Draft Guidance for Industry on Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution." The draft guidance is intended to assist establishments that are required to register ("registrants") and submit listing information for drugs and biological products in obtaining and submitting the necessary forms to meet registration and listing requirements; this draft guidance will also assist those private label distributors that are not required to register, but elect to submit designated information directly to FDA. FDA proposes to make available through the Internet, rather than through conventional mail, the following registration and listing forms: Form FDA 2656 (Registration of Drug Establishment), Form FDA 2656e (Annual Update of Drug Establishment), Form FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered Establishments' Report of Private Label Distributors).