Florida Regulations
Department of Health/Board of Pharmacy
Vol. 47, Issue 240, Florida Administrative Register 2021-12-14 p.5694
PUBLICATION DATE: 12/14/2021
ACTION DATE: 12/09/2021
EFFECTIVE DATE: 12/29/2021
PUBLICATION TYPE: Register
REGISTER SOURCE: Vol. 47, Issue 216, Florida Administrative Register 2021-11-05 pp.5188-5190
PUBLICATION DATE: 11/05/2021
ACTION DATE: 11/05/2021
PUBLICATION TYPE: Register
REGISTER SOURCE: Vol. 47, Issue 100, Florida Administrative Register 2021-05-24 pp.2409-2410
PUBLICATION DATE: 05/24/2021
ACTION DATE: 05/24/2021
COMMENT DEADLINE: 06/14/2021
PUBLICATION TYPE: Register
REGISTER SOURCE: Vol. 47, Issue 83, Florida Administrative Register 2021-04-29 p.1980
PUBLICATION DATE: 04/29/2021
ACTION DATE: 04/29/2021
COMMENT DEADLINE: 05/20/2021
PUBLICATION TYPE: Register

64B16-26.2032 Application for Pharmacy Intern Registration.

(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 for Pharmacy Education (ACPE) shall apply for pharmacy intern registration on form DH-MQA 104, Pharmacy Intern Application for ACPE Accredited Students/Graduates, Rev. 08/2021, which is hereby incorporated by reference and which can be obtained from http://www.flrules.org/Gateway/reference.asp?No=Ref-13939, 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 Non-U.S. Graduates, Rev. 08/2021, which is incorporated by reference and which can be obtained from https://www.flrules.org/Gateway/reference.asp?No=Ref-13940, 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), 456.0635, 465.003(12), (13), 465.007(1)(c), 465.0075(1)(c)2., 465.013 FS. History - New 4-1-07, Amended 7-7-10, 10-7-12, 3-15-17, 12-29-21.

64B16-26.300 Consultant Pharmacist Licensure.

(1) No person shall serve as consultant pharmacist as defined in Section 465.003(3), F.S., unless that person holds a license as a consultant pharmacist.

(2) Application for consultant pharmacist licensure shall be made on form DOH-MQA 1109, (Rev. 08/2021), Consultant Pharmacist Application, which is hereby incorporated by reference, and which can be obtained from http://www.flrules.org/Gateway/reference.asp?No=Ref-13941 and the Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254, or from the website located at http://floridaspharmacy.gov/Applications/app-consultant-pharmacist.pdf. The application shall be accompanied by an application fee.

(3) In order to be licensed as a consultant pharmacist, a person must meet the following requirements:

(a) Hold a license as a pharmacist which is active and in good standing; and

(b) Successfully complete a consultant pharmacist course of no fewer than twenty (20) hours approved by the Florida Board of Pharmacy Tripartite Continuing Education Committee which is based on the Statement of the Competencies Required in Institutional Pharmacy Practice and covers the subject matter set forth in Rule 64B16-26.301, F.A.C. The course shall be instructionally designed to include a cognitive test on which the applicant must score a passing grade for certification of successful completion of the course.

(4) After licensure a consultant pharmacist's license shall be renewed biennially upon payment of the fee set forth in Rule 64B16-26.1003, F.A.C., and upon completing twenty-four (24) hours of board approved continuing education based upon the provisions of Rule 64B16-26.302, F.A.C.

(5) The number of hours earned in recertification programs by a consultant pharmacist, if applied to the twenty-four (24) hours required for consultant pharmacist license renewal, may not be used toward the thirty (30) hours of continued professional pharmaceutical education credits as set forth in Rule 64B16-26.103, F.A.C.

Rulemaking Authority 456.013, 465.005, 465.0125 FS. Law Implemented 456.013, 465.0125 FS. History - New 5-19-72, Revised 4-19-74, Repromulgated 12-18-74, Amended 10-17-79, 4-8-80, 7-29-81, 7-1-83, 4-10-84, 4-30-85, Formerly 21S-1.26, 21S-1.026, Amended 7-31-91, 10-14-91, Formerly 21S-26.300, 61F10-26.300, Amended 9-19-94, 3-28-95, 3-10-96, Formerly 59X-26.300, Amended 5-22-01, 5-5-05, 11-29-06, 3-29-10, 6-23-16, 12-20-20, 12-29-21.

64B16-26.303 Nuclear Pharmacist Licensure.

(1) A pharmacist licensed to practice pharmacy in this state who performs a radiopharmaceutical service shall, prior to engaging in such specialized practice, be actively licensed as a nuclear pharmacist.

(2) A pharmacist seeking licensure as a nuclear pharmacist in this state shall submit to the Board of Pharmacy the following:

(a) An application for nuclear pharmacist licensure, form DH-5064-MQA 08/2021, Nuclear Pharmacist Application, which is hereby incorporated by reference, and which can be obtained from http://www.flrules.org/Gateway/reference.asp?No=Ref-13942, and the Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254, or from the website located at http://floridaspharmacy.gov/Applications/app-nuclear-pharmacist-2013.pdf;

(b) An application fee as specified by subsection 64B16-26.1002(3), F.A.C.;

(c) A course outline and certificate of training which document successful completion of the didactic training in compliance with subsection (3), below;

(d) Documentation of successful completion of on-the-job training and experience in compliance with subsection (5), below.

(3) All applicants must complete a minimum of 200 clock hours of formal didactic training from an accredited college of pharmacy or other program recognized by the Florida Department of Health and the Florida Board of Pharmacy as specified by subsection (4), below. All such formal training must include, at a minimum:

(a) Radiation physics and instrumentation (85 hours).

(b) Radiation protection (45 hours).

(c) Mathematics pertaining to the use and measurement of radioactivity (20 hours).

(d) Radiation biology (20 hours).

(e) Radiopharmaceutical chemistry (30 hours).

(4) Programs recognized by the Department and Board shall be determined to be comparable to those offered by accredited colleges of pharmacy for the training of nuclear pharmacists. Such academic training programs will be submitted to the Board of Pharmacy for approval by an accredited educational institution which operates under the auspices of or in conjunction with an accredited college of pharmacy.

(5) The minimum on-the-job training which shall be included in a radiopharmacy internship is 500 hours of training and experience in the handling of unsealed radioactive material under the supervision of a licensed nuclear pharmacist. The training and experience shall include but shall not be limited to the following:

(a) Ordering, receiving and unpackaging in a safe manner, radioactive material, including the performance of related radiation surveys.

(b) Calibrating dose calibrators, scintillation detectors, and radiation monitoring equipment.

(c) Calculating, preparing and verifying patient doses, including the proper use of radiation shields.

(d) Following appropriate internal control procedures to prevent mislabeling.

(e) Learning emergency procedures to safely handle and contain spilled materials, including related decontamination procedures and surveys.

(f) Eluting technetium-99m from generator systems, assaying the eluate for technetium-99m and for molybdenum-99 contamination, and processing the eluate with reagent kits to prepare technetium-99m labeled radiopharmaceuticals.

(g) Clinical practice concepts.

(6) If the didactic and experiential training required in this section have not been completed within the last seven (7) years, the applicant must have been engaged in the lawful practice of nuclear pharmacy in another jurisdiction at least 1,080 hours during the last seven (7) years.

Rulemaking Authority 465.005, 456.013, 465.0126 FS. Law Implemented 456.013, 465.0126 FS. History - New 1-18-05, Amended 6-7-16, 12-29-21.

64B16-26.350 Requirements for Pharmacy Technician Registration.

(1) As required by Section 465.014, F.S., no person shall work as a Pharmacy Technician unless such person is at least seventeen (17) years of age and is registered by the Board or who is currently registered as a Pharmacy Intern.

(2) All applicants for registration as a pharmacy technician must be made on form DH-MQA-PH1183, "Pharmacy Technician Registration Application," Rev. 08/2021, which is incorporated herein by reference. Copies of the application may be obtained from the Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, FL 32399-3254, (850)488-0595; the board's website at http://floridaspharmacy.gov/Applications/app-pharm-tech.pdf or from http://www.flrules.org/Gateway/reference.asp?No=Ref-13943. The application must be accompanied with a non-refundable application fee and an initial registration fee set forth in Rules 64B16-26.1001 and 64B16-26.1002, F.A.C.

(3) In addition to the requirements of subsection (2), all applicants must submit proof of completion of a Board approved training course as outlined in Rule 64B16-26.351, F.A.C.

Rulemaking Authority 465.005, 465.014 FS. Law Implemented 456.0635, 456.013(1), (2), (3), 465.014 FS. History - New 8-5-10, Amended 9-1-16, 12-29-21.