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Electronic Code of Federal Regulations

e-CFR data is current as of December 5, 2019

Title 21Chapter ISubchapter FPart 607


TITLE 21—Food and Drugs

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

SUBCHAPTER F—BIOLOGICS

PART 607—ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED DEVICES

rule

Subpart A—GENERAL PROVISIONS

§607.1
Scope.
§607.3
Definitions.
§607.7
Establishment registration and product listing of blood banks and other firms manufacturing human blood and blood products.
rule

Subpart B—PROCEDURES FOR DOMESTIC BLOOD PRODUCT ESTABLISHMENTS

§607.20
Who must register and submit a blood product list.
§607.21
Times for establishment registration and blood product listing.
§607.22
How to register establishments and list blood products.
§607.25
Information required for establishment registration and blood product listing.
§607.26
Amendments to establishment registration.
§607.30
Updating blood product listing information.
§607.31
Additional blood product listing information.
§607.35
Blood product establishment registration number.
§607.37
Public disclosure of establishment registration and blood product listing information.
§607.39
Misbranding by reference to establishment registration, validation of registration, or to registration number.
rule

Subpart C—PROCEDURES FOR FOREIGN BLOOD PRODUCT ESTABLISHMENTS

§607.40
Establishment registration and blood product listing requirements for foreign blood product establishments.
rule

Subpart D—EXEMPTIONS

§607.65
Exemptions for blood product establishments.
rule

Subpart E—ESTABLISHMENT REGISTRATION AND PRODUCT LISTING OF LICENSED DEVICES

§607.80
Applicability of part 607 to licensed devices.

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