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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
Dr.SportsMedIN
Senior Member
1,456
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Feb 2024
Indianapolis, IN
Jan 25, 2025 at 12:20 PM#21
bri_stats said:
Beyond-use dating (BUD) for compounded supply compounded products: Lyophilized (unreconstituted): typically 12 months from compounding date…

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.

27 2lucas_SP_BR, lisa_labSD, adam_van and 24 others
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mona_PHX
Member
189
890
Dec 2024
Phoenix, AZ
Jan 26, 2025 at 9:10 PM#22
bri_stats said:
Beyond-use dating (BUD) for compounded supply compounded products: Lyophilized (unreconstituted): typically 12 months from compounding date…

Vendor communication red flags for compounded supply:

  • Won't provide COA before purchase — walk away
  • Claims "100% pure" without analytical data — unrealistic
  • No physical address or phone number — accountability matters
  • Pushes you to buy more than you need — pressure tactics
  • Won't answer questions about their compounding process — transparency is key
  • Payment only via crypto or wire transfer — legitimate pharmacies accept cards

A legitimate compounding pharmacy operates like a healthcare business, not a gray market dealer.

26 1JenPlateau, SallyK_inj, CryptoCarl and 23 others
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HealthEcon_DC
Member
567
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Apr 2024
Washington, DC
Jan 28, 2025 at 6:01 AM#23
bri_stats said:
Beyond-use dating (BUD) for compounded supply compounded products: Lyophilized (unreconstituted): typically 12 months from compounding date…

Thank you for spelling out the reasoning rather than just the conclusion.

25 0KevinCompounds, TirzTom, TrialTracker_MD and 22 others
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carl_compliance
Member
234
1,123
Nov 2024
Raleigh, NC
Jan 29, 2025 at 2:53 PM#24

Clinical perspective, offered as context rather than as advice.

Regarding compounded supply compounding legality: compounding pharmacies can legally produce semaglutide and tirzepatide while these drugs remain on the FDA shortage list. If/when the shortage resolves, the legal landscape may change.

Stay informed. The FDA shortage list is updated regularly. Current status as of my last check: semaglutide partially resolved shortage, tirzepatide still in shortage. This directly impacts compounding availability.

24 24FDA_TrackerJim, ricardo_MIA, BrianDallas92 and 21 others
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tampaLisa73
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Oct 2024
Tampa, FL
Jan 30, 2025 at 11:46 PM#25
carl_compliance said:
Regarding compounded supply compounding legality: compounding pharmacies can legally produce semaglutide and tirzepatide while these drugs remain on…

Mine went the same way, slower. The detail I would add is minor and it is already implied above.

Last edited: Jan 31, 2025 at 12:46 AM
23 23TomFromTexas, mike.trainer_LA, sarah_nash92 and 20 others
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