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ForumsCompounding & FormulationCompounding pharmacy clean room standards — my results so far Page 3

Compounding pharmacy clean room standards — my results so far

SaraMom3 Thu, May 2, 2024 at 7:47 PM 12 replies 2,138 viewsPage 3 of 3
anders_CPH
Senior Member
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7,234
Feb 2024
Copenhagen, DK
May 4, 2024 at 1:01 AM#11
DebRD_ATL said:
Beyond-use dating (BUD) for compounded supply compounded products: Lyophilized (unreconstituted): typically 12 months from compounding date…

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.

44 17CryptoCarl, MariaRD, AussieAnna and 41 others
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NurseAsh_DET
Member
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Sep 2024
Detroit, MI
May 4, 2024 at 8:36 PM#12
wei_SG 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 for spelling out the reasoning rather than just the conclusion. Sending this to two other people who asked me the same thing last week.

45 18ricardo_MIA, BrianDallas92, labquiet_amy and 42 others
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MaxMetOK
Member
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Dec 2024
Oklahoma
May 5, 2024 at 4:11 PM#13
DebRD_ATL said:
Beyond-use dating (BUD) for compounded supply compounded products: Lyophilized (unreconstituted): typically 12 months from compounding date…

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.

Last edited: May 5, 2024 at 9:11 PM
46 19DoseLogDan, SleepFixSam, PurityPaulOR and 43 others
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jason_paloalto
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Nov 2024
Palo Alto, CA
May 6, 2024 at 11:47 AM#14
SaraMom3 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…

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

SourceMonthly CostTypePurity Verified
Brand (Ozempic)$905FDA-approvedN/A (pharma)
503B Compounding$135cGMP compoundedYes (in-house)
503A Compounding$95Patient-specificVaries
Research peptide$45Not 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.

Last edited: May 6, 2024 at 4:47 PM
47 20andrew_nyc, Dr.EndoEP, GraceAZ_72 and 44 others
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mike_mod
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New York
Online
May 7, 2024 at 7:23 AM#15

Moderator note: a post naming a supplier has been edited. Discuss suppliers in the review sections, not here. Carry on.

Last edited: May 7, 2024 at 9:23 AM
48 21PurityPaulOR, MaxMetOK, MounjBrad and 45 others
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