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.
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.
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