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FDA proposed adding three drugs: ● aprotinin ● bromocriptine mesylate, and ● ondansetron hydrochloride to their list of drug products that may not be compounded under sections 503A and 503B of the Food, Drug, and Cosmetic Act, “because the drug products or components of such drug products have been found to be unsafe or not effective.” FDA’s Federal Register notice provides background on the use of the drugs and elaborates on the reasoning behind the proposal, citing: ● prominent adverse reactions ● associated risks from case studies, and ● meetings where data was reviewed. The amendment also includes an extensive bibliography of references used to support the ruling.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
