FDA Compounders: Know Your Bulks and Excipients Suppliers
FDA guidance reminding compounders to know their bulk drug substance suppliers, the testing they perform, and how to identify the original API manufacturer. This is a regulatory information page, not a product catalog.
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Choose it if you need regulatory guidance on API supplier qualification.
Explains supplier diligence for APIs and excipients
Recommends knowing supplier testing practices
Requires clear identification of the original API manufacturer
💡 Pro Tip: For API compliance, document supplier testing methods and retain manufacturer traceability records.
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FDA
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Maryland
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