Set forth recordkeeping requirements for Florida manufacturers engaging in "limited quantities" of Rx drugs obtained from non-Florida licensed entities.
DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION
RULE NO.:RULE TITLE:
61N-1.012Records of Drugs, Cosmetics and Devices
PURPOSE AND EFFECT: Set forth recordkeeping requirements for Florida manufacturers engaging in "limited quantities" of Rx drugs obtained from non-Florida licensed entities.
SUBJECT AREA TO BE ADDRESSED: Definitions, records, storage requirements.
RULEMAKING AUTHORITY: 499.01(2)(g), 499.05, 499.0121 FS.
LAW IMPLEMENTED: 499.01, 499.003, 499.012, 499.0121, 499.01212, 499.028, 499.04, 499.041, 499.05, 499.051, 499.052, 499.06, 499.063, 499.064, 499.066, 499.067 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:
- Definitions, records, storage requirements
- Purpose:
- Set forth recordkeeping requirements for Florida manufacturers engaging in "limited quantities" of Rx drugs obtained from non-Florida licensed entities.
- Rulemaking Authority:
- 499.01(2)(g), 499.05, 499.0121 FS.
- Law:
- 499.01, 499.003, 499.012, 499.0121, 499.01212, 499.028, 499.04, 499.041, 499.05, 499.051, 499.052, 499.06, 499.063, 499.064, 499.066, 499.067 FS
- 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-1.012. Records of Drugs, Cosmetics and Devices