Compounding and the FDA: Questions and Answers

Why do some patients need compounded drugs?

A drug may be compounded for a patient who cannot be treated with an FDA-approved medication, such as a patient who has an allergy to a certain dye and needs a medication to be made without it, or an elderly patient or a child who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form. Practitioners in hospitals, clinics, and other health care facilities sometimes provide compounded drugs to patients when an FDA-approved drug is not medically appropriate to treat them. In these situations, compounding can serve an important patient need. 
 
Compounders also may prepare compounded versions of a drug on FDA’s drug shortages list if the compounded drug meets certain conditions detailed in federal law. 

Are compounded drugs approved by FDA?

Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed. Consumers and health care professionals rely on FDA’s drug approval process for verification of safety, effectiveness and quality.

Are compounded drugs and generic drugs the same?

No. A generic drug is approved by FDA under 505(j) of the FD&C Act and meets all of the requirements of that section (including establishing therapeutic equivalence to a brand name drug, among others), while a compounded drug is not approved by FDA.

What are the risks associated with compounded drugs?

Compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug. Unnecessary use of compounded drugs may expose patients to potentially serious health risks. For example, poor compounding practices can result in serious drug quality problems, such as contamination or a drug that contains too much or too little active ingredient. This can lead to serious patient injury and death.

Who can compound drugs?

Compounding commonly occurs in pharmacies, although it may also occur in other settings. 

Federal law addresses compounding by a licensed pharmacist in a state-licensed pharmacy, or federal facility, or by a physician, as well as compounding by or under the direct supervision of a licensed pharmacist in an outsourcing facility.

Outsourcing facilities are a category of compounders established in 2013 by the Drug Quality and Security Act. Outsourcing facilities are inspected by FDA according to a risk-based schedule and are subject to increased quality standards.

Who inspects facilities that compound drugs?

Generally, state boards of pharmacy have primary responsibility for the day-to-day oversight of state-licensed pharmacies that are not registered with FDA as outsourcing facilities. FDA does conduct surveillance and for-cause inspections of state-licensed pharmacies that are not registered as outsourcing facilities.   

Facilities that register with FDA as outsourcing facilities under section 503B are primarily overseen by FDA and inspected by FDA according to a risk-based schedule. 

What quality standards apply to compounded drugs?

Quality standards for compounded drugs differ depending on the setting where compounding occurs. Drugs compounded in outsourcing facilities are subject to current good manufacturing practice (CGMP) requirements. By contrast, drugs compounded by a licensed pharmacist in a state-licensed pharmacy or federal facility, or by a physician, in accordance with the conditions of section 503A of the FD&C Act, are not. 

Regardless of where compounding occurs, in a pharmacy, outsourcing facility or physician’s office, other federal law applies, including provisions regarding insanitary conditions. Compounding drugs under insanitary conditions can put patients at risk and lead to widespread patient harm. 

Is it safe to buy compounded drugs online?  

With respect to any online pharmacy or telehealth service, including those that market compounded drugs, FDA encourages consumers to research the online pharmacy before using its services. The agency provides tips for buying medicine online, including warning signs that an online pharmacy may be an unsafe website. 

Purchasing any medicine online from unregulated, unlicensed sources can expose patients to potentially poor-quality products. FDA recommends consumers check out BeSafeRx for more information.   

Consumers who purchase compounded drugs online, such as through online pharmacies and telehealth platforms, may not know the identity of the compounder that produced the drug, including whether the drug was produced by a compounder whose drugs meet appropriate quality standards and that is appropriately licensed and regulated (e.g., by state regulatory authorities).

FDA encourages consumers to:

• remain vigilant
• understand the risks of buying prescription medicine from online pharmacies or telehealth platforms 
• talk to a healthcare provider about questions related to prescription drugs 

Does FDA have authority over telehealth companies promoting compounded drugs?

Under federal law, prescription drug promotion disseminated by or on behalf of drug manufacturers, including compounders, must be truthful, non-misleading and accurate. 

If FDA has concerns that promotional materials are false or misleading, FDA may seek voluntary compliance from the manufacturer, packer or distributor responsible for the promotional material. 

FDA takes this responsibility seriously and continues to monitor promotional materials regarding prescription drugs, including compounded drugs.    

FDA also recommends consumers and patients talk to their health care professional about their specific circumstances before taking any medication. 

Can biologics be compounded?

No. Biological products are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act. Federal law does not provide a legal pathway for marketing biologics that have been prepared outside the scope of an approved biologics license application. 
 
FDA published guidance explaining the conditions under which FDA does not intend to take action when certain biological products are mixed, diluted, or repackaged in a manner not described in their approved labeling.