Compounded drugs can serve an important medical need for patients who cannot be treated with an FDA-approved medication, such as a patient who has an allergy and needs a drug to be made without a certain dye, or an elderly patient or a child who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form.
However, consumers should be aware that compounded drugs are not FDA-approved. This means that FDA does not review these drugs before they are marketed to evaluate their safety or effectiveness. In addition, and of particular concern, poor compounding practices can result in serious drug quality problems, such as contamination or medications that do not possess the strength, quality, and purity they are supposed to have. This can lead to serious patient injury and death.
In some cases compounders engage in activities that can put patients at risk and/or undermine the drug approval process. For example, FDA has observed that some compounders have made false and misleading statements that compounded drugs are safe and effective, sometimes for the treatment of serious diseases, incorrectly suggesting the drugs had met the standard for FDA approval.
Additional Information for Consumers and Health Care Professionals
- Compounding Risk Alerts
- Compounding and FDA: Questions and Answers
- The Special Risks of Pharmacy Compounding
- Outsourcing Facility Product Report (updated 4/20/2018)
- FDA Talk Paper: FDA Warns Against Women Using Unapproved Drug, Domperidone, to Increase Milk Production
- Is It Really 'FDA Approved?‘
- Human Drug Compounding: Inspections, Recalls, and other Actions
- Inspections, Recalls, and Other Actions with Respect to Firms that Engage in Animal Drug Compounding
- Transcript: Director's Corner – Drug Compounding
- Alerts: 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 Events:
- Consumers: If you have a serious reaction to a compounded medication, FDA encourages you to report the problem to your health care professional, as well as directly to FDA. For more information, see Reporting a Serious Problem – Reporting by Consumers.
- Health Care Providers: To report adverse events associated with compounded medications, see Reporting a Serious Problem – Reporting by Health Care Professionals.