FDA Drug Establishment Registration for Foreign Manufacturers: New 2026 Proposed Rule Explained

On July 13, 2026, the FDA published a proposed rule in the Federal Register that would significantly expand drug establishment registration requirements for foreign manufacturers. The rule targets two groups that have historically operated in a gray area: foreign establishments that manufacture active pharmaceutical ingredients (APIs) for drugs sold in the US but only ship those ingredients to other foreign facilities for further processing, and establishments engaged in distributed manufacturing. If finalized, the rule would close a registration gap that the FDA estimates affects roughly 1,625 foreign establishments worldwide — 25 that manufacture APIs for branded drugs and approximately 1,600 that produce components for over-the-counter monograph drugs.

What changed and why

Before this proposed rule, the FDA's registration regulations exempted foreign drug manufacturers from registering if the drug they produced underwent additional manufacturing at another foreign establishment before entering the United States. This meant that a Chinese API manufacturer shipping ingredients to an Indian formulator, who then exported the finished drug to the US, was not required to register with the FDA — even though the API ultimately ended up in the US drug supply chain. Section 2511 of the PREVENT Pandemics Act amended section 510(i) of the Federal Food, Drug, and Cosmetic Act to close this loophole. The statute now requires registration of foreign establishments engaged in the manufacturing or processing of a drug that is imported into the US, regardless of whether the drug undergoes further manufacturing at a different location outside the US.

Who must register under the proposed rule

The proposed rule would require registration from any foreign establishment that manufactures, repacks, relabels, or salvages a drug or API that is part of the supply chain for a drug imported or offered for import into the United States. This includes contract manufacturers, API producers, intermediate manufacturers, and testing laboratories that perform release testing on drugs destined for the US market. The FDA specifically identified two categories of currently unregistered facilities: branded drug API manufacturers (estimated at 25 establishments) and OTC monograph drug component manufacturers (estimated at 1,600 establishments). If your facility produces any ingredient, component, or intermediate that ends up in a drug sold in the United States — even if you never ship directly to a US buyer — the proposed rule would require you to register.

Consequences of non-registration

The proposed rule makes the consequences of non-registration explicit. If an upstream foreign establishment fails to register or list as required, any drug imported or offered for import that was manufactured at that establishment would be considered misbranded under the FD&C Act. Misbranded drugs are subject to refusal of admission at the port, seizure, injunction, and criminal penalties. For downstream buyers and importers, this means that purchasing APIs or components from unregistered foreign facilities creates direct regulatory risk for their own products — even if the importer's own facility is fully registered and compliant.

Comment period and timeline

The comment period for this proposed rule closes on September 11, 2026. After reviewing comments, the FDA will issue a final rule. The timeline for finalization is not specified, but given the legislative mandate under the PREVENT Pandemics Act, the FDA is expected to move relatively quickly. Foreign manufacturers who have not previously registered with the FDA should begin preparing now — the registration process requires a DUNS number, a US Agent designation, and accurate establishment and product listing data, all of which take time to assemble.

How FDABridge helps with drug establishment registration

FDABridge handles FDA drug establishment registration for foreign manufacturers, including DUNS number acquisition, US Agent appointment, drug listing, and NDC labeler code applications. If you are a foreign API manufacturer, contract manufacturer, or OTC drug producer affected by the proposed rule, our team can assess your registration obligations and manage the filing process. Visit fdabridge.com/drug to see our drug registration services or fdabridge.com/contact to speak with our team.