9 C.F.R. § 113.5

General testing

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(a) No biological product shall be released prior to the completion of tests prescribed in a filed Outline of Production or Standard Requirements for the product to establish the product to be pure, safe, potent, and efficacious.

(b) Tests of biological products shall be observed by a competent employee of the manufacturer during all critical periods. A critical period shall be the time when certain specified reactions must occur in required tests to properly evaluate the results.

(c) Records of all tests shall be kept in accordance with part 116 of this chapter. Results of all required tests prescribed in the filed Outline of Production or the Standard Requirements for the product shall be submitted to Animal and Plant Health Inspection Service. Blank forms shall be furnished upon request to Animal and Plant Health Inspection Service.

(d) When the initial or any subsequent test is declared a No Test, the reasons shall be reported in the test records, the results shall not be considered as final, and the test may be repeated. When a test is declared satisfactory, the test designation is considered to be a final conclusion. When a test is declared unsatisfactory, the test designation is considered to be a final conclusion. When the initial or any subsequent test is declared inconclusive, the reasons shall be reported in the test records, the result shall not be considered as final, and the test may be repeated as established in the filed Outline of Production or Standard Requirement. If a test is designated inconclusive or No Test and the biological product is not further tested, the test designation of unsatisfactory is the final conclusion.

(e) When new test methods are developed and approved by Animal and Plant Health Inspection Service, biological products tested thereafter shall be evaluated by such methods, and if not found to be satisfactory when so tested shall not be released.

(Approved by the Office of Management and Budget under control number 0579-0059) [34 FR 18004, Nov. 4, 1969, as amended at 39 FR 25463, July 11, 1974; 40 FR 45420, Oct. 2, 1975; 40 FR 46093, Oct. 6, 1975; 41 FR 6751, Feb. 13, 1976; 48 FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, 1991; 79 FR 55969, Sept. 18, 2014]

Notes of Decisions

Cited in 3 cases, 1998–2002 · 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). “” 9 C.F.R. § 113.5 . Any serial (lot) that does -, not pass the prescribed premarket tests may not be sold.”

Behrens v. United Vaccines, Inc., 189 F. Supp. 2d 945 (D. Minnesota 2002). · cites it 2× “The Plaintiffs urge that, because “[i]t is unlawful,” under 9 C.F.R. § 113.5 , “for a manufacturer to release an animal vaccine before completion of all testing required by the APHIS for that specific vaccine,” and because the Defendant obtained its license to market Biocom-DP…”

Richard Symens v. Smithkline Beecham (8th Cir. 1998). “” 9 C.F.R. § 113.5 . Any serial (lot) that does not pass the prescribed premarket tests may not be sold.”

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