The way drugs are manufactured has undergone significant change over the past several years. Many biopharmaceutical companies now rely on distributed manufacturing models, where multiple facilities work together under a centralized quality management system to produce the same drug or drug components.

However, FDA registration requirements haven’t always kept pace with these evolving manufacturing approaches. Under current regulations, each manufacturing unit within a distributed network must register separately with the FDA, creating additional administrative requirements for companies operating complex production networks.

To address this challenge, the FDA recently proposed a rule that would simplify registration requirements for certain drug manufacturers while improving the agency’s understanding of global pharmaceutical supply chains. If finalized, the rule could reduce administrative burdens for some manufacturers while giving regulators better insight into where and how drugs are produced.

What the FDA’s proposed rule would change

The proposed rule focuses on manufacturers that operate using a “hub-and-spoke” model, also known as a distributed manufacturing establishment. In this type of arrangement, a central facility oversees quality management while multiple manufacturing units located in different areas produce the same drug or drug components. Although these facilities operate as part of a single manufacturing network, each unit currently must register independently with the FDA.

Under the proposed changes, qualifying manufacturers could register their distributed manufacturing establishment as a single facility. Companies would still be required to notify the FDA when adding, relocating, or removing manufacturing units, but the update process would be more streamlined than the current registration approach.

This change could make it easier for manufacturers to manage complex production networks and adapt their operations as needs evolve, including newer approaches such as modular and continuous manufacturing.

Expanding FDA visibility into global manufacturing networks

The proposed rule also addresses a separate challenge: limited visibility into certain parts of the global drug supply chain.

Currently, some foreign establishments that manufacture active pharmaceutical ingredients (APIs) or other drug components may not be required to register with the FDA if those materials are distributed only to other foreign facilities before entering the U.S. market. These products may eventually become part of medicines used by U.S. patients, but the FDA often has limited information about where they originated.

The proposed rule would clarify registration and drug-listing requirements for certain foreign facilities, giving the FDA a more complete view of upstream manufacturing activities. This additional oversight could help the agency better trace drug components, identify potential risks, and respond more quickly to potential safety concerns.

For manufacturers, these changes could affect how companies evaluate and manage global supplier relationships. Organizations that rely on foreign API or drug component suppliers may need to determine whether those partners could face new registration or reporting obligations if the rule is finalized.

What manufacturers should consider

Although the FDA’s proposed rule is designed to simplify registration requirements in some areas, manufacturers should still evaluate how the changes could affect their operations.

That’s especially true for companies that use distributed manufacturing models. These entities can benefit from reviewing their current registration processes and confirming whether a single-establishment registration pathway could apply to their networks. They should also consider how potential changes to adding, relocating, or removing manufacturing units could affect their regulatory workflows.

Organizations that rely on global suppliers should also review existing supplier documentation and oversight practices. If additional foreign facilities are required to register with the FDA, companies may need to account for those changes during supplier qualification, audits, and ongoing compliance activities.

The proposed rule also highlights the importance of maintaining a clear understanding of where and how drug products are manufactured. As supply chains become more complex, companies that proactively assess potential regulatory changes will be better positioned to adapt if new requirements take effect.

Share your feedback on the FDA’s proposed changes

The proposed rule isn’t final, and the FDA is accepting public comments through the end of the day on September 11, 2026, allowing manufacturers and other industry stakeholders to share their perspectives.

If your company manages one or more complex manufacturing networks, this comment period provides a chance to highlight potential challenges and areas where additional clarification may be needed. To share your thoughts and submit a public comment, click here.