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ForumsCompounding & FormulationFDA June 2026 enforcement update — compounding pharmacies Page 5

FDA June 2026 enforcement update — compounding pharmacies

RegAffairsDC Mon, Feb 26, 2024 at 4:00 PM 366 replies 55,812 viewsPage 5 of 20
LipidDoc_ATL
Senior Member
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Apr 2024
Atlanta, GA
Mar 18, 2024 at 11:42 AM#21
Dr.RheumBOS said:
Compounded semaglutide formulations for compounded supply: some pharmacies add ingredients like B12, L-carnitine, or BPC-157 to their semaglutide…

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.

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DataDave
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Apr 2024
Washington
Online
Mar 26, 2024 at 1:12 PM#22
Dr.RheumBOS said:
Compounded semaglutide formulations for compounded supply: some pharmacies add ingredients like B12, L-carnitine, or BPC-157 to their semaglutide…

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 4 inspections.

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

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robert_kc
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Oct 2024
Kansas City, MO
Apr 3, 2024 at 2:37 PM#23

A narrower follow-up, since the general answer is now clear:

What would you measure differently if you were starting again?

Last edited: Apr 3, 2024 at 4:37 PM
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LeilaHI
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Jan 2025
Honolulu, HI
Apr 11, 2024 at 3:57 PM#24
DataDave said:
FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA…

Price comparison for compounded supply across sources I've used:

SourceMonthly CostTypePurity Verified
Brand (Ozempic)$1069FDA-approvedN/A (pharma)
503B Compounding$149cGMP compoundedYes (in-house)
503A Compounding$99Patient-specificVaries
Research peptide$59Not for human useOften Janoshik

I use the 503B option — best balance of quality, cost, and legality. The brand price is insane but insurance can help if you qualify.

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PurityPaulOR
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Apr 19, 2024 at 5:13 PM#25
DataDave said:
FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA…

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.

11 11mike_mod, SarahChen_PharmD, sarah.morrison and 8 others
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