Home/CFR/Title 21/Part 207
FEDERAL · 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

24 sections · Title 21: Food and Drugs

§ 207.1What definitions and interpretations of terms apply to this part?
§ 207.3Bulk drug substance.
§ 207.5What is the purpose of this part?
§ 207.9Who does this part cover?
§ 207.13Who is exempt from the registration and listing requirements?
§ 207.17Who must register?
§ 207.21When must initial registration information be provided?
§ 207.25What information is required for registration?
§ 207.29What are the requirements for reviewing and updating registration information?
§ 207.33What is the National Drug Code (NDC), how is it assigned, and what are its requirements?
§ 207.35What changes require a new NDC?
§ 207.37What restrictions pertain to the use of the NDC?
§ 207.41Who must list drugs and what drugs must they list?
§ 207.45When, after initial registration of an establishment, must drug listing information be submitted?
§ 207.49What listing information must a registrant submit for a drug it manufactures?
§ 207.53What listing information must a registrant submit for a drug that it repacks or relabels?
§ 207.54What listing information must a registrant submit for a drug that it salvages?
§ 207.55What additional drug listing information may FDA require?
§ 207.57What information must registrants submit when updating listing information and when?
§ 207.61How is registration and listing information provided to FDA?
§ 207.65How can a waiver of the electronic submission requirement be obtained?
§ 207.69What are the requirements for an official contact and a United States agent?
§ 207.77What legal status is conferred by registration and listing?
§ 207.81What registration and listing information will FDA make available for public disclosure?