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

December 8 & 9, 2003

 

MONDAY, DECember 8, 2003

 

10:15 a.m.

ROLL CALL

 

 

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

 

Robert P. Giacalone, R.Ph. (President); Diane C. Adelman, R.Ph.; Suzanne R. Eastman, R.Ph.; Elizabeth I. Gregg, 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; David Rowland, Legal Affairs Administrator; Robert Cole, Compli­ance Supervisor; and Sally Ann Steuk, Assistant Attorney General.

 

The Board discussed the 2004 NABP/AACP District IV meeting which they will be hosting with The Ohio State University College of Pharmacy.  The Board members agreed that the District IV meeting dates should be November 3-5, 2004 and that the site should be the Blackwell Center on the campus of The Ohio State University.

 

After discussion of the draft minutes from the November 3, 4, 5, 2003 meeting, Mrs. Adelman moved that they be approved as amended.  The motion was seconded by Mrs. Gregg and approved by the Board (Aye-6/Nay-0).

10:27 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 Mrs. Teater and a roll call vote was conducted by President Giacalone as follows: Adelman-Yes, Eastman-Yes, Gregg-Yes, Lipsyc-Yes, Teater-Yes, and Turner-Yes.

10:42 a.m.

 

Board Member Gregory Braylock arrived and joined the meeting in progress.

12:00 p.m.

R-2004-090

The Executive Session ended and the meeting was opened to the public.  Ms. Eastman moved that the Board summarily suspend the license to practice pharmacy belonging to Venubabu Talasila, R.Ph. (03-1-24354) 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 Mrs. Gregg and approved by the Board (Aye-6/Nay-0/Abstain-1[Braylock]).

 

R-2004-091

Mrs. Adelman moved that the Board accept the settlement offer received in the matter of Kelly Lutz.  The motion was seconded by Mr. Turner and approved by the Board (Aye-5/Nay-2).  The agreement will become final upon the signature of all parties.

 

R-2004-092

Ms. Eastman moved that the Board accept the settlement offer received in the matter of Samuel Postolski.  The motion was seconded by Mrs. Teater and approved by the Board (Aye-6/Nay-1).  The agreement will become final upon the signature of all parties.

12:16 p.m.

 

The Board recessed for lunch.

  1:58 p.m.

 

The Board reconvened in Room 1960, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio with the following members present:

 

Robert P. Giacalone, R.Ph. (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.; Dorothy S. Teater, Public Mem­ber; and James E. Turner, R.Ph.

 

R-2004-093

After a discussion of the results of the Public Hearing on the new and proposed rules, Mr. Braylock moved that the following rules be filed with an effective date of January 1, 2004.  The motion was seconded by Mrs. Gregg and approved by the Board (Aye-7/Nay-0).

 

 

( KEY >>   UNDERLINE = Add New Language     STRIKE THROUGH = Remove Language )

 

 

4729-5-31  Criteria for licensure by examination.

 

 

(A)

Pursuant to section 4729.07 of the Revised Code:

 

 

(1)

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

 

 

(2)    (a)

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

 

 

(b)

Pursuant to the procedures established by the NABP, a candi­date may transfer his/her NAPLEX score to Ohio only after the candidate has met all of the requirements set by the board for examination and licensure in Ohio.

 

 

(3)

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

 

 

(B)

Pursuant to section 4729.13 of the Revised Code:

 

 

(1)

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

 

 

(2)

The minimum passing scores for renewal of the pharmacist's iden­ti­fi­ca­tion card is a seventy-five on each exam.

 

 

(a)

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

 

 

(b)

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

 

 

(C)

Pursuant to section 4729.08 of the Revised Code:

 

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

 

 

(1)

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

 

 

(2)

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

 

 

(D)

Any examination candidate who fails to take both of the required ex­ami­na­tions within twelve months from the date the board receives the appli­ca­tion materials shall submit a new application for the required ex­ami­na­tion or examinations and remit the fee established by the state board of phar­macy.

 

 

(E)

The record of the passing score for an examination candidate who takes both of the required examinations, but successfully only completes one ex­ami­na­tion will:

 

 

(1)

Be maintained if no more than twelve months has elapsed between attempts to successfully complete the remaining examination.

 

 

(2)

Not be maintained if more than twelve months has elapsed between attempts to successfully complete the remaining examination.  It will then be necessary for the examination candidate to repeat both exami­nations for Ohio licensure.

 

 

(F)

Any candidate who has requested to transfer their NAPLEX score to Ohio must receive a passing score on take the Ohio jurisprudence examination within twelve months from the date the board receives the initial application or the transfer of their candidate completed the NAPLEX examination or the score transfer will be denied.

 

 

4729-7-01  Definitions.

 

As used in Chapter 4729-7 of the Administrative Code:

 

 

(A)

"Continuing pharmacy education", as required in section 4729.12 of the Revised Code, is defined as post-registration pharmacy education of approved quality undertaken to maintain professional competency to practice pharmacy, improve professional skills and preserve uniform qualifications for continuing the practice of the profession for the purpose of protecting public health and welfare.

 

 

(B)

"Continuing education unit (C.E.U.)" is defined as ten contact hours of par­ti­ci­pa­tion in an organized continuing pharmacy education experience pre­sented by an approved provider.

 

 

(C)

"Approved continuing education" is defined as participation in an organized and structured continuing pharmacy education experience which has been presented by an approved provider or the state board of pharmacy and which presents information directly related to the practice of pharmacy in the area of patient care, pharmacy jurisprudence, or pharmacy management.

 

 

(D)

"Approved provider" is defined as an individual, institution, organization, associa­tion, corporation, or agency that has been approved by the state board of phar­macy and/or the "American Council on Pharmaceutical Edu­ca­tion" (A.C.P.E.).

 

 

(E)

"Evidence of approved C.E.U.s" is defined as a certificate or other document cer­tifying that the pharmacist has satisfactorily participated in an organized and structured continuing pharmacy education experience which was pre­sented by an approved provider.

 

 

(F)

"Patient care" related continuing education shall include continuing pharmacy education experi­ences dealing with the properties and actions of drugs and dosage forms; the etiology, charac­teristics, therapeutics and prevention of disease states; and the monitoring and management of patients by the pharma­cist.

 

 

(G) (F)

"Pharmacy jurisprudence" related continuing education shall include Ohio state board of pharmacy approved continuing pharmacy education ex­peri­ences that deal with current laws, rules, and regulations dealing with the prac­tice of phar­macy and the recent changes that have occurred to those laws, rules, and regu­lations.

 

 

(H)

"Pharmacy management" related continuing education shall include continuing pharmacy educa­tion experiences that deal with professional practice management or the behavioral, social, or economic aspects of health care.

 

 

4729-9-14  Records of controlled substances.

 

 

(A)

Each prescriber or terminal distributor of dangerous drugs shall keep a record of all controlled substances received, administered, dispensed, sold, or used.

 

 

(1)

Records of receipt shall contain a description of all controlled substances received, the kind and quantity of controlled substances received, the name and address of the persons from whom received, and the date of receipt.

 

 

(2)

Records of administering, dispensing, or using controlled substances shall contain a description of the kind and quantity of the controlled substance administered, dispensed, or used, the date, the name and address of the person to whom or for whose use, or the owner and iden­tification of the animal for which, the controlled substance was admini­stered, dispensed, or used.

 

 

(3)

Records of drugs administered which become a permanent part of the patient's medical record shall be deemed to meet the name and address requirements of paragraph (A)(2) of this rule.

 

 

(B)

Each prescriber or terminal distributor of dangerous drugs shall maintain an inventory of all con­trolled substances as follows:

 

 

(1)

Each inventory shall contain a complete and accurate record of all con­trolled substances on hand on the date the inventory is taken.

 

 

(a)

The name of the substance.

 

 

(b)

The total quantity of the substance.

 

 

(i)

Each finished form (e.g., ten-milligram tablet or ten-milligram concentration per fluid ounce or milliliter).

 

 

(ii)

The number of units or volume of each finished form in each commercial container (e.g., one-hundred-tablet bottle or ten-milliliter vial).

 

 

(iii)

The number of commercial containers of each such fin­ished form (e.g., three one-hundred-tablet bottles or ten one-milliliter vials).

 

 

(c)

If the substance is listed in schedule I or II, the prescriber or terminal distributor of dangerous drugs shall make an exact count or measure of the contents.

 

 

(d)

If the substance is listed in schedule III, IV, or V, the prescriber or terminal distributor of dangerous drugs shall may make an estimated count or measure of the contents, unless the container holds more than one thousand tablets or capsules in which an exact count of the contents must be made.

 

 

(2)

A separate inventory shall be made for each place or establishment where controlled sub­stances are in the possession or under the control of the prescriber or terminal distributor.  Each inventory for each place or establishment shall be kept at the place or estab­lish­ment.

 

 

(3)

An inventory of all stocks of controlled substances on hand on the date the prescriber or terminal distributor first engages in the administer­ing, dispensing, or use of controlled sub­stances. In the event the pre­scriber or terminal distributor of dangerous drugs commences business with no controlled substances on hand, this fact shall be recorded as the initial inventory.

 

 

(4)

Each prescriber or terminal distributor of dangerous drugs shall take a new inventory of all stocks of controlled substances on hand every two years following the date on which the initial inventory is taken.

 

 

(5)

When a substance is added to the schedule of controlled substances by the federal drug enforcement administration or the state board of phar­macy, each prescriber or terminal dis­tributor of dangerous drugs shall take an inventory of all stock of such substance on hand at that time.

 

 

(6)

All records of receipt, distribution, administering, dispensing, inven­tory, or using controlled substances shall be kept for a period of three years at the place where the controlled sub­stances are located.  Any prescriber or terminal distributor of dangerous drugs intending to main­tain such records at a location other than this place must first send notification to the state board of pharmacy; if not contested by the board within sixty days, it will stand as approved.

 

 

4729-9-22  Records of dangerous drugs.

 

Each prescriber or terminal distributor of dangerous drugs shall keep a record of all dan­ger­ous drugs received, administered, dispensed, distributed, sold, destroyed, or used.

 

 

(A)

Records of receipt shall contain a description of all dangerous drugs received, the kind and quantity of dangerous drugs received, the name and address of the persons from whom received, and the date of receipt.

 

 

(B)

Records of administering, dispensing, or using dangerous drugs shall contain a description of the kind and quantity of the dangerous drugs administered, dis­pensed, sold, or used, the date, the name and address of the person to whom or for whose use, or the owner and identification of the animal for which, the dan­gerous drug was administered, dispensed, or used.

 

 

(C)

Records of dangerous drugs, other than controlled substances, administered, dis­pensed, or used which become a permanent part of the patient's medical record shall be deemed to meet the requirements of paragraph (B) of this rule.

 

 

(D)

All records of receipt, distribution, administering, dispensing, selling, destroying, or using dangerous drugs shall be kept for a period of three years at the place where the dangerous drugs are located.  Any terminal distributor of dangerous drugs intending to maintain such records at a location other than this place must first send notification to the state board of pharmacy by certified mail, return re­ceipt requested; if not contested by the board within sixty days, it will stand as approved.  A copy of the request with the return receipt shall be maintained with the other records of danger­ous drugs.  Any such alternate location shall be secured and accessible only to representatives of the termi­nal distributor.

 

 

4729-9-24  Retail and wholesale sales of dangerous drugs on-line.

 

 

(A)

All persons selling or offering to sell dangerous drugs at retail or wholesale in Ohio must be licensed or registered with the Ohio state board of pharmacy as a dangerous drug distributor.

 

 

(B)

All dangerous drug distributors registered or licensed with the Ohio state board of pharmacy and who sell or offer to sell dangerous drugs at retail or wholesale on the "Internet" to persons located in Ohio or any other state must make such sales only in compliance with all state and federal laws governing the legal distri­bution of dangerous drugs.

 

 

(C)

"Internet" sites owned and/or maintained by Ohio registered or licensed danger­ous drug distribu­tors must provide the following information to the public on the "Internet" site and no drugs are to be shipped at wholesale or retail except in accordance with Ohio's drug laws:

 

 

(1)

Name dangerous drug distributor is licensed to do business as in Ohio.

 

 

(2)

Full address of licensed or registered site.

 

 

(3)

Name of responsible person as it appears on the dangerous drug distri­butor license.

 

 

(4)

Telephone number where responsible person may be contacted.

 

 

(5)

A list of the states in which the dangerous drug distributor may legally sell prescription drugs at wholesale or retail.

 

 

(6)

The name, address, and how the drug law enforcement agency may be con­tacted in each state in which the person is authorized to do business.  This may include a link to the drug law enforcement agency's "Internet" site and/or their e-mail address.

 

 

(D)

Any Ohio licensed or registered dangerous drug distributor requesting personal information from the public by way of the "Internet" site (questionnaire forms or e-mail) must provide for security and confidentiality of the information.  This portion of the "Internet" site must also provide infor­mation regarding how the personal information will be used, pursuant to all federal and state laws, rules, and regulations, and ensure that such information is not used for purposes not disclosed without the written informed consent of the patient or person submit­ting personal information.

 

 

4729-13-02  Procedure for state board of pharmacy approval as a laboratory.

 

 

(A)

A person, as defined in division (S) of section 4729.01 of the Revised Code, desir­ing to be approved by the state board of pharmacy as a laboratory shall file with the state board of phar­macy a completed application containing information relative to the qualifications for approval as set forth in rule 4729-13-03 of the Administrative Code.