FDA Proposes Drug Manufacturing Registration Rule

The FDA proposal would simplify registration for hub-and-spoke manufacturing networks and clarify requirements for certain foreign drug suppliers.

The FDA has proposed updated registration rules for drug manufacturers to better reflect how medicines are made today. Some ingredients pass through several foreign sites before reaching the US, while newer hub-and-spoke manufacturing networks may have to register the same operation more than once.

The proposal would update drug establishment registration and listing requirements for both types of manufacturers.

Drug establishment registration tells the FDA which manufacturing sites are operating. Drug listing provides information about the products those sites make for commercial distribution.

The proposal would update these requirements for decentralized manufacturing and help the FDA better identify where drugs and their ingredients are produced.

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How the Distributed Manufacturing Pathway Would Work

The rule would create a registration pathway for a distributed manufacturing establishment, a model in which production takes place across several locations under one management structure.

These networks use a hub-and-spoke model. A central hub oversees one pharmaceutical quality system, while similar manufacturing units at separate locations make the same drug or drugs.

Current regulations generally require the hub and each manufacturing unit to register separately because they operate at different addresses. Under the proposal, a qualifying network could register as one drug manufacturing establishment.

Manufacturers could add or remove units through faster registration updates. Mobile units could also relocate, with advance notice required before certain moves.

The pathway would apply to units operated by one legal entity under a single quality system. Independent contract manufacturers under separate management would continue to register individually.

Foreign Facilities and Drug Supply Oversight

The proposal would also align FDA regulations with changes made under the PREVENT Pandemics Act for foreign facilities involved in the US drug supply.

Some foreign manufacturers make active pharmaceutical ingredients (APIs), the substances responsible for a drug’s intended effects, and send them to other foreign sites for further processing.

The proposal would clarify that covered facilities must register and list the drugs or ingredients they make, even when further processing takes place at another foreign location before the product enters the US.

The added information could help the FDA identify manufacturing sites, track the sources of drug ingredients and prioritize facilities for surveillance inspections. It could also support efforts to detect noncompliant products and respond to supply problems that may contribute to drug shortages.

The FDA is accepting public comments on the proposed rule until September 11, 2026.

The proposal is part of a wider FDA push to support US drug manufacturing. In June 2026, the agency selected seven companies for its PreCheck pilot, which gives manufacturers earlier FDA feedback while new facilities are being designed and prepared for operation. The participants are Amneal Pharmaceuticals, Cellares, Eli Lilly, FUJIFILM Biotechnologies, Kriya Therapeutics, Kyowa Kirin and Regeneron Pharmaceuticals.

FAQs

What is hub-and-spoke drug manufacturing?

It is a model in which one central hub oversees several manufacturing units at different locations. The units operate under the same management and quality system.

Is the FDA rule already in effect?

No. It is a proposed rule. The FDA is accepting public comments before deciding whether to issue a final version.

Would all contract manufacturers register as one establishment?

No. The streamlined pathway would apply to qualifying units controlled by one legal entity under a single quality system. Independent contract manufacturers would continue to register separately.

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