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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG 230.120- Human Blood and Blood Products as Drugs

 

BACKGROUND:

The January 31, 1973 Federal Register1 announced the amendment and revision of 21 CFR, Part 273.2 The preamble to this announcement also directs attention to the classification of blood and blood products as drugs under the Federal Food, Drug, and Cosmetic Act as well as biologics under the Public Health Service Act.

Excerpts from the preamble of the January 31, 1973 Federal Register announcement responding to questions concerning the classification of blood as a drug follow:

". . . Section 201(g)(1) definition of drug in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), reveals that blood and related blood products fall clearly within that definition. That section states "The term 'drug' means (A) articles recognized in the official United States Pharmacopeia . . .; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals: . . ." Blood is covered by both parts of this definition. Human blood was first recognized in the United States Pharmacopeia (U.S.P.), XV Edition (Dec. 15, 1955), and has been included in each U.S.P. since that edition. Indications for use of blood products also fall directly within the broad therapeutic scope of the definition. While it is, of course, true that blood is human living tissue, it is incorrect to assume that it must be either a living human tissue or a drug. That human blood and blood products may be characterized as living human tissue for some purposes, and as biologics for purposes of regulation under the Public Health Service Act (Section 351, 58 Stat. 702, as amended; 42 U.S.C. 262) in no way alters the fact that blood is also a drug subject to regulation under applicable provisions of the Federal Food, Drug, and Cosmetic Act . . ."

POLICY:

Human blood and blood products are characterized as biologics for purposes of regulation under the Public Health Service Act, as amended and also as drugs subject to regulation under applicable provisions of the Federal Food, Drug, and Cosmetic Act.

1 Federal Register Volume 28, No. 20 Wednesday, January 31, 1973

2 Recodified as 21 CFR 600

Issued: 6/17/74
Revised: 10/1/80