Follow ACMA
Twitter Facebook Linkedin Instagram
Updates & Calls to ActionMake a Donation

FDA Revises Draft Guidance on Hospital and Health System Drug Compounding

For COOs, pharmacy staff, licensing & certification staff

Posted on: 10/11/2021

The Food and Drug Administration (FDA) has issued revised draft guidance on hospital and health system compounding under section 503A, updating draft guidance released in 2016. As advocated for by CHA, the FDA has revised the 2016 guidance to remove a requirement that would have limited the distribution of compounded drugs to health care facilities located within a one-mile radius of the compounding pharmacy.

The draft guidance describes how the FDA intends to prioritize enforcement of the requirement to obtain a prescription for an individual patient for compounded drugs. Under the revised draft guidance, the FDA would not take action if the compounded drugs are administered only to patients within the hospital or health system, the drugs are used or discarded within 24 hours of leaving the pharmacy, and compounding is done in compliance with provisions of FDA law and regulation.

The FDA also proposes a risk-based approach for other circumstance to prioritize enforcement of poor compounding practices or a lack of sterility assurance, non-patient-specific compounded drugs that are not for emergency uses, routine, large amounts of non-patient-specific compounded drugs, interstate distribution of large amounts of non-patient-specific compounded drugs, and lack of a procedure to obtain non-patient-specific compounded drugs from an outsourcing facility.

The FDA also proposes that it would generally not take action against a hospital or health system pharmacy that is not an outsourcing facility for compounding a drug product regularly or in inordinate amounts that is essentially a copy of a commercially available drug product.

Comments on the draft guidance are due Dec. 6.


California Hospital Association. (n.d.). FDA Revises Draft Guidance on Hospital and Health System Drug Compounding. Retrieved Octobver 11, 2021, from https//

Return to Legislative Postings



Join us for the 25th Anniversary ACMA National Conference, April 19-22, 2024 in Nashville, TN. Don't miss out on the most exciting case management conference of the year! Experience ACMA at National!

REGISTER TODAY! | ACMA 2023 Leadership & Physician Advisor Conference

Our 2023 Leadership and Physician Advisor Conference is October 18-20 in San Antonio, TX! Health plans and providers, this conference has everything you need. Find out more here!

Celebrate National Case Management Week

October 8-14 is National Case Management Week and ACMA has everything you need to celebrate. Let's come together and recognize the good work we do and the good people who do it. This year's theme is keeping the person at the heart of collaborative care. ACMA is helping you set the standard for celebration and recognition by providing materials and ideas to use at your location. Learn More >>>

Share Your Research | Collaborative Case Management

Do you have a project or measurable initiative you've instituted at your organization? Have you conducted research on a current issue in the field? Share your experiences and results with your professional community! Email your proposal (or ask any questions): Learn More >>>

Get ACMA News in the Palm of Your Hand

Join the conversation with ACMA! Text the keyword ACMA to 844-554-2497 to stay up to date on all the latest news and announcements, delivered straight to your phone!

Now Accepting Presentations for Chapter Conferences

We are now accepting presentations for upcoming ACMA chapter conferences. If you have a unique solution, intervention or strategy to improve case management, this is a great opportunity to share your knowledge and be a part of ACMA's national-caliber education at the local level. There is no deadline to submit; presentations will be accepted throughout the year so you can prepare a submission as your schedule allows. Submit a presentation >>

American Case Management Association
17200 Chenal Parkway Ste 300 #345
Little Rock, AR 72223
Phone: 501-907-ACMA (2262)
Fax: 501-227-4247