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FDA Reviewing Information Collections on Drug Producer Registration, Drug Listing

Monday, March 23, 2015
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is accepting through May 22 comments on the proposed extension of information collections associated with the registration of producers of drugs and the listing of drugs in commercial distribution. The information collected is used for activities such as postmarket surveillance for serious adverse drug reactions, inspection of drug manufacturing and processing facilities, and monitoring of imported drug products.

Under FDA regulations, manufacturers, repackers and relabelers that engage in the manufacture, preparation, propagation, compounding or processing of human or veterinary drugs and biological products, including bulk drug substances and bulk drug substances for prescription compounding, and drug premixes as well as finished dosage forms, whether prescription or over-the-counter, are required to register their establishment. They must also submit a listing of every drug or biological product in commercial distribution. Owners or operators of establishments that distribute under their own label or trade name a drug product manufactured by a registered establishment are not required either to register or list. However, distributors may elect to submit drug listing information in lieu of the registered establishment that manufactures the drug product. Foreign drug establishments must also comply with the establishment registration and product listing requirements if they import or offer for import their products into the United States.

Historically, drug establishment registration and drug listing information have been submitted in paper form using form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment), form FDA 2657 (Drug Product Listing) and form FDA 2658 (Registered Establishments' Report of Private Label Distributors). Under the Food and Drug Administration Amendments Act of 2007, however, drug establishment registration and drug listing information must be submitted electronically unless a waiver is granted.

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