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.

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