The purpose and effect of the proposed rule amendment is to alleviate burden on business by requiring distributions that are the result of an error do not have to be listed on the pedigree if the return occurs within 14 calendar days rather than ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION
Drugs, Devices and Cosmetics

RULE NO.: RULE TITLE:
61N-1.012: Records of Drugs, Cosmetics and Devices

PURPOSE AND EFFECT: The purpose and effect of the proposed rule amendment is to alleviate burden on business by requiring distributions that are the result of an error do not have to be listed on the pedigree if the return occurs within 14 calendar days rather than the current 7 day requirement.

SUBJECT AREA TO BE ADDRESSED: The listing on pedigrees of distributions that are made in error if the return is completed within 14 days of the original distribution.

RULEMAKING AUTHORITY: 499.003, 499.05, 499.0121, 499.0122, 499.013, 499.014, 499.052 FS.
LAW IMPLEMENTED: 499.01, 499.003, 499.012, 499.0121, 499.0122, 499.013, 499.014, 499.028, 499.04, 499.041, 499.05, 499.051, 499.052, 499.06, 499.063, 499.064, 499.066, 499.067 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 WEEKLY.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: R. Kathleen Brown-Blake, 1940 North Monroe Street, Suite 42, Tallahassee, FL 32399, [phone]

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS AVAILABLE AT NO CHARGE FROM THE CONTACT PERSON LISTED ABOVE.