15984841, 61N-1.001 - Florida Administrative Rules, Law, Code, Register

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Notice: 15984841

Notice of Meeting/Workshop Hearing

Department:

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Division:

Drugs, Devices and Cosmetics

Chapter:

REGULATIONS FOR DRUGS, DEVICES AND COSMETICS

Overview

RULE:

61N-1.001	General Regulations; Definitions
61N-1.012	Records of Drugs, Cosmetics and Devices
61N-1.013	Prescription Drugs; Receipt, Storage and Security

The Division of Drugs, Devices and Cosmetics announces a workshop to which all persons are invited.

DATE AND TIME:

PLACE:

Subject:

The Division proposes the rule amendments to clarify the definitions of terms set forth in Chapter 499, F.S., and the Division’s rules 61N-1.001, 61N-1.012 and 61N-1.013; set forth the records which must be created and maintained by entities in Florida engaging in the possession of limited quantities of prescription drugs, obtained from non-Florida licensed sources, for the purpose of research and development; and set forth the storage requirements for those entities.

Limited Quantities: [61N-1.001(2)(n), F.A.C.]

(n) “Limited quantities” pursuant to Section 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.

Records of Drugs: [61N-1.012(17)]

(17) For purposes of prescription drugs obtained in “limited quantities” for research and development (“R&D”) purposes under Section 499.01(3) and (4)(b), F.S. and Rule 61N-1.001(2)(n), F.A.C., the required records must identify the requirements and schedule the acquisition and use of each such drug relative to anticipated and ongoing R&D activities.  These records must be created in advance of or within 30 calendar days of the particular R&D activities, and are subject to inspection under 499.051, F.S.  Non-clinical/pre-clinical R&D quantities must be updated annually, and clinical quantities must be updated semiannually.  The researcher must maintain all other records required under Chapter 499, including, without limitations, Section 499.01(3) or (4)(b), and applicable federal laws.

Storage & Security: [61N-1.013(3)(d)3.]

3. Prescription drugs obtained in “limited quantities” for research and development (“R&D”) purposes under Section 499.01(3) and(4)(b), F.S. and Rule 61N-1.001(2)(n), F.A.C., must be physically segregated from all other products intended for manufacturing, compounding, dispensing, or administration.  In a manufacturer’s establishment, these drugs must also be stored and maintained in a separate and clearly designated area.

A copy of the agenda may be obtained by contacting: Dinah Greene at The Division of Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399-1047, 850-717-1802.

PRINT PUBLISH DATE:

5/12/2015 Vol. 41/92

REFERENCE MATERIALS:

No reference(s).

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