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ForumsCompounding & FormulationCompounded sema potency testing — 6 month update Page 3

Compounded sema potency testing — 6 month update

fiona_glasgow Tue, Sep 24, 2024 at 7:33 AM 14 replies 1,904 viewsPage 3 of 3
Dr.SurgeonPGH
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Mar 2024
Pittsburgh, PA
Sep 24, 2024 at 7:08 PM#11
TinaHashiRN said:
Compounded has been just as effective for me.

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.

Last edited: Sep 24, 2024 at 10:08 PM
25 0DoseLogDan, SleepFixSam, PurityPaulOR and 22 others
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SleepDoc_PDX
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Sep 24, 2024 at 10:47 PM#12
NauseaFreeNow said:
Agreed, and the enforcement dates were staggered by category — 503A first, 503B a few weeks later — because outsourcing facilities have manufactured…

This answered a question I did not know how to ask. Taking it to my next appointment.

24 24hank_denver, carlos_SATX, sophie_paris and 21 others
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Dr.RaviCardio
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Sep 25, 2024 at 2:26 AM#13
TinaHashiRN said:
Compounded has been just as effective for me.

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.

Last edited: Sep 25, 2024 at 3:26 AM
23 23mark_tokyo, hans_munich, jason_sac26 and 20 others
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Sigma-Aldrich — Research-Grade Standards

Certified reference materials, analytical reagents, and research-grade standards for peptide verification. Trusted by laboratories worldwide.

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PeptideChemSF
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Jan 2024
San Francisco, CA
Sep 25, 2024 at 6:05 AM#14
fiona_glasgow 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…

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: Sep 25, 2024 at 10:05 AM
22 22ricardo_MIA, BrianDallas92, labquiet_amy and 19 others
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Admin
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Sep 25, 2024 at 9:45 AM#15

Moderator note: leaving this open. It is being argued well and the disagreement is the useful part.

21 21PeptideSynthNJ, Dr.KarenChen, Dr.NateNeph and 18 others
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