Drugs

Compounding and the FDA: Questions and Answers

On this page:

  1. What is “compounding”? 

In general, compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.
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  1. Is combining two or more drugs considered compounding?

Yes, compounding includes the combining of two or more drugs. 
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  1. Why do some patients need compounded drugs?

Sometimes, the health needs of a patient cannot be met by an FDA-approved medication. For example:
 

  • if a patient has an allergy and needs a medication to be made without a certain dye; or
  • 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.

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  1. Are compounded drugs approved by the FDA?

Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, or effectiveness of compounded drugs. Consumers and health professionals rely on the drug approval process to ensure that drugs are safe and effective and made in accordance with Federal quality standards. Compounded drugs also lack an FDA finding of manufacturing quality before such drugs are marketed. 

Generally, state boards of pharmacy will continue to have primary responsibility for the day-to-day oversight of state-licensed pharmacies that compound drugs in accordance with the conditions of section 503A of the FDCA, although FDA retains some authority over their operations. However, outsourcing facilities that register under section 503B are regulated by FDA and must comply with CGMP requirements and will be inspected by FDA according to a risk-based schedule. 


  1. What are the risks associated with compounded drugs?

There can be health risks associated with compounded drugs that do not meet federal quality standards.  Compounded drugs made using poor quality practices may be sub- or super‑potent, contaminated, or otherwise adulterated. Additional 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.  
 


  1. Who regulates and inspects facilities that compound drugs?

Generally, state boards of pharmacy will continue to have primary responsibility for the day-to-day oversight of state-licensed pharmacies that compound drugs in accordance with the conditions of section 503A of the FDCA, although FDA retains some authority over their operations. For example, the adulteration or misbranding of drugs compounded under section 503A, or false or misleading statements in the labeling or advertising of such drugs, may result in violations of Federal law. Firms that register with FDA as “outsourcing facilities” under section 503B will be regulated by FDA and inspected by FDA according to a risk-based schedule. 
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  1. What is FDA doing to implement the new law? 

Please see FDA implementation of the Compounding Quality Act.


  1. What is an outsourcing facility?

The Drug Quality and Security Act, signed into law on November 27, 2013, creates a new section 503B in the FDCA. Under section 503B, a compounder can become an “outsourcing facility.” The law defines an “outsourcing facility” as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B.

An outsourcing facility can qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not the exemption from current good manufacturing practice (CGMP) requirements. Outsourcing facilities:

  • must comply with CGMP requirements;
  • will be inspected by FDA according to a risk-based schedule; and
  • must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.

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  1. How does an outsourcing facility register with FDA?
FDA has issued draft guidance on registering and reporting for those entities that intend to register as outsourcing facilities.
 
They should register using FDA’s electronic drug registration system or by sending an email to FDA’s drug registration and listing staff with the required registration information. FDA will provide assistance to outsourcing facilities that need assistance with the electronic registration system. FDA is also providing an interim process that registered outsourcers may use to provide information about the products that they make under the reporting provisions of the new law.
 
In the future, FDA plans to makes necessary modifications to its electronic listing system to accommodate the information outsourcing facilities must provide. The interim provisions provide an Excel spreadsheet format that an outsourcing facility may use to provide the necessary information. 

  1. What happens to compounders who conduct outsourcing operations but do not register with FDA?

If a compounder does not register with FDA as an outsourcing facility, it will not qualify for the section 503B exemption from the FDA approval requirements and the requirement to label products with adequate directions for use. If that compounder also fails to satisfy the conditions for the section 503A exemption, it will be subject to all of the requirements of the FDCA that are applicable to drugs made by conventional manufacturers, including the new drug approval, adequate directions for use, and CGMP requirements.

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  1. How will FDA deal with compounders that do not register as outsourcers but fail to comply with the requirements of section 503A of the FDCA?

If a compounded drug does not qualify for the exemptions under either section 503A or 503B of the FDCA, it would be subject to all of the requirements of the FDCA that are applicable to drugs made by conventional manufacturers, including the new drug approval, adequate directions for use, and CGMP requirements.

FDA issued a draft guidance that describes FDA’s intention with regard to the provisions of section 503A that require rulemaking or other action to implement. This draft guidance also describes the provisions of the law that are applicable to compounded drugs that do not qualify for the exemptions described above, and the other provisions of the FDCA applicable to compounded drugs regardless of whether they qualify for the exemptions under section 503A.

  1. Does the Drug Quality and Security Act (DQSA) cover the compounding of animal drugs?

No, the DQSA does not cover animal compounding. For questions about animal drug compounding, contact FDA’s Center for Veterinary Medicine at CVM_ExecSec@cvm.fda.gov.

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Page Last Updated: 12/16/2014
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