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ForumsCompounding & FormulationUSP <797> 2023 revision impact on peptide compounding — need advice Page 3

USP <797> 2023 revision impact on peptide compounding — need advice

Dr.PulmRoch Sun, Oct 6, 2024 at 4:53 PM 18 replies 2,010 viewsPage 3 of 4
Dr.EndoIndy
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Oct 7, 2024 at 12:02 PM#11
Dr.SleepRoch said:
They are two different exemptions from the same federal requirements and they buy different things.

This answered a question I did not know how to ask. Adding it to my notes with a link back to this thread.

47 22mia_MS2, LeilaHI, marcus_mpls and 44 others
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VanRx_Mike
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Oct 7, 2024 at 3:39 PM#12

From the other side of the consultation, briefly.

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 4 hours. They answered my questions about reconstitution thoroughly and professionally.

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

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Dr.PeteFamMed
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Oct 7, 2024 at 7:16 PM#13
SarahChen_PharmD said:
Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials: State Board of Pharmacy…

Compounded has been just as effective for me. If compounded supply is the concern, the COA from my 503B pharmacy shows 99.1% purity. Verified by Janoshik.

Last edited: Oct 7, 2024 at 8:16 PM
45 20LindaRN_retired, tommy_boulder, hyun_seoul and 42 others
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Dr.RaviCardio
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Oct 7, 2024 at 10:53 PM#14
Dr.PulmRoch said:
Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.

Beyond-use dating (BUD) for compounded supply compounded products:

Lyophilized (unreconstituted): typically 9 months from compounding date
Reconstituted with BAC water: typically 28-30 days refrigerated
Reconstituted with sterile water: typically 7 days (no preservative!)

Always use BAC water for multi-dose vials. Sterile water has no preservative and supports bacterial growth after first puncture. This is a common and potentially dangerous mistake.

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mike_mod
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Oct 8, 2024 at 2:30 AM#15

Moderator note: a post naming a supplier has been edited. Discuss suppliers in the review sections, not here. No action needed from anybody.

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