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ForumsCompounding & FormulationCompounded sema potency testing — what worked for you? Page 2

Compounded sema potency testing — what worked for you?

Dr.PathRoch Thu, Aug 7, 2025 at 8:38 PM 13 replies 1,517 viewsPage 2 of 3
DataDave
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Aug 8, 2025 at 12:44 AM#6
TirzTom said:
The shortage clause is the answer to the second question and it is a subtraction rather than an addition.

I read this differently from TirzTom, on substance rather than tone. A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to. It is a different legal universe with no pharmacy oversight, no patient relationship and no content guarantee, and conflating the two in these threads helps nobody.

Last edited: Aug 8, 2025 at 1:44 AM
32 10VendorMark, COA_Karl, MikeFit_NJ and 29 others
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lisa_labSD
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Oct 2024
San Diego, CA
Aug 8, 2025 at 2:20 AM#7
Dr.PathRoch 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…

Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials:

  1. State Board of Pharmacy license — check on your state BOP website
  2. FDA registration (for 503B) — check on fda.gov
  3. DEA registration if handling controlled substances
  4. PCAB accreditation — voluntary but demonstrates commitment to quality
  5. USP <797>/<800> compliance for sterile compounding

This takes 10 minutes of research and could save you from receiving substandard or unsafe medication.

33 11maya_sedona, stefan_berlin, Dr.EM_Chicago and 30 others
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newstart_MO
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Springfield, MO
Aug 8, 2025 at 3:56 AM#8
DataDave said:
A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.

503A vs 503B compounding pharmacies for compounded supply — this distinction matters enormously:

Feature503A503B
RegulationState Board of PharmacyFDA-registered
PrescriptionRequired (patient-specific)Can compound without patient Rx
TestingVaries by statecGMP required
ScaleSmall batchesLarger production
Quality consistencyVariableGenerally higher

I strongly recommend 503B facilities. The FDA oversight and cGMP requirements mean more consistent product quality.

34 12HPLC_Greg, LibrarianMeg, bri_stats and 31 others
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DerekSJ_a1c
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Aug 8, 2025 at 5:32 AM#9

A narrower follow-up, since the general answer is now clear:

Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?

35 13traveltech_sara, AttorneyGrant, DebRD_ATL and 32 others
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Dr.PathRoch
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Rochester, MN
Aug 8, 2025 at 1:11 PM#10

Closing the loop on my own question.

The bulks-list asymmetry was the piece I had missed entirely. It explains why one of my two pharmacies is still arguing it can supply and the other simply stopped.

5 3Dr.MetabolicMD, RetaRick_CA, JenPlateau and 2 others
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