Title 21

PART 607

Part 607 - Establishment Registration And Product Listing For Manufacturers Of Human Blood And Blood Products And Licensed Devices

PART 607 - ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND 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.

• 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.

21:7.0.1.1.4.1	SUBPART A	Subpart A - General Provisions
21:7.0.1.1.4.1.1.1	SECTION 607.1	607.1 Scope.
21:7.0.1.1.4.1.1.2	SECTION 607.3	607.3 Definitions.
21:7.0.1.1.4.1.1.3	SECTION 607.7	607.7 Establishment registration and product listing of blood banks and other firms manufacturing human blood and blood products.
21:7.0.1.1.4.2	SUBPART B	Subpart B - Procedures for Domestic Blood Product Establishments
21:7.0.1.1.4.2.1.1	SECTION 607.20	607.20 Who must register and submit a blood product list.
21:7.0.1.1.4.2.1.2	SECTION 607.21	607.21 Times for establishment registration and blood product listing.
21:7.0.1.1.4.2.1.3	SECTION 607.22	607.22 How to register establishments and list blood products.
21:7.0.1.1.4.2.1.4	SECTION 607.25	607.25 Information required for establishment registration and blood product listing.
21:7.0.1.1.4.2.1.5	SECTION 607.26	607.26 Amendments to establishment registration.
21:7.0.1.1.4.2.1.6	SECTION 607.30	607.30 Updating blood product listing information.
21:7.0.1.1.4.2.1.7	SECTION 607.31	607.31 Additional blood product listing information.
21:7.0.1.1.4.2.1.8	SECTION 607.35	607.35 Blood product establishment registration number.
21:7.0.1.1.4.2.1.9	SECTION 607.37	607.37 Public disclosure of establishment registration and blood product listing information.
21:7.0.1.1.4.2.1.10	SECTION 607.39	607.39 Misbranding by reference to establishment registration, validation of registration, or to registration number.
21:7.0.1.1.4.3	SUBPART C	Subpart C - Procedures for Foreign Blood Product Establishments
21:7.0.1.1.4.3.1.1	SECTION 607.40	607.40 Establishment registration and blood product listing requirements for foreign blood product establishments.
21:7.0.1.1.4.4	SUBPART D	Subpart D - Exemptions
21:7.0.1.1.4.4.1.1	SECTION 607.65	607.65 Exemptions for blood product establishments.
21:7.0.1.1.4.5	SUBPART E	Subpart E - Establishment Registration and Product Listing Of Licensed Devices
21:7.0.1.1.4.5.1.1	SECTION 607.80	607.80 Applicability of part 607 to licensed devices.

---