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ForumsCompounding & FormulationHas anyone dealt with compounding pharmacy accreditation: pcab vs achc vs state-only? Page 3

Has anyone dealt with compounding pharmacy accreditation: pcab vs achc vs state-only?

mel_PDX Sat, Jul 12, 2025 at 3:28 AM 39 replies 1,918 viewsPage 3 of 8
labquiet_amy
Senior Member
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Mar 2024
Cambridge, MA
Jul 13, 2025 at 5:11 AM#11
Dr.LeslieOBGYN said:
Compounding pharmacy response time test for compounded supply: I email customer service at odd hours to test responsiveness.

FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA website.

Check for: Form 483 observations (violations), warning letters, and recall history. A clean inspection record is a strong indicator of quality. My pharmacy has had 0 Form 483 observations in their last 4 inspections.

This is public information. Use it. Link: fda.gov/inspections-compliance-enforcement-and-criminal-investigations

Last edited: Jul 13, 2025 at 7:11 AM
21 21TrialNerd_Beth, HPLC_Greg, LibrarianMeg and 18 others
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PharmHunterJen
Member
567
2,345
Jul 2024
Illinois
Jul 13, 2025 at 10:39 AM#12
Dr.LipidDallas 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…

Saving this. It is the first explanation that did not require me to already understand it. Sending this to two other people who asked me the same thing last week.

Last edited: Jul 13, 2025 at 4:39 PM
20 20alex_tucson, kevin_tulsa, Dr.PainCLE and 17 others
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patPC_UT
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Nov 2024
Park City, UT
Jul 13, 2025 at 4:07 PM#13
Dr.LeslieOBGYN said:
Compounding pharmacy response time test for compounded supply: I email customer service at odd hours to test responsiveness.

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.

19 19TomFromTexas, mike.trainer_LA, sarah_nash92 and 16 others
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TrialTracker_MD
Senior Member
2,345
15,678
Jan 2024
Maryland
Jul 13, 2025 at 9:35 PM#14
mel_PDX 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…

Regarding compounded supply compounding legality: compounding pharmacies can legally produce semaglutide and tirzepatide while these drugs remain on the FDA shortage list. If/when the shortage resolves, the legal landscape may change.

Stay informed. The FDA shortage list is updated regularly. Current status as of my last check: semaglutide shortage ongoing, tirzepatide partially resolved. This directly impacts compounding availability.

Last edited: Jul 14, 2025 at 2:35 AM
18 18Dr.PulmRoch, maya_sedona, stefan_berlin and 15 others
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mike_mod
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Nov 2023
New York
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Jul 14, 2025 at 3:03 AM#15

Moderator note: the sourcing question belongs in the vendor section and has been split out. No action needed from anybody.

17 17PurityPaulOR, MaxMetOK, MounjBrad and 14 others
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