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U.S. Code of Federal Regula...
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Title 21-Food and Drugs
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CHAPTER I—FOOD AND DRUG ADM...
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PART 207—REQUIREMENTS FOR FOREIGN AND DOMESTIC ...
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
§ 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?
§ 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?
§ 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?
§ 207.41 - 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?
§ 207.61 - How is registration and listing information provided to FDA?
§ 207.65 - How can a waiver of the electronic submission requirement be obtained?
§ 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?