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Code · STATUTE-COMPILATIONS · Food and Drug Administration Safety and Innovation Act · Sec. 1122

Sec. 1122. COMBATING PRESCRIPTION DRUG ABUSE

317 words·~1 min read·/statute-compilations/comps-9932/sec-1122

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## SEC. 1122 COMBATING PRESCRIPTION DRUG ABUSE ###
(a)In General To combat the significant rise in prescription drug abuse and the consequences of such abuse, the Secretary of Health and Human Services (referred to in this section as the “Secretary”), in coordination with other Federal agencies, as appropriate, shall review current Federal initiatives and identify gaps and opportunities with respect to— ####
(1)ensuring the safe use of prescription drugs with the potential for abuse; and ####
(2)the treatment of prescription drug dependence. ###
(b)Report Not later than 1 year after the date of enactment of this Act, the Secretary shall post on the Department of Health and Human Service’s Internet Web site a report on the findings of the review under subsection (a). Such report shall include findings and recommendations on— ####
(1)how best to leverage and build upon existing Federal and federally funded data sources, such as prescription drug monitoring program data and the sentinel initiative of the Food and Drug Administration under section 505(k)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(k)(3)), as it relates to collection of information relevant to adverse events, patient safety, and patient outcomes, to create a centralized data clearinghouse and early warning tool; ####
(2)how best to develop and disseminate widely best practices models and suggested standard requirements to States for achieving greater interoperability and effectiveness of prescription drug monitoring programs, especially with respect to provider participation, producing standardized data on adverse events, patient safety, and patient outcomes; and ####
(3)how best to develop provider, pharmacist, and patient education tools and a strategy to widely disseminate such tools and assess the efficacy of such tools. ###
(c)Guidance on Abuse-Deterrent Products **[**[21 U.S.C. 355 note](/us/usc/t21/s355)**]** Not later than 6 months after the date of enactment of this Act, the Secretary shall issue guidance on the development of abuse-deterrent drug products.
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Sec. 1122
COMBATING PRESCRIPTION DRUG ABUSE
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