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ForumsCompounding & FormulationFDA warning letters to compounding pharmacies — need advice Page 3

FDA warning letters to compounding pharmacies — need advice

lori_vegas Tue, Sep 2, 2025 at 10:56 AM 12 replies 1,308 viewsPage 3 of 3
jennifer_SEA
Member
234
890
Nov 2024
Seattle, WA
Sep 7, 2025 at 2:03 PM#11
Dr.NephBHM_UK said:
Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.

Bookmarking. The distinction being drawn above is the one nobody else makes. Sending this to two other people who asked me the same thing last week.

5 3lucas_SP_BR, lisa_labSD, adam_van and 2 others
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ingrid_STO
Member
345
1,456
Jul 2024
Stockholm, SE
Sep 8, 2025 at 8:39 AM#12

Adding the clinical framing, because it changes how the question reads.

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.

6 4COA_Karl, MikeFit_NJ, InsuranceTom and 3 others
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anders_CPH
Senior Member
1,567
7,234
Feb 2024
Copenhagen, DK
Sep 9, 2025 at 3:15 AM#13
NurseKim_ATL said:
Vendor communication red flags for compounded supply: Won't provide COA before purchase — walk away Claims "100% pure" without analytical data —…

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.

7 5AussieAnna, BethLabQueen, ChrisMacros and 4 others
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stefan_berlin
Member
234
1,123
Oct 2024
Berlin, DE
Sep 9, 2025 at 9:50 PM#14
lori_vegas said:
The shortage clause is the answer to the second question and it is a subtraction rather than an addition.

Compounding pharmacy response time test for compounded supply: I email customer service at odd hours to test responsiveness. A pharmacy that can't answer questions promptly is a red flag.

My current pharmacy: average response time 2 hours. They answered my questions about storage conditions thoroughly and professionally.

Communication quality is a proxy for operational quality. A pharmacy that communicates well is likely manufacturing well too.

8 6TirzTom, TrialTracker_MD, JennaRN and 5 others
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mike_mod
Moderator
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Nov 2023
New York
Online
Sep 10, 2025 at 4:25 PM#15

Moderator note: a post naming a supplier has been edited. Discuss suppliers in the review sections, not here. Tagging this one for the weekly digest.

9 7PurityPaulOR, MaxMetOK, MounjBrad and 6 others
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