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ForumsCompounding & FormulationIs it normal for the powder to not fully dissolve — my results so far

Is it normal for the powder to not fully dissolve — my results so far

FitDadDave Sat, Feb 22, 2025 at 3:59 PM 9 replies 1,594 viewsPage 1 of 2
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FitDadDave
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Feb 22, 2025 at 3:59 PM#1

Two pharmacies quoted me last year, one describing itself as 503A and one as 503B, and I assumed 503B just meant bigger until both stopped within weeks of each other.

The narrow version of the question is why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission.

Numbers rather than impressions, if you have them.

12 15Dr.NephBHM_UK, kim_atl_prep, sarah_TO and 9 others
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sarah.morrison
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Feb 22, 2025 at 4:13 PM#2

Short answer first, then the reasoning. They are two different exemptions from the same federal requirements and they buy different things. A 503A pharmacy is regulated primarily by the state board, needs a patient-specific prescription, is exempt from CGMP, and may use a bulk substance that has a USP monograph, is a component of an approved drug, or appears on the 503A bulks list — three independent doorways. A 503B outsourcing facility registers with the FDA, is inspected on a risk basis, must comply with CGMP, may compound for office stock without a patient-specific prescription, and has one doorway to a permitted bulk substance: the 503B bulks list, or the drug shortage list.

Ask again with the specifics and you will get a better answer than this one.

13 16roxy_nash, tony_orlando, Dr.NephBHM_UK and 10 others
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greg_boulder
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Feb 22, 2025 at 4:27 PM#3
sarah.morrison said:
They are two different exemptions from the same federal requirements and they buy different things.

Agreed, and the enforcement dates were staggered by category — 503A first, 503B a few weeks later — because outsourcing facilities have manufactured inventory and clinic contracts to unwind while a 503A makes to order.

14 17Dr.DermMIA, fiona_VT, denise_HTX and 11 others
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SurmountFan_IN
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Feb 22, 2025 at 4:41 PM#4
FitDadDave said:
Two pharmacies quoted me last year, one describing itself as 503A and one as 503B, and I assumed 503B just meant bigger until both stopped within…

This matches mine closely enough to be worth saying so. Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists. For 503B the shortage clause was the only route to these molecules, so that route shut completely. A 503A pharmacy can still argue a doorway via "component of an approved drug" — but only for the substance in the form present in the approved product, which is exactly where the base-versus-salt argument lives, and it does nothing about the copy restriction, which came back into force on resolution.

Last edited: Feb 22, 2025 at 5:41 PM
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VendorMark
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Feb 22, 2025 at 5:52 PM#5

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.

16 19claudia_zurich, nancy_portland, rick_sfbay and 13 others
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