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.
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.
If you have an adverse reaction to a medication, including to any compounded medications, FDA encourages you to report the problem to your health care professional and directly to FDA. If you are unsure if your medication is compounded, ask your health care professional.
FDA also encourages health care professionals to report serious adverse events associated with a drug from an outsourcing pharmacies that provide drugs in bulk to the to outsourcing pharmacy that produced it.
For more information and to report a problem, see Reporting a Serious Problem – Reporting by Consumers or Reporting a Serious Problem – Reporting by Health Care Professionals.
- Compounding and FDA: Questions and Answers
- Search for drugs made in bulk by outsourcing pharmacies that provide drugs to hospitals, healthcare systems, clinics, and private practices
- Human Drug Compounding: Inspections, Recalls, and other Actions
- To search for recalls of medications, go to Recalls, Market Withdrawals, and Safety Alerts.
- What does FDA do with the reported adverse event or product quality issue reports? Learn about the Compounding Incidents Program.