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ForumsCompounding & FormulationFDA June 2026 enforcement update — compounding pharmacies Page 6

FDA June 2026 enforcement update — compounding pharmacies

RegAffairsDC Mon, Feb 26, 2024 at 4:00 PM 366 replies 55,812 viewsPage 6 of 20
Dr.PainCLE
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Cleveland, OH
Apr 27, 2024 at 6:24 PM#26
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…

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

10 10Dr.PathRoch, mona_PHX, andrew_nyc and 7 others
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NurseKim_ATL
Senior Member
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Feb 2024
Atlanta, GA
May 5, 2024 at 7:30 PM#27

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)
9 9raj_cambridge, ingrid_STO, pete_nash and 6 others
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JakeSmashed95
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May 13, 2024 at 8:32 PM#28
NurseKim_ATL 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…

Can confirm. Same sequence, different timescale. Posting only so the count is not one.

Last edited: May 14, 2024 at 1:32 AM
8 8alex_tucson, kevin_tulsa, Dr.PainCLE and 5 others
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dave_SLC
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Salt Lake City, UT
May 21, 2024 at 9:29 PM#29
NurseKim_ATL 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 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.

7 7FranDenver, Dr.BariatricHTX, LindaRN_retired and 4 others
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RegAffairsDC
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May 29, 2024 at 10:21 PM#30
NurseKim_ATL 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…

GMP compliance checklist relevant to compounded supply compounding quality:

  • Clean room environment with HEPA filtration
  • Environmental monitoring (viable and non-viable)
  • Personnel training and competency assessment
  • Validated analytical methods for testing
  • Stability testing program
  • Complete batch records and traceability
  • Quality management system with deviation handling

A 503B pharmacy following cGMP should be able to answer questions about ALL of these if you ask. Don't be afraid to ask — it's your health.

Last edited: May 30, 2024 at 12:21 AM
35 10gary_naperville, sean_dublin, hannah_MT and 32 others
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