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.
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.
Who We Are
Eagle consultants and scientists are helping compounding facilities implement successful quality systems. Our team has over 200 years of combined experience in the FDA-regulated pharmaceutical industry and can provide guidance in establishing the systems and processes that will help facilities producing compounded medications meet and exceed regulatory expectations. Follow the link below to learn more about our consulting services.
- Antimicrobial Effectiveness | USP 795 & 797 Revisions - July 18, 2023
- 2023 PDA/FDA Joint Regulatory Conference, 09/18 – 09/20 - July 11, 2023
- APC: Compounders on Capitol Hill, 09/19 – 09/20 - July 11, 2023