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ForumsPublic SquarePSA: Verify your compounding pharmacy accreditation (PCAB/ACHC) — looking for input Page 3

PSA: Verify your compounding pharmacy accreditation (PCAB/ACHC) — looking for input

stefan_berlin Fri, Apr 19, 2024 at 2:39 AM 20 replies 2,246 viewsPage 3 of 4
PurityPaulOR
Senior Member
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Mar 2024
Oregon
Apr 20, 2024 at 10:43 PM#11
rachel_ABQ said:
I have been on both brand and compounded, and in the context of compounded supply, my experience has been equivalent with both.

For compounded supply users considering compounded for the first time: here's a step-by-step guide:

  1. Get a prescription from your doctor (telehealth counts)
  2. Research 503B compounding pharmacies with good community reviews
  3. Verify their FDA registration and inspection history
  4. Request a COA for your specific compound before ordering
  5. Start with a 1-month supply to test
  6. Consider sending a sample to Janoshik for independent verification
  7. Track your response compared to brand (if you were on it previously)
17 17Dr.LeslieOBGYN, MikeNYC_runner and 14 others
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mia_MS2
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Jun 2026
Ann Arbor, MI
Apr 21, 2024 at 5:00 AM#12
zoe_NC said:
Agreed, and the enforcement dates were staggered by category — 503A first, 503B a few weeks later — because outsourcing facilities have manufactured…

Thank you for spelling out the reasoning rather than just the conclusion. Printing the relevant bit and taking it with me.

Last edited: Apr 21, 2024 at 8:00 AM
16 16FDA_TrackerJim, ricardo_MIA, BrianDallas92 and 13 others
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pete_nash
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Aug 2024
Nashville, TN
Apr 21, 2024 at 11:17 AM#13
rachel_ABQ said:
I have been on both brand and compounded, and in the context of compounded supply, my experience has been equivalent with both.

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: Apr 21, 2024 at 5:17 PM
15 15mike_mod, SarahChen_PharmD, sarah.morrison and 12 others
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BethLabQueen
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May 2024
Virginia
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Apr 21, 2024 at 5:34 PM#14
stefan_berlin said:
My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.

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

Lyophilized (unreconstituted): typically 12 months from compounding date
Reconstituted with BAC water: typically 28-30 days refrigerated
Reconstituted with sterile water: typically 48 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.

14 14cory_ATX, lori_vegas, Dr.PulmRoch and 11 others
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Admin
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Apr 21, 2024 at 11:51 PM#15

Moderator note: a couple of off-topic posts removed.

Last edited: Apr 22, 2024 at 3:51 AM
13 13PeptideSynthNJ, Dr.KarenChen, Dr.NateNeph and 10 others
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