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ForumsBuyer Beware⚠ Compounding pharmacies with FDA 483 observations — what worked for you? Page 4

⚠ Compounding pharmacies with FDA 483 observations — what worked for you?

LipidDoc_ATL Sat, Oct 19, 2024 at 5:34 AM 29 replies 2,300 viewsPage 4 of 6
FDA_TrackerJim
Senior Member
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Nov 3, 2024 at 4:15 AM#16
PedsEndoPhilly 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.

4 2Dr.Martinez, mike_mod, SarahChen_PharmD and 1 other
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Dr.SurgeonPGH
Senior Member
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Mar 2024
Pittsburgh, PA
Nov 4, 2024 at 11:30 PM#17

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

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.

5 3TomTeleRx, DoseLogDan, SleepFixSam and 2 others
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lisa_labSD
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Oct 2024
San Diego, CA
Nov 6, 2024 at 6:44 PM#18
Dr.SurgeonPGH said:
Regarding compounded supply compounding legality: compounding pharmacies can legally produce semaglutide and tirzepatide while these drugs remain on…

Same pattern here, and in the same order. Posting only so the count is not one.

6 4Dr.PulmRoch, maya_sedona, stefan_berlin and 3 others
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claudia_zurich
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Jul 2024
Zurich, CH
Nov 8, 2024 at 1:57 PM#19
Dr.SurgeonPGH said:
Regarding compounded supply compounding legality: compounding pharmacies can legally produce semaglutide and tirzepatide while these drugs remain on…

Compounding pharmacy response time test for compounded supply: I email customer service at odd hours to test responsiveness. A pharmacy that can't answer questions promptly is a red flag.

My current pharmacy: average response time 2 hours. They answered my questions about storage conditions thoroughly and professionally.

Communication quality is a proxy for operational quality. A pharmacy that communicates well is likely manufacturing well too.

Last edited: Nov 8, 2024 at 7:57 PM
7 5alex_tucson, kevin_tulsa, Dr.PainCLE and 4 others
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Admin
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Nov 10, 2024 at 9:09 AM#20

Moderator note: the sourcing question belongs in the vendor section and has been split out. Tagging this one for the weekly digest.

29 2PeptideSynthNJ, Dr.KarenChen, Dr.NateNeph and 26 others
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