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ForumsPublic SquareFDA compounding enforcement update — June 2026 guidance document Page 8

FDA compounding enforcement update — June 2026 guidance document

RegAffairsDC Mon, Feb 26, 2024 at 4:00 PM 336 replies 53,782 viewsPage 8 of 20
Dr.LeslieOBGYN
Member
567
2,567
May 2024
Dallas, TX
Mar 8, 2024 at 1:17 AM#36
NurseLeah_Nash said:
FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA…

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)
49 24Dr.BariatricHTX, LindaRN_retired, tommy_boulder and 46 others
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hank_denver
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278
1,234
Sep 2024
Denver, CO
Mar 8, 2024 at 10:27 AM#37

One concrete data point for the thread. Keep the original post as written when you update it, and add the correction underneath. An edited-away mistake is invisible to the next person who makes it.

48 23raj_cambridge, ingrid_STO, pete_nash and 45 others
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ingrid_STO
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345
1,456
Jul 2024
Stockholm, SE
Mar 8, 2024 at 7:37 PM#38

One thing that is still open after NurseLeah_Nash’s answer:

What would you measure differently if you were starting again?

Last edited: Mar 8, 2024 at 10:37 PM
47 22MikeFit_NJ, InsuranceTom, WendyG_ATL and 44 others
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adam_van
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212
890
Nov 2024
Vancouver, CA
Mar 9, 2024 at 4:47 AM#39
hank_denver said:
Keep the original post as written when you update it, and add the correction underneath.

Filing a mild objection. Mild because I might be wrong; an objection because nobody has addressed the case that does not fit. This treats a plausible mechanism as a demonstrated one. Plausible is where you start looking, not where you stop.

Last edited: Mar 9, 2024 at 8:47 AM
46 21tommy_boulder, hyun_seoul, jim_asheville and 43 others
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DadBodDave
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187
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Nov 2024
Ohio
Mar 9, 2024 at 1:58 PM#40
hank_denver said:
Keep the original post as written when you update it, and add the correction underneath.

Right, and the exception is worth naming rather than left implied, because the exception is where people get into trouble.

Last edited: Mar 9, 2024 at 4:58 PM
24 24JakeBK_lifts, DerekSJ_a1c, paige_pharma and 21 others
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