RECORD OF THE PROCEEDINGS -- MAY 3, 4, 5, 2004

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.

STATE BOARD OF PHARMACY; 77 SOUTH HIGH STREET, ROOM 1702; COLUMBUS, OHIO 43215-6126

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

Minutes Of The Meeting

Ohio State Board of Pharmacy

May 3, 4, 5, 2004

MONDAY, MAY 3, 2004

10:05 a.m. ROLL CALL

The State Board of Pharmacy convened in the Medical Sciences Building-E701, University of Cincinnati, Cincinnati, Ohio with the following members present:

Robert P. Giacalone, R.Ph. (President); Lawrence J. Kost, R.Ph. (Vice-President); Diane C. Adelman, R.Ph.; Gregory Braylock, R.Ph.; Suzanne R. Eastman, R.Ph.; Elizabeth I. Gregg, R.Ph.; Nathan S. Lipsyc, R.Ph.; and Dorothy S. Teater, Public Member.

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

This meeting was held at the University of Cincinnati so that the students from the College of Pharmacy could attend. President Giacalone, Board members, and Board staff introduced themselves to the students and a brief explanation of the meeting process was given.

10:17 a.m.

R-2004-186 Mr. Winsley presented a settlement offer to the Board that had been received in the matter of Terrell L. Mundhenk, R.Ph. After discussion, Mr. Braylock moved that the settlement offer be denied and that the hearing scheduled for that afternoon proceed. The motion was seconded by Mr. Kost and approved by the Board (Aye-7/Nay-0).

Mr. Keeley presented a detailed legislative report to the Board.

Mr. McMillen presented a detailed licensing report to the Board.

11:30 a.m.

The Board recessed for lunch.

1:09 p.m.

The Board reconvened in the Medical Sciences Building-E701, University of Cincinnati, Cincinnati, Ohio with the following members present:

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 Anthony Kornokovich, R.Ph., Timberlake. Mr. Lipsyc recused himself from the hearing and the resulting deliberations.

2:25 p.m.

The hearing ended and the record was closed. The Board took a brief recess.

3:00 p.m.

5:40 p.m.

The hearing ended and the record was closed. The Board meeting recessed until Tuesday, May 4, 2004.

TUESDAY, MAY 4, 2004

8:10 a.m. ROLL CALL

The State Board of Pharmacy convened in Room West-B&C, 31st Floor, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with the following members present:

Mr. Rowland announced that the following settlement agreements for Stephen A. Summers, R.Ph. and Elaine Woll, R.Ph. had been signed and were effective.

R-2004-187 SETTLEMENT AGREEMENT WITH THE STATE BOARD OF PHARMACY

(Docket No. D-040211-059)

In The Matter Of:

STEPHEN ANDREW SUMMERS, R.Ph.

9597 Pence Jones Road

Waynesville, Ohio 45068

(R.Ph. No. 03-2-16556)

This Settlement Agreement is entered into by and between Stephen Andrew Summers and the Ohio State Board of Pharmacy, a state agency charged with enforcing the Pharmacy Practice Act and Dangerous Drug Distribution Act, Chapter 4729. of the Ohio Revised Code.

Stephen Andrew Summers voluntarily enters into this Agreement being fully informed of his rights afforded under Chapter 119. of the Ohio Revised Code, including the right to representation by counsel, the right to a formal adjudication hearing on the issues contained herein, and the right to appeal. Stephen Andrew Summers acknowledges that by entering into this agreement he has waived his rights under Chapter 119. of the Revised Code.

Whereas, the Board is empowered by Section 4729.16 of the Ohio Revised Code to suspend, revoke, place on probation, refuse to grant or renew an identification card or enforce a monetary penalty on the license holder for violation of any of the enumerated grounds therein.

Whereas, Stephen Andrew Summers is licensed to practice pharmacy in the State of Ohio.

Whereas, on or about February 11, 2004, pursuant to Chapter 119. of the Ohio Revised Code, Stephen Andrew Summers was notified of the allegations or charges against him, his right to a hearing, his rights in such hearing, and his right to submit contentions in writing. Stephen Andrew Summers requested a hearing; it was scheduled and continued. The February 11, 2004, Notice of Opportunity for Hearing contains the following allegations or charges:

(1) Records of the Board of Pharmacy indicate that Stephen Andrew Summers was originally licensed in the State of Ohio on August 6, 1986, pursuant to examination, and is currently licensed to practice pharmacy in the State of Ohio.

(2) Stephen Andrew Summers did, from January, 2003, through September, 2003, with purpose to deprive, knowingly obtain or exert control over the property of Mr. Prescription Pharmacy, by deception, to wit: Stephen Andrew Summers admittedly stole cash from his employer. Audit figures show the amount stolen to exceed $38,000. Such conduct is in violation of Section 2913.02 of the Ohio Revised Code.

(3) Stephen Andrew Summers did, from January, 2003, through September, 2003, knowing that an investigation was likely to be instituted, alter, destroy, conceal, or remove a record, document, or thing with purpose to impair its value or availability as evidence in such investigation, to wit: during a course of stealing money from his employer's cash register, Stephen Andrew Summers cleared or altered cash register entries so that his thefts would not be detected or proven. Such conduct is in violation of Section 2921.12 of the Ohio Revised Code.

Stephen Andrew Summers neither admits nor denies the allegations stated in the Notice of Opportunity for Hearing letter dated January 7, 2004; however, the Board has evidence sufficient to sustain the allegations and hereby adjudicates the same.

Wherefore, in consideration of the foregoing and mutual promises hereinafter set forth, and in lieu of a formal hearing at this time, Stephen Andrew Summers knowingly and voluntarily agrees with the State Board of Pharmacy to the following:

(A) Stephen Andrew Summer’s pharmacist identification card, No. 03-2-16556, will be placed on probation for two years, effective from the date of this Agreement.

(B) Stephen Andrew Summers agrees to the imposition of a monetary penalty of two thousand five hundred dollars ($2,500.00) due and owing within thirty days from the effective date of this Agreement. Checks 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

(1) The State Board of Pharmacy hereby declares that Stephen Andrew Summer’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) Stephen Andrew Summers may not serve as a responsible pharmacist.

(3) Stephen Andrew Summers must, during the period of probation, notify any future employers of his probation and its terms.

(4) Stephen Andrew Summers may destroy, assist in, or witness the destruction of controlled substances.

(5) Stephen Andrew Summers must not violate the drug laws of the State of Ohio, any other state, or the federal government.

(6) Stephen Andrew Summers must abide by the rules of the Ohio State Board of Pharmacy.

(7) Stephen Andrew Summers must comply with the terms of this Agreement.

If, in the judgment of the Board, Stephen Andrew Summers appears to have violated or breached any terms or conditions of this Agreement, the Ohio State Board of Pharmacy reserves the right to, at any time, revoke probation, modify the conditions of probation, and reduce or extend the period of probation, and/or the Board may institute formal disciplinary proceedings for any and all possible violations or breaches, including but not limited to, alleged violation of the laws of Ohio occurring before the effective date of this Agreement.

Stephen Andrew Summers acknowledges that he has had an opportunity to ask questions concerning the terms of this agreement and that all questions asked have been answered in a satisfactory manner. Any action initiated by the Board based on alleged violation of this Agreement shall comply with the Administrative Procedure Act, Chapter 119. of the Ohio Revised Code.

Stephen Andrew Summers waives any and all claims or causes of action he may have against the State of Ohio or the Board, and members, officers, employees, and/or agents of either, arising out of matters which are the subject of this Agreement. Stephen Andrew Summers waives any rights of appeal pursuant to Chapter 119. of the Ohio Revised Code.

This Settlement Agreement shall be considered a public record, as that term is used in Section 149.43 of the Ohio Revised Code, and shall become effective upon the date of the Board President’s signature below.

/s/ S A Summers		/d/ 4/21/04
Stephen Andrew Summers, R.Ph., Respondent		Date of Signature
/s/ J D Revelson		/d/ 04/21/04
Jay D. Revelson, Attorney for Respondent		Date of Signature
/s/ Robert P. Giacalone		/d/ 5/4/04
Robert P. Giacalone, President, Ohio State Board of Pharmacy		Date of Signature
/s/ Sally Ann Steuk		/d/ 5–5–04
Sally Ann Steuk, Ohio Assistant Attorney General		Date of Signature

R-2004-188 SETTLEMENT AGREEMENT WITH THE STATE BOARD OF PHARMACY

(Docket No. D-040107-051)

In The Matter Of:

ELAINE L. WOLL, R.Ph.

4468 Classic Drive

Cincinnati, Ohio 45241

(R.Ph. No. 03-2-13136)

This Settlement Agreement is entered into by and between Elaine L. Woll and the Ohio State Board of Pharmacy, a state agency charged with enforcing the Pharmacy Practice Act and Dangerous Drug Distribution Act, Chapter 4729. of the Ohio Revised Code.

Elaine L. Woll voluntarily enters into this Agreement being fully informed of her rights afforded under Chapter 119. of the Ohio Revised Code, including the right to representation by counsel, the right to a formal adjudication hearing on the issues contained herein, and the right to appeal. Elaine L. Woll acknowledges that by entering into this agreement she has waived her rights under Chapter 119. of the Revised Code.

Whereas, Elaine L. Woll is licensed to practice pharmacy in the State of Ohio.

Whereas, on or about January 7, 2004, pursuant to Chapter 119. of the Ohio Revised Code, Elaine L. Woll was notified of the allegations or charges against her, her right to a hearing, her rights in such hearing, and her right to submit contentions in writing. Elaine L. Woll requested a hearing; it was scheduled and continued. The January 7, 2004, Notice of Opportunity for Hearing contains the following allegations or charges:

(1) Records of the Board of Pharmacy indicate that Elaine L. Woll was originally licensed in the State of Ohio on August 9, 1978, pursuant to examination, and is currently licensed to practice pharmacy in the State of Ohio.

(2)

(3)

(4)

(5)

Elaine L. Woll neither admits nor denies the allegations stated in the Notice of Opportunity for Hearing letter dated January 7, 2004; however, the Board has evidence sufficient to sustain the allegations and hereby adjudicates the same.

Wherefore, in consideration of the foregoing and mutual promises hereinafter set forth, and in lieu of a formal hearing at this time, Elaine L. Woll knowingly and voluntarily agrees with the State Board of Pharmacy to the following:

(A) Elaine L. Woll’s pharmacist identification card, No. 03-2-13136, will be placed on probation for two years, effective from the date of this Agreement.

(B) Elaine L. Woll agrees to the imposition of a monetary penalty of five thousand dollars ($5,000.00) due and owing within thirty days from the effective date of this Agreement. Checks 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)

(D) The terms of probation are as follows:

(1) The State Board of Pharmacy hereby declares that Elaine L. Woll's pharmacist identification card is not in good standing.

(2) Elaine L. Woll must, during the period of probation, notify any future employers of her probation and its terms.

(3) Elaine L. Woll must not violate the drug laws of the State of Ohio, any other state, or the federal government.

(4) Elaine L. Woll must abide by the rules of the Ohio State Board of Pharmacy.

(5) Elaine L. Woll must comply with the terms of this Agreement.

If, in the judgment of the Board, Elaine L. Woll appears to have violated or breached any terms or conditions of this Agreement, the Ohio State Board of Pharmacy reserves the right to, at any time, revoke probation, modify the conditions of probation, and reduce or extend the period of probation, and/or the Board may institute formal disciplinary proceedings for any and all possible violations or breaches, including but not limited to, alleged violation of the laws of Ohio occurring before the effective date of this Agreement.

Elaine L. Woll acknowledges that she has had an opportunity to ask questions concerning the terms of this agreement and that all questions asked have been answered in a satisfactory manner. Any action initiated by the Board based on alleged violation of this Agreement shall comply with the Administrative Procedure Act, Chapter 119. of the Ohio Revised Code.

Elaine L. Woll waives any and all claims or causes of action she may have against the State of Ohio or the Board, and members, officers, employees, and/or agents of either, arising out of matters which are the subject of this Agreement. Elaine L. Woll waives any rights of appeal pursuant to Chapter 119. of the Ohio Revised Code.

/s/ Elaine L. Woll		/d/ 4/19/04
Elaine L. Woll, R.Ph., Respondent		Date of Signature
/s/ Peter Rosenwald		/d/ 20 Apr 04
Peter Rosenwald, Attorney for Respondent		Date of Signature
/s/ Robert P. Giacalone		/d/ 5/4/04
Robert P. Giacalone, President, Ohio State Board of Pharmacy		Date of Signature
/s/ Sally Ann Steuk		/d/ 5–5–04
Sally Ann Steuk, Ohio Assistant Attorney General		Date of Signature

8:12 a.m.

Mrs. Gregg 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. Braylock and a roll call vote was conducted by President Giacalone as follows: Adelman-Yes, Braylock-Yes, Eastman-Yes, Gregg-Yes, Kost-Yes, Lipsyc-Yes, Teater-Yes, and Turner-Yes.

9:00 a.m.

R-2004-189 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 Anthony Kornokovich, R.Ph.:

ORDER OF THE STATE BOARD OF PHARMACY

(Docket No. D-031016-021)

In The Matter Of:

ANTHONY KORNOKOVICH, R.Ph.

86 Eastshore Boulevard

Timberlake, Ohio 44095

(R.Ph. No. 03-3-16986)

INTRODUCTION

THE MATTER OF ANTHONY KORNOKOVICH CAME FOR HEARING ON MAY 3, 2004, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ROBERT P. GIACALONE, R.Ph. (presiding); DIANE C. ADELMAN, R.Ph.; GREGORY BRAYLOCK, R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ELIZABETH I. GREGG, R.Ph.; LAWRENCE J. KOST, R.Ph.; DOROTHY S. TEATER, PUBLIC MEMBER.

ANTHONY KORNOKOVICH WAS REPRESENTED BY JOHN R. IRWIN, M.D. AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GENERAL.

SUMMARY OF EVIDENCE

State’s Witnesses

None

Respondent's Witnesses

1. Anthony Kornokovich, R.Ph., Respondent

2. Christopher M. Holzman, R.Ph.

State's Exhibits

1. Reinstatement Hearing Request letter from John R. Irwin, M.D. [10-07-03]

1A-1E. Procedurals

2A. Copy of State Board of Pharmacy Order in re Anthony Kornokovich, R.Ph. [05-15-03]

Respondent's Exhibits

A1-A3. Facsimile copy of PRO Pharmacist's Recovery Contract for Tony Kornokovich [12-10-02]

B. Support Group Attendance Verification cover letter from Anthony Kornokovich [04-28-04]

C1-C13. Calendar pages for April 2003 to April 2004

D1-D21. Support Group Attendance Records [04-04-03 to 04-28-04]

E1-E14. Support Group Attendance Records [05-13-03 to 04-28-04]

F. Letter from Anthony J. Kornokovich [04-29-04]

G1-G15. Calendar pages for February 2003 to April 2004

H1-H3. Compass Vision Licensee Summary Report [02-10-03 to 03-02-04]

I1-I2. Compass Vision Drug Screen Report [04-23-04]

J. Letter from Michael D. Quigley, R.Ph. [04-30-04]

K1-K2.

R. Ohio Bureau of Motor Vehicles Notification/Reinstatement Requirement for Driver License Status of Anthony J. Kornokovich [03-18-04]

S1-S2. Copy of Cleveland Clinic Progress Reports [04-06-04 and 04-19-04]

S3-S4. The Cleveland Clinic Foundation letter confirming Vicodin prescription [10-24-03]; copy of Rx #970949 [10-24-03]

S5. Treatment Compliance letter from Stacey B. Foerstner, Ph.D. [not dated]

S6-S7. Letters of Support [04-28-04 and 04-30-04]

T1-T33. Continuing Pharmaceutical Education Credits and Certificates [12-10-00 to 04-25-04]

FINDING OF FACT

After having heard the testimony, observed the demeanor of the witnesses, considered the evidence, and weighed the credibility of each, the State Board of Pharmacy finds that Anthony Kornokovich has complied with the terms set forth in the Order of the State Board of Pharmacy, Docket No. D-021016-020, effective May 15, 2003.

DECISION OF THE BOARD

On the basis of the Finding of Fact set forth above, and after consideration of the record as a whole, the State Board of Pharmacy hereby approves the reinstatement of the pharmacist identification card, No. 03-3-16986, held by Anthony Kornokovich to practice pharmacy in Ohio and places Anthony Kornokovich on probation for five years beginning on the effective date of this Order, with the following conditions:

(A) Anthony Kornokovich must enter into a new contract, signed within thirty days after the effective date of this Order, with an Ohio Department of Alcohol and Drug Addiction Services (ODADAS) treatment provider or a treatment provider acceptable to the Board for a period of not less than five years and submit a copy of the signed contract to the Board office before his pharmacist identification card is issued. The contract must provide that:

(1) Random, observed urine drug screens shall be conducted at least once each month for the first year and then at least once every three months for the remaining four years.

(a) The urine sample must be given within twelve hours of notification. The urine drug screen must include testing for creatinine or specific gravity of the sample as the dilutional standard.

(b) Soma, Valium, Fioricet, Vicodin, Lortab, and Ultram must be added to the standard urine drug screen.

(c) Results of all drug screens must be negative. Any positive results, including those that may have resulted from ingestion of food, but excluding false positives that resulted from medication legitimately prescribed, indicate a violation of probation.

(d) Refusals of urine screens or diluted urine screens are equivalent to a positive result and indicate a violation of probation.

(2) The intervener/sponsor shall provide copies of all drug screen reports to the Board in a timely fashion.

(3) Attendance is required a minimum of three times per week at an Alcoholics Anonymous, Narcotics Anonymous, and/or similar support group meeting.

(4) The program shall immediately report to the Board any violations of the contract and/or lack of cooperation.

(B) Anthony Kornokovich must submit quarterly progress reports to the Board (due January 10, April 10, July 10, and October 10 of each year of probation) that include:

(1) The written report and documentation provided by the treatment program pursuant to the contract, and

(2) A written description of Anthony Kornokovich's progress towards recovery and what Anthony Kornokovich has been doing during the previous three months.

(1) The State Board of Pharmacy hereby declares that Anthony Kornokovich'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) Anthony Kornokovich may not serve as a responsible pharmacist.

(3) Anthony Kornokovich may not destroy, assist in, or witness the destruction of controlled substances.

(4) Anthony Kornokovich may not work in a pharmacy more than 40 hours per week during the first twelve months of practice.

(5) Anthony Kornokovich must abide by the contract with his treatment provider and must immediately report any violation of the contract to the Board.

(6) Anthony Kornokovich must not violate the drug laws of Ohio, any other state, or the federal government.

(7) Anthony Kornokovich must abide by the rules of the State Board of Pharmacy.

(8) Anthony Kornokovich must comply with the terms of this Order.

(9) Anthony Kornokovich’s license is deemed not in good standing until successful completion of the probationary period.

(D) Any violation of probation may result in a Board hearing to consider alternative or additional sanctions under Section 4729.16 of the Ohio Revised Code.

Anthony Kornokovich 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.

THIS ORDER WAS APPROVED BY A VOTE OF THE STATE BOARD OF PHARMACY.

MOTION CARRIED.

SO ORDERED.

The motion was seconded by Mrs. Gregg and approved by the Board (Aye-6/Nay-0/Abstain-2[Lipsyc, Turner]).

R-2004-190 Mr. Braylock then moved that the Board adopt the following Order in the matter of Terrell L. Mundhenk, R.Ph.:

ORDER OF THE STATE BOARD OF PHARMACY

(Docket No. D-031024-026 and D-040218-061)

In The Matter Of:

TERRELL L. MUNDHENK, R.Ph.

7571 Cloverbrook Park Drive

Centerville, Ohio 45459

(R.Ph. No. 03-3-08732)

INTRODUCTION

THE MATTER OF TERRELL L. MUNDHENK CAME FOR HEARING ON MAY 3, 2004, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ROBERT P. GIACALONE, R.Ph. (presiding); DIANE C. ADELMAN, R.Ph.; GREGORY BRAYLOCK, R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ELIZABETH I. GREGG, R.Ph.; LAWRENCE J. KOST, R.Ph.; NATHAN S. LIPSYC, R.Ph.; AND DOROTHY S. TEATER, PUBLIC MEMBER.

TERRELL L. MUNDHENK WAS REPRESENTED BY RAY A. COX AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GENERAL.

SUMMARY OF EVIDENCE

State’s Witnesses

1. Jesse Wimberly, Ohio State Board of Pharmacy

Respondent's Witnesses

1. Robert A. Blair, R.Ph.

2. Julia K. Wharff, Pastor

3. Terrell Mundhenk, R.Ph., Respondent

State's Exhibits

1. Copy of Notice of Opportunity For Hearing letter [10-24-03]

1A-1E. Procedurals

1F. Copy of Summary Suspension Order/Notice of Opportunity For Hearing letter [02-18-04]

1G. Procedural

2. Copy of e-mail letter from Cassie to Brent Kovalyak [07-25-03]

3. Copy of Statement of Terrell Mundhenk [09-04-03]

4. Copy of letter from Edmund Choroski [03-22-04]; copy of record of Ann Mundhenk’s prescriptions [10-21-02 to 08-30-03]; copy of record of Terrell Mundhenk’s prescriptions [10-31-02 to 05-30-03]; copy of letter from Audrey J. Aronsohn [03-23-04]

5. Copy of Walgreens Prescription Refill Request for Ann Mundhenk [07-23-03]; copy of Walgreens Second Prescription Refill Request for Ann Mundhenk [07-25-03]

6. Copy of twenty-three page Prescription Profile for Ann Mundhenk [05-20-02 to 09-02-03]

7. Copy of Statement of J. Koren, D.O. [09-04-03]

8. Copy of nineteen page Prescription Profile for Amy Mundhenk [05-20-02 to 09-02-03]

9. Copy of Statement of S. Lee, M.D. [09-04-03]

10. Copy of eleven page Prescription Profile for Terrell L. Mundhenk [05-20-02 to 09-02-03]

11. Indictment [11-06-03]; Entry of Plea of Not Guilty [11-20-03]; Motion for Intervention in Lieu of Conviction [12-02-03]; Decision and Order of Intervention in Lieu of Conviction [02-04-04] State of Ohio vs. Terrell L. Mundhenk, Case No. 2003 CR 03614, Montgomery County Common Pleas Court

Respondent's Exhibits

A. Letter from Robert Blair, R.Ph., [04-27-04]

B. Letter from Ronald E. Seigla, R.Ph. [not dated]

C. Letter from William M. Powers, Jr. [04-26-04]

D. Letter from Julia K. Wharff, Pastor [04-27-04]

E. Copy of Demand for Payment letter from Civil Recovery Services [11-10-03]; copy of Section 2307.61 (Damages Recoverable For Willful Damage Or theft; Demand; Agreement for Payment: Procedure) of the Ohio Revised Code [10-13-97]; copy of United States Postal Service Money Order Receipt, No. 04611184402 [12-08-03]; copy of U.S. Postal Service Certified Mail Receipt No. 7003 1680 0004 2120 8811 [02-26-04]

F. Copy of Miami Valley Pharmacists Association MVPA Newsletter [not dated]

G. Letter from James H. Davis, M.D. [04-22-04]

H. Letter from James A. Derksen, M.D., FAAFP [04-28-04]

FINDINGS OF FACT

After having heard the testimony, observed the demeanor of the witnesses, considered the evidence, and weighed the credibility of each, the State Board of Pharmacy finds the following to be fact:

(1) Records of the State Board of Pharmacy indicate that Terrell L. Mundhenk was originally licensed by the State of Ohio as a pharmacist on February 13, 1967, pursuant to examination, and that his license to practice pharmacy in Ohio was summarily suspended effective February 18, 2004.

(2) Terrell L. Mundhenk did, on or about the following dates, intentionally create and/or knowingly possess a false or forged prescription, to wit: Terrell L. Mundhenk created the following documents to obtain drugs for his wife without authorization from a prescriber:

Rx #	Drug	Qty.	Date
147619	Aciphex 20 mg	30	03/21/03
147798	ranitidine 150 mg	60	03/24/03
149156	Levoxyl .05 mg	60	04/04/03
150308	Allegra-D	60	04/14/03
150424	ranitidine 150 mg	60	04/15/03
150835	chlordiazepoxide	90	04/18/03
152046	clotrimazole/Cream 1%	45	04/30/03
152937	ranitidine 150 mg	60	05/07/03
155498	ranitidine 150 mg	60	05/30/03
156034	Levoxyl .05 mg	60	06/05/03
156417	Aciphex 20 mg	30	06/09/03
160993	Allegra-D	60	07/23/03

Such conduct violates Section 2925.23(B) of the Ohio Revised Code.

(3) Terrell L. Mundhenk did, on or about the following dates, intentionally create and/or knowingly possess a false or forged prescription, to wit: Terrell L. Mundhenk created the following documents to obtain drugs for his daughter, in order to "keep her calm and stable," without authorization from a prescriber:

Rx #	Drug	Qty.	Date
144286	omeprazole 20 mg	30	01/09/03
148655	omeprazole 20 mg	30	03/31/03
150303	fluoxetine 20 mg	30	04/14/03
150304	clonazepam 1 mg	60	04/14/03
150306	hydrocodone/APAP 5/500	40	04/14/03
153135	clonazepam 1 mg	60	05/09/03
153136	hydrocodone/APAP 5/500	40	05/09/03
155905	hydrocodone/APAP 5/500	40	06/04/03
156429	clonazepam 1 mg	60	06/09/03
157479	fluoxetine 20 mg	30	06/19/03
159212	hydrocodone/APAP 5/500	40	07/07/03
159213	mirtazapine 15 mg	30	07/07/03

Such conduct violates Section 2925.23(B) of the Ohio Revised Code.

(4) Terrell L. Mundhenk did, on or about the following dates, intentionally create and/or knowingly possess a false or forged prescription, to wit: Terrell L. Mundhenk created the following documents to obtain drugs for himself without authorization from a prescriber:

Rx #	Drug	Qty.	Date
145453	Paxil 20 mg	30	02/02/03
155499	omeprazole 20 mg	30	05/30/03
153289	Glucotrol XL 5 mg	30	03/04/02
153291	Paxil 20 mg	30	04/11/02
152617	Actos 15 mg	30	06/17/02
157882	Actos 15 mg	30	07/19/02
158231	Paxil 20 mg	60	07/21/02
158232	Glucotrol XL 5mg	30	07/21/02
164240	Paxil 20 mg	30	08/26/02
164242	Actos 15 mg	30	08/26/02
170288	Glucotrol XL 5 mg	30	09/30/02
170289	Paxil 20 mg	30	09/30/02
170290	Actos 15 mg	30	09/30/02
172395	Nexium 40 mg	7	10/10/02
175781	Paxil 20 mg	30	10/31/02
175782	Glucotrol XL 5 mg	30	10/31/02
175783	Actos 15 mg	30	10/31/02
179535	Nexium 40 mg	30	11/19/02
180875	Paxil 20 mg	30	11/26/02
180876	Actos 15 mg	30	11/26/02
180877	Glucotrol XL 5 mg	30	11/26/02
186862	Actos 15 mg	30	01/01/03
186863	Paxil 20 Mg	30	01/01/03
186864	Glucotrol XL 5mg	30	01/01/03

Such conduct violates Section 2925.23(B) of the Ohio Revised Code.

(5) Terrell L. Mundhenk did, on or about the following dates, by deception, procure the dispensing of a dangerous drug, to wit: by creating false or forged prescriptions to disguise the illegitimacy of his actions, Terrell L. Mundhenk procured the following dispensings of dangerous drugs:

Rx #	Drug	Qty.	Date
147619	Aciphex 20 mg	30	03/21/03
147798	ranitidine 150 mg	60	03/24/03
149156	Levoxyl .05 mg	60	04/04/03
150308	Allegra-D	60	04/14/03
150424	ranitidine 150 mg	60	04/15/03
150835	chlordiazepoxide	90	04/18/03
152046	clotrimazole/Cream 1%	45	04/30/03
152937	ranitidine 150 mg	60	05/07/03
155498	ranitidine 150 mg	60	05/30/03
156034	Levoxyl .05 mg	60	06/05/03
156417	Aciphex 20 mg	30	06/09/03
160993	Allegra-D	60	07/23/03
144286	omeprazole 20 mg	30	01/09/03
148655	omeprazloe 20 mg	30	03/31/03
150303	fluoxetine 20 mg	30	04/14/03
150304	clonazepam 1 mg	60	04/14/03
150306	hydrocodone/APAP 5/500	40	04/14/03
153135	clonazepam 1 mg	60	05/09/03
153136	hydrocodone/APAP 5/500	40	05/09/03
155905	hydrocodone/APAP 5/500	40	06/04/03
156429	clonazepam 1 mg	60	06/09/03
157479	fluoxetine 20 mg	30	06/19/03
159212	hydrocodone/APAP 5/500	40	07/07/03
159213	mirtazapine 15 mg	30	07/07/03
145453	Paxil 20 mg	30	02/02/03
155499	omeprazole 20 mg	30	05/30/03
153289	Glucotrol XL 5 mg	30	03/04/02
153291	Paxil 20 mg	30	04/11/02
152617	Actos 15 mg	30	06/17/02
157882	Actos 15 mg	30	07/19/02
158231	Paxil 20 mg	60	07/21/02
158232	Glucotrol XL 5mg	30	07/21/02
164240	Paxil 20 mg	30	08/26/02
164242	Actos 15 mg	30	08/26/02
170288	Glucotrol XL 5 mg	30	09/30/02
170289	Paxil 20 mg	30	09/30/02
170290	Actos 15 mg	30	09/30/02
172395	Nexium 40 mg	7	10/10/02
175781	Paxil 20 mg	30	10/31/02
175782	Glucotrol XL 5 mg	30	10/31/02
175783	Actos 15 mg	30	10/31/02
179535	Nexium 40 mg	30	11/19/02
180875	Paxil 20 mg	30	11/26/02
180876	Actos 15 mg	30	11/26/02
180877	Glucotrol XL 5 mg	30	11/26/02
186862	Actos 15 mg	30	01/01/03
186863	Paxil 20 Mg	30	01/01/03
186864	Glucotrol XL 5mg	30	01/01/03

Such conduct violates Section 2925.22 of the Ohio Revised Code.

(6) In accordance with Section 2929.24 of the Ohio Revised Code, the office of the Prosecuting Attorney of Montgomery County, Ohio, submitted to this Board information which indicates that on February 4, 2004, Terrell L. Mundhenk was found by a court to be eligible for Intervention in Lieu of Conviction, State of Ohio vs. Terrell L. Mundhenk, Case No. 2003 CR 03614, Montgomery County Common Pleas Court.

CONCLUSIONS OF LAW

(1) The State Board of Pharmacy concludes that paragraphs (2) through (5) 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.

(2) The State Board of Pharmacy concludes that paragraphs (2) through (5) 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) The State Board of Pharmacy concludes that paragraphs (2) through (6) of the Findings of Fact constitutes being guilty of willfully violating, conspiring to violate, attempting to violate, or aiding and abetting the violation of provisions of Chapter 2925. of the Revised Code as provided in Division (A)(5) of Section 4729.16 of the Ohio Revised Code.

DECISION OF THE BOARD

Pursuant to Section 3719.121 of the Ohio Revised Code, the State Board of Pharmacy hereby removes the Summary Suspension Order issued to Terrell L. Mundhenk on February 18, 2004.

Pursuant to Section 4729.16 of the Ohio Revised Code, and after consideration of the record as a whole, the State Board of Pharmacy adjudicates the matter of Terrell L. Mundhenk as follows:

(A) On the basis of the Findings of Fact and the Conclusions of Law set forth above, the State Board of Pharmacy hereby suspends for one year the pharmacist identification card, No. 03-3-08732, held by Terrell L. Mundhenk effective as of the date of the mailing of this Order. Further, the Board suspends the suspension and places his identification card on probation for three years, with the following conditions:

(1) Terrell L. Mundhenk may not dispense prescriptions for himself or for any member of his family.

(2) The State Board of Pharmacy hereby declares that Terrell L. Mundhenk'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.

(3) Terrell L. Mundhenk may not serve as a responsible pharmacist.

(4) Terrell L. Mundhenk must not violate the drug laws of Ohio, any other state, or the federal government.

(5) Terrell L. Mundhenk must abide by the rules of the State Board of Pharmacy.

(6) Terrell L. Mundhenk must comply with the terms of this Order.

(7) Terrell L. Mundhenk’s license is deemed not in good standing until successful completion of the probationary period.

(8) Any violation of probation may result in a Board hearing to consider alternative or additional sanctions under Section 4729.16 of the Ohio Revised Code.

(B) On the basis of the Findings of Fact and Conclusions of Law set forth above, the State Board of Pharmacy hereby imposes on Terrell L. Mundhenk a monetary penalty of five thousand dollars ($5,000.00) due and owing within thirty days of the issuance of this Order. The monetary penalty 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.

Terrell L. Mundhenk 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.

THIS ORDER WAS APPROVED BY A VOTE OF THE STATE BOARD OF PHARMACY.

MOTION CARRIED.

SO ORDERED.

The motion was seconded by Mr. Lipsyc and approved by the Board (Aye-7/Nay-0/Abstain-1[Turner]).

9:15 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 matters of Christopher Kiel, R.Ph., Sagamore Hills; Teregen Labs, T.D., Willoughby; and Teregen Labs, W.D., Willoughby.

11:15 a.m.

The hearing was recessed for lunch.

12:30 p.m.

The hearing resumed.

1:30 p.m.

R-2004-191 While the hearing continued, the following candidates for licensure by reciprocity participated in a discussion of pharmacy laws and rules with Mr. McMillen in Room South-A, 31st Floor, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio, and were then presented with their pharmacist identification cards.

LINO DIMATTEO	03-1-26154	NEW JERSEY
CLAYTON DAVID EDWARDS	03-1-26199	PENNSYLVANIA
KARISSA YOONSOOK KIM	03-1-26173	NEVADA
JOHN PATRICK MAHONEY	03-1-26108	ARIZONA
JAMES JOSEPH McDONALD	03-1-26165	TEXAS
ANDREA LEIGH RAFTERY	03-1-26141	MISSOURI
RODD A. REINHART	03-1-26076	OREGON
THOMAS J. VIGNA	03-1-26194	PENNSYLVANIA
REBECCA JEAN WRIGHT	03-1-26171	MISSOURI

8:27 p.m.

The hearing ended and the record was closed. The Board took a brief recess.

8:37 p.m.

Mrs. Gregg 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 Giacalone as follows: Adelman-Yes, Braylock-Yes, Eastman-Yes, Gregg-Yes, Kost-Yes, Lipsyc-Yes, Teater-Yes, and Turner-Yes.

9:50 p.m.

R-2004-192 The Executive Session ended. Mr. Turner moved that the Board adopt the following Order in the matter of Teregen Labs, W.D.:

ORDER OF THE STATE BOARD OF PHARMACY

(Docket No. D-031110-033)

In The Matter Of:

TEREGEN LABS

c/o George Fiderio, President

38320 Western Parkway

Willoughby, Ohio 44094

(W.D. No. 01-0361600)

INTRODUCTION

THE MATTER OF TEREGEN LABS CAME FOR HEARING ON MAY 4, 2004, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ROBERT P. GIACALONE, R.Ph. (presiding); DIANE C. ADELMAN, R.Ph.; GREGORY BRAYLOCK, R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ELIZABETH I. GREGG, R.Ph.; LAWRENCE J. KOST, R.Ph.; NATHAN S. LIPSYC, R.Ph.; DOROTHY S. TEATER, PUBLIC MEMBER; AND JAMES E. TURNER, R.Ph.

TEREGEN LABS WAS REPRESENTED BY JOSEPH W. DIEMERT, JR. AND DIANE A. CALTA AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GENERAL.

SUMMARY OF EVIDENCE

State’s Witnesses

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

2. Frederick Lochner, U.S. Food and Drug Administration (FDA)

Respondent's Witnesses

1. Christopher Kiel, R.Ph.

State's Exhibits

1W. Copy of Notice of Opportunity For Hearing letter [11-10-03]

1A-1W-E. Procedurals

1W-F. Copy of Amendment Notice [03-03-04]

1G-1W-K. Procedurals

2. Copy of Ohio State Board of Pharmacy Compliance Bulletin 93-002 [09-15-93]

2A. Copy of letter from Joseph Diemert, Jr. to Debra Grille [11-29-00]

2B. Copy of letter from Joseph W. Diemert, Jr. to Timothy Benedict [12-08-00]

2C. Dangerous Drug Distributor Inspection Report of Teregen Labs, License No. 02-1235150, with attachments [12-14-00]

2D. Copy of letter from Charles S. Price to Diane A. Calta [01-02-01]

3. Facsimile copy of Rx #201315, Rx #201316, Rx #201317, and Rx #201318 [01-08-01]

3A. Copy of letter from Joseph W. Diemert, Jr. to George Fiderio [01-12-01]

3B. Copy of Purchase Order from Nevada Dermatology [12-04-01]

4. Dangerous Drug Distributor Inspection Report of Teregen Labs, License No. 02-1235150 [08-19-03]

4A. Copy of Dangerous Drug Distributor Inspection Report of Teregen Labs, License No. 01-0361600 [08-19-03]

5. Dangerous Drug Distributor Inspection Report of Teregen Labs, License No. 02-1235150 [08-21-03]

5A. Pink Sheet Response with enclosures from Diane Calta and Christopher Kiel, R.Ph. to William T. Winsley [09-09-03]

6. Dangerous Drug Distributor Inspection Report of Teregen Labs, License No. 01-0361600 [08-21-03]

6A. Pink Sheet Response with enclosures from Diane Calta and George V. Fiderio to William T. Winsley [09-09-03]

7. Vial of Dexamethasone Acetate Suspension 8 mg/mL [not dated]

7A. New Hampshire Board of Pharmacy Possessed Property Report with invoice attachments [09-23-03]

8-8K. One sheet of Teregen Vial Labels [03-10-04] and Teregen Package Inserts for Betamethasone, Brompheniramine, Dexamethasone acetate, Dexamethasone Na phosphate, Estradiol cypionate, Estradiol valerate, Estrone, Methylprednisolone acetate, Pyridoxine HCI, Triamcinolone acetonide, and Triamcinolone diacetate [Feb 2001 to Feb 2003]

9. Building layout for Teregen (WD & TD) and Drug World Compounding Pharmacy [not dated]

9A. Clean room layout of Teregen Labs [not dated]

9B. Ten photographs of Clean room [not dated]

10. Report of Vials Produced Per Month at Teregen Labs [08-19-03]

10A. Copy of Inventory On Hand at Teregen Labs [08-20-03]

10B. Sales History of Teregen-Produced Sterile Product [12-00 to 09-03]

10C. Teregen Labs In-Stock Warehouse Inventory [10-01-03]

11. Copy of letter with enclosures from Diane A. Calta to Fred L. Dailey [09-03-03]

11A. Copy of letter from William A. Hopper, Jr. to Diane A. Calta [09-19-03]

11B. Copy of letter with attachments from Christopher Kiel, R.Ph. to Mr. Hopper [09-24-03]

11C. Copy of letter from Steven Silverman to William T. Winsley, M.S., R.Ph. [11-13-03]

11C-1. Copy of letter from Carol A. Heppe to Steven C. LaTourette, Congressman [03-17-04]

11D. Copy of letter from Fred L. Dailey to Diane A. Calta [11-21-03]

12. Ohio State Board of Pharmacy News, November 2003

13. Dangerous Drug Distributor Inspection Report of Teregen Labs, License No. 02-1235150 [03-11-04]

13A. Dangerous Drug Distributor Inspection Report of Teregen Labs, License No. 01-0361600 [03-11-04]

13B. Copy of Productivity Record [03-10-04]

13C. Teregen Labs Production Records [10-27-03 to 03-03-04]

14. Teregen Labs 2001 Physician Orders, Total Quantity Purchased [03-25-04]

14A. Copy of Betamethasone Distribution Records [11-28-01]

14B. Copy of Brompheniramine Distribution Records [02-21-01]

14C. Copy of Dexamethasone Acetate Distribution Records [10-17-01]

14D. Copy of Dexamethasone Na Phosphate Distribution Records [09-26-01]

14E. Copy of Estradiol Cypionate Distribution Records [03-23-01]

14F. Copy of Estradiol Valerate Distribution Records [07-25-01]

14G. Copy of Estrone Distribution Records [02-21-01]

14H. Copy of Methylprednisolone Acetate Distribution Records [12-04-01]

14I. Copy of Pyridoxine HCI Distribution Records [12-03-01]

14J. Copy of Triamcinolone Acetonide Distribution Records [02-05-01]

14K. Copy of Triamcinolone Diacetate Distribution Records [11-27-01]

14L. Dexamethasone Acetate Batch Records [10-10-01]

15. Teregen Labs 2002 Physician Orders, Total Quantity Purchased [03-25-04]

15A. Copy of Betamethasone Distribution Records [09-12-02]

15B. Copy of Brompheniramine Distribution Records [05-13-02]

15C. Copy of Dexamethasone Acetate Distribution Records [07-01-02]

15D. Copy of Dexamethasone Na Phosphate Distribution Records [09-27-02]

15E. Copy of Estradiol Cypionate Distribution Records [03-06-02]

15F. Copy of Estradiol Valerate Distribution Records [12-13-02]

15G. Copy of Estrone Distribution Records [09-20-02]

15H. Copy of Methylprednisolone Acetate Distribution Records [07-30-02]

15I. Copy of Pyridoxine HCI Distribution Records [09-25-02]

15J. Copy of Triamcinolone Acetonide Distribution Records [04-09-02]

15K. Copy of Triamcinolone Diacetate Distribution Records [09-26-02]

15L. Dexamethasone Acetate Batch Records [06-18-02]

16. Teregen Labs 2003 Physician Orders, Total Quantity Purchased [03-25-04]

16A. Copy of Betamethasone Distribution Records [09-10-03]

16B. Copy of Brompheniramine Distribution Records [06-09-03]

16C. Copy of Dexamethasone Acetate Distribution Records [05-15-03]

16D. Copy of Dexamethasone Na Phosphate Distribution Records [04-22-03]

16E. Copy of Estradiol Cypionate Distribution Records [06-24-03]

16F. Copy of Estradiol Valerate Distribution Record [08-20-03]

16G. Copy of Estrone Distribution Records [01-14-03]

16H. Copy of Methylprednisolone Acetate Distribution Records [04-28-03]

16I. Copy of Pyridoxine HCI Distribution Records [06-26-03]

16J. Copy of Triamcinolone Acetonide Distribution Records [08-28-03]

16K. Copy of Triamcinolone Diacetate Distribution Records [06-20-03]

16L. Dexamethasone Acetate Batch Records [04-25-03]

17. Rx #818899 [02-10-03]

17A. Teregen Labs Rx #818899 Label [02-10-03]

17B. Copy of Tax Insurance Summary for Drug World Pharmacy [01-01-01 to 11-05-03]

18. Rx #819878 [06-03-03]

19. Rx #817388 [07-03-02]

20. Letter with enclosures from Regina C. Hamlin, M.D. to Joann D. Predina, MBA, R.Ph. [11-02-03]

21. Copy of Ohio Revised Code (ORC) Section 3715.65 (Application for new drugs) [07-22-98]

21A. Copy of Division (A)(10) of ORC Section 3715.01 (Definitions) defining "New drug" [not dated]

21B. Copy of Division (C) of ORC Section 4729.01 (Definitions) defining "Compounding" [not dated]

21C. Copy of Division (H) of ORC Section 4729.01 (Definitions) defining "Prescription" [not dated]

21D. Copy of paragraph (B) of Ohio Administrative Code (OAC) Rule 4729-5-01 (Definitions) defining "Dispense" [not dated]

21E. Copy of OAC Rule 4729-5-30 (Manner of issuance of a prescription) [not dated]

21F. Copy of OAC Rule 4729-9-21 (Drugs compounded in a pharmacy) [03-01-99]

22. FDA Inspectional Observations (Form FDA 483) for Gentere Inc. [03-10-04 to 03-19-04]

Respondent's Exhibits

A. Pink Sheet Response with enclosures from Diane Calta and George V. Fiderio to William T. Winsley [09-09-03]

B. Notice of Opportunity for Hearing letter to Teregen Labs, License No. 01-0361600 [11-10-03]

C. Copy of Amendment Notice letter To Teregen Labs, License No. 01-0361600 [03-03-04]

D. Copy of Pink Sheet Response with enclosures from Diane Calta and Christopher Kiel, R.Ph. to William T. Winsley [09-09-03]

E. Notice of Opportunity for Hearing letter to Teregen Labs, License No. 02-1235150 [11-10-03]

F. Amendment Notice letter to Teregen Labs, License No. 02-1235150 [03-03-04]

G. Copy of Pink Sheet Response from Christopher Kiel, R.Ph. to Ohio State Board of Pharmacy [08-25-03]

H. Copy of Notice of Opportunity for Hearing letter to Christopher Kiel, R.Ph. [11-10-03]

I. Copy of Amendment Notice letter to Christopher Kiel, R.Ph. [03-03-04]

J. Copy of letter with enclosures from Diane A. Calta to William A. Hopper, Jr. [09-30-03]

K. Letter with enclosure from William A. Hopper, Jr. to Diane A. Calta, Esq. [11-21-03]

L. Copy of letter from Steven Silverman to William T. Winsley, M.S., R.Ph. [11-13-03]

M. Copy of e-mail letter from Bill Winsley to Betty Hiner [10-23-03]

N. Copy of Dangerous Drug Distributor Inspection Report of Teregen Labs, License No. 02-1235150 [12-14-00]

O. Copy of letter from Joseph W. Diemert, Jr. to Debra Grille [11-29-00]; copy of Fax Cover Sheet from Diane Calta to Tim Benedict [11-30-00]

P. Copy of letter from Joseph W. Diemert, Jr. to Timothy Benedict [12-08-00]

Q. Copy of letter from Charles S. Price to Diane A. Calta [12-28-00]

R. Copy of letter with enclosure from Joseph W. Diemert, Jr. to George Fiderio [01-12-01]

S. Copy by Westlaw of Ohio Revised Code (ORC) Section 4729.01 (Definitions) [06-26-03]

T. Copy by Westlaw of ORC Section 4729.29 (Exceptions to certain provisions) [03-09-99]

U. Copy by Westlaw of Ohio Administrative Code (OAC) Rule 4729-5-30 (Manner of issuance of a prescription) [02-01-03]

V. Copy by Westlaw of OAC Rule 4729-5-01 (Definitions) [01-01-04]

W. Copy by Westlaw of OAC Rule 4729-9-12 (Verification of license as a distributor of dangerous drugs or exempt status of a prescriber) [03-01-99]

X. Copy by Westlaw of ORC Sections 3715.01 (Definitions) [11-21-01] and 3715.65 (Application for new drugs) [07-22-98]

Y. Copy of Guidance for FDA Staff and Industry Compliance Policy Guides Manual, Section 460.200 (Pharmacy Compounding) [05-29-02]

Z. Six photographs of Teregen Laboratory Facility [not dated]

AA. Copy by Westlaw of 2003 Ohio Senate Bill 196 (SN) As Introduced [02-12-04]; Bill Analysis by the Ohio Legislative Service Commission of S.B. 196 As Introduced [02-26-04

BB. Copy of pages 2498 through 2501 of the United States Pharmacopeial (USP) for Section 1075 (Good Compounding Practices) [not dated]

CC. Copy of letter from David L. Rosen, B.S. Pharm, J.D. to Carol A. Heppe [04-27-04]

FINDINGS OF FACT

After having heard the testimony, observed the demeanor of the witnesses, considered the evidence, and weighed the credibility of each, the State Board of Pharmacy finds the following to be fact:

(1) Records of the State Board of Pharmacy indicate that Teregen Labs, 38320 Western Parkway, Willoughby, Ohio, is registered as a Wholesale Distributor of Dangerous Drugs, No. 01-0361600, and George Fiderio is the president and contact person pursuant to Section 4729.53(A)(5) of the Ohio Revised Code within the meaning of Section 4729.56 of the Ohio Revised Code.

(2) Teregen Labs did, on or about the following dates in 2001, sell a new drug without an application with respect to the drug having become effective under Section 505 of the Federal Food, Drug, and Cosmetic Act, to wit: after having received verbal and written warning against doing so, the facility sold dangerous drugs, the following being representative examples, without obtaining patient-specific orders for the products:

Invoice#	Date	Qty	Drug
30486	11/28/01	25 vials	betamethasone Na phos & acetate 6 mg/ml inj.-5 ml
26495	02/21/01	12 vials	brompheniramine maleate 10 mg/ml inj.-10 ml
29925	10/17/01	30 vials	dexamethasone acetate 8 mg/ml inj.-5 ml
29631	09/26/01	12 vials	dexamethasone Na phos. 4 mg/ml inj.-5 ml
26810	03/23/01	4 vials	estradiol cypionate 5 mg/ml inj.-10 ml
28680	07/25/01	2 vials	estradiol valerate 40 mg/ml inj.-10 ml
26490	02/21/01	10 vials	estrone 5 mg/ml inj.-10 ml
30547	12/04/01	15 vials	methylprednisolone acetate 40 mg/ml inj.-10 ml
30529	12/03/01	200 vials	pyridoxine HCI 100 mg/ml inj.- 30 ml
26333	02/05/01	30 vials	triamcinolone acetonide 40 mg/ml inj.- 5 ml
30466	11/27/01	2 vials	triamcinolone diacetate 40 mg/ml inj.-5 ml

Such conduct violates Section 3715.65 of the Ohio Revised Code.

(3) Teregen Labs did, on or about the following dates in 2002, sell a new drug without an application with respect to the drug having become effective under Section 505 of the Federal Food, Drug, and Cosmetic Act, to wit: after having received verbal and written warning against doing so, the facility sold dangerous drugs, the following being representative examples, without obtaining patient-specific orders for the products:

Invoice#	Date	Qty	Drug
34259	09/12/02	4 vials	betamethasone Na phos. & acetate 6 mg/ml inj.-5 ml
32613	05/13/02	2 vials	brompheniramine maleate 10 mg/ml inj.-10 ml
33265	07/01/02	300 vials	dexamethasone acetate 8 mg/ml inj.-5 ml
34467	09/27/02	20 vials	dexamethasone Na phos. 4 mg/ml inj.-5 ml
31704	03/06/02	2 vials	estradiol cypionate 5 mg/ml inj.-10 ml
35410	12/13/02	4 vials	estradiol valerate 40 mg/ml inj.-10 ml
34380	09/20/02	5 vials	estrone 5 mg/ml inj.- 10 ml
33660	07/30/02	12 vials	methylprednisolone acetate 40 mg/ml inj.-10 ml
34433	09/25/02	6 vials	pyridoxine HCI 100 mg/ml inj.-30 ml
32162	04/09/02	8 vials	triamcinolone acetonide 40 mg/ml inj.-5 ml
34455	09/26/02	8 vials	triamcinolone diacetate 40 mg/ml inj.-5 ml

Such conduct violates Section 3715.65 of the Ohio Revised Code.

(4) Teregen Labs did, on or about the following dates in 2003, sell a new drug without an application with respect to the drug having become effective under Section 505 of the Federal Food, Drug, and Cosmetic Act, to wit: after having received verbal and written warning against doing so, the facility sold dangerous drugs, the following being representative examples, without obtaining patient-specific orders for the products:

Invoice#	Date	Qty	Drug
38531	09/10/03	40 vials	betamethasone Na phos. & acetate 6 mg/ml inj.-5 ml
37430	06/09/03	10 vials	brompheniramine maleate 10 mg/ml inj.- 10 ml
37145	05/15/03	12 vials	dexamethasone acetate 8 mg/ml inj.-5 ml
36851	04/22/03	12 vials	dexamethasone Na phos. 4 mg/ml inj.-5 ml
37617	06/24/03	3 vials	estradiol cypionate 5 mg/ml inj.-10 ml
38287	08/20/03	4 vials	estradiol valerate 40 mg/ml inj.-10 ml
35702	01/14/03	10 vials	estrone 5 mg/ml inj.-10 ml
36929	04/28/03	15 vials	methylprednisolone acetate 40 mg/ml inj.-10 ml
37639	06/26/03	600 vials	pyridoxine HCI 100 mg/ml inj.-30 ml
38379	08/28/03	30 vials	triamcinolone acetonide 40 mg/ml inj.-5 ml
37569	06/20/03	4 vials	triamcinolone diacetate 40 mg/ml inj.-5 ml

Such conduct violates Section 3715.65 of the Ohio Revised Code.

CONCLUSION OF LAW

The State Board of Pharmacy concludes that paragraphs (2) through (4) of the Findings of Fact constitutes being guilty of violating any federal, state, or local drug law or any provision of Chapter 3715. of the Revised Code as provided in Division (A)(2) of Section 4729.56 of the Ohio Revised Code.

DECISION OF THE BOARD

Pursuant to Section 4729.56 of the Ohio Revised Code, and after consideration of the record as a whole, the State Board of Pharmacy adjudicates the matter of Teregen Labs, Wholesale Distributor Registration No. 01-0361600, as follows:

(A) On the basis of the Findings of Fact and Conclusions of Law set forth above, the State Board of Pharmacy hereby imposes a monetary penalty of six thousand dollars ($6,000.00) on Teregen Labs, Wholesale Distributor Registration No. 01-0361600, and payment of 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.

(B) Teregen Labs, Wholesale Distributor Registration No. 01-0361600, must cease distributing drugs that are not approved by the FDA effective as of the date of the mailing of this Order.

THIS ORDER WAS APPROVED BY A VOTE OF THE STATE BOARD OF PHARMACY.

MOTION CARRIED.

SO ORDERED.

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

R-2004-193 Mr. Braylock then moved that the Board adopt the following Order in the matter of Teregen Labs, T.D.:

ORDER OF THE STATE BOARD OF PHARMACY

(Docket No. D-031110-038)

In The Matter Of:

TEREGEN LABS

c/o Christopher Kiel, R.Ph.

38320 Western Parkway

Willoughby, Ohio 44094

(T.D. No. 02-1235150)

INTRODUCTION

TEREGEN LABS WAS REPRESENTED BY JOSEPH W. DIEMERT, JR. AND DIANE A. CALTA AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GENERAL.

SUMMARY OF EVIDENCE

State’s Witnesses

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

2. Frederick Lochner, U.S. Food and Drug Administration (FDA)

Respondent's Witnesses

1. Christopher Kiel, R.Ph.

State's Exhibits

1T. Copy of Notice of Opportunity For Hearing letter [11-10-03]

1A-1T-E. Procedurals

1T-F. Copy of Amendment Notice [03-03-04]

1G-1T-K. Procedurals