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?
§ 207.7 - Establishment registration and product listing for human blood and blood products and for medical devices.
§ 207.9 - Who does this part cover?
§ 207.13 - Who is exempt from the registration and listing requirements?
Subpart B - Registration
§ 207.10 - Exemptions for establishments.
§ 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
§ 207.20 - Who must register and submit a drug list.
§ 207.22 - How and where to register and list drugs.
§ 207.26 - Amendments to registration.
§ 207.30 - Updating drug listing information.
§ 207.31 - Additional drug listing 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?
§ 207.39 - Misbranding by reference to registration or to registration number.
Subpart D - Listing
§ 207.40 - Establishment registration and drug listing requirements for foreign establishments.
§ 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?
Subpart F - Miscellaneous
§ 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?