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Code · BILL · 113th Congress · H.R. 3204 (Introduced in House) — To amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain securi... · Sec. 107

Sec. 107. GAO study

152 words·~1 min read·/bill/113/hr/3204/ih/section-107·

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Not later than 36 months after the date of the enactment of this Act, the Comptroller General of the United States shall submit to Congress a report on pharmacy compounding and the adequacy of State and Federal efforts to assure the safety of compounded drugs. The report required under this section shall include— a review of pharmacy compounding in each State, and the settings in which such compounding occurs; a review of the State laws and policies governing pharmacy compounding, including enforcement of State laws and policies; an assessment of the available tools to permit purchasers of compounded drugs to determine the safety and quality of such drugs; an evaluation of the effectiveness of the communication among States and between States and the Food and Drug Administration regarding compounding; and an evaluation of the Food and Drug Administration's implementation of sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.
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