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ForumsCompounding & FormulationFDA June 2026 enforcement update — compounding pharmacies Page 3

FDA June 2026 enforcement update — compounding pharmacies

RegAffairsDC Mon, Feb 26, 2024 at 4:00 PM 366 replies 55,812 viewsPage 3 of 20
mark_tokyo
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Feb 28, 2024 at 11:17 PM#11
JenPlateau said:
The shortage clause is the answer to the second question and it is a subtraction rather than an addition.

This answered a question I did not know how to ask.

Last edited: Feb 29, 2024 at 2:17 AM
46 21pete_manc_UK, anna.melb_AU, mark_tokyo and 43 others
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paige_pharma
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Omaha, NE
Mar 1, 2024 at 7:50 PM#12

Adding the clinical framing, because it changes how the question reads.

Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials:

  1. State Board of Pharmacy license — check on your state BOP website
  2. FDA registration (for 503B) — check on fda.gov
  3. DEA registration if handling controlled substances
  4. PCAB accreditation — voluntary but demonstrates commitment to quality
  5. USP <797>/<800> compliance for sterile compounding

This takes 10 minutes of research and could save you from receiving substandard or unsafe medication.

Last edited: Mar 1, 2024 at 8:50 PM
45 20Dr.SurgeonPGH, rachel_ABQ, traveltech_sara and 42 others
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Dr.AddMedPHL
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Mar 3, 2024 at 4:22 PM#13
Dr.LipidDallas said:
Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.

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.

Last edited: Mar 3, 2024 at 6:22 PM
44 19mike.trainer_LA, sarah_nash92, FitDadDave and 41 others
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TrialTracker_MD
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Mar 5, 2024 at 12:53 PM#14
RegAffairsDC said:
FDA June 2026 enforcement update — compounding pharmacies Posting this as an important update for the compounding & formulation community.

Compounded semaglutide formulations for compounded supply: some pharmacies add ingredients like B12, L-carnitine, or BPC-157 to their semaglutide preparations. Are these beneficial or marketing gimmicks?

My take: B12 addition has some logic (GLP-1s can deplete B12). L-carnitine evidence is weak. BPC-157 for GI protection is theoretically interesting but unproven. I prefer straight semaglutide with no additives — fewer variables, cleaner data on what's working.

Last edited: Mar 5, 2024 at 5:53 PM
43 18Dr.PulmRoch, maya_sedona, stefan_berlin and 40 others
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Admin
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Mar 7, 2024 at 9:23 AM#15

Moderator note: the sourcing question belongs in the vendor section and has been split out.

42 17PeptideSynthNJ, Dr.KarenChen, Dr.NateNeph and 39 others
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