Sec. 512. Extending expiration dates for certain drugs
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Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary ) shall issue draft guidance, or revise existing guidance, to address recommendations for sponsors of applications submitted under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) regarding— the submission of stability testing data in such applications, including considerations for data requirements that could be streamlined or reduced to facilitate faster review of longer proposed expiration dates; establishing in the labeling of drugs the longest feasible expiration date scientifically supported by such data, taking into consideration how extended expiration dates may— help prevent or mitigate drug shortages; and affect product quality; and the use of innovative approaches for drug and combination product stability modeling to support initial product expiration dates and expiration date extensions.
Not later than 2 years after the date of enactment of this Act, and again 2 years thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes— the number of drugs for which the Secretary has requested the manufacturer make a labeling change regarding the expiration date; and for each drug for which the Secretary has requested a labeling change with respect to the expiration date, information regarding the circumstances of such request, including— the name and dose of such drug; the rationale for the request; whether the drug, at the time of the request, was listed on the drug shortage list under section 506E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356e ), or was at risk of shortage; whether the request was made during a public health emergency declared under section 319 of the Public Health Service Act ( 42 U.S.C. 247d ); and whether the manufacturer made the requested change by the requested date, and for instances where the manufacturer does not make the requested change, the manufacturer’s justification for not making the change, if the manufacturer agrees to provide such justification for inclusion in the report.
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