription issued by a staff prescriber of a hospital may not be dis­pensed unless the prescription is issued in compliance with this rule and rule 4729-17-13 of the Administrative Code and unless it bears the identi­fication number issued by the employing hospital or institution pursuant to rule 4729-17-13 of the Administrative Code.

 

(E)  If a board-approved electronic prescription transmission system is used to fax a prescription to a pharmacy, the faxed order is exempt from paragraphs (A) and (B) of this rule.  The faxed order must comply with rule 4729-5-30
of the Administrative Code and must be filed in the most restrictive file according to rule 4729-5-09 of the Administrative Code.

 

 

4729-5-24  Prescription copy.  [OAC: 02/01/2002]

 

(A)  A pharmacist may transfer a copy of a prescription; a pharmacist may refill
a copy of a prescription; such actions must be in accordance with the follow­ing:

 

(1)  Copies of prescriptions shall be transferred only between pharmacists; copies of prescriptions for controlled substances pursuant to sections 3719.41, 3719.43, and 3719.44 of the Revised Code shall be communicated directly between two pharmacists and shall be transferred only one time.  However, pharmacies electronically sharing a real-time, on-line database may transfer a controlled substance prescription up to the maximum number of refills permitted by law and the prescriber's authorization pursuant to paragraph (A)(4) of this rule.

 

(2)  The copy transferred shall be an exact duplicate of the original pre­scription except that it shall also include:

 

(a)  Serial prescription number assigned to the prescription;

 

(b)  Name and address (and "D.E.A." number for controlled substance prescriptions) of the pharmacy transferring the copy;

 

(c)  Date of issuance of the prescription;

 

(d)  Date of original dispensing of the prescription;

 

(e)  Original number of refills;

 

(f)  Date of last refill;

 

(g)  Number of valid refills remaining; and

 

(h)  The full name of the transferring pharmacist.

 

(3)  Copies transferred for non-refillable prescriptions shall be marked on the face of the prescription or orally noted by the transferring phar­macist "For Information Purposes Only" and are not valid prescriptions for the dispensing of drugs.

 

(4)  The pharmacist transferring a copy of a prescription must:

 

(a)  Cancel the original prescription by writing the word "void" on the face of the prescription in such a way as to avoid destroying any of the original information contained on the prescription;

 

(b)  Record on the reverse side of the original written prescription:

 

(i)  Date of transfer;

 

(ii)  His/her signature; and

 

(iii)  When transferring an oral prescription, the name and address (and "D.E.A." number for controlled substance prescriptions) of, and name of the pharmacist at, the receiving pharmacy.

 

(c)  Except, if an automated data processing system is being used as an alternate system of recordkeeping for prescriptions pursuant to rules 4729-5-27 and 4729-5-28 of the Administrative Code, copies of prescriptions may be transferred by a pharmacist if the prescrip­tion record in the system is invalidated to prevent further dis­pensing at the original site.  The prescription record in the sys­tem must contain the date of transfer, name of pharmacist making transfer, and the name and address of the pharmacy receiving the copy.  Also, original written prescriptions for controlled sub­stances must be canceled as required in paragraphs (A)(4)(a) and (A)(4)(b) of this rule.

 

(5)  The pharmacist receiving a copy of a prescription must:

 

(a)  Exercise reasonable diligence to determine validity of the copy;

 

(b)  Reduce an oral prescription to writing by recording all of the information transferred (must include all information required in paragraph (A)(2) of this rule) and write the word "transfer" on the face of the prescription;

 

(c)  Record date of transfer on the face of the prescription.

 

(B)  A prescription copy may be transferred between two pharmacies if the two pharmacies are accessing the same prescription records in a centralized database or pharmacy computers linked in any other manner.  The computerized systems must satisfy all information requirements of paragraphs (A)(2) and (A)(4)(c) of this rule.  This shall include invalidation of the prescription record in the system to prevent further dispensing at the original site and, if a controlled substance prescription, the canceling of the original written prescription as required in paragraphs (A)(4)(a) and (A)(4)(b) of this rule.  A system must be in place that will allow only authorized access to these computerized prescription records by a pharmacist and indicate on the pre­scription record when and by whom such access was made.

 

(C)  A prescription copy may be transferred between two pharmacists by the use
of a facsimile machine.  This facsimile may be considered to be a copy of a prescription if all information requirements of paragraph (A) of this rule, including invalidation of the original prescription or computer records, are met.  A system must be in place that will show on the facsimile positive identification of the transferring and receiving pharmacists which must become a part of the prescription record.  Facsimile copies must be recorded in writing pursuant to section 4729.37 of the Revised Code, or stored in such a manner that will allow retention of the prescription record for three years from the date of the last transaction.

 

(D)  Information on a prescription is the property of the patient and is intended to authorize the dispensing of a specific amount of medication for use by the patient.  Original copies of prescriptions shall be maintained by pharmacies for the purpose of documenting the dispensing of drugs to a particular patient.

 

(1)  In the event that the pharmacy is not able to provide the medication when needed by the patient pursuant to an authorized refill, the pharma­cist shall, upon the request of the patient, transfer the prescription information to the pharmacy designated by the patient.

 

(2)  No pharmacy shall refuse to transfer information about a previously dis­pensed prescription to another pharmacy when requested by the patient.  Prescription information shall be transferred in accordance with this rule as soon as possible in order to assure that the patient’s drug therapy is not interrupted.

 

(E)  Prescriptions entered into a computer system but not dispensed may be trans­ferred to another pharmacy if all of the following conditions are met:

 

(1)  The complete prescription information has been entered into the computer system;

 

(2)  The information is displayed on the patient’s profile;

 

(3)  There is positive identification, either in the computer system or on the hard-copy prescription, of the pharmacist who is responsible for entering the prescription information into the system;

 

(4)  The original prescription is filed in accordance with rule 4729-5-09 of the Administrative Code;

 

(5)  All requirements of this rule are met for the transfer of the prescrip­tion.

 

(F)  Transfer of prescription information between two pharmacies which are access­ing the same real-time, on-line database pursuant to the operation of a board-approved central filling operation shall not be considered a prescrip­tion copy and, therefore, is not subject to the requirements of this rule.

 

 

4729-5-27  Recordkeeping.  [OAC: 02/01/2002]

 

The following recordkeeping requirements do not apply to records relating to the practice of pharmacy for an inpatient as defined in rule 4729-17-01 of the Admini­strative Code.

 

(A)  There must be positive identification of the pharmacist or pharmacists re­sponsible for performing all activities relating to the practice of pharmacy including, but not limited to:

 

(1)  Prescription information entered into the recordkeeping system;

 

(2)  Prospective drug utilization review as defined in rule 4729-5-20 of
the Administrative Code;

 

(3)  Dispensing;

 

(4)  Patient counseling;

 

(5)  Administering adult immunizations;

 

(6)  Prescription information reduced to writing from an order received
by telephone, facsimile, or recording device.

 

(B)  When a pharmacist dispenses a drug pursuant to an original prescription, he/she must record the date of such dispensing and either manually record his/her name or initials on the original prescription or, if approved by the state board of pharmacy, enter his/her positive identification into the com­puterized recordkeeping system as required in rule 4729-5-28 of the Admini­strative Code.  If an alternate recordkeeping system is being used pursuant to this rule, the record of dispensing the original prescription must also
be recorded in the alternate recordkeeping system.

 

(C)  When a pharmacist dispenses a drug pursuant to an authorized refill of a pre­scription, he/she must record the date of such dispensing and manually record his/her name or initials on the original prescription or enter such infor­mation on an alternate record meeting the requirements of this rule.  If an alternate recordkeeping system is being used pursuant to this rule, this alternate record must be used to record the dispensing of all prescriptions.

 

(D)  The quantity dispensed shall be considered the quantity prescribed unless:

 

(1)  If the quantity dispensed on a new prescription is less than the quan­tity prescribed, the pharmacist shall note the quantity dispensed on
the original prescription.  If the quantity dispensed on a new pre­scription is greater than the quantity prescribed, the pharmacist shall also record on the original prescription the name of the authorizing prescriber, the full name of the agent of the prescriber if applicable, the quantity authorized to be dispensed, and the date and time that the prescriber was contacted and approval authorization was obtained.

 

(2)  If the quantity dispensed on a refill prescription is less than the quantity prescribed, the pharmacist shall note the quantity dispensed
on the original prescription or enter the quantity dispensed on an alternate record meeting the requirements of this rule.  If the quantity dispensed on a refill prescription is greater than the quantity pre­scribed, the pharmacist shall also record the name of the authorizing prescriber, the full name of the agent of the prescriber if applicable, the quantity authorized to be dispensed, and the date and time that the prescriber was contacted and approval authorization was obtained.

 

(E)  Where a prescription is written using a generic name, or where the pharmacist dispenses an equivalent drug product pursuant to the provisions of sections 4729.38 and 4729.381 of the Revised Code, the brand name or drug name and name of the manufacturer or distributor of the drug or the national drug code (NDC) number of the drug dispensed must be recorded on the record of dispens­ing by the pharmacist.

 

(F)  Records of dispensing drugs must provide accountability and ensure that patients do not receive more drugs than intended by the prescriber.  All recordkeeping systems shall provide records which are readily retrievable and uniformly maintained for a period of three years from the date of the last dispensing.

 

(G)  If an alternate recordkeeping system is being used pursuant to this rule, such record shall include at a minimum the following data:

 

(1)  The serial number assigned to and recorded on the original prescrip­tion preserved on file at the pharmacy in accordance with section 4729.37 of the Revised Code.

 

(2)  Name, strength, and dosage form of the drug dispensed.

 

(3)  Date of dispensing (filling or refilling).

 

(4)  Quantity dispensed.  If the quantity dispensed is greater than that prescribed, the pharmacist must record the date and time that he/she contacted the prescriber and obtained approval.

 

(5)  The positive identification of the dispensing pharmacist.

 

(H)  All records relating to the practice of pharmacy shall be readily available, and promptly produced, upon request for inspection by a state board of phar­macy officer, agent, and/or inspector during regular business hours.

 

(I)  All prescriptions or other records relating to the practice of pharmacy, which are required to be kept for three years according to section 4729.37 of the Revised Code, may be microfilmed or placed on electronic, magnetic media.  The microfilm or electronic, magnetic media used for this purpose must comply with the "International Standards Organization" standards of quality approved for permanent records.  Such records are subject to all other paragraphs of this rule.

 

(J)  Any pharmacy intending to maintain records relating to the practice of phar­macy at a location other than the place licensed with the state board of pharmacy must first send written notification to the state board of pharmacy by certified mail, return receipt requested or facsimile.  If not contested within sixty days of receipt by the The state board of pharmacy office, such request will stand as approved send written notification of the approval or disapproval of the request.  Only after receiving the notice of the board's approval may the records be placed in the new location.

 

(K)  Records shall be maintained for three years on all adult immunizations administered pursuant to section 4729.41 of the Revised Code and must include at least the following information:

 

(1)  Full name and address of the patient;

 

(2)  Patient’s date of birth or age;

 

(3)  Patient’s gender;

 

(4)  Patient’s applicable allergy information;

 

(5)  Date of administration by the pharmacist;

 

(6)  Name, strength, and dose of the adult immunization administered;

 

(7)  Lot number and expiration date of the immunization;

 

(8)  Route of administration;

 

(9)  Location of the injection site;

 

(10) Positive identification of the administering pharmacist;

 

(11) Documentation of patient informed consent.

 

(L)  A pharmacist who administers adult immunizations pursuant to section 4729.41 of the Revised Code shall maintain and immediately make available, upon the request of the state board of pharmacy, the following records:

 

(1)  Documentation of the successful completion of a board-approved course
in the administration of adult immunizations;

 

(2)  Documentation of the certification to perform basic life-support pro­cedures pursuant to division (B)(2) of section 4729.41 of the Revised Code.

 

 

4729-5-29  Confidentiality of patient records.  [OAC: 02/01/2002]

 

(A)  Records relating to the practice of pharmacy or administering of drugs are not a public record.  A person having custody of, or access to, such records shall not divulge the contents thereof, or provide a copy thereof, to anyone except:

 

(1)  The patient for whom the prescription or medication order was issued.

 

(2)  The prescriber who issued the prescription or medication order.

 

(3)  Certified/licensed health care personnel who are responsible for the care of the patient.

 

(4)  A member, inspector, agent, or investigator of the state board of phar­macy or any federal, state, county, or municipal officer whose duty is to enforce the laws of this state or the United States relating to drugs and who is engaged in a specific investigation involving a designated person or drug.

 

(5)  An agent of the state medical board when enforcing Chapter 4731. of the Revised Code.

 

(6)  An agency of government charged with the responsibility of providing medical care for the patient upon a written request by an authorized representative of the agency requesting such information.

 

(7)  An agent of a medical insurance company who provides prescription insur­ance coverage to the patient upon authorization and proof of insurance by the patient or proof of payment by the insurance company for those medications whose information is requested.

 

(8)  An agent who contracts with the pharmacy as a "business associate" in accordance with the regulations promulgated by the secretary of the United States department of health and human services pursuant to the federal standards for privacy of individually identifiable health information.

 

(9)  Any person, other than those listed in paragraphs (A)(1) to (A)(7) (A)(8) of this rule, only when the patient has given consent for such disclosure in writing, except where a patient requiring medication is unable to deliver a written consent to the necessary disclosure.  Any consent must be signed by the patient and dated.  Any consent for disclosure is valid until rescinded by the patient.  In an emergency, the pharmacist may disclose the prescription information when, in the professional judgment of the pharmacist, it is deemed to be in the best interest of the patient.  A pharmacist making an oral disclosure in an emergency situa­tion must prepare a written memorandum showing the patient's name, the date and time the disclosure was made, the nature of the emergency, and the names of the individuals by whom and to whom the information was disclosed.

 

(B)  Any Testimonial privilege is not waived for any communication between a phy­sician, a pharmacist, and a patient, pursuant to a consult agreement, except when requested by a federal, a state, or a local government entity, is privi­leged from discovery or other use and disclosure in civil process section 2317.02 of the Revised Code.

 

(C)  Records relating to the practice of pharmacy or administering drugs which may be required as evidence of a violation shall be released to a member, inspec­tor, agent, or investigator of the state board of pharmacy or any state, county, or municipal officer whose duty is to enforce the laws of this state or the United States relating to drugs and who is engaged in a specific in­vestigation involving a designated person or drug upon his request.  Such person shall furnish a receipt to the person having legal custody of the records.  If the record is a prescription, the receipt shall list the follow­ing information:

 

(1)  Prescription identification number; or, if an order for medication,
the name of the patient;

 

(2)  The drugs prescribed;

 

(3)  Quantity of drugs prescribed and dispensed;

 

(4)  Name of the prescriber;

 

(5)  Date, name of agency, and signature of person removing the records.

 

(D)  All such records, including consents, memoranda of emergency disclosures, and written requests pursuant to paragraph (A)(8) (A)(9) of this rule, shall be kept on file at the pharmacy for a period of three years in a readily retrievable manner.

 

 

4729-5-30  Manner of issuance of prescription. (Replaced by new 4729-5-30)

 

4729-5-30  Manner of issuance of a prescription.  [OAC: 02/01/2002]

 

(A)  A prescription, to be valid, 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 bona fide treatment of a patient 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 of law.

 

(B)  All prescriptions issued by a prescriber shall:

 

(1)  Be dated as of and on the day when issued.

 

(2)  Indicate the full name and address of the prescriber.

 

(3)  Indicate the full name and address of the patient.

 

(4)  Indicate the drug name and strength.

 

(5)  Indicate the quantity to dispense.

 

(6)  Indicate the appropriate directions for use.

 

(7)  Specify the number of times or the period of time for which the pre­scription may be refilled.  If no such authorization is given, the prescription may not be refilled except in accordance with section 4729.281 of the Revised Code.  A prescription marked "Refill P.R.N." or some similar designation is not considered a valid refill authorization.

 

(8)  Not authorize any refills for schedule II controlled substances.

 

(9)  Authorize refills for schedules III and IV controlled substances only as permitted by section 3719.05 of the Revised Code.

 

(10) Not authorize a refill beyond one year from the date of issuance for schedule V controlled substances and for dangerous drugs that are not controlled substances.

 

(11) Identify the trade name or generic name of the drug(s) in a compounded prescription.

 

(12) Not be coded in such a manner that it cannot be dispensed by any pharmacy of the patient's choice.

 

(13) For prescriptions issued to a patient by a prescriber, be:

 

(a)  Manually signed on the day issued by the prescriber in the same manner as he/she would sign a check or legal document.

 

(b)  Issued in compliance with rule 4729-5-13 of the Administrative Code.

 

(14) Be issued in compliance with all applicable federal and state laws, rules, and regulations.

 

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

 

(D)  A pharmacist may not dispense a dangerous drug for the first time beyond six months from the date of issuance of a prescription.

 

(E)  Oral transmission by the prescriber or the prescriber’s agent of original prescriptions and refills authorized by a prescriber, pursuant to the requirements of this rule, may be transmitted by telephone only to:

 

(1)  A pharmacist.  The prescriber or prescriber’s agent must provide his/her full name.  The pharmacist shall make a record of the prescriber's agent on the original prescription and, if used, on the alternate system of recordkeeping.  The pharmacist is responsible for assuring the validity of the source of the oral prescription.

 

(2)  A recording device within the pharmacy if the pharmacist is unavailable.  The prescriber or prescriber's agent must provide his/her full 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.

 

(3)  A licensed pharmacy intern if the pharmacist on duty who is supervising the activity of the intern determines that the intern is competent to receive telephone prescriptions.

 

(a)  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.

 

(b)  The supervising pharmacist on duty is responsible for the accuracy of the prescription.

 

(c)  The supervising pharmacist on duty must be immediately avail­able to answer questions or discuss the prescription with the caller.

 

(F)  Original written prescriptions authorized and signed by a prescriber may be transmitted by the prescriber or the prescriber’s agent by facsimile machine to a pharmacy pursuant to the following:

 

(1)  The prescription must be issued in compliance with this rule.

 

(2)  The original prescription signed by the prescriber from which the fac­simile is produced shall not be issued to the patient.  The original prescription signed by the prescriber must remain with the patient’s records at the prescriber’s office or the institutional facility where it was issued.

 

(3)  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.

 

(4)  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.

 

(5)  Prescriptions for schedule II controlled substances may not be transmit­ted by facsimile except:

 

(a)  Pursuant to rules 4729-17-09 and 4729-19-02 of the Administra­tive Code.

 

(b)  For a narcotic substance issued for a patient enrolled in
a hospice.  The original prescription must indicate that the patient is a hospice patient.  The facsimile transmission must also meet the other requirements of this rule.

 

(6)  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.

 

(G)  A prescription may be transmitted by means of a board-approved electronic prescription transmission system, without further verification by the pharma­cist of the prescriber’s identity, provided that:

 

(1)  The system shall require positive identification of the prescriber as defined in rule 4729-5-01 of the Administrative Code and the full name of any authorized agent of the prescriber who transmits the prescrip­tion.

 

(2)  The computer data must be retained for a period of three years at the prescriber's office.

 

(H)  A pharmacist who modifies a patient's drug therapy pursuant to a consult agreement and:

 

(1)  Is also responsible for the dispensing of the drug to the patient must include on the drug order the name of the physician who originally pre­scribed the drug, sign the pharmacist's full name, and be in compliance with this rule in the same manner as the prescriber.

 

(2)  Is not responsible for the dispensing of the drug to the patient may transmit the order to a pharmacy by acting as an agent of the physician.  Such pharmacist must personally transmit the order verbally or by facsimile to another pharmacist and be in compliance with this rule.

 

 

4729-6-01  Definitions; impaired pharmacists.  [OAC: 02/01/2002]

 

As used in Chapter 4729-6 of the Administrative Code:

 

(A)  "Substance abuse/chemical dependency" means a condition involving the use of alcohol or other drugs to a degree that it interferes in the functional life of the licensee, as manifested by physical health, family, job, legal, finan­cial, or emotional/psychiatric problems.

 

(B)  "Impaired pharmacist" means a pharmacist who, because of his/her use of psychoactive substances, is unable to practice pharmacy with requisite judgment, skill, competence, or safety to the public.

 

(C)  "Approved treatment provider" means a board approved and designated treatment program pursuant to section 4729.18 of the Revised Code and Chapter 4729-6
of the Administrative Code that has been certified by the Ohio department of alcohol and drug addiction services (ODADAS) pursuant to division (A) of sec­tion 3793.06 of the Revised Code and who provides or has contractual arrange­ments to provide all of the following services: to identify, verify, assess the degree of impairment, detoxify, rehabilitate, and monitor the impaired pharmacist.

 

(D)  "Limited approved treatment provider" means a board approved and designated treatment program pursuant to section 4729.18 of the Revised Code and Chapter 4729-6 of the Administrative Code who provides or has contractual arrange­ments to provide identification and referral services for the impaired phar­macist and may provide monitoring during rehabilitation.

 

(E)  "Intervenor" means a person who participates in a process whereby a phar­macist alleged to be impaired is confronted to evaluate the presence of impairment and, if indicated, who refers the pharmacist for assessment and treatment of the problem.

 

(F)  "Referral for assessment" means a process whereby an intervenor who has reason to believe that a pharmacist is impaired directs that individual to be examined for diagnosis and treatment.

 

(G)  "Treatment assessor" means an individual who is licensed under Chapter 4731. of the Revised Code as a doctor of medicine or a doctor of osteopathic medi­cine and surgery and who is a certified addictionist or an individual who
is certified by the Ohio department of alcohol and drug addiction services (ODADAS) as a certified chemical dependency counselor 3 or 2 pursuant to section 3793.07 of the Revised Code and Chapter 3793:2 of the Administrative Code and who by training and experience can make an assessment of a pharma­cist's impairment.

 

(H)  "Individualized treatment plan" is a written document which shall provide
for inpatient treatment, outpatient treatment, family therapy, psychotherapy, professional support groups, twelve-step programs, aftercare including sup­port and self-help groups, monitoring programs consisting of random, chain of evidence drug screens, and work site review.  The above services and other services may be determined by an approved treatment provider.

 

(I)  "Treatment contract" means the document which outlines the individualized treatment plan, the requirement to cease practice, the requirement for com­pliance by the impaired pharmacist, and the requirement for notification of the board for non-compliance or relapse pursuant to section 4729.18 of the Revised Code.

 

(J)  "Inpatient treatment" shall consist of placing the pharmacist in an approved treatment provider facility that will provide lodging and food, as well as care and treatment for detoxification and rehabilitation as indicated by the treatment contract.

 

(K)  "Outpatient treatment" shall consist of the pharmacist not residing in an inpatient treatment facility but who is participating in aftercare, twelve-step programs, professional support group (if available), and monitoring programs consisting of random, chain of evidence drug screens and work site review, to establish compliance for a minimum of two years.

 

(L)  "Responsible person" for an approved treatment provider or limited approved treatment provider is an individual who shall be in full and actual charge of the treatment program; including but not limited to, having a current license as an approved treatment provider or limited approved treatment provider, assuring the provider has the necessary facilities and personnel to provide services, maintaining records, and notification of the board when required.

 

(M)  "Twelve-step program" is a self-help program such as Alcoholics Anonymous or Narcotics Anonymous which the individual shall be required to personally attend.  The minimum attendance required shall not be less than three docu­mented meetings each week during the first two years in recovery.

 

(N)  "Aftercare" is a counselor-facilitated group meeting which directly responds to problems relating to the ongoing treatment and monitoring of the pharma­cist's sobriety, and should extend for a minimum of six months.

 

(O)  "Professional support group" is a group of peers meeting to discuss the problems peculiar to recovery and re-entry to practice of the licensed professional.

 

(P)  "Relapse" means a positive drug screen or a return to a pattern of impairment activities which affects the pharmacist's ability to practice.

 

 

4729-6-02  Applicability.  [OAC: 02/01/2002]

 

(A)  No person, except a licensed approved treatment provider, shall purport to be or operate as a treatment facility for the purpose of administering care in the detoxification and rehabilitation of an impaired pharmacist.

 

(B)  The rules in Chapter 4729-6 of the Administrative Code are applicable to all licensed pharmacists, pharmacy interns, and any other board licensees.  For the purposes of this chapter only, the word "pharmacist" shall include phar­macy interns and other persons individuals licensed by the board.

 

(C)  Should the board have reason to believe that a pharmacist suffers from impairment because of conduct or behavior committed or displayed by the pharmacist, the board may compel the individual to be examined by an approved treatment provider.  If the pharmacist fails to submit to an assessment as ordered by the board, or if the assessment discloses impairment, or if there is an admission of impairment, or if the board has other reliable, substan­tial, and probative evidence demonstrating impairment, the board may:

 

(1)  Refer the licensee for treatment;

 

(2)  Initiate action against the licensee pursuant to Chapter 119. of the Revised Code;

 

(3)  Summarily suspend the license of a pharmacist pursuant to rule 4729-6-10 of the Administrative Code if the licensee's continued practice poses a danger of immediate and serious harm to others.

 

(D)  Before being eligible to apply for reinstatement of a license suspended be­cause of impairment, the pharmacist must demonstrate to the board that he/she possesses the requisite judgment, skill, and competence to ensure public safety in the practice of pharmacy.  Such demonstration shall include but not be limited to the following:

 

(1)  Certification from an approved treatment provider that the pharmacist:

 

(a)  Has signed a treatment contract and is participating in and complying with an individualized treatment plan;

 

(b)  Has successfully completed the required inpatient treatment;

 

(c)  Is actively participating in an outpatient treatment program;

 

(d)  Has been shown to be alcohol and drug free by random, chain of evidence drug screens for a period of time as determined by the board at the time of the suspension;

 

(e)  Has been evaluated by an approved treatment provider who has made a clear determination, documented in a written statement, that the pharmacist is capable of practicing.

 

(2)  Certification that the pharmacist has met all requirements of the board order and satisfactory evidence has been submitted to the board, includ­ing but not limited to:

 

(a)  A copy of the signed and agreed to treatment contract;

 

(b)  Written reports and documentation from the approved treatment program;

 

(c)  Written reports from the pharmacist describing progress towards recovery.

 

 

4729-6-08  Requirements for approved treatment providers and limited approved treatment providers.  [OAC: 02/01/2002]

 

(A)  An intervenor associated with either an approved treatment provider or a limited approved treatment provider shall:

 

(1)  Respond to information from concerned individuals;

 

(2)  Ascertain validity of the information received;

 

(3)  Assess the situation and, if the pharmacist is showing evidence of impairment, the intervenor shall refer the individual for examination;

 

(4)  If the pharmacist fails to comply within one week to a referral for ex­amination, the intervenor must report the name of the pharmacist to the board of pharmacy by phone within one working day and follow with a written report within two working days.

(B)  A treatment assessor associated with an approved treatment provider shall examine a pharmacist referred to the approved treatment provider to determine if the pharmacist has a substance abuse/chemical dependency related impair­ment.

 

(C)  If such an impairment exists, the approved treatment program shall formulate the pharmacist's individualized treatment plan as defined in rule 4729-6-01 of the Administrative Code.  The specific requirements shall be determined
by an assessment of psychological, physical, developmental, family, social, environmental, recreational, and professional needs.  The individualized treatment plan shall be part of a treatment contract which the impaired phar­macist must sign.  If the impaired pharmacist fails to sign the treatment contract and enter treatment within forty-eight hours of the determination that the pharmacist needs treatment, the approved treatment provider must report the name of the pharmacist to the board of pharmacy by phone within one working day and follow with a written report within two working days.

 

(D)  The responsible person for the approved treatment provider shall:

 

(1)  Establish a system of records that will provide for complete information about an impaired pharmacist from intervention through the rehabilita­tion stage;

 

(2)  Establish treatment contracts meeting the requirements of this chapter and a system of follow up to determine compliance by the impaired phar­macist with the treatment contract;

 

(3)  Assure confidentiality of the impaired pharmacist, except:

 

(a)  If the pharmacist fails to comply within one week to a referral
for examination,

 

(b)  If the impaired pharmacist fails to sign the contract and enter treatment within forty-eight hours of the determination that the pharmacist needs treatment,

 

(c)  If the impaired pharmacist does not suspend practice on entering treatment,

 

(d)  If the impaired pharmacist does not comply with the terms of the treatment contract,

 

(e)  If the impaired pharmacist resumes practice before the approved treatment provider has made a clear determination that the phar­macist is capable of practicing,

 

(f)  If the impaired pharmacist suffers a relapse at any time during
or following rehabilitation.

 

(4)  Notify the board of pharmacy by phone within one working day and follow with a written report within two working days if the pharmacist violates any portion of this rule.

 

(E)  The responsible person for the limited approved treatment provider shall:

 

(1)  Assure confidentiality of the impaired pharmacist, except:

 

(a)  If the pharmacist fails to comply within one week to a referral for examination, or,

 

(b)  If the impaired pharmacist suffers a relapse at any time during or following rehabilitation.

 

(2)  Notify the board of pharmacy by phone within one working day and follow with a written report within two working days if the pharmacist violates any portion of this rule.

 

 

4729-7-02  Requirements for renewal of a pharmacist identification card.  [OAC: 02/01/2002]

 

(A)  Except as provided in rule 4729-7-08 of the Administrative Code, evidence of four and one-half six C.E.U.s of approved continuing education shall be sub­mitted with the application for renewal of a pharmacist identification card by the date indicated on the continuing pharmacy education report form and at intervals not to exceed three years.  At least 0.3 C.E.U.s of the total required C.E.U.s must be obtained from Ohio state board of pharmacy approved programs in jurisprudence.  Beginning with those pharmacists required to report continuing education in 2001, evidence of six C.E.U.s of approved continuing education shall be submitted with the application for renewal
of a pharmacist identification card at intervals not to exceed three years.  Beginning with those pharmacists required to report continuing education in 2001, at least four and one-half C.E.U.s of the total required C.E.U.s must be obtained in patient care related programs and at least 0.3 C.E.U.s of the total required C.E.U.s must be obtained from board approved programs in jurisprudence.

 

(B)  Documentation of the required C.E.U.s shall be submitted on forms provided by the state board of pharmacy and in the manner required for renewal of the pharmacist identification card.

 

(C)  The C.E.U.s must be obtained on or after July first of the year that is three years prior to the year in which evidence of the continuing pharmacy educa­tion is required for identification card renewal.  Beginning with those pharmacists required to report continuing education in 2004, as long as the continuing pharmacy education report forms are filed in a timely manner, the C.E.U.s must be obtained on or after March first of the year that is three years prior to the year in which evidence of the continuing pharmacy education is required for identification card renewal.  If the continuing pharmacy education report forms are not filed in a timely manner, the C.E.U.s must have been obtained during the three-year period immediately preceding the date that the continuing pharmacy education report form is filed.

 

(D)  C.E.U.s obtained in excess of the required C.E.U.s at the time the continuing education is required for identification card renewal may not be transferred and applied to future requirements.

 

(E)  A pharmacist whose identification card has lapsed or has been suspended may renew his/her identification card, if he/she qualifies for renewal pursuant to section 4729.12 or section 4729.13 of the Revised Code, by paying the required fee, completing the application for renewal, and, if he/she would have been required to report continuing pharmacy education during the period of lapse or suspension, by providing evidence of having obtained the number of C.E.U.s required at the time of renewal by submitting the certificates of participation obtained during the three-year period immediately preceding the date of applying for renewal.

 

(F)  Ohio-registered pharmacists who hold a current license in states where con­tinuing education is mandatory, have met the continuing pharmacy education requirements of that state, and who do not practice pharmacy in Ohio, may renew their identification card by paying the required fee, completing the application for renewal, and submitting the following signed statement on their continuing pharmacy education report form:

 

"I declare under penalties of falsification that I hold a current and valid pharmacist license, number (insert license number), in the state of (insert name of state), that I have met the continu­ing pharmacy education requirements of this state and I do not presently practice pharmacy in the state of Ohio.  I hereby agree to immediately notify the Ohio state board of pharmacy if I re­turn and commence the practice of pharmacy in the state of Ohio."

 

 

4729-9-04  Returned drugs.  [OAC: 02/01/2002]

 

(A)  No drug that has been dispensed pursuant to a prescription and has left the physical premises of the terminal distributor of dangerous drugs shall be dispensed again except:

 

(1)  Drugs dispensed for inpatients pursuant to paragraph (C) of rule 4729-17-01 of the Administrative Code, or provided that:

 

(a)  The drugs are packaged in unopened, single-dose or tamper-evident containers and

 

(b)  The drugs have not been in the possession of the ultimate user.

 

(2)  Non-controlled drugs dispensed by a government entity and delivered for outpatients to a psychiatric outpatient facility licensed with the state board of pharmacy provided that:

 

(a)  The drugs are packaged in unopened, single-dose or tamper-evident containers and

 

(b)  The drugs have not been in the possession of the ultimate user.

 

(B)  Drugs that have not been dispensed or possessed in accordance with this rule are considered to be adulterated.

 

 

4729-10-02  Licensure.  [OAC: 02/01/2002]

 

Each nonresident terminal distributor of dangerous drugs that sells dangerous drugs at retail in the state of Ohio shall obtain a terminal distributor of dan­gerous drugs license pursuant to sections 4729.54 and 4729.55 of the Revised Code and Chapter 4729-10 of the Administrative Code.

 

(A)  Conditions of licensure.  The nonresident terminal distributor of dangerous drugs shall provide the following information relative to the qualifications of a terminal distributor of dangerous drugs set forth in section 4729.55 of the Revised Code:

 

(1)  Full name, address, and telephone number of the person who desires to be licensed as a nonresident terminal distributor of dangerous drugs.

 

(a)  If incorporated, the application for licensure must include copies of the incorporation papers; and names, dates of birth, addresses, and social security numbers of the officers of the corporation and all stockholders holding more than ten percent of the stock.

 

(b)  If a proprietorship, the application for licensure must include the name, address, date of birth, and social security number of the owner(s).

 

(c)  If a partnership, the application for licensure must include the names, addresses, dates of birth, and social security numbers of the partners.

 

(d)  If the entity applying for a license is a private investment group, the application for licensure must include the names, addresses, dates of birth, and social security numbers of the investors.

 

(2)  Certification from the appropriate licensing authority that the appli­cant maintains at all times a valid, unexpired license, permit, or registration to properly carry on the business of a distributor of dangerous drugs in the state in which the facility is located and from where dangerous drugs are being sold at retail to residents in Ohio.  The certification(s) must include licenses, permits, or registrations required to cover the categories of dangerous drugs which the nonresi­dent terminal distributor of dangerous drugs will be selling at retail to persons in the state of Ohio (i.e., controlled substance drug pro­ducts as well as noncontrolled substance drug products).

 

(3)  A copy of the most recent inspection report, any warning notices, notice of deficiency reports, or any other related reports issued by the regu­latory licensing agency and drug law enforcement agencies of the state in which it is located or any federal agencies regulating and enforcing laws governing the legal distribution of drugs.

 

(4)  A narrative description of the type of business the nonresident terminal distributor of dangerous drugs will be carrying on within the category of licensure requested.  The description shall include the type of pro­fessional services that will be provided in accordance with federal and state laws governing the legal distribution of drugs and professional pharmacy practice.

(5)  If the nonresident terminal distributor is a pharmacy, the application shall be accompanied by:

 

(a)  The name and license number of the responsible pharmacist (pharmacist-in-charge).

 

(b)  Certification from the appropriate licensing authority that the responsible pharmacist’s license is current and in good standing.

 

(c)  The telephone number where the responsible pharmacist may be reached during normal business hours.

 

(d)  A list of all pharmacists employed by the pharmacy who are dis­pensing dangerous drugs pursuant to prescriptions to residents of this state.  The list shall include each pharmacist’s license number and the date that the license will expire.

 

(e)  A description of the following:

 

(i)  Normal delivery protocols and times;

 

(ii)  Any special packaging or procedures used in delivering temperature-sensitive drug products;

 

(iii)  The procedure to be followed if the patient’s prescription drug is not available at the nonresident pharmacy, or if delivery will be delayed beyond the normal delivery time;

 

(iv)  The procedure to be followed upon receipt of a prescription for an acute illness that assures the patient the opportunity to obtain the medication immediately.

 

(v)  The procedure to be followed that will ensure that the patient’s medication therapy is not interrupted when the non­resident pharmacy has been advised by the patient or patient’s caregiver that the patient’s prescription medication has not been received within the normal delivery time.

 

(6)  Nonresident terminal distributors of dangerous drugs where the respon­sible person is a dentist, optometrist, physician, or veterinarian shall submit the following information with their application:

 

(a)  The name and license number of the responsible dentist, optome­trist, physician, or veterinarian.

 

(b)  Certification from the appropriate licensing authority that the responsible person’s license is current and in good standing.

 

(c)  The telephone number where the responsible dentist, optometrist, physician, or veterinarian may be reached during normal business hours.

 

(d)  A list of all dentists, optometrists, physicians, or veterinarians employed by the nonresident terminal distributor who are selling dangerous drugs at retail to residents of this state.  The list shall include the license numbers and the date that the licenses
to practice will expire.

(B)  Discipline.

 

(1)  In accordance with Chapter 119. of the Revised Code, the board may deny, revoke, suspend, or refuse to renew a nonresident terminal distributor license, or may issue a monetary penalty or forfeiture in accordance with section 4729.57 of the Revised Code:

 

(a)  For making any false material statements in an application for a license as a nonresident terminal distributor of dangerous drugs.

 

(b)  For failure to comply with any provision of Chapter 4729-10 of the Administrative Code.

 

(c)  For serious misconduct on the part of the nonresident terminal dis­tributor that results in harm to one or more patients within Ohio.

 

(d)  If it determines that the nonresident terminal distributor has
been disciplined by another state or federal agency for serious misconduct that may cause patients within Ohio to be at risk of harm.

 

(e)  For ceasing to satisfy the qualifications of a nonresident terminal distributor of dangerous drugs set forth in section 4729.551 of the Revised Code.

 

(2)  Except in a case that creates an imminent danger to the public health or safety, prior to initiating a disciplinary action against a nonresident terminal distributor under paragraphs (B)(1)(c) and (B)(1)(d) of this rule, the board must file a complaint against the nonresident terminal distributor with the regulatory or licensing agency of the state in which the nonresident terminal distributor is located.  The board may initiate its own action to discipline a nonresident terminal distributor if:

 

(a)  The regulatory or licensing agency of the state in which the nonresident terminal distributor is located fails to initiate an action by the sixtieth day after the date that the board filed the complaint under this rule;

 

(b)  The regulatory or licensing agency of the state in which the nonresident terminal distributor is located fails to resolve the complaint within one year after the date that the complaint was filed; or

 

(c)  The regulatory or licensing agency of the state in which the nonresident terminal distributor is located lacks or fails to exercise jurisdiction.

 

(3)  Nothing in this rule shall require the board to take disciplinary action against the nonresident terminal distributor if it determines that another state has already taken suitable action for the same offense.

 

 

4729-21-04  Requirements for a cryogenic medical gases safety program.  [OAC: 06/10/2002]

 

(A)  A medical gases safety program developed pursuant to section 4729.70 of the Revised Code shall meet at least the following requirements:

 

(1)  The instructors shall have the appropriate education and experience to teach a program in medical gases safety.

 

(2)  The program shall be presented to all individuals who fill, install, connect, or disconnect medical gases contained in cryogenic vessels that are portable and intended for use in administering direct treatment to one or more individuals.

 

(3)  Successful participation and demonstrated competency in a program must be completed prior to an individual filling, installing, connecting, or disconnecting a medical gas contained within a cryogenic vessel.

 

(4)  The program must include at least the following:

 

(a)  The description of a cryogenic vessel including at least the following:

 

(i)   Valve inlet and outlet connections.

 

(ii)  Safety systems associated with each outlet.

 

(iii) Proper labeling.

 

(iv)  Color coding.

 

(v)   Gas identification.

 

(b)  A review of each medical gas listed in division (C)(2) of section 4729.70 of the Revised Code that may be contained in a cryogenic vessel including at least the following:

 

(i)   A description of the properties of the gas and liquid.

 

(ii)  The precautions and warnings associated with the gas and liquid.

 

(iii) What to do when there is an exposure to the gas or liquid.

 

(iv)  What to do in an emergency hazardous material situation with the gas or liquid.

 

(c)  The proper installation of cryogenic vessels including at least the following:

 

(i)   Connecting and disconnecting supply lines.

 

(ii)  Recognizing silver-brazed fittings or other acceptable mechanical means that make the connection a permanent and integral part of the valve.

 

(iii) Recognizing that changing or adapting the fittings for another gas service is strictly prohibited unless pursuant
to rule 4729-21-05 of the Administrative Code.

 

(iv)  Recognizing the appropriate devices through which medical gases are delivered from cryogenic vessels.

 

(v)   Detecting and reporting leaks.

 

(vi)  Transporting cryogenic vessels appropriately within
a facility.

 

(vii) Appropriate storage of cryogenic vessels.

 

(B)  The program instructor must document the participation of an individual in
a medical gases safety program.  The documentation must be maintained by
the individual’s employer for a period of at least three years and made available, upon request, to those business entities receiving service and to the state board of pharmacy.

 

(C)  Individuals who install, connect, or disconnect medical gases from cryogenic vessels must attend a medical gases safety program at least once every two years.

 

 

4729-21-05  Modifying cryogenic vessels, connections, adaptors, and valves.  [OAC: 06/10/2002]

 

(A)  No person shall modify a cryogenic vessel, connection, or valve or adapt
a connection for another gas service pursuant to division (D) of section 4729.70 of the Revised Code.

 

(B)  Paragraph (A) of this rule does not apply to an employee or agent of a firm owning the cryogenic vessel and is charged with the responsibility of conducting applicable vessel maintenance, changing service from one medical gas to another, or bringing a vessel into compliance with section 4729.70 of the Revised Code.

 

(1)  Such employee or agent shall meet at least the following requirements:

 

(a)  Successful completion of a medical gases safety program pursuant
to rule 4729-21-04 of the Administrative Code.

 

(b)  Successful participation and demonstrated competency in a cryogenic vessel modification program administered by an instructor with the appropriate education and experience.  The program must be based
on written and validated procedures.  The employee or agent must participate in the program annually and it must include at least the following procedures:

 

(i)   Removing, adding, or adapting cryogenic vessel connections and valves.

 

(ii)  Modifying cryogenic vessels.

 

(iii) Conducting cryogenic vessel maintenance.

 

(iv)  Changing the cryogenic vessel from one medical gas to another.

 

(v)   Bringing a cryogenic vessel into compliance with section 4729.70 of the Revised Code.

 

(vi)  Silver brazing or welding techniques and certification of
the individual if applicable.

 

(vii) Removing and adding suitable mechanical means to make a connection a permanent and integral part of the valve.

 

(2)  The employer must document the successful participation and demonstrated competency of an employee or agent in a cryogenic vessel modification program.  The documentation must be maintained by the employer for a period of at least three years and made available, upon request, to those business entities receiving service and to the state board of pharmacy.