503A’s Can Temporarily Compound Certain Drugs

The FDA has issued a temporary guidance which enables 503A compounding pharmacies to compound certain medications without the requirement of a patient-specific prescription during the COVID-19 public health emergency. The new guidance comes days after FDA issued a similar temporary policy for 503B outsourcing facilities.

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According to the document published Monday April 20th, “many hospitals are currently experiencing difficulties accessing FDA-approved drug products used for patients with COVID-19.”

The Agency places emphasis on the policy being “a temporary measure during the public health emergency related to COVID-19” and states “FDA does not intend to take action against a pharmacy for compounding a drug that is essentially a copy of a commercially available drug, or for providing a drug to a hospital without obtaining a patient-specific prescription, if all of the following circumstances are present and the other conditions of section 503A of the FD&C Act are met.”

Stay tuned as Eagle will be posting a summarized version of the article, outlining what compounders need to know about the temporary policy.

Visit the link below to view the complete guidance document on the FDA website.

Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency

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