503A vs. 503B
10/3 - As of today, compounded tirzepatide has been removed from the FDA shortage list. I am in the process of updating the site and removing references to accessing compounded tirzepatide. 503B will continue to fill scripts for 2 months. From what I understand, 503A must cease immediately. Semaglutide will continue to be available.
See OrderlyMeds for semaglutide.
503A - DIRECT TO PATIENTS (ALL OF US)
All compounded tirzepatide comes from 503A sterile facilities. These facilities have <797> sterile clean rooms for producing injectables, as required by the FDA. The FDA delegates inspection of these facilities to the State Pharmacy Board using strict FDA protocol. If needed, the State calls in the FDA for additional inspections. Citations and resolutions are common in the industry and the nature of good oversight (just as with brand pharma manufacturing facilites). These 503A compounding facilities serve individual patients directly with a valid prescription.
503B - BULK FACILITIES / HOSPITALS
Some compounding pharmacies have a separate 503B facility where they produce orders for hospitals. Our medication never comes from a 503B facility.
When I was researching this topic, I noticed that 503B facilities at some pharmacies were in different states. I sent an email asking Empower, a 503A & 503B accredited pharmacy whether they were always two separate facilities. To my surprise, I had included my phone number and my phone rang. It was the pharmacist from Empower.
She was glad to clear the air on this topic and let me know that indeed, 503A & 503B are always two separate facilities. 503B just tells us that a compounding pharmacy is a big player. The FDA relies on them to provide medication to hospitals. It's reassurance that you are dealing with a respected pharmacy. The 503B facility has cGMP compliance and FDA inspections. For our 503A facilities, the FDA confidently delegates inspection to the State Pharmacy Board using strict FDA protocol.
In short: If a pharmacy is not 503B accredited, it doesn't mean anything to us, really. It just means their sole focus is on providing medication direct to patients like us.
For additional oversight, you can also look for PCAB accreditation. That means the pharmacy volunteers for additional oversight and inspections through the Accreditation Commission for Heathcare. That is the highest benchmark in the industry.
For example: Hallandale is 503A and PCAB accredited. They are not 503B accredited only because they focus on direct-to-patient prescription orders. They are the largest volume compounded tirzepatide provider in the nation.
I have also exchanged emails with two pharmacists at the FDA to confirm.
More reading:
https://www.thefdagroup.com/blog/503a-vs-503b-compounding-pharmacies
PCAB President Scott Brunner - 4/7/24 Statement on FDA oversight of 503A compounded tirzepatide