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:
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:
- Recent Congressional Testimony:
- Public Meeting: Framework for Pharmacy Compounding: State and Federal Roles (12/19/2012)
- Related outbreak: Multistate outbreak of meningitis and other infections (2012)
- 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.|
- 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.
- FDA Compliance Policy Guide: Pharmacy Compounding (CPG Sec. 460.200, reissued 05/29/2002)
For more information, see Pharmacy Compounding: FDA Actions.
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: