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

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

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

Minutes Of The Meeting

Ohio State Board of Pharmacy

January 6 & 7, 2003

MONDAY, JANUARY 6, 2003

10:12 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: Diane C. Adelman, R.Ph. (President); Robert P. Giacalone, R.Ph. (Vice-President); 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. Also present were William T. Winsley, Executive Director; Timothy Benedict, Assistant Executive Director; William McMillen, Licensing Administrator; Mark Keeley, Legislative Affairs Administrator; Robert Cole, Compliance Supervisor; David Rowland, Legal Affairs Administrator; and Sally Ann Steuk, Assistant Attorney General.
10:14 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 and for the purpose of conferring with an attorney for the Board regarding pending or imminent court action pursuant to Section 121.22(G)(3) of the Revised Code. The motion was seconded by Mr. Kost and a roll call vote was conducted by President Adelman as follows: Eastman-Yes, Giacalone-Yes, Gregg-Yes, Kost-Yes, Lipsyc-Yes, Teater-Yes, and Turner-Yes.
10:24 a.m.
	Mr. Braylock arrived and joined the Executive Session in progress.
11:55 a.m.
	The Board recessed for lunch.
1:35 p.m.
	The State Board of Pharmacy reconvened, still in Executive Session, 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: Diane C. Adelman, R.Ph. (President); Robert P. Giacalone, R.Ph. (Vice-President); 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.
2:20 p.m.
	The Executive Session ended and the meeting was opened to the public.
R-2003-083	Ms. Eastman moved that, pursuant to Section 3719.121 of the Revised Code, the Board summarily suspend the license to practice pharmacy belonging to Thomas A. Scott, R.Ph. (03-3-16170) due to the fact that a continuation of his professional practice presents a danger of immediate and serious harm to others. The motion was seconded by Mr. Kost and approved by the Board (Aye-8/Nay-0).
R-2003-084	Mrs. Gregg then moved that the Board accept the settlement offered in the matter of Joseph A. Cusma, R.Ph. that had been scheduled for a hearing at 1:00 p.m. The motion was seconded by Mr. Braylock and approved by the Board (Aye-8/Nay-0). Upon the signature of President Adelman, the following settlement agreement became final.
	SETTLEMENT AGREEMENT WITH THE STATE BOARD OF PHARMACY VOLUNTARY SURRENDER WITH DISCIPLINARY ACTION PENDING (Docket No. D-020212-039) In The Matter Of: JOSEPH ANTHONY CUSMA, R.Ph. 7919 Erika Circle N.W. Massillon, Ohio 44646 (R.Ph. No. 03-1-08957)
	This Settlement Agreement is entered into by and between Joseph Anthony Cusma 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. Joseph Anthony Cusma 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 and the right to a formal adjudication hearing on the issues contained herein. Joseph Anthony Cusma is knowingly and voluntarily acknowledging that, in order to settle the disciplinary charges that have been filed by the Board against him and in order to obviate the need to conduct an administrative hearing to consider possible disciplinary sanctions against Joseph Anthony Cusma’s license to practice pharmacy in the State of Ohio, this Agreement is entered into on the basis of the following stipulations, admissions, and understandings:
	(A)   The Ohio State Board of Pharmacy 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 impose a monetary penalty on the license holder for violation of any of the enumerated grounds.
	(B)    Joseph Anthony Cusma neither admits nor denies the allegations stated in the Notice of Opportunity for Hearing letter dated February 12, 2002; however, the Board has duly filed the allegations in its Notice of Opportunity as stated therein and will withhold conducting an adjudication hearing pursuant to the terms of this agreement.
	Wherefore, in consideration of the foregoing and mutual promises hereinafter set forth, and in lieu of a formal hearing at this time, Joseph Anthony Cusma knowingly and voluntarily surrenders PERMANENTLY to the State Board of Pharmacy his license and registration to practice pharmacy, with disciplinary action pending, and is PRECLUDED FROM MAKING ANY APPLICATION FOR FURTHER REGISTRATION.
	Pursuant to Rule 4729-9-01, Joseph Anthony Cusma may not be employed by or work in any facility licensed by the Board of Pharmacy to possess or distribute dangerous drugs.
	Joseph Anthony Cusma 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.
	Joseph Anthony Cusma 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. Joseph Anthony Cusma 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/          Joseph A. Cusma	/d/   1/4/2003
Joseph Anthony Cusma, R.Ph., Respondent	Date of Signature
/s/          Robert D. Noble	/d/   1/6/03
Robert D. Noble, Attorney for Respondent	Date of Signature
/s/          Diane C. Adelman	/d/    1/6/03
Diane C. Adelman, President, Ohio State Board of Pharmacy	Date of Signature
/s/          Sally Ann Steuk	/d/    1–6–03
Sally Ann Steuk, Ohio Assistant Attorney General	Date of Signature

R-2003-085	Mr. Turner then moved that the Board approve a settlement agreement offered in the matter of Harold Fletcher, R.Ph. as revised by the Board. The settlement agreement is to become final upon the signature of the Board President. The motion was seconded by Mr. Kost and approved by the Board (Aye-8/Nay-0).
R-2003-086	Mr. Kost moved that the Board agree to withdraw the Notice of Opportunity for a Hearing issued to The Young For Life Medical Clinic scheduled for a hearing on Wednesday, January 8, 2003. The Respondents have moved out of Ohio and have withdrawn their application for a license as a Terminal Distributor of Dangerous Drugs. The motion was seconded by Mrs. Gregg and approved by the Board (Aye-8/Nay-0).
R-2003-087	Mr. Giacalone moved that the Board approve the settlement agreement offered in the matters of Cynthia Ann Musson, R.Ph. and Chester Lee Parker, R.Ph. The settlement agreements are to become final upon the signature of the Board President. The motion was seconded by Mr. Kost and approved by the Board (Aye-8/Nay-0).
R-2003-088	Mr. Giacalone then moved that the Board approve the settlement agreement offered in the matters of Big Bear Pharmacy #208 and William Gongola, R.Ph. if the Respondents agree to the terms as revised by the Board. The settlement agreements are to become final upon the signature of the Board President. The motion was seconded by Mr. Kost and approved by the Board (Aye-6/Nay-2).
R-2003-089	Mr. Winsley then presented a request from The Cleveland Clinic Main Outpatient Pharmacy (02-0079600) and Fairview Health Center Pharmacy (02-0140100) for an exemption to Rule 4729-5-10 (Pick-up station) so that Cleveland Clinic Health System (CCHS) employee prescription requests, both new and refill, could be left in drop boxes located at several CCHS hospitals. The prescriptions would be picked up by a courier and filled at one of the two pharmacies listed above. The finished prescription would then be returned to the appropriate hospital pharmacy where the CCHS employee would pick up the medication. After discussion, Ms. Eastman moved that the Board deny the request as it did not qualify for an exemption under the terms of the rule. The motion was seconded by Mrs. Gregg and approved by the Board (Aye-8/Nay-0).
R-2003-090	Mr. Benedict and Compliance Specialist Joann Predina presented a request from Marc Wolf, R.Ph. for an exemption to Rule 4729-5-10 (Pick-up station) for two different Complete Pharmacy Services facilities (02-0581500/Euclid and Pending/Willowick), seeking Board approval to have prescriptions filled at one location and shipped out of the other location to facilitate the addition of non-prescription items to the package at the second location. After discussion, Mrs. Gregg moved that the Board deny the request as it did not qualify for an exemption under the terms of the rule. The motion was seconded by Ms. Eastman and approved by the Board (Aye-8/Nay-0).
R-2003-091	After a brief discussion, Mr. Kost moved that the following rules be implemented with an effective date of February 1, 2003. The motion was seconded by Mr. Braylock and approved by the Board (Aye-8/Nay-0).

4729-3-01 Definitions.

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 paragraph (D) of 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. A "Statement of Preceptor" form is not required to be submitted to the board when using an academic experience affidavit.

(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 reported on the affidavit by shall be the total number of hours obtained each week during the reported time period rounded to the nearest hour. 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)	"Academic experience affidavit" is the form that may be used to submit practical experience obtained from a structured program where academic credit is awarded.

(1)	The academic experience coordinator at a school of pharmacy is responsible for assuring that during the time of the experience each practice site and preceptor are currently licensed and are in good standing with the appropriate professional licensing board or have been previously approved by the board of pharmacy.
(2)	The preceptor at each practice site must sign the academic experience affidavit certifying the hours of practical experience obtained by the intern.
(3)	The academic experience coordinator at a school of pharmacy must submit a signed academic experience affidavit certifying that the intern obtained a passing grade and that the practice sites and the preceptors are currently licensed and in good standing with the appropriate professional licensing board or have been previously approved by the board of pharmacy.
(4)	The academic experience coordinator at a school of pharmacy is responsible for maintaining records of intern experience at each practice site.
(5)	Academic experience affidavits 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 the July that immediately follows the successful completion of the academic course.

(I)(J))

"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.

(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 is actively working towards the requirements for licensure as a pharmacist and desires to work as a pharmacy intern in Ohio, he/she must:

(1)    (a)	Have successfully completed forty-eight semester or seventy-two quarter hours of college and have been accepted into be enrolled in a school of pharmacy; or
(2) (b)	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) (c)	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)(2)

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

4729-3-03 Application for registration as a pharmacy intern.

(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 An original 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 enrollment into a school of pharmacy certifying that the person is enrolled in a school of pharmacy and is actively working towards the requirements for licensure as a pharmacist; or
(6)	All items listed in paragraphs (A)(1) to (A)(3) of this rule and:

(a)	certification 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
(b)	certification 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.

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 school of pharmacy or is able to provide evidence that he/she has been accepted for enrollment in a school of pharmacy and is actively working towards the requirements for licensure as a pharmacist; or
(2)	He/she is a member of the armed forces and can provide evidence that he/she has been accepted for enrollment in a school of pharmacy upon his/her release from the armed forces; or
(3)