# Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments

**Action Urgency Score:** 45/100

| Field | Value |
|---|---|
| Agency | Health and Human Services Department; Food and Drug Administration |
| Type | Proposed rule |
| Action | Proposed rule. |
| Published | 2026-07-13 |
| Comments close | 2026-09-11 |
| Significant | Yes (EO 12866) |
| CFR parts | 21 CFR 207 |
| Summary | The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the drug establishment registration and drug listing requirements with respect to establishments engaged in distributed manufacturing and foreign drug establishments. This action, if finalized, will provide a pathway for a distributed manufacturing establishment that manufactures drugs at multiple different physical locations to register as a single drug manufacturing establishment and align drug establishment registration and drug listing regulations applicable to foreign drug establishments with statutory changes |
| Document number | 2026-14073 |

## Why this score
- Significant rule under EO 12866.

Source: Federal Register API (Office of the Federal Register) (https://www.federalregister.gov/documents/2026/07/13/2026-14073/drug-establishment-registration-and-drug-listing-requirements-for-establishments-engaged-in). Last refreshed: 2026-11-04T21:40:49.974Z.
Data from the Federal Register API; the published Federal Register document is authoritative. Informational only, not legal advice.