What US 21 CFR Part 207: Drug Establishment Registration and Drug Listing requires
US 21 CFR Part 207 requires owners and operators of all drug establishments to register with the FDA and submit information about each drug they manufacture, repack, relabel, or salvage. The regulation covers initial registration, annual renewal, drug listing in the Structured Product Labeling (SPL) format submitted via the Electronic Submissions Gateway (ESG), and notification of changes. It applies to domestic establishments and to foreign establishments that import drugs into the US. Registration grants an FDA Establishment Identifier (FEI) used for inspections and enforcement. Compliance is foundational to lawful US drug commerce and is verified during FDA inspections.
Pillar: Pharmaceuticals & Life Sciences · Authority: US FDA · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-207
SHA-256 integrity: 58dd30aa5699a3eabc8a787680f84eb719bd04a57f1989c47a04ca5cfaa93977
Primary Citations — 5 traced to source
- Title 21 Code of Federal Regulations Drug Establishment Registration and Drug Listing
- FDCA Registration of Producers of Drugs
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