Jun 13, 2024 at 7:11 PM#6
Wow, I didn't know about the non-resident pharmacy license thing. How do I check that?
Last edited: Jun 14, 2024 at 1:11 AM
17 20CarlaRPh_TPA, steph_laguna, fiona_glasgow and 14 others
Reply Quote Save Share Report
Jun 14, 2024 at 5:29 AM#7
Go to your own state's board of pharmacy website and search for the pharmacy name in their licensee lookup. They should show up as a "non-resident pharmacy" or "out-of-state pharmacy" with an active license.
For example, if you live in Florida and the pharmacy is in Texas:
- The pharmacy needs a Texas pharmacy license (home state)
- AND a Florida non-resident pharmacy license
If they don't have the non-resident license in your state, they technically shouldn't be shipping to you. Doesn't mean the medication is bad, but it means they're cutting regulatory corners, which tells you something about their overall compliance culture.
18 21maya_sedona, stefan_berlin, Dr.EM_Chicago and 15 others
Reply Quote Save Share Report
Jun 14, 2024 at 3:47 PM#8
Just checked. My pharmacy IS on the FDA 503B list and has a non-resident license in my state. Feeling much better about my source now. Thanks everyone.
19 22Dr.EM_Chicago, pete_RVA, CarlaRPh_TPA and 16 others
Reply Quote Save Share Report
Sigma-Aldrich — Research-Grade Standards
Certified reference materials, analytical reagents, and research-grade standards for peptide verification. Trusted by laboratories worldwide.
Shop Reference StandardsJun 15, 2024 at 2:05 AM#9
Pinning this for the FAQ. One more distinction worth noting:
503A pharmacies are required to compound from bulk drug substances that are either:
- Components of FDA-approved drugs, OR
- On the FDA's "bulks list" (positive list under 503A)
503B facilities can compound from bulk drug substances that appear on the FDA's "clinical need" list (though this list is still being developed).
Both semaglutide and tirzepatide base are currently available as bulk drug substances because of the ongoing shortage designations. If/when those shortage designations end, the legal landscape for compounding these drugs could change dramatically. The FDA has signaled that they may give compounders a wind-down period, but nothing is guaranteed.
This is the elephant in the room that every compounder and patient should be thinking about.
Last edited: Jun 15, 2024 at 4:05 AM
20 23Dr.ObesityMed, HealthEcon_DC, PedsEndoPhilly and 17 others
Reply Quote Save Share Report
Jun 17, 2024 at 3:32 AM#10
That point is valid about the shortage situation. I'd also add that the quality of bulk API (Active Pharmaceutical Ingredient) matters enormously regardless of whether it's 503A or 503B.
Reputable compounders source their semaglutide API from suppliers with:
- A Certificate of Analysis (CoA) for each lot
- USP or equivalent monograph testing
- A Drug Master File (DMF) on record with the FDA
- GMP certification of the manufacturing facility
Ask your compounder where they source their API and whether they can provide a CoA. If they can't or won't answer, that's another red flag.
42 17mike_mealprep, NicoleRaleigh, james_edin and 39 others
Reply Quote Save Share Report