C.F.R. » Title 9 » CHAPTER I—ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE › SUBCHAPTER E—VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS › PART 113—STANDARD REQUIREMENTS

9 C.F.R. § 113.50

Ingredients of biological products

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All ingredients used in a licensed biological product shall meet accepted standards of purity and quality; shall be sufficiently nontoxic so that the amount present in the recommended dose of the product shall not be toxic to the recipient; and in the combinations used shall not denature the specific substances in the product below the minimum acceptable potency within the dating period when stored at the recommended temperature.

[38 FR 29889, Oct. 30, 1973]
Notes of Decisions
Cited in 2 cases, 1998–1998 · leading case: prod.liab.rep. (Cch) P 15,330 Richard Symens Joyce Symens v. Smithkline Beecham Corp., Ivan Sjovall v. Smithkline Beecham Corp., 152 F.3d 1050 (8th Cir. 1998).
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prod.liab.rep. (Cch) P 15,330 Richard Symens Joyce Symens v. Smithkline Beecham Corp., Ivan Sjovall v. Smithkline Beecham Corp., 152 F.3d 1050 (8th Cir. 1998). “See 9 C.F.R. §§ 113.50 -.55. APHIS-mandated testing procedures ensure the “purity, safety, potency, and efficacy” of the vaccine.”
Richard Symens v. Smithkline Beecham (8th Cir. 1998). “See 9 C.F.R. §§ 113.50 -.55. APHIS-mandated testing procedures ensure the “purity, safety, potency, and efficacy” of the vaccine.”
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