Drugs
Pharmacy Compounding and the FDA: Questions and Answers
On this page:
- What is “compounding”?
- Is combining two or more drugs considered compounding?
- Why do some patients need compounded drugs?
- Are compounded drugs approved by the FDA?
- Who regulates and inspects pharmacies that compound drugs?
- What are the risks associated with compounded drugs?
- Does FDA want to prevent traditional pharmacy compounding?
- Questions and Answers Related to Specific Medications
What is “compounding”?
Pharmacy compounding is a practice in which a licensed pharmacist combines, mixes, or alters ingredients of a drug in response to a prescription to create a medication tailored to the medical needs of an individual patient.
Is combining two or more drugs considered compounding?
Yes, if it is done by a pharmacist in response to a licensed practitioner’s prescription and produces a medication tailored to an individual patient’s special medical needs.
Why do some patients need compounded drugs?
Pharmacy compounding can serve an important public health need if a patient cannot be treated with an FDA-approved medication. Some examples of the need for compounding include:
- If a patient has an allergy and needs a medication to be made without a certain dye.
- If an elderly patient or a child can’t swallow a pill and needs a medicine in a liquid form that is not otherwise available.
Are compounded drugs approved by the FDA?
Compounded drugs are not FDA-approved. This means that FDA does not verify the quality, safety and effectiveness of compounded drugs. This also means that compounded drugs lack an FDA finding of manufacturing quality. Consumers and health professionals rely on the drug approval process to ensure that drugs are safe and effective.
Who regulates and inspects compounding pharmacies?
Each compounding pharmacy is licensed by its state’s board of pharmacy, which has primary responsibility for day-to-day oversight. The FDA's regulatory authority over certain compounding pharmacies is more limited than its authority over other drug manufacturers. For example, compounded drugs are not FDA approved. In addition, compounding pharmacies are not generally required to register with FDA and therefore do not tell FDA what drugs they are making.
What are the risks associated with compounded drugs?
Compounded drugs can pose both direct and indirect health risks.
- Direct health risks include unsafe compounded products. Compounded drugs made using poor quality compounding practices may be sub- or super‑potent, contaminated, or otherwise adulterated.
- Indirect health risks include the possibility that patients will use ineffective compounded drugs instead of FDA-approved drugs that have been shown to be safe and effective.
Does FDA want to prevent traditional pharmacy compounding?
No. FDA believes that pharmacists engaging in traditional pharmacy compounding provide a valuable medical service that is important to patient health.
Questions and Answers Related to Specific Medications
- Makena: Questions and Answers on Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena) (2012)
- Colchicine: Questions and Answers About FDA's Enforcement Action Against Unapproved Injectable Colchicine Products (2009)
- Hormone therapy: Compounded Menopausal Hormone Therapy Questions and Answers (2008)
- Topical Anesthetic Creams: FDA Warns Five Firms To Stop Compounding Topical Anesthetic Creams (2006)
- Inhalation Drugs: FDA Warns Three Pharmacies To Stop Mass-Producing Unapproved Inhalation Drugs (2006)
- Domeperidone: FDA Warns Against Women Using Unapproved Drug, Domperidone, to Increase Milk Production (2004)
