U.S. Food and Drug Administration • Center for Drug Evaluation
and Research |
U.S. Food and Drug Administration • Center for Drug Evaluation
and Research |
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Regulatory Information |
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Drug Registration and ListingWelcome to CDER's web page on drug registration and listing. CDER has created this page so readers can follow the Agency's activities as it implements section 510 of the Food, Drug, and Cosmetic Act. Additional documents and information will be added as they become available. Section 510 of the Federal Food, Drug, and Cosmetic Act requires manufacturers, repackers, and relabelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and human biological products to register their establishment(s) and submit a listing of every product in commercial distribution with the FDA. This information helps FDA maintain a catalog of all human and veterinary drugs and biologics in commercial distribution in the United States. The ActSection 510 of the Food, Drug and Cosmetic Act - Registration of Producers of Drugs and Devices. The Regulations21 CFR 207 - Registration of Producers of Drugs And Listing of Drugs in Commercial Distribution Federal Register NoticesForeign Establishment Registration and Listing; Final Rule. [Text] [PDF] Effective February 11, 2002 Comments by November 26, 2002. Electronic Filing of Drug Registration and Listing Information; Notice of Pilot Project Agency. Optional format: PDF. (Issued 1/9/01). Written comments by February 8, 2001 Forms Needed to Register and ListForm FDA 2656 - Registration of Drug Establishment/Labeler Code Assignment This form is used by manufacturers, repackers, and relabelers to register establishments and by private label distributors to obtain a labeler code. This form is also used to provide updates in registration information annually or at the discretion of the registrant, when any changes occur. Form FDA 2657 – Drug Product Listing This form is used by registrants to report within 5 days of beginning the manufacturing, repackaging, or relabeling of drug or biological products a listing for every product in commercial distribution, and private label distributors who elect to submit listing information to FDA for products they distribute. This form is also used to provide updates to product listing information every June and December or at the discretion of the registrant, when any change occurs. Form FDA 2658 – Registered Establishment’s Report of Private Label Distributors This form is used by manufacturers to report product listing information for those private label distributors who do not elect to list the products they distribute, and to update product listing information for private label distributors, every June and December or, at the discretion of the registrant, when any change occurs. Guidance DocumentsForms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution [HTML] or [PDF] (5/14/2001)Foreign Establishment Registration According to the Federal Register Notice, November 27, 2001 (Vol. 6, No. 228), http://www.fda.gov/ohrms/dockets/98fr/112701a.htm, effective May 24, 2002, all foreign drug establishments are required to register with the Food and Drug Administration (FDA). As published, foreign firms are required to register and identify a United States agent. Firms may have previously submitted a registration form (Form FDA 2656) to the FDA in order to obtain a labeler code (these previously assigned labeler codes will be retained by firms) however, FDA's Center for Drug Evaluation and Research (CDER) is requiring the resubmission of this form with updated information. You may obtain forms from http://forms.psc.gov/forms/FDA/fda.html. A copy of the guidance documents for annual registration is also available at http://www.fda.gov/cder/drls/registration_listing.htm. To comply with the requirement to designate a United States agent, a letter must be submitted to the address below along with a Form FDA 2656. The United States Agent must be physically located in the United States and is the point of contact between the FDA and the firm concerning site registration and drug product listings. This letter must be on company letterhead, and signed by an authorized official from the firm. It must contain the name of the agent (firm and individual), address and telephone number. This is also a good opportunity for firms to update product listings with any changes and to submit any new product listings on Form FDA 2657 to the FDA. Submit the forms (Form FDA 2656, Registration of Drug Establishment and Form FDA 2657, Drug Product Listing), and the United States Agent letter to the Food and Drug Administration, CDER/OIT/DDMS/IMT, HFD-095, 5600 Fishers Lane, Rockville, MD 20857. PublicationsNational Drug Code (NDC) Directory. The National Drug Code (NDC) System was originally established as an essential part of an out-of-hospital drug reimbursement program under Medicare. The NDC serves as a universal product identifier for human drugs. The current edition of the National Drug Code Directory is limited to prescription drugs and a few selected OTC products. Drug Registration and Listing System Instruction Booklet The Drug Registration and Listing Instructions provide guidance on how to complete drug registration and listing forms efficiently and correctly. Please review before completing the forms. The instructions provide detailed explanation of the procedures for submitting information to the FDA, a copy of the Code of Federal Regulations (CFR) pertaining to the Drug Listing Act of 1972, a glossary of terms, a list of FDA District Offices, and several tables listing abbreviations to be used in completing the forms.
FDA/Center for Drug Evaluation and Research |
