Product Tracking and Tracing – Definitions

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.028Product Tracking and Tracing – Definitions

NOTICE OF CHANGE

Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 42 No. 32, February 17, 2016 issue of the Florida Administrative Register.

61N-1.028 Product Tracking and Tracing - Definitions.

(1) through (6) No change.

(7) “GRANDFATHERED” means, with respect to a product, a product that is not labeled with a product identifier and that entered the pharmaceutical distribution supply chain on or before March 1, 2016 January 1, 2015.

(8) through (13) No change.

(14) “PRODUCT” means a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution), but does not include blood or blood components intended for transfusion, radioactive drugs or radioactive biological products (as defined in section 600.3(ee) of title 21, Code of Federal Regulations) (as of 12/1/15) which is incorporated by reference herein that are regulated by the Nuclear Regulatory Commission or by a State pursuant to an agreement with such Commission under section 274 of the Atomic Energy Act of 1954 (42 U.S.C. s. 2021) (as of 12/1/15) which is incorporated by reference herein, imaging drugs, an intravenous product described in subparagraphs clause 14., 15. or 16. of suparagraph (25)(b) below, any medical gas (as defined in 21 U.S.C. s. 360ddd) (as of 12/1/15) which is incorporated by reference herein, homeopathic drugs marketed in accordance with applicable guidance under this Act, or a drug compounded in compliance with 21 U.S.C. s. 353a (as of 12/1/15) which is incorporated by reference herein or 21 U.S.C. s. 353b (as of 12/1/15) which is incorporated by reference herein.

(15) through (18) No change.

(19) “RETURNS PROCESSOR or REVERSE LOGISTICS PROVIDER” means a person who owns or operates an establishment that dispositions or otherwise processes saleable or nonsaleable product received from an authorized trading partner such that the product may be processed for credit to the purchaser, manufacturer, or seller or disposed of for no further distribution.

(20) through (22) No change.

(23) “THIRD PARTY LOGISTICS PROVIDER” means an entity that provides or coordinates warehousing, or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have has responsibility to direct the sale or disposition of the product.

(24) through (30) No change.

(31) “WHOLESALE DISTRIBUTOR” means a person, (other than a manufacturer, a manufacturer’s co-licensed partner, a third-party logistics provider, or repackager), engaged in wholesale distribution.