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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
sean_dublin
Member
212
890
Nov 2024
Dublin, IE
Mar 4, 2024 at 6:07 AM#26

From the other side of the consultation, briefly.

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.

Last edited: Mar 4, 2024 at 7:07 AM
30 5hannah_MT, Dr.SportsMedIN, amy_econ_NJ and 27 others
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Dr.EndoIndy
Member
267
1,234
Oct 2024
Indianapolis, IN
Mar 4, 2024 at 3:10 PM#27
sean_dublin said:
Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials: State Board of Pharmacy…

Adding a me-too, because a thread of one person's experience is not much use. The detail I would add is minor and it is already implied above.

29 4LeilaHI, marcus_mpls, DeniseRN_TPA and 26 others
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ChrisMacros
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567
2,345
Sep 2024
Michigan
Mar 5, 2024 at 12:13 AM#28
sean_dublin said:
Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials: State Board of Pharmacy…

Compounded semaglutide formulations for compounded supply: some pharmacies add ingredients like B12, L-carnitine, or BPC-157 to their semaglutide preparations. Are these beneficial or marketing gimmicks?

My take: B12 addition has some logic (GLP-1s can deplete B12). L-carnitine evidence is weak. BPC-157 for GI protection is theoretically interesting but unproven. I prefer straight semaglutide with no additives — fewer variables, cleaner data on what's working.

28 3HPLC_Greg, LibrarianMeg, bri_stats and 25 others
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dave_SLC
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345
1,567
Aug 2024
Salt Lake City, UT
Mar 5, 2024 at 9:17 AM#29
sean_dublin said:
Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials: State Board of Pharmacy…

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.

27 2FranDenver, Dr.BariatricHTX, LindaRN_retired and 24 others
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RegAffairsDC
Member
678
3,456
May 2024
Washington, DC
Mar 5, 2024 at 6:21 PM#30
ChrisMacros said:
Compounded semaglutide formulations for compounded supply: some pharmacies add ingredients like B12, L-carnitine, or BPC-157 to their semaglutide…

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

SourceMonthly CostTypePurity Verified
Brand (Ozempic)$1013FDA-approvedN/A (pharma)
503B Compounding$143cGMP compoundedYes (in-house)
503A Compounding$123Patient-specificVaries
Research peptide$53Not 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.

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