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 ...  

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