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ForumsCompounding & Formulation503A vs 503B compounding — looking for input Page 5

503A vs 503B compounding — looking for input

MeganSA_TX Mon, Jan 20, 2025 at 2:31 PM 44 replies 2,688 viewsPage 5 of 9
kevin_tulsa
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Jun 2024
Tulsa, OK
Jan 25, 2025 at 12:20 PM#21

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

Did your prescriber agree with that reading, and if not what was their objection?

27 2fiona_glasgow, Dr.RheumBOS, greg_boulder and 24 others
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steph_laguna
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Nov 2024
Laguna Beach, CA
Jan 26, 2025 at 9:10 PM#22
MariaRD said:
FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA…

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: Jan 27, 2025 at 3:10 AM
26 1GraceAZ_72, carl_compliance, DanielChem_CHI and 23 others
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wanda_boise
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Aug 2024
Boise, ID
Jan 28, 2025 at 6:01 AM#23
MariaRD 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 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.

25 0pam_columbus, nick_SD_fit, ben_calgary and 22 others
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bbq_ray_KC
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Jul 2024
Kansas City, KS
Jan 29, 2025 at 2:53 PM#24
MariaRD 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.

24 24WendyG_ATL, SaraMom3, Dr.MetabolicMD and 21 others
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Dr.SleepRoch
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Rochester, MN
Jan 30, 2025 at 11:46 PM#25

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

Beyond-use dating (BUD) for compounded supply compounded products:

Lyophilized (unreconstituted): typically 12 months from compounding date
Reconstituted with BAC water: typically 28-30 days refrigerated
Reconstituted with sterile water: typically 48 hours (no preservative!)

Always use BAC water for multi-dose vials. Sterile water has no preservative and supports bacterial growth after first puncture. This is a common and potentially dangerous mistake.

23 23roxy_nash, tony_orlando, Dr.NephBHM_UK and 20 others
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