13017999, 61N-1.001 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 13017999

Notice of Development of Rulemaking

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

PURPOSE:

The Division proposes the rule amendments to clarify the definitions of terms set forth in Chapter 499, F.S., and the Division’s rules; 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.

SUBJECT:

Definitions, records, storage requirements

RULEMAKING AUTHORITY:

499.003;499.01(3),(4),(6);499.012(12);499.0121;499.0122;499.013;499.014;

LAW:

499.028 (6), 499.003, 499.004, 499.005, 499.0054, 499.0057, 499.006, 499.007, 499.008, 499.009, 499.01, 499.012, 499.0121, 499.0122, 499.013, 499.014, 499.015, 499.023, 499.024, 499.025, 499.028, 499.03, 499.033, 499.035, 499.039, 499.04, 499.041, 499.05, 499.051, 499.052, 499.06, 499.063, 499.064, 499.066, 499.067, 499.069, 499.61, 499.62, 499.63, 499.64, 499.65, 499.66, 499.67, 499.71, 499.75.

PRINT PUBLISH DATE:

5/20/2013 Vol. 39/98

RELATED STATUTES
AND LAWS:

499.003;499.01(3),(4),(6);499.012(12);499.0121;499.0122;499.013;499.014;, 499.028 (6), 499.003, 499.004, 499.005, 499.0054, 499.0057, 499.006, 499.007, 499.008, 499.009, 499.01, 499.012, 499.0121, 499.0122, 499.013, 499.014, 499.015, 499.023, 499.024, 499.025, 499.028, 499.03, 499.033, 499.035, 499.039, 499.04, 499.041, 499.05, 499.051, 499.052, 499.06, 499.063, 499.064, 499.066, 499.067, 499.069, 499.61, 499.62, 499.63, 499.64, 499.65, 499.66, 499.67, 499.71, 499.75.

OVERSIGHT COMMITTEE:

Joint Administrative Procedures Committee
Florida Administrative Law Central Online Network (F.A.L.C.O.N.)

RELATED COURT CASES:

Division of Administrative Hearings

FEDERAL eRULEMAKING
WEB PORTAL:

Regulations.gov

HOW TO LINK TO
THIS NOTICE:

http://www.flrules.org/gateway/ruleno.asp?id=61N-1.001&PDate=5/20/2013&Section=1

REFERENCE MATERIALS:

No reference(s).

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