What is a compounded drug?
Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounded drugs are not FDA-approved. In some cases, they can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product. For example, a patient may be unable to swallow a pill or may have an allergy to an inactive ingredient in an FDA-approved drug.
However, compounded drugs pose a higher risk to patients than FDA-approved drugs because they do not undergo FDA premarket review for safety, effectiveness, or quality. Unnecessary use of compounded drugs exposes patients to potentially serious health risks. The FDA’s compounding program aims to protect patients from poor quality compounded drugs, while preserving access to lawfully marketed compounded drugs for patients who have a medical need for them.
Can compounded drugs help during drug shortages?
The short answer is sometimes. Depending on the circ*mstances, compounded drugs can be made and distributed with fewer restrictions when the drug appears on FDA’s drug shortages list.
The longer answer is that compounded drugs must meet a variety of conditions to qualify for exemptions from certain federal requirements that typically apply to drugs. When a drug appears on FDA’s drug shortages list, some of these restrictions may be lifted – in particular, restrictions on compounding drugs that are essentially copies of approved drugs. However, other conditions remain, and compounded drugs may not be able to meet these.
It is also not always practical or possible for compounders to compound drugs on the FDA drug shortages list. For example, compounders may not have the expertise or equipment to carry out more complicated manufacturing processes needed to make certain drugs or may have business reasons they prefer not to.
In some cases, FDA has issued temporary policies for a specific drug in short supply or experiencing increased demand to increase the supply of compounded drugs. For example, in January 2023, with three viral epidemics affecting the United States, FDA issued temporary guidance on compounding ibuprofen oral suspension to bolster the supply of this drug used to treat children’s pain and fevers.
FDA also issued temporary guidance on compounding amoxicillin oral suspension in November 2022 in response to high demand for this drug used to treat bacterial respiratory infections in children.
Learn more about drug shortages on FDA’s drug shortages website. This site includes a link to FDA’s searchable drug shortages database which is updated daily.
What does federal law allow?
Sections 503A and 503B of the Food, Drug, and Cosmetic Act set conditions under which compounded human drug products are exempt from certain federal requirements, such as pre-market drug approval.
Section 503A addresses compounding by state-licensed pharmacies, among others, who make and distribute drugs based on individual patient prescriptions. Such pharmacies make up a majority of compounders in the U.S. and are primarily regulated by the states. If these compounded drugs meet the conditions of section 503A they are also exempt from current good manufacturing practice requirements – the quality standard generally applied to drug manufacturers.
One of the conditions of section 503A restricts compounded drugs that are essentially copies of commercially available drugs, but FDA does not consider a drug to be commercially available when it appears on FDA’s drug shortages list. If a drug is not in shortage, “copies” can be compounded under section 503A as long as the compounding is not done "regularly or in inordinate amounts." All other conditions of section 503A would have to be met, including compounding based on a valid prescription for an identified individual patient.
Section 503B addresses compounding by “outsourcing facilities” – a special group of compounders that may distribute supplies of drugs directly to doctor’s offices or hospitals without receiving individual patient prescriptions. Outsourcing facilities register with FDA, must comply with current good manufacturing practice requirements, and report products they produce to FDA, among other requirements.
Most of the time, drugs that outsourcing facilities compound are to meet the needs of patients that cannot use an approved drug, and there is some difference between the compounded drug and the approved drug that makes a clinical difference to an individual patient. However, during a drug shortage, outsourcing facilities may compound drugs that are identical or nearly identical to FDA-approved drugs on the FDA drug shortages list.
Information on the products reported by outsourcing facilities can be found on the FDA website at Outsourcing Facility Product Report.
What patients should know?
If your medical needs cannot be met by an FDA-approved drug, a compounded drug might be appropriate.However, compounded drugs pose a higher risk to patients than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, effectiveness, or quality. Compounded drugs should only be used to fulfill the needs of patients whose medical needs cannot be met by an FDA-approved drug.
