503A’s Can Temporarily Compound Certain Drugs
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.
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