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.
Have questions? Our experts are here to help. Fill our “Coronavirus Fact Check Form” for answers to this or any other subject related to COVID-19. Our scientific experts are committed to providing answers to help you in navigating these challenging times.
