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c/compounding·submitted 1 year ago by u/bilal_osei

[Discussion] 503B is doing more work than we give it credit for

Discussionbranch of 14 comments

503B is doing more work than we give it credit for, which sounds obvious until you try to state the evidence for it. Nothing in this thread is medical advice, and the choice between arrangements is one for you and a prescriber who knows your history. Concentration on the compounded vial was different from what I had…

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This branch

14 comments, started 1 year ago
u/lipid_panel_larrybloodwork191 points·1 year ago

a telehealth intake that asks nothing has told you what it is

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u/maren_sorensen148 points·1 year ago

Cosigning the beyond-use date question. What it is based on tells you whether anybody has done stability work.

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u/amara_kuipers121 points·1 year ago

if a clinic will not name the facility, that is your answer

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u/sofia_nascimento44 points·1 year ago

I would not read the price difference as a quality signal. Most of it is the consultation model, not the vial.

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u/jonas_eriksen10 points·1 year ago

Was there potency testing on the finished preparation, or only on the starting material?

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u/marit_laurent8 points·1 year ago·edited

Was there potency testing on the finished preparation, or only on the starting material?

Adding one thing — ask for the facility name. Most will give it, and the ones that will not have answered you.

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u/mateusz_adebayo43 points·1 year ago·edited

Salt form matters for mass: a preparation specified as one salt and dosed as the free base gives you a different amount of peptide for the same number on the label.

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u/marit_laurent14 points·1 year ago

ask which facility, then ask for their testing

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u/naomi_erdogan12 points·1 year ago

Agreed. The 503A versus 503B distinction changes who is allowed to make what, and almost every confused thread here starts by ignoring it.

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[deleted]5 points·1 year ago

[deleted]

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u/slow_logbook2 points·1 year ago

Who is the prescriber, and are they the same organisation as the pharmacy?

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u/stubborn_batchlist_pls5 points·1 year ago

do not assume the concentration matches the branded product

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u/ffmi_watcher4 points·1 year ago

do not assume the concentration matches the branded product

Disagreeing with this bit: registration is not equivalence, and the two get run together constantly.

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u/joaquin_trevino-22 points·1 year ago

Compounded preparations are not approved products and carry no bioequivalence claim. That is a statement about regulatory category, not about quality.

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About c/compounding

Compounded GLP-1s as a supply route: the 503A/503B distinction, the shortage-list mechanics that made compounding legal and then didn't, state board rules, telehealth prescriber models, and what a compounding pharmacy will and will not tell you about its API source.

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