Notice of Proposed Rule

DEPARTMENT OF HEALTH
Board of Pharmacy
RULE NO: RULE TITLE
64B16-26.2033: Pharmacy Intern Registration and Internship Requirements (Foreign Pharmacy Graduates)
PURPOSE AND EFFECT: The Board proposes the rule promulgation to incorporate new application and to provide the requirements for Pharmacy Intern registration and internship for foreign pharmacy graduates.
SUMMARY: A new application will be incorporated into the rule; requirements for pharmacy intern registration and internship for foreign pharmacy graduates will be provided.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared. The Board determined the proposed rule will not have an impact on small business.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 456.033, 465.005, 465.0075 FS.
LAW IMPLEMENTED: 456.013(1), 456.033, 465.007, 465.0075, 465.002 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca R. Poston, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3253

THE FULL TEXT OF THE PROPOSED RULE IS:

64B16-26.2033 Pharmacy Intern Registration and Internship Requirements (Foreign Pharmacy Graduates).

A foreign pharmacy graduate is required to be registered with the Department of Health as an intern before being employed as an intern in a pharmacy in Florida.

(1) All applicants for intern registration must be made on form DH-MQA 102, “Pharmacy Intern Application for Foreign Graduates and Instructions,” effective September 2009, which is incorporated by reference. Contact the Board of Pharmacy at 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254 or (850)488-0595 to request a form or download the form from the board’s website at http://www.doh.state.fl.us/mqa/pharmacy.

(2) An applicant for foreign pharmacy graduate intern registration in Florida must submit proof of:

(a) Eligibility by the Foreign Pharmacy Graduate Equivalency Committee to sit for the Foreign Pharmacy Graduate Equivalency Examination, or

(b) A passing score on the Foreign Pharmacy Graduate Equivalency Examination to be considered a graduate of an accredited college or school of pharmacy.

(3) Upon the receipt of proof satisfactory to the Board that the intern applicant meets the requirements of either paragraph (a) or (b) of subsection (1), and submitted a completed application as required in subsection (2) unless there exists good cause for the Board’s refusal to certify an applicant as set forth in Section 465.013, F.S., the Board shall certify the applicant to the Department for registration as an intern.

(4) No intern shall perform any acts relating to the filling, compounding, or dispensing of medicinal drugs unless it is done under the direct and immediate personal supervision of a person actively licensed to practice pharmacy in this state.

(5) All internship experience for the purpose of qualifying for the examination pursuant to Section 465.007(1)(c), F.S., shall be obtained in a community pharmacy, institutional pharmacy or any Florida Board of Pharmacy approved pharmacy practice, which includes significant aspects of the practice of pharmacy as defined in Section 465.003(13), F.S.

(6) An internship program at an accredited college or school of pharmacy shall assure that community or institutional pharmacies utilized for the obtaining of internship experience meet the following minimum requirements:

(a) The pharmacy shall hold a current license or permit issued by the state in which they are operating and shall have available all necessary equipment for professional services, necessary reference works, in addition to the official standards and current professional journals.

(b) The pharmacy shall be operated at all times under the supervision of a pharmacist and shall be willing to train persons desiring to obtain professional experience.

(c) The pharmacy shall establish to the program’s satisfaction that the pharmacy fills, compounds and dispenses a sufficient number, kind and variety of prescriptions during the course of a year so as to afford to an intern a broad experience in the filling, compounding and dispensing of prescription drugs.

(d) The pharmacy shall have a clear record as to observance of federal, state and municipal laws and ordinances covering any phase of activity in which it is engaged.

(e) No pharmacist may be responsible for the supervision of more than one intern at any one time.

(7) The program shall assure that all preceptors meet the following requirements:

(a) The pharmacist shall willingly accept the responsibility for professional guidance and training of the intern and be able to devote time to preceptor training sessions and to instruction of the intern.

(b) The pharmacist shall hold current licensure in the state in which pharmacy is practiced.

(c) The pharmacist shall be ineligible to serve as a preceptor during any period in which the pharmacist’s license to practice pharmacy is revoked, suspended, on probation, or subject to payment of an unpaid fine levied by lawful Board order, or during any period in which the pharmacist’s license is the subject of ongoing disciplinary proceedings.

(d) The pharmacist shall agree to assist the school or college of pharmacy in the achievement of the educational objectives set forth and to provide a professional environment for the training of the intern.

(e) Evidence shall be provided of the pharmacist’s desire to continue broadening professional education and of an active involvement in a patient‑oriented practice.

(7) In the event a program meets all the requirements set forth in subsection (2) of this rule, except for prior approval by the Florida Board of Pharmacy, any applicant submitting it for the purpose of qualifying for licensure by examination must show in addition to successful completion of the internship:

(a) Approval of the program by a state board of pharmacy; and

(b) Sufficient hours to total 1580 hours; or

(c) Licensure in another state and work performed as a pharmacist for a sufficient number of hours to total 1580 hours when combined with the internship hours.

(8) All internship hours may be obtained prior to the applicant’s graduation.

(9) Proof of completion of an internship program shall consist of a certification that the applicant has completed the program. If additional hours are required to total 2080 hours, satisfactory proof of the additional hours shall be constituted by the program’s certification of completion of the additional hours.

(10) Hours worked in excess of 50 hours per week prior to the applicant’s graduation or in excess of 60 hours per week after an applicant’s graduation, will not be credited toward meeting the required internship hours.

(11) The Board approves all internships that are required to obtain the doctor of pharmacy degree from institutions which are accredited as provided by Section 465.007(1)(b)1., F.S. Applicants graduating after January 1, 2001 with the doctor of pharmacy degree from such institutions shall be deemed to have met the requirements of this section with documentation of graduation.

(12) The Board may conduct periodic review of programs to assure compliance with these rules.

(13) Proof of current licensure in another state and work as a pharmacist for up to 1580 hours may substitute for all or part of the internship hours requirement.

(14) Governmental and private radiopharmacy internship programs shall not apply to the pharmacy internship required under subsection (1) of this rule.

(15) All foreign pharmacy graduates must complete 500 hours of supervised work activity within the state of Florida as provided by Section 465.007(b)2., F.S. The supervised work activity program experience shall be documented on form DH-MQA 1153, “Foreign Pharmacy Graduate Registered Intern Work Activity Manual,” effective April 2009 which is incorporated by reference. Contact the Board of Pharmacy at 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254 or (850)488-0595 to request a form or download the form from the board’s website at http://www.doh.state.fl.us/mqa/pharmacy.

Further, no supervised work activity program shall be approved for any applicant until said applicant has obtained the passing score on the Foreign Pharmacy Graduate Equivalency Exam as provided in Section 465.007, F.S.

Rulemaking Authority 456.033, 465.005, 465.0075 FS. Law Implemented 456.013(1), 456.033, 465.007, 465.0075, 465.002 FS. History–New_________.


NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Pharmacy
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Pharmacy
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: September 10, 2009
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: July 17, 2009