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ForumsBuyer Beware⚠ Compounding pharmacies with FDA 483 observations — what worked for you? Page 4

⚠ Compounding pharmacies with FDA 483 observations — what worked for you?

LipidDoc_ATL Sat, Oct 19, 2024 at 5:34 AM 29 replies 2,300 viewsPage 4 of 6
kate.chem
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Nov 3, 2024 at 4:15 AM#16
Dr.NephBHM_UK said:
Beyond-use dating (BUD) for compounded supply compounded products: Lyophilized (unreconstituted): typically 9 months from compounding date…

Mine went the same way, slower. The detail I would add is minor and it is already implied above.

Last edited: Nov 3, 2024 at 7:15 AM
4 2steve_okc, dave_SLC, FDA_TrackerJim and 1 other
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JakeSmashed95
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Nov 4, 2024 at 11:30 PM#17
quinn_sf said:
Vendor communication red flags for compounded supply: Won't provide COA before purchase — walk away Claims "100% pure" without analytical data —…

Same pattern here, and in the same order. I had assumed I was the exception until I read this.

5 3kevin_tulsa, Dr.PainCLE, mike_mealprep and 2 others
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DebRD_ATL
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Nov 6, 2024 at 6:44 PM#18
quinn_sf said:
Vendor communication red flags for compounded supply: Won't provide COA before purchase — walk away Claims "100% pure" without analytical data —…

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

6 4SleepDoc_PDX, RegAffairsDC, BiostatsBrad and 3 others
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DanielChem_CHI
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Mar 2024
Chicago, IL
Nov 8, 2024 at 1:57 PM#19
quinn_sf said:
Vendor communication red flags for compounded supply: Won't provide COA before purchase — walk away Claims "100% pure" without analytical data —…

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)
7 5ben_calgary, patPC_UT, Dr.DermMIA and 4 others
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mike_mod
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Nov 10, 2024 at 9:09 AM#20

Moderator note: two posts asking for a source have been merged into one. Please search the thread before asking again. Tagging this one for the weekly digest.

29 2PurityPaulOR, MaxMetOK, MounjBrad and 26 others
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