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ForumsCompounding & FormulationFDA June 2026 enforcement update — compounding pharmacies Page 8

FDA June 2026 enforcement update — compounding pharmacies

RegAffairsDC Mon, Feb 26, 2024 at 4:00 PM 366 replies 55,812 viewsPage 8 of 20
FDA_TrackerJim
Senior Member
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Feb 2024
Rockville, MD
Jul 16, 2024 at 4:13 PM#36
lisa_labSD said:
503A vs 503B compounding pharmacies for compounded supply — this distinction matters enormously: Feature 503A 503B Regulation State Board of Pharmacy…

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 still in shortage, tirzepatide removed from shortage list. This directly impacts compounding availability.

29 4Dr.Martinez, mike_mod, SarahChen_PharmD and 26 others
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dan_philly
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Jul 2024
Philadelphia, PA
Jul 24, 2024 at 2:55 PM#37

The figures, for anyone assembling their own picture. One habit that pays for itself: post the method alongside the number. A figure without its method cannot be checked, and an unchecked figure is how this community accumulates folklore.

I would rather be corrected than agreed with, if it comes to it.

28 3AmyNC_wife, SkepticalSean, Dr.CardioMD and 25 others
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maria_elpaso
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Sep 2024
El Paso, TX
Aug 1, 2024 at 1:33 PM#38

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

Was that from a primary source or from a summary of one?

Last edited: Aug 1, 2024 at 7:33 PM
27 2TrialNerd_Beth, HPLC_Greg, LibrarianMeg and 24 others
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WendyG_ATL
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Apr 2024
Georgia
Aug 9, 2024 at 12:06 PM#39
dan_philly said:
One habit that pays for itself: post the method alongside the number.

I read this differently from dan_philly, on substance rather than tone. The objection nobody has made: this only works if the measurement is doing what we assume it is doing, and that assumption has not been tested here.

26 1AttorneyGrant, DebRD_ATL, KristenIndy and 23 others
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SaraMom3
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Aug 2024
Ohio
Aug 17, 2024 at 10:35 AM#40
dan_philly said:
One habit that pays for itself: post the method alongside the number.

No disagreement, though it depends on where somebody is starting from, and this thread has been assuming a starting point nobody stated.

Last edited: Aug 17, 2024 at 2:35 PM
4 4ZaraB_AL, JakeSmashed95, NauseaFreeNow and 1 other
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