Title 21

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 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.

• 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.

21:4.0.1.1.7.1	SUBPART A	Subpart A - General
21:4.0.1.1.7.1.1.1	SECTION 207.1	207.1 What definitions and interpretations of terms apply to this part
21:4.0.1.1.7.1.1.2	SECTION 207.3	207.3 Bulk drug substance.
21:4.0.1.1.7.1.1.3	SECTION 207.5	207.5 What is the purpose of this part
21:4.0.1.1.7.1.1.4	SECTION 207.9	207.9 Who does this part cover
21:4.0.1.1.7.1.1.5	SECTION 207.13	207.13 Who is exempt from the registration and listing requirements
21:4.0.1.1.7.2	SUBPART B	Subpart B - Registration
21:4.0.1.1.7.2.1.1	SECTION 207.17	207.17 Who must register
21:4.0.1.1.7.2.1.2	SECTION 207.21	207.21 When must initial registration information be provided
21:4.0.1.1.7.2.1.3	SECTION 207.25	207.25 What information is required for registration
21:4.0.1.1.7.2.1.4	SECTION 207.29	207.29 What are the requirements for reviewing and updating registration information
21:4.0.1.1.7.3	SUBPART C	Subpart C - National Drug Code
21:4.0.1.1.7.3.1.1	SECTION 207.33	207.33 What is the National Drug Code (NDC), how is it assigned, and what are its requirements
21:4.0.1.1.7.3.1.2	SECTION 207.35	207.35 What changes require a new NDC
21:4.0.1.1.7.3.1.3	SECTION 207.37	207.37 What restrictions pertain to the use of the NDC
21:4.0.1.1.7.4	SUBPART D	Subpart D - Listing
21:4.0.1.1.7.4.1.1	SECTION 207.41	207.41 Who must list drugs and what drugs must they list
21:4.0.1.1.7.4.1.2	SECTION 207.45	207.45 When, after initial registration of an establishment, must drug listing information be submitted
21:4.0.1.1.7.4.1.3	SECTION 207.49	207.49 What listing information must a registrant submit for a drug it manufactures
21:4.0.1.1.7.4.1.4	SECTION 207.53	207.53 What listing information must a registrant submit for a drug that it repacks or relabels
21:4.0.1.1.7.4.1.5	SECTION 207.54	207.54 What listing information must a registrant submit for a drug that it salvages
21:4.0.1.1.7.4.1.6	SECTION 207.55	207.55 What additional drug listing information may FDA require
21:4.0.1.1.7.4.1.7	SECTION 207.57	207.57 What information must registrants submit when updating listing information and when
21:4.0.1.1.7.5	SUBPART E	Subpart E - Electronic Format for Registration and Listing
21:4.0.1.1.7.5.1.1	SECTION 207.61	207.61 How is registration and listing information provided to FDA
21:4.0.1.1.7.5.1.2	SECTION 207.65	207.65 How can a waiver of the electronic submission requirement be obtained
21:4.0.1.1.7.6	SUBPART F	Subpart F - Miscellaneous
21:4.0.1.1.7.6.1.1	SECTION 207.69	207.69 What are the requirements for an official contact and a United States agent
21:4.0.1.1.7.6.1.2	SECTION 207.77	207.77 What legal status is conferred by registration and listing
21:4.0.1.1.7.6.1.3	SECTION 207.81	207.81 What registration and listing information will FDA make available for public disclosure

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