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 ...

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION
Drugs, Devices and Cosmetics
RULE NOS.:RULE TITLES:
61N-1.001General Regulations; Definitions
61N-1.012Records of Drugs, Cosmetics and Devices
61N-1.013Prescription Drugs; Receipt, Storage and Security
PURPOSE AND EFFECT: 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 AREA TO BE ADDRESSED: Definitions, records, storage requirements.
RULEMAKING AUTHORITY: 499.003, 499.01(3), (4), (6), 499.012(12), 499.0121, 499.0122, 499.013, 499.014 FS.
LAW IMPLEMENTED: 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 FS.
IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE NOTICED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE REGISTER.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Dinah Greene, Operations Review Specialist, Division of Drugs, Devices and Cosmetics, Department of Business and Professional Regulation, 1940 North Monroe Street, Suite 26A, Tallahassee, Florida 32399-1047, (850)488-1802
THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS AVAILABLE AT NO CHARGE FROM THE CONTACT PERSON LISTED ABOVE.

Document Information

Subject:: Definitions, records, storage requirements
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.
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.
Contact:: Dinah Greene, Operations Review Specialist, Division of Drugs, Devices and Cosmetics, Department of Business and Professional Regulation, 1940 North Monroe Street, Suite 26A, Tallahassee, Florida 32399-1047; 850-488-1802.
Related Rules: (3): 61N-1.001. General Regulations; Definitions; 61N-1.012. Records of Drugs, Cosmetics and Devices; 61N-1.013. Prescription Drugs; Receipt, Storage and Security