Clear up the definitions of certain terms, as well as to define "limited quantities" as used in ss.499.01 (3) & (4), F.S.

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.001General Regulations; Definitions

PURPOSE AND EFFECT: Clear up the definitions of certain terms, as well as to define "limited quantities" as used in subsections 499.01 (3) & (4), F.S.

SUBJECT AREA TO BE ADDRESSED: The Division proposes 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.

RULEMAKING AUTHORITY: 499.01(3), (4), (6), 499.012(12), 499.0121, 499.0122, 499.013, 499.014, 499.024, 499.025(5), 499.03(4), 499.05, 499.052 FS.

LAW IMPLEMENTED: 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, 499.041, 499.05, 499.051, 499.052, 499.06, 499.066, 499.067, 499.069, 499.61, 499.62, 499.63, 499.64, 499.65, 499.66, 499.67, 499.71, 499.75 FS.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Dinah Greene, Division of Drugs, Devices and Cosmetics

1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399, [phone]

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS NOT AVAILABLE.