C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER F—BIOLOGICS › PART 607—ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED DEVICES › Subpart A—General Provisions

21 C.F.R. § 607.7

Establishment registration and product listing of blood banks and other firms manufacturing human blood and blood products

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All owners or operators of establishments that engage in the manufacturing of blood products are required to register, pursuant to section 510 of the Federal Food, Drug, and Cosmetic Act. Registration and listing of blood products must comply with this part. Registration does not permit any blood bank or similar establishment to ship blood products in interstate commerce.

[81 FR 60222, Aug. 31, 2016]
Notes of Decisions
Cited in 1 case, 1982–1982 · leading case: United States v. Pedro M. Diaz & Susana Diaz, 690 F.2d 1352 (11th Cir. 1982).
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United States v. Pedro M. Diaz & Susana Diaz, 690 F.2d 1352 (11th Cir. 1982). “21 C.F.R. § 607.7 (a) (1982). For this a license is required.”
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