Part 207 — Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code
Current through Sep 8, 2026
Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271.
Source: 81 FR 60212, Aug. 31, 2016, unless otherwise noted.
Sections
- § 207.1 What definitions and interpretations of terms apply to this part?
- § 207.3 Bulk drug substance.
- § 207.5 What is the purpose of this part?
- § 207.9 Who does this part cover?
- § 207.13 Who is exempt from the registration and listing requirements?
- § 207.17 Who must register?
- § 207.21 When must initial registration information be provided?
- § 207.25 What information is required for registration?
- § 207.29 What are the requirements for reviewing and updating registration information?
- § 207.33 What is the National Drug Code (NDC), how is it assigned, and what are its requirements?
- § 207.35 What changes require a new NDC?
- § 207.37 What restrictions pertain to the use of the NDC?
- § 207.41 Who must list drugs and what drugs must they list?
- § 207.45 When, after initial registration of an establishment, must drug listing information be submitted?
- § 207.49 What listing information must a registrant submit for a drug it manufactures?
- § 207.53 What listing information must a registrant submit for a drug that it repacks or relabels?
- § 207.54 What listing information must a registrant submit for a drug that it salvages?
- § 207.55 What additional drug listing information may FDA require?
- § 207.57 What information must registrants submit when updating listing information and when?
- § 207.61 How is registration and listing information provided to FDA?
- § 207.65 How can a waiver of the electronic submission requirement be obtained?
- § 207.69 What are the requirements for an official contact and a United States agent?
- § 207.77 What legal status is conferred by registration and listing?
- § 207.81 What registration and listing information will FDA make available for public disclosure?