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
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, (850)717-1802
THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS NOT AVAILABLE.
Document Information
- Subject:
- 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.
- Purpose:
- Clear up the definitions of certain terms, as well as to define "limited quantities" as used in ss.499.01 (3) & (4), F.S.
- Rulemaking Authority:
- : 499.003, 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:
- 12/27/2007
- Contact:
- Dinah Greene, Division of Drugs, Devices and Cosmetics 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399 850-717-1802.
- Related Rules: (1)
- 61N-1.001. General Regulations; Definitions