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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
VendorMark
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Mar 6, 2024 at 3:30 AM#31

From the other side of the consultation, briefly.

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 still in shortage, tirzepatide removed from shortage list. This directly impacts compounding availability.

4 4DebRD_ATL, KristenIndy, MarkLI_maint and 1 other
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Dr.DermMIA
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May 2024
Miami, FL
Mar 6, 2024 at 12:39 PM#32
VendorMark said:
Regarding compounded supply compounding legality: compounding pharmacies can legally produce semaglutide and tirzepatide while these drugs remain on…

Mine went the same way, slower. I had assumed I was the exception until I read this.

3 3Dr.RenalNash, LipidDoc_ATL, BariatricNurseD
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RetaRick_CA
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Jan 2024
California
Mar 6, 2024 at 9:48 PM#33
VendorMark said:
Regarding compounded supply compounding legality: compounding pharmacies can legally produce semaglutide and tirzepatide while these drugs remain on…

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.

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HPLC_Greg
Senior Member
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Feb 2024
Research Triangle, NC
Mar 7, 2024 at 6:57 AM#34
VendorMark said:
Regarding compounded supply compounding legality: compounding pharmacies can legally produce semaglutide and tirzepatide while these drugs remain on…

Vendor communication red flags for compounded supply:

  • Won't provide COA before purchase — walk away
  • Claims "100% pure" without analytical data — unrealistic
  • No physical address or phone number — accountability matters
  • Pushes you to buy more than you need — pressure tactics
  • Won't answer questions about their compounding process — transparency is key
  • Payment only via crypto or wire transfer — legitimate pharmacies accept cards

A legitimate compounding pharmacy operates like a healthcare business, not a gray market dealer.

1 1Dr.MetabolicMD
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SandraNC_45
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Sep 2024
Charlotte, NC
Mar 7, 2024 at 4:07 PM#35

Following on from VendorMark — and this may be the naive question:

Did your prescriber agree with that reading, and if not what was their objection?

Last edited: Mar 7, 2024 at 9:07 PM
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