Title 21, 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
Section 207.1
What definitions and interpretations of terms apply to this part?
Section 207.3
Bulk drug substance.
Section 207.5
What is the purpose of this part?
Section 207.9
Who does this part cover?
Section 207.13
Who is exempt from the registration and listing requirements?
Section 207.17
Who must register?
Section 207.21
When must initial registration information be provided?
Section 207.25
What information is required for registration?
Section 207.29
What are the requirements for reviewing and updating registration information?
Section 207.33
What is the National Drug Code (NDC), how is it assigned, and what are its requirements?
Section 207.35
What changes require a new NDC?
Section 207.37
What restrictions pertain to the use of the NDC?
Section 207.41
Who must list drugs and what drugs must they list?
Section 207.45
When, after initial registration of an establishment, must drug listing information be submitted?
Section 207.49
What listing information must a registrant submit for a drug it manufactures?
Section 207.53
What listing information must a registrant submit for a drug that it repacks or relabels?
Section 207.54
What listing information must a registrant submit for a drug that it salvages?
Section 207.55
What additional drug listing information may FDA require?
Section 207.57
What information must registrants submit when updating listing information and when?
Section 207.61
How is registration and listing information provided to FDA?
Section 207.65
How can a waiver of the electronic submission requirement be obtained?
Section 207.69
What are the requirements for an official contact and a United States agent?
Section 207.77
What legal status is conferred by registration and listing?
Section 207.81
What registration and listing information will FDA make available for public disclosure?