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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter C - Drugs: General |
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? |