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ForumsBuyer Beware⚠ Compounding pharmacies with FDA 483 observations — what worked for you? Page 3

⚠ 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 3 of 6
hyun_seoul
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Jul 2024
Seoul, KR
Oct 25, 2024 at 3:45 AM#11
claudia_zurich said:
The shortage clause is the answer to the second question and it is a subtraction rather than an addition.

Saving this. It is the first explanation that did not require me to already understand it. Sending this to two other people who asked me the same thing last week.

49 22Dr.ObesityMed, HealthEcon_DC, PedsEndoPhilly and 46 others
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PedsEndoPhilly
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Jun 2024
Philadelphia, PA
Oct 26, 2024 at 11:05 PM#12

Clinical perspective, offered as context rather than as advice.

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.

Last edited: Oct 27, 2024 at 4:05 AM
50 23wendy_avl, jason_paloalto, Dr.LeslieOBGYN and 47 others
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Dr.RenalNash
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Mar 2024
Nashville, TN
Oct 28, 2024 at 6:24 PM#13
PharmacoVig_BOS said:
Compounding pharmacy customer here with experience relevant to compounded supply.

Compounded semaglutide formulations for compounded supply: some pharmacies add ingredients like B12, L-carnitine, or BPC-157 to their semaglutide preparations. Are these beneficial or marketing gimmicks?

My take: B12 addition has some logic (GLP-1s can deplete B12). L-carnitine evidence is weak. BPC-157 for GI protection is theoretically interesting but unproven. I prefer straight semaglutide with no additives — fewer variables, cleaner data on what's working.

1 24Dr.NutriCornell
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HPLC_Greg
Senior Member
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8,901
Feb 2024
Research Triangle, NC
Oct 30, 2024 at 1:42 PM#14
LipidDoc_ATL said:
They are two different exemptions from the same federal requirements and they buy different things.

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

Lyophilized (unreconstituted): typically 6 months from compounding date
Reconstituted with BAC water: typically 28-30 days refrigerated
Reconstituted with sterile water: typically 24 hours (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.

2 0Dr.MetabolicMD, RetaRick_CA
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mike_mod
Moderator
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Nov 2023
New York
Online
Nov 1, 2024 at 8:59 AM#15

Moderator note: leaving this open. It is being argued well and the disagreement is the useful part.

3 1PurityPaulOR, MaxMetOK, MounjBrad
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