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ForumsCompounding & FormulationMy pharmacy just stopped compounding sema - now what?? — my results so far Page 3

My pharmacy just stopped compounding sema - now what?? — my results so far

RunnerRach Tue, Jan 9, 2024 at 6:50 AM 15 replies 2,283 viewsPage 3 of 3
DebRD_ATL
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Atlanta, GA
Jan 10, 2024 at 6:04 PM#11
NurseKim_ATL said:
Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials: State Board of Pharmacy…

GMP compliance checklist relevant to compounded supply compounding quality:

  • Clean room environment with HEPA filtration
  • Environmental monitoring (viable and non-viable)
  • Personnel training and competency assessment
  • Validated analytical methods for testing
  • Stability testing program
  • Complete batch records and traceability
  • Quality management system with deviation handling

A 503B pharmacy following cGMP should be able to answer questions about ALL of these if you ask. Don't be afraid to ask — it's your health.

28 1BiostatsBrad, PeptideSynthNJ, Dr.KarenChen and 25 others
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patPC_UT
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Park City, UT
Jan 10, 2024 at 9:32 PM#12
DataDave said:
Agreed, and the enforcement dates were staggered by category — 503A first, 503B a few weeks later — because outsourcing facilities have manufactured…

This is exactly what I could not find anywhere else. Taking it to my next appointment.

29 2mike.trainer_LA, sarah_nash92, FitDadDave and 26 others
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ZaraB_AL
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Jan 11, 2024 at 1:00 AM#13
NurseKim_ATL said:
Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials: State Board of Pharmacy…

Beyond-use dating (BUD) for compounded supply compounded products:

Lyophilized (unreconstituted): typically 6 months from compounding date
Reconstituted with BAC water: typically 28-30 days refrigerated
Reconstituted with sterile water: typically 24 hours (no preservative!)

Always use BAC water for multi-dose vials. Sterile water has no preservative and supports bacterial growth after first puncture. This is a common and potentially dangerous mistake.

Last edited: Jan 11, 2024 at 2:00 AM
30 3TirzTom, TrialTracker_MD, JennaRN and 27 others
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TirzTom
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Jan 11, 2024 at 4:28 AM#14
RunnerRach 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 customer here with experience relevant to compounded supply.

I've ordered from 2 different compounding pharmacies over the past 2 years. The quality variation is real — purity ranged from 94% to 101% of label claim based on independent Janoshik testing.

My current compounder (a 503B facility) has been consistently 98-101% purity across 10 orders. I pay $157/month vs $1,287 for brand. The savings are substantial and the product is equivalent in my experience.

Re: compounded supply — this applies whether you're using brand or compounded. The clinical principles are the same.

Last edited: Jan 11, 2024 at 8:28 AM
31 4SandraNC_45, Dr.EndoIndy, tom_AK and 28 others
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mike_mod
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Jan 11, 2024 at 7:56 AM#15

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

Last edited: Jan 11, 2024 at 9:56 AM
32 5PurityPaulOR, MaxMetOK, MounjBrad and 29 others
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