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ForumsCompounding & FormulationState pharmacy board compounding enforcement actions — what worked for you? Page 4

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

LondonLisa Thu, May 16, 2024 at 1:58 PM 16 replies 2,265 viewsPage 4 of 4
PharmD_Rodriguez
Senior Member
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Jan 2024
Miami, FL
May 21, 2024 at 11:38 AM#16

Adding the clinical framing, because it changes how the question reads.

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.

6 4paul_denver, TinaHashiRN, robert_kc and 3 others
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lori_vegas
Member
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1,678
Aug 2024
Las Vegas, NV
May 22, 2024 at 5:54 AM#17
BiostatsBrad said:
GMP compliance checklist relevant to compounded supply compounding quality: Clean room environment with HEPA filtration Environmental monitoring…

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 22, 2024 at 7:54 AM
7 5bbq_ray_KC, oliver_london, tane_welly and 4 others
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LabKate
Senior Member
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Oregon
May 23, 2024 at 12:09 AM#18
BiostatsBrad said:
GMP compliance checklist relevant to compounded supply compounding quality: Clean room environment with HEPA filtration Environmental monitoring…

This is exactly what I could not find anywhere else. I will report back once I have actually tried it.

Last edited: May 23, 2024 at 3:09 AM
8 6Dr.SleepRoch, laura_annarbor, JenMemphis and 5 others
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LindaRN_retired
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Dec 2024
Sarasota, FL
May 23, 2024 at 6:24 PM#19

Clinical perspective, offered as context rather than as advice.

Price comparison for compounded supply across sources I've used:

SourceMonthly CostTypePurity Verified
Brand (Ozempic)$951FDA-approvedN/A (pharma)
503B Compounding$131cGMP compoundedYes (in-house)
503A Compounding$101Patient-specificVaries
Research peptide$41Not for human useOften Janoshik

I use the 503B option — best balance of quality, cost, and legality. The brand price is insane but insurance can help if you qualify.

9 7LondonLisa, mike_nyc, VendorMark and 6 others
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Admin
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Oct 2023
Online
May 24, 2024 at 12:39 PM#20

Moderator note: the sourcing question belongs in the vendor section and has been split out.

31 4PeptideSynthNJ, Dr.KarenChen, Dr.NateNeph and 28 others
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