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ForumsPublic SquareFDA compounding enforcement update — June 2026 guidance document Page 7

FDA compounding enforcement update — June 2026 guidance document

RegAffairsDC Mon, Feb 26, 2024 at 4:00 PM 336 replies 53,782 viewsPage 7 of 20
LarryQC_SD
Senior Member
2,123
9,876
Jan 2024
San Diego, CA
Mar 6, 2024 at 3:30 AM#31
RegAffairsDC said:
Price comparison for compounded supply across sources I've used: Source Monthly Cost Type Purity Verified Brand (Ozempic) $1013 FDA-approved N/A…

I have been on both brand and compounded, and in the context of compounded supply, my experience has been equivalent with both. The key is finding a reliable 503B pharmacy with independent testing.

Last edited: Mar 6, 2024 at 4:30 AM
4 4NurseKim_ATL, paul_denver, TinaHashiRN and 1 other
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paul_denver
Member
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3,234
May 2024
Denver, CO
Mar 6, 2024 at 12:39 PM#32
RegAffairsDC said:
Price comparison for compounded supply across sources I've used: Source Monthly Cost Type Purity Verified Brand (Ozempic) $1013 FDA-approved N/A…

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.

3 3jason_paloalto, Dr.LeslieOBGYN, MikeNYC_runner
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roxy_nash
Member
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Dec 2024
Nashville, TN
Mar 6, 2024 at 9:48 PM#33
RegAffairsDC said:
Price comparison for compounded supply across sources I've used: Source Monthly Cost Type Purity Verified Brand (Ozempic) $1013 FDA-approved N/A…

Genuinely useful, thank you. I had the facts and not the framework.

2 2tony_orlando, Dr.NephBHM_UK
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NurseLeah_Nash
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Sep 2024
Nashville, TN
Mar 7, 2024 at 6:57 AM#34

From the other side of the consultation, briefly.

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 3 inspections.

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

1 1Dr.KarenChen
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tony_orlando
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Nov 2024
Orlando, FL
Mar 7, 2024 at 4:07 PM#35
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…

This is my experience too, for whatever a second data point is worth.

Last edited: Mar 7, 2024 at 5:07 PM
50 0KetoKyle, CanadaChris, ZaraB_AL and 47 others
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