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Evidence-based GLP-1 & peptide discussion since 2023
ForumsPublic SquareFDA compounding enforcement update — June 2026 guidance document Page 5

FDA compounding enforcement update — June 2026 guidance document

RegAffairsDC Mon, Feb 26, 2024 at 4:00 PM 336 replies 53,782 viewsPage 5 of 20
InsuranceTom
Senior Member
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Mar 2024
Connecticut
Mar 2, 2024 at 8:54 AM#21
BethLabQueen said:
Compounding pharmacy red flag checklist for compounded supply — if ANY of these apply, find a different source: No verifiable physical address No…

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.

35 10lisa_labSD, adam_van, Dr.SurgeonPGH and 32 others
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Dr.SurgeonPGH
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Mar 2024
Pittsburgh, PA
Mar 2, 2024 at 5:56 PM#22
BethLabQueen said:
Compounding pharmacy red flag checklist for compounded supply — if ANY of these apply, find a different source: No verifiable physical address No…

That reframing is the part I needed. Adding it to my notes with a link back to this thread.

34 9TomTeleRx, DoseLogDan, SleepFixSam and 31 others
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Dr.EndoEP
Member
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Oct 2024
El Paso, TX
Mar 3, 2024 at 2:58 AM#23

Clinical perspective, offered as context rather than as advice.

For compounded supply users considering compounded for the first time: here's a step-by-step guide:

  1. Get a prescription from your doctor (telehealth counts)
  2. Research 503B compounding pharmacies with good community reviews
  3. Verify their FDA registration and inspection history
  4. Request a COA for your specific compound before ordering
  5. Start with a 1-month supply to test
  6. Consider sending a sample to Janoshik for independent verification
  7. Track your response compared to brand (if you were on it previously)
Last edited: Mar 3, 2024 at 4:58 AM
33 8FranDenver, Dr.BariatricHTX, LindaRN_retired and 30 others
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PedsEndoPhilly
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Jun 2024
Philadelphia, PA
Mar 3, 2024 at 12:01 PM#24
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…

Same pattern here, and in the same order. Posting only so the count is not one.

32 7Dr.LeslieOBGYN, MikeNYC_runner and 29 others
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pat_auckland
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Jun 2024
Auckland, NZ
Mar 3, 2024 at 9:04 PM#25
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…

Compounding pharmacy customer here with experience relevant to compounded supply.

I've ordered from 2 different compounding pharmacies over the past 2 years. The quality variation is real — purity ranged from 94% to 101% of label claim based on independent Janoshik testing.

My current compounder (a 503B facility) has been consistently 98-101% purity across 10 orders. I pay $121/month vs $1,291 for brand. The savings are substantial and the product is equivalent in my experience.

Re: compounded supply — this applies whether you're using brand or compounded. The clinical principles are the same.

Last edited: Mar 4, 2024 at 1:04 AM
31 6dan_philly, MeganSA_TX, LarryQC_SD and 28 others
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