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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

Policy clarifications:

  • The agency’s guidance for hospital and health systems, which includes the “one mile radius” provision, is still in draft and we are planning to issue a revision. This draft guidance document was issued for public comment and has not been implemented.
  • Although federal law specifies a 5 percent limit on interstate distribution of compounded drug products for pharmacy compounders, we do 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 MOU is currently in draft form.
  • The agency does not consider drugs that are on FDA’s shortage list or that have been discontinued and are no longer marketed as “commercially available” under the “essentially a copy” provision for pharmacy compounders.
  • The agency also does not consider a compounded drug produced by an outsourcing facility as “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.


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