For Rule 64B16-26.2032, F.A.C., the Board proposes the rule amendment to update the rule and revise the incorporated forms. For Rules 64B16-26.400 and 64B16-26.2033, F.A.C., the Board proposes the rule amendments to update the rules.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NOS.:RULE TITLES:

64B16-26.2032Pharmacy Intern Registration Internship Requirements (U.S. Pharmacy Students/Graduates)

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

64B16-26.400Pharmacy Interns; Registration; Employment

PURPOSE AND EFFECT: For Rule 64B16-26.2032, F.A.C., the Board proposes the rule amendment to update the rule and revise the incorporated forms. For Rules 64B16-26.400 and 64B16-26.2033, F.A.C., the Board proposes the rule amendments to update the rules.

SUMMARY: Rule 64B16-26.2032, F.A.C. will be updated and the incorporated forms will be revised. Rules 64B16-26.400 and 64B16-26.2033, F.A.C., will be updated.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

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.

RULEMAKING AUTHORITY: 465.005 FS.

LAW IMPLEMENTED: 456.003(12), 456.013(1), 465.007, 465.0075, 465.013 465.002 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Allison Dudley, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

(Substantial rewording of Rule 64B16-26.2032, F.A.C. follows. See Florida Administrative Code for present text.)

64B16-26.2032 Application for Pharmacy Intern Registration Pharmacy Intern Registration Internship Requirements (U.S. Pharmacy Students/Graduates).

(l)(a) Students/Graduates of ACPE Accredited Programs.  Students currently enrolled in, or graduates of, colleges or schools of pharmacy which are accredited by the Accreditation Council of Pharmaceutical Education (ACPE) shall apply for pharmacy intern registration on form DH-MQA 104, Pharmacy Intern Application for ACPE Accredited Students/Graduates and Instructions, 07/16, which is hereby incorporated by reference and which can be obtained from http://www.flrules.org/Gateway/reference.asp?No=Ref-        , the Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254, or the Board's website at http://floridaspharmacy.gov/Applications/app-pharmacy-intern-us.pdf.

(b) Graduates of non-ACPE Accredited Programs.  Graduates of colleges or schools of pharmacy which are not ACPE accredited shall apply for pharmacy intern registration on form DH-MQA 102, Pharmacy Intern Application for Foreign Graduates and Instructions, 07/16, which is incorporated by reference and which can be obtained from http://www.f1rules.org/Gateway/reference.asp?No=Ref-    , the Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254, or the Board’s website at http://floridaspharmacy.gov/Applications/app-pharmacy-intern-foreign.pdf.

(2) In addition to the application required by subsection (1), an applicant for pharmacy intern registration must submit proof satisfactory to the Board of:

(a) Enrollment in an intern program at an accredited college or school of pharmacy; or

(b) Graduation from an accredited college or school of pharmacy and who is not yet licensed in the state. For purposes of this rule only, any individual who has been accepted by the Foreign Pharmacy Graduate Examination Commission to sit for the Foreign Pharmacy Graduate Equivalency Examination, or who has obtained a passing score on the Examination, shall be considered a graduate of an accredited college or school of pharmacy.

(3) Upon the receipt of proof satisfactory to the Board that the applicant meets the requirements of this rule, and 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.

Rulemaking Authority 465.005, FS. Law Implemented 456.013(1), (2), (3), (13), 465.003(12), (13), 465.007(1)(c), 465.0075(1)(c)2., F.S.  History New 4-1-07, Amended 7-7-10, 10-7-12, ______________.

 

(Substantial rewording of Rule 64B16-26.2033, F.A.C. follows. See Florida Administrative Code for present text.)

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

(1) For the purpose of qualifying for licensure by examination pursuant to Section 465.007(1)(c), F.S., or for licensure by endorsement pursuant to Section 465.0075(1)(c)2., F.S., the following are determined to be "internship programs approved by the Board:"

(a) Internship programs offered by schools or colleges of pharmacy which are accredited by the Accreditation Council on Pharmacological Education (ACPE);

(b) 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.  Documentation of graduation from such institutions after January 1, 2001 with the doctor of pharmacy degree shall constitute satisfactory proof the applicant has satisfied the requirements of this paragraph; or

(c) Internship programs which meet all requirements of subsection (2), below.

(2) The Board will approve internship programs other than those accredited programs enumerated in paragraphs (1)(a)-(b), above, upon presentation of proof satisfactory to the Board of the following.

(a) The internship experience 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., provided such pharmacy:

1. Holds 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;

2. Is operated at all times under the supervision of a pharmacist and shall be willing to train persons desiring to obtain professional experience;

3. Demonstrates 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; and

4. Has a clear record as to observance of federal, state and municipal laws and ordinances covering any phase of activity in which it is engaged.

(b) Pharmacists serving as preceptors of pharmacy interns shall:

1. 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;

2. Hold current licensure in the state in which pharmacy is practiced;

3. 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;

4.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; and

5. Provide documentation or evidence of the pharmacist’s continued professional education and of an active involvement in a patient-oriented practice.

(c) In the event an internship program meets all the requirements set forth in subsections (a) and (b), any applicant submitting it for the purpose of qualifying for licensure must show in addition to successful completion of the internship:

1. Approval of the program by a state board of pharmacy; and

2.a. Sufficient hours to total two thousand eighty (2080) hours; or

b. Licensure in another state and work performed as a pharmacist for a sufficient number of hours to total two thousand eighty (2080) hours when combined with the internship hours.

(3) All internship hours may be obtained prior to the applicant’s graduation. Hours worked in excess of fifty (50) hours per week prior to the applicant’s graduation or in excess of sixty (60) hours per week after an applicant’s graduation will not be credited toward meeting the required internship hours.

(4) Proof of current licensure in another state and work as a pharmacist for up to two thousand eighty (2080) hours may substitute for all or part of the internship requirement. However, pursuant to section 465.007(1)(b)2., F.S., all foreign pharmacy graduates must complete five hundred (500) hours of supervised work activity within the state of Florida. The supervised work activity program experience shall be documented on form DH-MQA 1153, “Foreign Graduate Registered Intern Work Activity Manual,” incorporated by reference in Rule 64B16-26.2031, F.A.C. Further, supervised work activity hours may not be credited to any applicant until said applicant has obtained the passing score on the Foreign Pharmacy Graduate Equivalency Exam as provided in Section 465.007(1)(b)2., F.S. and as defined in Rule 64B16-26.203, F.A.C.

(5) Governmental and private radiopharmacy internship programs are not approved by the Board.

(6) Proof of completion of an internship program shall consist of the program's certification that the applicant has completed the program.  If additional hours are required to total two thousand eighty (2080) hours, satisfactory proof of the additional hours shall consist of the program’s certification of completion of the additional hours.

Rulemaking Authority 465.005, 465.007(1)(c) FS. Law Implemented 465.003(12, (13), 465.007(1)(c), 465.0075(1)(c)2., 465.013, 465.015(1)(b), (2)(b) FS. History–New 4-1-07, Amended 7-7-10, 10-7-12,               .

 

64B16-26.400 Pharmacy Interns; Registration; Employment; Supervision.

(1) No change.

(2) An applicant for pharmacy intern registration must submit proof of:

(a) Enrollment in an intern program at an accredited college or school of pharmacy or;

(b) Graduation from an accredited college or school of pharmacy and not yet licensed in the state. For purposes of this rule only, any individual who has been accepted by the Foreign Pharmacy Graduate Examination Commission to sit for the Foreign Pharmacy Graduate Equivalency Examination shall be considered a graduate of an accredited college or school of pharmacy. The internship experience allowed under this provision shall not count toward the 500-hours internship required subsequent to passage of the Foreign Pharmacy Graduate Equivalency Examination as mandated in Section 465.007(1)(b)2., F.S., and as defined in Rule 64B16-26.203, F.A.C.

(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 (2), and 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.

(2)(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.

Rulemaking Specific Authority 465.005, FS. Law Implemented 465.013, 465.015(1)(b), (2)(b), FS. History–Amended 8-20-63, 5-19-72, 8-18-73, Repromulgated 12-18-74, Amended 11-10-80, 4-30-85, Formerly 21S-1.21, Amended 10-20-88, Formerly 21S-1.021, Amended 7-31-91, 1-10-93, Formerly 21S-26.400, 61F10-26.400, 59X-26.400, Amended 3-10-05,                        .

 

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: June 8, 2016

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 3, 2016