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商业 · 2023/1/251 分钟阅读
Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
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摘要
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act." This guidance describes FDA's regulatory and enforcement priorities regarding compounding certain ibuprofen oral suspension products in outsourcing facilities for administration in hospitals and health systems.
来源原始语言: Federal Register — Food and Drug Administration打开原始公告 →