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Electronic Code of Federal Regulations

e-CFR data is current as of March 26, 2020


21 CFR--PART 600

View Printed Federal Register page 85 FR 10063 in PDF format.

Amendment(s) published February 21, 2020, in 85 FR 10063

Effective Dates: Mar. 23, 2020

2. Amend §600.3 by revising paragraph (h) introductory text and adding paragraph (h)(6) to read as follows:

§600.3   Definitions.

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(h) Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.

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(6) A protein is any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. When two or more amino acid chains in an amino acid polymer are associated with each other in a manner that occurs in nature, the size of the amino acid polymer for purposes of this paragraph (h)(6) will be based on the total number of amino acids in those chains, and will not be limited to the number of amino acids in a contiguous sequence.

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