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FDA Guidance for Industry: Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act

Origin/Publisher:

FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM496287.pdf

Content:
This guidance describes how FDA intends to apply section 503A of the FD&C Act to drugs compounded by licensed pharmacists or physicians in state-licensed hospital or health system pharmacies for use within the hospital or health system.

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