21 C.F.R. § 610.15

Constituent materials

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(a) Ingredients, preservatives, diluents, adjuvants. All ingredients used in a licensed product, and any diluent provided as an aid in the administration of the product, shall meet generally accepted standards of purity and quality. Any preservative used shall be sufficiently nontoxic so that the amount present in the recommended dose of the product will not be toxic to the recipient, and in the combination used it shall not denature the specific substances in the product to result in a decrease below the minimum acceptable potency within the dating period when stored at the recommended temperature. Products in multiple-dose containers shall contain a preservative, except that a preservative need not be added to Yellow Fever Vaccine; Poliovirus Vaccine Live Oral; viral vaccines labeled for use with the jet injector; dried vaccines when the accompanying diluent contains a preservative; or to an Allergenic Product in 50 percent or more volume in volume (v/v) glycerin. An adjuvant shall not be introduced into a product unless there is satisfactory evidence that it does not affect adversely the safety or potency of the product. The amount of aluminum in the recommended individual dose of a biological product shall not exceed:

(1) 0.85 milligrams if determined by assay;

(2) 1.14 milligrams if determined by calculation on the basis of the amount of aluminum compound added; or

(3) 1.25 milligrams determined by assay provided that data demonstrating that the amount of aluminum used is safe and necessary to produce the intended effect are submitted to and approved by the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing addresses in § 600.2(a) or (b) of this chapter).

(b) Extraneous protein; cell culture produced vaccines. Extraneous protein known to be capable of producing allergenic effects in human subjects shall not be added to a final virus medium of cell culture produced vaccines intended for injection. If serum is used at any stage, its calculated concentration in the final medium shall not exceed 1:1,000,000.

(c) Antibiotics. A minimum concentration of antibiotics, other than penicillin, may be added to the production substrate of viral vaccines.

(d) The Director of the Center for Biologics Evaluation and Research or the Director of the Center for Drug Evaluation and Research may approve an exception or alternative to any requirement in this section. Requests for such exceptions or alternatives must be in writing.

[38 FR 32056, Nov. 20, 1973, as amended at 46 FR 51903, Oct. 23, 1981; 48 FR 13025, Mar. 29, 1983; 48 FR 37023, Aug. 16, 1983; 49 FR 23834, June 8, 1984; 50 FR 4134, Jan. 29, 1985; 51 FR 15607, Apr. 25, 1986; 55 FR 11013, Mar. 26, 1990; 70 FR 14985, Mar. 24, 2005; 76 FR 20518, Apr. 13, 2011; 80 FR 18093, Apr. 3, 2015]

Notes of Decisions

Cited in 10 cases, 2002–2012 · leading case: Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289 (E.D. Pa. 2007).

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Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289 (E.D. Pa. 2007). · cites it 5× “21 C.F.R. § 610.15 (emphasis added). Thimerosal has been used as a preservative in a number of biological products since the 1930s to prevent the growth of microbial contaminants.”

Reilly Ex Rel. Reilly v. Wyeth, 876 N.E.2d 740 (Ill. App. Ct. 2007). · cites it 3× “§300aa—33(5) (2000)) because its purpose is to prevent the corruption of the vaccine.”

Coalition for Mercury-free Drugs v. Sebelius, 671 F.3d 1275 (D.C. Cir. 2012). · cites it 2× “See 21 C.F.R. § 610.15 (a). Preservatives are important because injection with a contaminated vaccine can be fatal.”

Owens Ex Rel. Schafer v. Am. Home Prod., 203 F. Supp. 2d 748 (S.D. Tex. 2002). · cites it 2× “See 21 C.F.R. § 610.15 (a) (“Products in multiple-dose containers shall contain a preservative”).”

Wax v. Aventis Pasteur, Inc., 240 F. Supp. 2d 191 (E.D.N.Y 2002). · cites it 2× “21 C.F.R. § 610.15 provides: Constituent Materials: (a) Any preservative used shall be sufficiently nontoxic so that the amount present in the recommended dose of the product will not be toxic to the recipient, and in the combination used it shall not denature the specific…”

Horne v. Novartis Pharm. Corp., 541 F. Supp. 2d 768 (W.D.N.C. 2008). “See 21 C.F.R. § 610.15 ; 21 U.S.C. § 352 . And if Bayer added the plaintiffs’ additional warnings about the alleged risks of injury resulting from thimerosal, the label content would not have been substantiated by “reasonable evidence of an association of a serious hazard with a…”

Blackmon v. Am. Home Prods. Corp., 267 F. Supp. 2d 667 (S.D. Tex. 2003). · cites it 2× “See 21 C.F.R. § 610.15 (a) (“Products in multiple-dose containers shall contain a preservative”).”

Liu v. Aventis Pasteur, Inc., 219 F. Supp. 2d 762 (W.D. Tex. 2002). “21 C.F.R. § 610.15 . 6 . The Vaccine Act does not toll the statute of limitations for the parents’ claims while they are representing their child in the Court of Federal Claims.”

Wright v. Aventis Pasteur, Inc., 14 A.3d 850 (Pa. Super. Ct. 2011). · cites it 2× “; 21 C.F.R. § 610.15 ). The FDA's licensing process requires demonstration that a product is "safe, pure, and potent.”

Reilly v. Wyeth (Ill. App. Ct. 2007). · cites it 3× “§300aa-33(5) (2000)) because its purpose is to prevent the corruption of the vaccine. At the time the vaccine was made, it was “intentionally added” as an 8 1-06-1174 approved ingredient in the formulation of a vaccine to preserve it.”

Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.