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

why does nobody talk about 503A

Regulatorybranch of 7 comments

why does nobody talk about 503A. I would rather ask a basic question now than get this wrong quietly for two months. Compounded preparations are not approved products and carry no bioequivalence claim. That is a statement about regulatory category, not about quality. The shortage list is the legal hinge: the…

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7 comments, started 1 year ago
u/eu_apotheke_a235 points·1 year ago

Nothing in this thread is medical advice, and the choice between arrangements is one for you and a prescriber who knows your history.

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u/prior_auth_painappeals191 points·1 year ago

ask which facility, then ask for their testing

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u/ignacio_vanhecke61 points·1 year ago

the price difference is mostly the intake, not the vial

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u/controversial_only23 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/milos_mensa14 points·1 year ago

What concentration is on the label, and does it match what you were expecting?

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u/gustav_cardoso6 points·1 year ago

a 503B has to register and report, so there is a paper trail to ask for

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u/incretin_ivypharmacology3 points·1 year ago

Yes. The shortage list is the legal hinge for the whole arrangement and its status is public.

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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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