503A vs. 503B

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.

In some cases, 503B facilities sell to 503A facilities for dispensing. If these medications are removed from the FDA Shortage List, 503A facilities must cease production immediately. They will still have the ability to source from 503B bulk ordering facilities. The 503B facilities will be allowed to produce for 60 days. There is some gray legal area about 503A facilities being allowed to dispense after the 60 days. I personally suspect that 503A's will try to order as much product from the 503B facilities as possible to stock for serving patients as long as possible. For some of their patients, these medications are the fulcrum for the balance of their entire health. Many find these drugs improve their cardiovascular health, regulate blood sugar, and some rely on their addiction suppression. It's a big deal beyond looking good for many.

503B - BULK FACILITIES / HOSPITALS

Some compounding pharmacies have a separate 503B facility where they produce orders for hospitals. Our medication never comes directly 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.