FDA Reaffirms Import Requirements for Human Drugs Under FD&C Act and 21 CFR

Foreign drug manufacturers supplying the U.S. market face the same compliance bar as domestic facilities, and FDA's border enforcement posture makes that parity operational, not theoretical. A refreshed agency guidance document consolidates the full spectrum of import requirements under the Federal Food, Drug and Cosmetic Act (FD&C Act) and 21 CFR, giving QA directors and regulatory leads a single reference for what FDA verifies at ports of entry.

Marketing authorisation sits at the top of the checklist. Imported finished drugs must be covered by an approved NDA, ANDA, or BLA, an OTC monograph under section 505G of the FD&C Act, or an active IND before they cross the border. For QA teams managing third-party or contract manufacturers abroad, that approval status must be confirmed before shipment, not at the dock.

Establishment registration carries its own hard deadline. Under section 510(i) of the FD&C Act and 21 CFR 207.17, any foreign facility that manufactures, repacks, relabels, or salvages drugs destined for the U.S. must register with FDA prior to import and renew that registration annually. Critically, those registrations must now enumerate all known importers per 21 CFR 207.25(h)(2), a detail that supply-chain and regulatory teams should audit against current importer lists before the next renewal cycle.

Drug listing obligations run parallel. Foreign manufacturers, repackers, relabelers, and salvagers must list all commercially distributed finished drugs with FDA under section 510(j) of the FD&C Act and 21 CFR 207.41, identified by drug listing number or NDC. Labeling compliance adds another layer: OTC products must carry a Drug Facts panel meeting 21 CFR 201.66; prescription products must state "Rx only" and satisfy 21 CFR 201.57. Labels that are false or misleading remain grounds for refusal of admission regardless of other compliance status.

CGMP conformance applies without geographic exception. All imported drugs, finished dosage forms and active pharmaceutical ingredients alike, must be manufactured in accordance with 21 CFR Parts 210–211. The guidance explicitly classifies APIs and other drug components as drugs under section 201(g)(1)(D) of the FD&C Act, meaning the full human drug regulatory framework applies at the component level, not only at the finished-product stage.

Regulatory teams managing foreign supplier qualification programs should treat the importer-listing requirement under 21 CFR 207.25(h)(2) as the near-term action item most likely to surface gaps ahead of the next annual registration window.

Source: FDA via What's New: Drugs RSS Feed, 15 June 2026.