21 CFR
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
Subpart A - General
- § 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?
Subpart B - Registration
- § 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?
Subpart C - National Drug Code
- § 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?
Subpart D - Listing
- § 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?
Subpart E - Electronic Format for Registration and Listing
- § 207.61 How is registration and listing information provided to FDA?
- § 207.65 How can a waiver of the electronic submission requirement be obtained?