21 CFR Part 207
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
- 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
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter C—Drugs: General
- 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?
- 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?
Feedback