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FDA Regulation of Compounded Drugs

Welcome to CDER's web page on pharmacy compounding. CDER has created web this page so readers can follow the Agency's activities on pharmacy compounding.

Pharmacy Compounding News

Guidance for Industry

  • Guidance for FDA Staff and Industry, Compliance Policy Guides Manual, Sec 460.200, Pharmacy Compounding. [HTML] or [PDF ] (6/7/2002)
    • Federal Register Notice Announcing the Availability of the Pharmacy Compounding Compliance Policy Guide [HTML] or [PDF ] (6/7/2002)


Significant Compliance Actions

Public Presentations

FDA Modernization Act Additional Information

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PDF requires the free Adobe Acrobat Reader

Date created: December 15, 2005, updated August 15, 2008

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