General Regulations; Definitions  



    Drugs, Devices and Cosmetics


    61N-1.001General Regulations; Definitions


    Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 41 No. 192, October 2, 2015 issue of the Florida Administrative Register.

    61N-1.001 General Regulations; Definitions.

    (1) A word or phrase defined in the federal Food, Drug, and Cosmetic Act as defined in subsection 499.002(1)(b), F.S. 21 U.S.C. ss. 301 et seq. or federal regulations promulgated thereunder in Title 21 Code of Federal Regulations (C.F.R.), (as of 10/1/03) which are incorporated by reference herein, shall have the same meaning as in those provisions unless specifically defined otherwise in Chapter 499, F.S. or Rule Chapter 61N-1, F.A.C.

    (2) No change.

    (a) through (m) No change.

    (n) “Limited quantities” for the purpose of prescription drugs or active pharmaceutical ingredients obtained in “limited quantities” for research and development (“R&D”) purposes pursuant to Section ss. 499.01(3) and (4)(b), F.S., means the number of transactions necessary for research and development purposes, the number of transactions necessary for research and development purposes to obtain a final FDA approval, or the number of transactions necessary for research and development purposes to obtain a final approval from a foreign regulatory authority; all transactions must be based on requirements set forth in the acquiring entity’s research and development records created contemporaneously with the research and development activities requires that the entity must identify the R&D requirements, the acquisition schedule and the use of each drgu acquired relative to anticipated and ongoing R&D activities.

    (o) through (cc) No change.

    (dd) “State Current Good Manufacturing Practices” means current good manufacturing practices and quality system regulations as prescribed as of 6/1/2015 in Title 21 Code of Federal Regulations, Parts 210, 211, 212, 600-610, and 820, and the federal guidelines which are incorporated by reference herein and made a part of this rule, and the requirements of this chapter. Current good manufacturing practices for cosmetics means the guidelines requirements for manufacturing cosmetics as set forth in Rule 61N-1.010, F.A.C.

    (ee) through (jj) No change.

    Rulemaking Authority 499.024, 499.025(5), 499.01(2), 499.01(4)499.0121(6), 499.012(5), 499.012(12), 499.025, 499.03(4), 499.05 FS. Law Implemented 499.003, 499.005, 499.0054, 499.006, 499.007, 499.008, 499.009, 499.01, 499.012, 499.0121, 499.015, 499.023, 499.024, 499.025, 499.028, 499.03, 499.033, 499.035, 499.039, 499.041, 499.05, 499.051, 499.052, 499.06, 499.066, 499.067, 499.61, 499.62, 499.63, 499.64, 499.65, 499.66, 499.67, 499.71, 499.75 FS. History–New 1-1-77, Amended 12-12-82, 1-30-85, Formerly 10D-45.31, Amended 11-26-86, 2-4-93, 7-1-96, Formerly 10D-45.031, Amended 1-26-99, 4-17-01, 6-30-03, 10-7-03, 1-1-04, 1-29-04, 5-29-05, 1-19-06, 2-14-06, 8-6-06, 12-27-07, Formerly 64F-12.001, Amended _______.

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Related Rules: (1)
61N-1.001. General Regulations; Definitions