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ForumsVendor ReviewsFirst time ordering compounded - what do I even look for?? — anyone have experience? Page 2

First time ordering compounded - what do I even look for?? — anyone have experience?

JakeBK_lifts Sat, Oct 19, 2024 at 6:24 AM 37 replies 2,114 viewsPage 2 of 8
dave_SLC
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Aug 2024
Salt Lake City, UT
Oct 19, 2024 at 7:31 AM#6
JakeBK_lifts said:
They are two different exemptions from the same federal requirements and they buy different things.

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.

18 13mike_mealprep, NicoleRaleigh, james_edin and 15 others
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kevin_tulsa
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Jun 2024
Tulsa, OK
Oct 19, 2024 at 7:57 AM#7

One thing that is still open after PharmacoVig_BOS’s answer:

Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?

Last edited: Oct 19, 2024 at 9:57 AM
17 12Dr.RheumBOS, greg_boulder, quinn_sf and 14 others
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pete_nash
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Aug 2024
Nashville, TN
Oct 19, 2024 at 8:23 AM#8
dave_SLC said:
Regarding compounded supply compounding legality: compounding pharmacies can legally produce semaglutide and tirzepatide while these drugs remain on…

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.

16 11mike_mod, SarahChen_PharmD, sarah.morrison and 13 others
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JakeBK_lifts
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Jul 2024
Brooklyn, NY
Oct 19, 2024 at 8:49 AM#9

Closing the loop on my own question.

The bulks-list asymmetry was the piece I had missed entirely. It explains why one of my two pharmacies is still arguing it can supply and the other simply stopped.

15 10kate.chem, DataDave, Dr.GutHealth and 12 others
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LondonLisa
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Mar 2024
London, UK
Oct 19, 2024 at 10:56 AM#10
pete_nash said:
Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials: State Board of Pharmacy…

pete_nash has the substance of this right. The condition it depends on is worth stating. Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces a significant clinical difference for that patient. A grid of fixed doses offered to everybody is not that, whatever the intake form says.

Last edited: Oct 19, 2024 at 12:56 PM
31 4SallyK_inj, CryptoCarl, MariaRD and 28 others
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