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ForumsCompounding & FormulationState pharmacy board compounding enforcement actions — what worked for you? Page 3

State pharmacy board compounding enforcement actions — what worked for you?

LondonLisa Thu, May 16, 2024 at 1:58 PM 16 replies 2,265 viewsPage 3 of 4
LabKate
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May 17, 2024 at 4:13 PM#11
Dr.LeslieOBGYN said:
Vendor communication red flags for compounded supply: Won't provide COA before purchase — walk away Claims "100% pure" without analytical data —…

FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA website.

Check for: Form 483 observations (violations), warning letters, and recall history. A clean inspection record is a strong indicator of quality. My pharmacy has had 1 Form 483 observations in their last 2 inspections.

This is public information. Use it. Link: fda.gov/inspections-compliance-enforcement-and-criminal-investigations

1 24JenMemphis
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jason_sac26
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May 18, 2024 at 10:31 AM#12
josh_phd_bmore said:
Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces…

Thank you — that is the clearest version of this I have read, and I have read a lot of them. I will report back once I have actually tried it.

2 0Dr.EM_Chicago, pete_RVA
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DeniseRN_TPA
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May 19, 2024 at 4:48 AM#13
Dr.LeslieOBGYN said:
Vendor communication red flags for compounded supply: Won't provide COA before purchase — walk away Claims "100% pure" without analytical data —…

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.

Last edited: May 19, 2024 at 7:48 AM
3 1tommy_boulder, hyun_seoul, jim_asheville
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DanielChem_CHI
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May 19, 2024 at 11:05 PM#14
LondonLisa 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…

I have been on both brand and compounded, and in the context of compounded supply, my experience has been equivalent with both. The key is finding a reliable 503B pharmacy with independent testing.

4 2ben_calgary, patPC_UT, Dr.DermMIA and 1 other
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Admin
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May 20, 2024 at 5:22 PM#15

Moderator note: the sourcing question belongs in the vendor section and has been split out. Thread quality here is what the rules are for. Keep it up.

5 3PeptideSynthNJ, Dr.KarenChen, Dr.NateNeph and 2 others
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