360bbb) have improved access for individual patients to investigational drugs who do not qualify for clinical trials of such investigational drugs, and what barriers to such access remain; On February 4, 2020, the Secretary determined pursuant to his authority under section 564 of the FD&C Act … Federal Food, Drug, and Cosmetic Act (FD&C Act). Failure to comply with any regulation in subpart D of this part will render an infant formula adulterated under section 412(a)(1) of the Federal Food, Drug, and Cosmetic Act. Section 906(e)(1)(B) of the Federal Food, Drug, and Cosmetic Act relating to the establishment of good manufacturing practice requirements for tobacco products. Section 5 of Orphan Drug Act Cross-reference of FD&C Act and U.S. Code section numbers The FDA's online reference edition of the Federal Food, Drug and Cosmetic Act is based on the publication Compilation of Selected Acts Within the Jurisdiction of the Committee on Energy and Commerce; Food, Drug, and Related Law, As Amended These Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by Secretary of Health and Human Services (HHS) that The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act are the Federal laws governing food products under FDA's jurisdiction. Sec. "(C) consideration of whether the guidance or regulations issued to implement section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 107(c) of such Public Law con-cerned the applicability of the amendments, and is included in the appendix to this compilation. This proposed rule is being issued under FDA's authority to require premarket review of new tobacco products under section 910 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 201 FEDERAL FOOD, DRUG, AND COSMETIC ACT 6 1 The amendments made to this Act by the Drug Amendments of 1962 included amendments establishing the requirement that new drugs be effective. Notwithstanding any provision of this chapter and section 351 of the Public Health Service Act [42 U.S.C. 3 Sec. The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act. (c) Subpart D of this part contains the nutrient requirements for infant formula under section 412(i) of the Federal Food, Drug, and Cosmetic Act. "(b) The provisions of such Act of June 30, 1906, as amended, [sections 1 to 5, 7 to 15, and 372a of this title] to the extent that they impose, or authorize the imposition of, any requirement imposed by section 403(k) of the Federal Food, Drug, and Cosmetic Act [section 343(k) of this title], shall remain in force until January 1, 1940. 387j), FDA's authority to require records and reports under section 909(a) of the FD&C Act (21 U.S.C. Except as provided in § 207.13(l), the following classes of persons are exempt from registration and drug listing in accordance with section 510(g) of the Federal Food, Drug, and Cosmetic Act or because FDA has determined, under section 510(g)(5) of the Federal Food, Drug, and Cosmetic Act, that their registration is not necessary for the protection of the public health. (Name of person giving the guaranty or undertaking) hereby guarantees that no article listed herein is adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, or is an article which may not, under the provisions of section 404, 505, or 512 of the act, be introduced into interstate commerce. 201 FEDERAL FOOD, DRUG, AND COSMETIC ACT 3 The amendments made to this Act by the Drug Amendments of 1962 included amendments establishing the requirement that new drugs be effective. Section 107(c) of such Public Law con-cerned the applicability of the amendments, and is included in the appendix to this compilation.
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