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ForumsPublic SquareFDA compounding enforcement update — June 2026 guidance document Page 6

FDA compounding enforcement update — June 2026 guidance document

RegAffairsDC Mon, Feb 26, 2024 at 4:00 PM 336 replies 53,782 viewsPage 6 of 20
Dr.PathRoch
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Jun 2024
Rochester, MN
Mar 4, 2024 at 6:07 AM#26
Dr.EndoEP said:
For compounded supply users considering compounded for the first time: here's a step-by-step guide: Get a prescription from your doctor (telehealth…

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.

30 5MikeFit_NJ, InsuranceTom, WendyG_ATL and 27 others
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jim_asheville
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1,234
Aug 2024
Asheville, NC
Mar 4, 2024 at 3:10 PM#27

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

What would you measure differently if you were starting again?

29 4BenResearch_OR, MikeKY_noInsulin, Dr.RaviCardio and 26 others
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jason_paloalto
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890
Nov 2024
Palo Alto, CA
Mar 5, 2024 at 12:13 AM#28
Dr.PathRoch said:
I have been on both brand and compounded, and in the context of compounded supply, my experience has been equivalent with both.

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

SourceMonthly CostTypePurity Verified
Brand (Ozempic)$993FDA-approvedN/A (pharma)
503B Compounding$173cGMP compoundedYes (in-house)
503A Compounding$103Patient-specificVaries
Research peptide$58Not 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.

28 3mona_PHX, andrew_nyc, Dr.EndoEP and 25 others
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PurityPaulOR
Senior Member
1,890
7,890
Mar 2024
Oregon
Mar 5, 2024 at 9:17 AM#29
Dr.PathRoch said:
I have been on both brand and compounded, and in the context of compounded supply, my experience has been equivalent with both.

503A vs 503B compounding pharmacies for compounded supply — this distinction matters enormously:

Feature503A503B
RegulationState Board of PharmacyFDA-registered
PrescriptionRequired (patient-specific)Can compound without patient Rx
TestingVaries by statecGMP required
ScaleSmall batchesLarger production
Quality consistencyVariableGenerally higher

I strongly recommend 503B facilities. The FDA oversight and cGMP requirements mean more consistent product quality.

27 2Dr.Martinez, mike_mod, SarahChen_PharmD and 24 others
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RegAffairsDC
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May 2024
Washington, DC
Mar 5, 2024 at 6:21 PM#30
jason_paloalto said:
Price comparison for compounded supply across sources I've used: Source Monthly Cost Type Purity Verified Brand (Ozempic) $993 FDA-approved N/A…

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

Last edited: Mar 5, 2024 at 8:21 PM
5 5gary_naperville, sean_dublin, hannah_MT and 2 others
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