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ForumsBuyer BewareHow do I even know if my compounding pharmacy is legit — looking for input

How do I even know if my compounding pharmacy is legit — looking for input

lisa_labSD Mon, May 26, 2025 at 9:27 AM 14 replies 1,622 viewsPage 1 of 3
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lisa_labSD
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San Diego, CA
May 26, 2025 at 9:27 AM#1

Two pharmacies quoted me last year, one describing itself as 503A and one as 503B, and I assumed 503B just meant bigger until both stopped within weeks of each other.

The bit I cannot resolve on my own is what actually distinguishes 503A from 503B, in terms of what each may make and from what starting material.

Practical detail welcome, however dull — the duller the better.

19 14stefan_berlin, Dr.EM_Chicago, pete_RVA and 16 others
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PeptideChemSF
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May 26, 2025 at 10:29 AM#2

Taking the question as asked, rather than the general version of it. Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists. For 503B the shortage clause was the only route to these molecules, so that route shut completely. A 503A pharmacy can still argue a doorway via "component of an approved drug" — but only for the substance in the form present in the approved product, which is exactly where the base-versus-salt argument lives, and it does nothing about the copy restriction, which came back into force on resolution.

18 13dave_SLC, FDA_TrackerJim, ricardo_MIA and 15 others
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stefan_berlin
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Berlin, DE
May 26, 2025 at 11:31 AM#3
PeptideChemSF said:
Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.

Agreed, and the enforcement dates were staggered by category — 503A first, 503B a few weeks later — because outsourcing facilities have manufactured inventory and clinic contracts to unwind while a 503A makes to order.

Last edited: May 26, 2025 at 2:31 PM
17 12KevinCompounds, TirzTom, TrialTracker_MD and 14 others
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VanRx_Mike
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May 26, 2025 at 12:33 PM#4
lisa_labSD said:
Two pharmacies quoted me last year, one describing itself as 503A and one as 503B, and I assumed 503B just meant bigger until both stopped within…

Same position here, arrived at the long way round. The shortage clause is the answer to the second question and it is a subtraction rather than an addition. Both exemptions forbid compounding something that is essentially a copy of a commercially available approved product. A product FDA has listed as in shortage is not treated as commercially available, so listing removed the objection that otherwise blocked compounding. It never created a permission; it withdrew a prohibition, which is why it evaporated the moment the supply fact changed.

Last edited: May 26, 2025 at 3:33 PM
16 11Dr.Martinez, mike_mod, SarahChen_PharmD and 13 others
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traveltech_sara
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Jan 2025
Remote, USA
May 26, 2025 at 6:29 PM#5

Clinical perspective, offered as context rather than as advice.

Compounding pharmacy red flag checklist for compounded supply — if ANY of these apply, find a different source:

  1. No verifiable physical address
  2. No pharmacist available for consultation
  3. COA not available or clearly template/fake
  4. Prices dramatically below market ($30-40/month = suspicious)
  5. No prescription required
  6. Ships without cold pack or temperature control
  7. No batch/lot numbers on product labeling
  8. Pushes "research use only" products for human injection

Your health depends on product quality. Don't cut corners on source verification.

15 10BenResearch_OR, MikeKY_noInsulin, Dr.RaviCardio and 12 others
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