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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C - DRUGS: GENERAL
 
PART 207REQUIREMENTS 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?
   § 207.9 - 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?

Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271.
Source: 81 FR 60212, Aug. 31, 2016, unless otherwise noted.

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