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  5. Compounding when Drugs are on FDA’s Drug Shortages List
  1. Human Drug Compounding

Compounding when Drugs are on FDA’s Drug Shortages List

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Compounding drugs when the drug is in shortage

FDA understands that when a drug is in shortage, patients and health care professionals may look to compounded drugs as an option to get the medication they need.

Generally, when an FDA approved drug is on FDA’s drug shortages list some federal law restrictions may be lifted, such as restrictions on compounding drugs that are essentially copies of approved drugs. However, other requirements remain, and compounded drugs may not be able to meet these federal law restrictions.

What prescribers should know

  • FDA recommends patients be prescribed an FDA-approved drug when available and appropriate for the patient.
  • When a drug is on FDA’s drug shortages list, compounders may be able to make a compounded version of that drug if they meet certain federal law requirements. However, it is not always 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 these manufacturing processes needed to make certain drugs or may have business reasons not to do so.

What patients should know

  • A compounded drug might be appropriate if your medical needs cannot be met by an FDA-approved drug or the FDA-approved drug you need is not commercially available. 
  • However, compounded drugs pose a higher risk than FDA-approved drugs because compounded drugs do not undergo FDA review for safety, effectiveness or quality before they are marketed.
  • Visit questions and answers for more information.

Compounders operating under section 503A of the FD&C Act

  • Section 503A of the FD&C Act restricts compounded drugs that are essentially copies of commercially available drugs, but certain amounts are permissible under the law as long as the compounding is not done “regularly or in inordinate amounts.”
  • A drug is not considered to be commercially available if it is on FDA’s drug shortages list and limitations on compounding are lifted in these circumstances.
  • All other conditions of section 503A must be met, including compounding based on a valid prescription for an individual patient.

Outsourcing facilities operating under section 503B of the FD&C Act

  • Outsourcing facilities are restricted from making essentially a copy of an FDA-approved drug.
  • This limitation is lifted for identical or nearly identical copies of an FDA-approved drug that is on the FDA’s drug shortages list.
  • When a drug is on FDA’s drug shortages list, an outsourcing facility can use a bulk drug substance, also known as an active pharmaceutical ingredient, to make that drug.
  • The agency recognizes there may be circumstances where an outsourcing facility may not be able to predict when a drug shortage will be resolved, and the facility may have orders for a compounded drug in-house that were in progress when the drug was removed from FDA’s drug shortage list.
    • FDA policy provides flexibility when an outsourcing facility fills orders that it received for a compounded drug while the drug was in shortage.
    • However, the agency may take action if an outsourcing facility continues to fill new orders after the approved drug is removed from FDA’s drug shortage list, or if it continues to fill existing orders more than 60 days after the drug has been removed from FDA’s drug shortages list.
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