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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 F - BIOLOGICS
 
PART 607ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED DEVICES
 

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.

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.

Subpart C - Procedures for Foreign Blood Product Establishments
   § 607.40 - Establishment registration and blood product listing requirements for foreign blood product establishments.

Subpart D - Exemptions
   § 607.65 - Exemptions for blood product establishments.

Subpart E - Establishment Registration and Product Listing Of Licensed Devices
   § 607.80 - Applicability of part 607 to licensed devices.

Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271.
Source: 40 FR 52788, Nov. 12, 1975, unless otherwise noted.

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