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Electronic Code of Federal Regulations

e-CFR data is current as of January 23, 2020

Title 21Chapter ISubchapter CPart 207


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

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

rule

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?
rule

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?
rule

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?
rule

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?
rule

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?
rule

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?

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