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ForumsCompounding & FormulationHas anyone dealt with fda warning letters to compounding pharmacies? Page 4

Has anyone dealt with fda warning letters to compounding pharmacies?

DebRD_ATL Thu, Oct 31, 2024 at 2:36 AM 50 replies 2,916 viewsPage 4 of 10
VanRx_Mike
Member
678
2,890
May 2024
Vancouver, CA
Nov 3, 2024 at 11:02 AM#16

Clinical perspective, offered as context rather than as advice.

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.

3 3Dr.LeslieOBGYN, MikeNYC_runner
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RunnerRach
Member
467
2,123
Aug 2024
Boston, MA
Nov 3, 2024 at 1:13 PM#17
lisa_labSD said:
Beyond-use dating (BUD) for compounded supply compounded products: Lyophilized (unreconstituted): typically 9 months from compounding date…

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

SourceMonthly CostTypePurity Verified
Brand (Ozempic)$927FDA-approvedN/A (pharma)
503B Compounding$157cGMP compoundedYes (in-house)
503A Compounding$117Patient-specificVaries
Research peptide$42Not 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.

2 2MikeKY_noInsulin, Dr.RaviCardio
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dave_SLC
Member
345
1,567
Aug 2024
Salt Lake City, UT
Nov 3, 2024 at 3:24 PM#18
lisa_labSD said:
Beyond-use dating (BUD) for compounded supply compounded products: Lyophilized (unreconstituted): typically 9 months from compounding date…

Thank you — that is the clearest version of this I have read, and I have read a lot of them. Sending this to two other people who asked me the same thing last week.

1 1james_edin
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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.

Shop Reference Standards
Dr.NateNeph
VIP Member
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16,234
Dec 2023
Houston, TX
Nov 3, 2024 at 5:35 PM#19

From the other side of the consultation, briefly.

Compounded has been just as effective for me. If compounded supply is the concern, the COA from my 503B pharmacy shows 99.1% purity. Verified by Janoshik.

50 0B12Beth, RickReta_CO, PharmHunterJen and 47 others
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Admin
Administrator
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Oct 2023
Online
Nov 3, 2024 at 7:46 PM#20

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

Last edited: Nov 3, 2024 at 11:46 PM
28 3PeptideSynthNJ, Dr.KarenChen, Dr.NateNeph and 25 others
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