Pharmacy Compounding

Pharmacy compounding is a practice in which a licensed pharmacist combines, mixes, or alters ingredients in response to a prescription to create a medication tailored to the medical needs of an individual patient. Pharmacy compounding, if done properly, can serve an important public health need if a patient cannot be treated with an FDA-approved medication.

On this page: News and Updates Information for Consumers Information for Health Care Providers Regulatory and Policy Information FDA Actions Related Topics: Medical Devices and Animal Drugs

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News and Updates

For recent compliance actions, safety alerts, and related news releases, see Pharmacy Compounding: FDA Actions.

• Summary: 2013 FDA Pharmacy Inspection Assignment (04/11/2013)
• FDA Voice Blogs:
  • Proactive Inspections Further Highlight Need for New Authorities for Pharmacy Compounding (04/11/2013)
  • FDA Must Have New Authorities to Regulate Pharmacy Compounding (03/22/2013)
• Recent Congressional Testimony:
  • Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak (11/15/2012)
  • The Fungal Meningitis Outbreak: Could It Have Been Prevented? (11/14/2012)
• Public Meeting: Framework for Pharmacy Compounding: State and Federal Roles (12/19/2012)
• Related outbreak: Multistate outbreak of meningitis and other infections (2012) 

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Information for Consumers
 

• Pharmacy Compounding and the FDA: Questions and Answers
• The Special Risks of Pharmacy Compounding
  Find out what “compounding” is and how to minimize the risks associated with these drugs.
• Video: FDA and Pharmacy Compounding
  Learn about the benefits and risks of compounding, as well as the role FDA plays with pharmacy compounding. 
  
  
   
  
   

IMPORTANT: If you have a serious reaction to a compounded medication, the FDA encourages you to report the problem to your health care provider. You may also report the problem directly to the FDA. For more information, see: Reporting a Serious Problem – Reporting by Consumers.

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Information for Health Care Providers
 

• Alerts: To keep up with the latest information on compounded medications, subscribe to MedWatch Safety Alerts. Alerts are available by email, RSS feed, and Twitter.
• Recalls: To search for recalls of medications, go to Recalls, Market Withdrawals, and Safety Alerts.
• Adverse Effects: To report adverse events associated with compounded medications, see Reporting a Serious Problem – Reporting by Health Care Professionals. 

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Regulatory and Policy Information
 

• FDA Compliance Policy Guide: Pharmacy Compounding (CPG Sec. 460.200, reissued 05/29/2002)

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FDA Actions
 

For more information, see Pharmacy Compounding: FDA Actions. 

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Related Topics: Medical Devices and Animal Drugs

FDA also issues guidance on devices used in pharmacies that compound animal drugs.

• Medical Devices: Pharmacy Compounding Systems - Final Guidance for Industry and FDA
• Animal Drugs:
  • FDA Compliance Policy Guide: Compounding of Drugs for Use in Animals (CPG Sec. 608.400)
  • FDA Statement on Compounding of Pergolide Products for Animal Use (03/16/2012)