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Related post: requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess. The Judiciary Committee issued a second report to explain its proposed changes in S. 1552 (S. Rep. No. 1744, Pt. 2, 87th Cong., 2d Sess. (Aug. 21, 1962)). On pages 3 and 4, it discussed the revision of section 5 as follows: The President, in the recommendations submitted for the consideration of the committee with his letter of August 3, 1962, proposed a revised version which included the following principal amendments to the reported bill: (1) It proposed to replace the provisions on regulations with prima facie evidentiary effect with a provision that the adequacy of the quality controls be determined "in accordance with regulations promulgated by the Secretary on the basis of good manufacturing practice" after formal rulemaking procedures, i.e., after affording an opportunity for hearing, and for judicial review on the basis of the hearing record, with respect to such regulations. * * * * * The explanation accompanying the recommendations of the President expressed concern lest the language as to interpretative regulations with prima facie evidentiary effect invite endless de novo litigation on the question of what constitutes a good manufacturing practice each time there is enforcement action under the new quality control provisions. The committee acceded to the President's request for elimination of the "prima facie" regulatory authority in the bill. It felt, however, on balance, that there was no need for inserting provisions for regulations through formal rulemaking on the subject of what is good manufacturing practice. Section 701(a) (21 U.S.C. 371(a)) now vests in the Secretary "authority to promulgate regulations for the efficient enforcement of this Act." This permits the Department to issue such regulations as it desires and their scope and effect will be the same as that of other regulations issued under such general authority. Numerous regulations have been issued under section 701(a) and have been the subject of consideration and application in the courts in actions arising under the various provisions of the act not now subject to formal rulemaking procedures. During the floor debate on S. 1552 on August 23, Senator Eastland, Chairman of the Judiciary Committee, elaborated on the meaning of section 501(a)(2) as it would be amended by the bill: Section 5, as it would read under the August 20 amendments, is designed to assure that drugs are manufactured according to good manufacturing practice. It would deem a drug to be adulterated and thus subject to seizure if made under facilities, methods, or controls that are inadequate to assure that the drug meets the specifications of a quality product. Adulteration could also be found if such facilities, methods, or controls were not operated or administered in conformity with good manufacturing practice. Since the competitive position of responsible manufacturers depends in large part on the confidence of the medical profession and the public, it will be in their own interest to maintain high standards of current good manufacturing practice which will provide a Purchase Trihexyphenidyl Online readily determinable Order Trihexyphenidyl Online basis for enforcement proceedings against any substandard operator. The Secretary could use his general rulemaking authority under section 701(a) of the act to announce what he, in the administration of the act, considers to be good manufacturing practice insofar as methods, facilities, controls, and their operation and administration are concerned. As in the case of other regulations, the court in the final analysis will pass upon Order Trihexyphenidyl the scope and effect of such regulations. (108 Cong. Rec. 16303-4 (Aug. 23, 1962).) Senator Kefauver concurred in this change, stating, "This provision has been strengthened considerably in comparison to the bill which was reported in July." (Id., at 16306-7). The Commissioner thus concludes that when it unanimously approved S. 1552 on August 23, 1962, the Senate obviously believed that the problem identified by the President--"endless de novo litigation * * * each time there is enforcement action"--had been resolved. The Senate must, therefore, have intended that regulations issued under section 501(a)(2)(B) of the act be more than merely prima facie evidence of what constitutes current good manufacturing practice, i.e., that they be given at least the same force as any other regulation issued under section 701(a) of the act. He also finds that the statement relied upon Buy Trihexyphenidyl Online by most comments as proof that only interpretive regulations could be issued appeared in the Purchase Trihexyphenidyl first Senate Report and was explicitly reversed in the second Senate Report. One month later, the House Interstate and Foreign Commerce Committee reported out H.R. 11581, the House bill that preceded the Drug Amendments of 1962. (H.R. Rep. No. 2464, 87th Cong., 2d Sess. (1962)). Section 101(a) of this bill proposed to amend section 501(a)(2) of the act to read as follows: (2)(A) if it has been prepared, packed, or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls used for its manufacture, processing, packing, or holding do not conform to or are Buy Trihexyphenidyl not operated or administered in conformity with current good manufacturing practice (as determined in accordance with regulations promulgated by the Secretary) to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess. In addition, paragraph (b) of section 101 would have amended section 701(e) of the act to provide that regulations under section 501(a) would be issued by formal rulemaking procedures (rather than the informal procedures under section 701(a) of the act). The Committee Report accompanying H.R. 11581 explained this provision as follows (H. Rep. 2464, 87th Cong., 2d Sess. 2 (Sept. 22, 1962)): Section 101 of the reported bill would amend section 501(a)(1) [sic] of the Federal Food, Drug, and Cosmetic Act to deem a drug to be adulterated if the methods, facilities, or controls used in its manufacture, processing, packaging, or holding fail to conform to, or are not operated or administered in conformity with, good manufacturing practices as determined in accordance with regulations to be issued by the Secretary of Health, Education, and Welfare which are designed to assure that the drug is safe and has the identity and strength and meets the quality and purity characteristics which it purports or is represented to possess * * * The promulgation of these regulations would be subject to opportunity for hearing and judicial review. Thus, legal action could be brought against firms failing to abide by these standards and against the products they ship. The House of Representatives debated H.R. 11581 on September 27, 1962. Congressman Schenck offered several amendments that day, one of which would delete the parenthetical element in section 101(a), and all of section 101(b), from the bill. He explained this amendment as follows: My amendment to section 101 of the bill, which was approved by the committee, provides simply that the drug will deem[sic: be deemed] to be adulterated and subject to seizure if the methods, facilities, or controls used in the manufacture of the drug do not conform with current good manufacturing practice, as determined in accordance with regulations promulgated by the
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