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21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
34 FR 18004, Nov. 7, 1969, unless otherwise noted.
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Subscribe to: 9 CFR 113.9
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Nomenclature changes to part 113 appear at 79 FR 55969, Sept. 18, 2014.
A potency test written into the filed Outline of Production for a product shall be considered confidential information by Animal and Plant Health Inspection Service until at least two additional product licenses are issued for the product or unless use of the test is authorized by the licensee, in which case, such potency test may be published as part of the Standard Requirement for the product.
(a) Until a potency test is published as part of the Standard Requirement for the product, reference to such a test shall be made in the filed Outline of Production and the test shall be conducted.
(b) When a potency test has been published as part of the Standard Requirement, such test shall be conducted unless the product is specifically exempted as provided in § 113.4.
[40 FR 14084, Mar. 28, 1975, as amended at 56 FR 66784, Dec. 26, 1991]