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ForumsPublic SquareFDA compounding enforcement update — June 2026 guidance document Page 3

FDA compounding enforcement update — June 2026 guidance document

RegAffairsDC Mon, Feb 26, 2024 at 4:00 PM 336 replies 53,782 viewsPage 3 of 20
kevin_tulsa
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Mar 1, 2024 at 4:22 AM#11
Dr.SportsMedIN said:
The shortage clause is the answer to the second question and it is a subtraction rather than an addition.

Bookmarking. The distinction being drawn above is the one nobody else makes.

16 16fiona_glasgow, Dr.RheumBOS, greg_boulder and 13 others
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Dr.Martinez
Medical Advisor
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Mar 1, 2024 at 7:13 AM#12

From the other side of the consultation, briefly.

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.

15 15traveltech_sara, AttorneyGrant, DebRD_ATL and 12 others
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Dr.SportsMedIN
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Mar 1, 2024 at 10:04 AM#13
Dr.LeslieOBGYN said:
Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.

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.

Last edited: Mar 1, 2024 at 3:04 PM
14 14adam_van, Dr.SurgeonPGH, rachel_ABQ and 11 others
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labquiet_amy
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Mar 2024
Cambridge, MA
Mar 1, 2024 at 12:55 PM#14
RegAffairsDC said:
FDA compounding enforcement update — June 2026 guidance document Posting this as an important update for the public square community.

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 4 hours. They answered my questions about reconstitution thoroughly and professionally.

Communication quality is a proxy for operational quality. A pharmacy that communicates well is likely manufacturing well too.

Last edited: Mar 1, 2024 at 2:55 PM
13 13bri_stats, pete_manc_UK, anna.melb_AU and 10 others
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Admin
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Mar 1, 2024 at 3:46 PM#15

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

12 12PeptideSynthNJ, Dr.KarenChen, Dr.NateNeph and 9 others
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