Introduction

The Drug Listing Act of 1972, amending the Federal Food, Drug, and Cosmetic Act, became effective February 1, 1973. (See Annex B ) Its purpose is to provide the Commissioner of the Food and Drug Administration (FDA) a current list of all drugs manufactured, prepared, propagated, compounded, or processed by a drug establishment registered under the Federal Food, Drug, and Cosmetic Act. Until 1973, the FDA had no means of obtaining this information except by periodic inspection of registered establishments. This act requires submission of information on commercially marketed drugs and is a substantial help in the enforcement of the Federal Food, Drug, and Cosmetic Act.

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.

If you have questions please call us 301-210-2840 or e-mail us at drls@fda.hhs.gov.

The forms to be used are:

 

 

Where to mail  completed forms:

Food and Drug Administration
CDER/Drug Registration and Listing (HFD-337)
5600 Fishers Lane
Rockville, MD 20857

If using Federal Express, DHL or any special carrier to return the forms, please use the following address (packages accepted between 7:30 and 4:30 EST):

Food and Drug Administration
CDER/Drug Registration and Listing (HFD-337)
5901 B Ammendale Road,

Beltsville, MD 20705-1266

NOTE: Acceptance of the above forms by FDA is not to be construed as federal government endorsement or approval of the establishment or its products. Further, in cases where this booklet and 21 CFR 207 are in conflict, the current version of 21 CFR 207 applies.