Biological product definition

Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any 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.
Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood
Biological product means the same as defined in 42 U.S.C. § 262(i), as in effect on January 1, 2017.

Examples of Biological product in a sentence

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product or arsphenamine or derivative of arsphenamine (or any other trivalent arsenic compound) intended to prevent, treat, or cure a disease or condition of humans or animals.

  • Biological product consisting of two or more li- censed biological products.

  • For the purposes of this subpart, the following definitions apply: (a) Biological product.

  • Biological product means any biological product, as that term is definedin Public Health Service Act (“PHS Act”) section 351(i), that is licensed by the Food and Drug Administration pursuant to section 351 and is subject to the requirements of Federal Food, Drug, and Cosmetic Act (FDCA) section 503(b)(1).(b) Prescription drug.

  • Biological product deviation reports, and fatalities as a result of complications of blood collection or transfusion.


More Definitions of Biological product

Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or de- rivative, allergenic product, or analo- gous product, or arsphenamine or de- rivative of arsphenamine (or any other trivalent arsenic compound) applicable to the prevention, treatment, or cure of a disease or condition of human beings or animals. A biological product includes a material subject to regula- tion under 42 U.S.C. 262 or 21 U.S.C. 151–159. Unless otherwise excepted, a bi- ological product known or reasonably expected to contain a pathogen that meets the definition of a Category A or B infectious substance must be as- signed the identification number UN 2814, UN 2900, or UN 3373, as appro- priate.
Biological product means, with respect to the prevention, treatment or cure of a disease or condition of human beings, a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component, blood derivative, allergenic product, protein other than a chemically synthesized polypeptide, analogous products or arsphenamine or any other trivalent organic arsenic compound.¶
Biological product means the same as that term is defined in 9 section 1 of P.L.2015, c.130 (C.24:6K-1).
Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, 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 as defined in the Public Health Service Act, 42 U.S.C. § 262.
Biological product means the same as that term is defined in 42 U.S.C. Sec. 262.
Biological product means a biological product as defined by 42 U.S.C. 262(i)(1), as existing on January 1, 2019; and;
Biological product means any product containing: (a) a plasmid, a protein structure, a cDNA clone, a promoter, a gene or a chimeric gene, antibodies, or fragments thereof and their sequences derived from or containing the Biological Materials; (b) any protein structure produced or encoded by the Biological Materials; or (c) a compound (substantially similar or identical to a compound in (a) or (b) above), produced by chemical synthesis or by any other method which could not have been produced but for the use of the Biological Materials. Biological Products may either be Patent Products or Proprietary Products.