Page:United States Statutes at Large Volume 121.djvu/973

 121 STAT. 952

21 USC 334. 21 USC 381.

PUBLIC LAW 110–85—SEPT. 27, 2007

and for which the existence of such investigations has been made public, unless— ‘‘(1) such drug or such biological product was marketed in food before any approval of the drug under section 505, before licensure of the biological product under such section 351, and before any substantial clinical investigations involving the drug or the biological product have been instituted; ‘‘(2) the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, approving the use of such drug or such biological product in the food; ‘‘(3) the use of the drug or the biological product in the food is to enhance the safety of the food to which the drug or the biological product is added or applied and not to have independent biological or therapeutic effects on humans, and the use is in conformity with— ‘‘(A) a regulation issued under section 409 prescribing conditions of safe use in food; ‘‘(B) a regulation listing or affirming conditions under which the use of the drug or the biological product in food is generally recognized as safe; ‘‘(C) the conditions of use identified in a notification to the Secretary of a claim of exemption from the premarket approval requirements for food additives based on the notifier’s determination that the use of the drug or the biological product in food is generally recognized as safe, provided that the Secretary has not questioned the general recognition of safety determination in a letter to the notifier; ‘‘(D) a food contact substance notification that is effective under section 409(h); or ‘‘(E) such drug or biological product had been marketed for smoking cessation prior to the date of the enactment of the Food and Drug Administration Amendments Act of 2007; or ‘‘(4) the drug is a new animal drug whose use is not unsafe under section 512.’’. (b) CONFORMING CHANGES.—The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended— (1) in section 304(a)(1), by striking ‘‘section 404 or 505’’ and inserting ‘‘section 301(ll), 404, or 505’’; and (2) in section 801(a), by striking ‘‘is adulterated, misbranded, or in violation of section 505,’’ and inserting ‘‘is adulterated, misbranded, or in violation of section 505, or prohibited from introduction or delivery for introduction into interstate commerce under section 301(ll),’’. SEC. 913. ASSURING PHARMACEUTICAL SAFETY.

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.), as amended in section 403, is amended by inserting after section 505C the following:

VerDate Aug 31 2005

‘‘SEC. 505D. PHARMACEUTICAL SECURITY.

Standards.

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21 USC 355e.

‘‘(a) IN GENERAL.—The Secretary shall develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs. ‘‘(b) STANDARDS DEVELOPMENT.—

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