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  5. Compounding Activities | COVID-19
  1. Coronavirus (COVID-19) | Drugs

Compounding Activities | COVID-19

FDA is working to provide guidance to states and compounders on issues associated with compounding drugs during the COVID-19 pandemic. The agency’s guidance aims to protect patients from unsafe, ineffective and poor-quality compounded drugs, while preserving access for patients.

Outsourcing Facility Product Reports for Hospitalized Patients with COVID-19

The agency issued a guidance for temporary compounding of certain drugs by outsourcing facilities during the COVID-19 public health emergency. Hospitals that cannot obtain FDA-approved drugs covered by the guidance and seek to use compounded drugs for their patients should first contact outsourcing facilities, which produce compounded drugs under more robust quality standards than those made by state-licensed pharmacies or federal facilities not registered as outsourcing facilities. Hospitals can use the product report to help determine which outsourcing facilities are compounding drugs used for hospitalized patients with COVID-19.

Policy Clarifications

  • The agency’s draft hospital and health systems guidance, which includes the “one mile radius” provision, is still in draft and we are planning to issue a revision. This draft guidance was issued for public comment and has not been implemented.
  • Although federal law specifies a 5 percent limit on distribution out of state of drugs compounded by pharmacies and physicians regulated under section 503A of the Federal Food, Drug and Cosmetic Act, the agency does not intend to enforce the 5 percent limit until after the agency has finalized a Memorandum of Understanding (MOU) and given states an opportunity to sign it.
  • The agency does not consider drugs that are on FDA’s shortage list or that have been discontinued and are no longer marketed to be “commercially available” under the “essentially a copy” provision for pharmacy and physician compounders regulated under section 503A of the FD&C Act.
  • The agency does not consider a compounded drug produced by an outsourcing facility to be “essentially a copy” if it is identical or nearly identical to an FDA-approved drug that is on FDA’s drug shortage list. The agency also does not intend to take action under this provision if the facility fills orders for a compounded drug that is essentially a copy of an approved drug that has been discontinued and is no longer marketed.

 


Contact Us

FDA is responding to stakeholder inquiries on issues associated with compounding drugs during the COVID-19 emergency. Contact compounding@fda.hhs.gov with any questions.


Resources

 

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