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On July 6, 1945 the Federal Food, Drug and Cosmetic Act was amended to provide for the certification of batches of drugs composed wholly or partly, of any kind of penicillin. The Federal Security Administrator, in accordance with the provisions of this amendment, has promulgated regulations providing such standards of identity, strength, quality and purity as will insure the safety and efficacy for use of a number of penicillin products. Before distribution in interstate commerce, each manufacturer must submit samples of each batch of any penicillin product to the Food and Drug Administration for examination and must obtain a certificate showing that the batch complies with the applicable regulations.
Inclusion of the penicillin products listed in the regulations providing for certification was based on a review of the available scientific evidence and on information developed in consultations with experts in the field of chemotherapy and the medical and
KEEFER CS, HERWICK RP, VAN WINKLE W, PUTNAM LE. NEW DOSAGE FORMS OF PENICILLIN: STATEMENT CONCERNING CERTIFIABLE PENICILLIN PRODUCTS, INCLUDING RECOMMENDED INDICATIONS, DOSAGES AND PRECAUTIONS. JAMA. 1945;128(16):1161–1164. doi:10.1001/jama.1945.92860330003009
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