Drug Establishment Registration

Key facts

Legal basis

FD&C Act Section 510; 21 CFR Part 207

Annual renewal

Between October 1 and December 31 each year

Format

Electronic Structured Product Labeling (SPL) submissions

Facility identifier

DUNS number as the unique facility identifier

Public data

FDA Drug Establishments Current Registration Site

What is drug establishment registration?

Section 510 of the Federal Food, Drug, and Cosmetic Act requires owners and operators of drug establishments to register each facility with the Food and Drug Administration (FDA). Registration tells FDA who makes drugs for the U.S. market and where, which the agency uses to plan inspections and respond to quality problems.

Registration goes hand in hand with drug listing. Registrants must list each drug they place into commercial distribution, and each listing carries the National Drug Codes (NDCs) for the product. Listing data feeds the NDC Directory.

Foreign facilities have the same obligation and must also name a United States agent. Registration is not approval, and FDA treats any claim that registration means approval as misleading.

How registration and listing work

The main obligations are:

Medical device establishments register under a separate system in 21 CFR Part 807.

• Initial registration: shortly after a facility begins manufacturing or processing drugs, within the deadline set in 21 CFR Part 207.
• Annual renewal: every registration must be renewed between October 1 and December 31, or it can be deactivated.
• Listing updates: registrants update listing information in June and December each year to reflect changes.
• Electronic submission: registrations and listings are SPL files sent through the FDA Electronic Submissions Gateway or the CDER Direct portal.
• Amount reporting: since the CARES Act of 2020, registrants must also report annually the amount of each listed drug they manufacture; FDA does not publish these volumes.

Why registration data matters

Registration and listing records map the physical drug supply chain:

• Supply chain mapping: listing SPLs name the establishments and operations, such as manufacturing, packaging or analysis, behind a product.
• Competition and shortage risk: the number of registered sources for a molecule is a practical proxy for supplier concentration.
• Compliance checks: buyers can verify that a supplier, repackager or ingredient maker holds a current registration.
• Data joins: DUNS and FDA Establishment Identifier (FEI) numbers link registrations to inspections, Form 483s, warning letters and import alerts.

Limitations of registration data

Registration and listing information is submitted by firms, and FDA does not verify all of it before publication. A current registration also says nothing about compliance status or whether a facility is actually producing a listed product.