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

[Question] Spain — has anyone got a straight answer on 503B

Questionbranch of 6 comments

Genuine question, and the title is the question: Spain — has anyone got a straight answer on 503B. Asked for potency testing on the finished preparation. They had it. I had assumed they would not. Kept the label from every vial. When the shortage status changed, having the paper trail made the conversation much…

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6 comments, started 1 year ago
u/escrow_evangelist56 points·1 year ago

The intake asked me three questions and none of them were about my history. That told me everything I needed to know about the model.

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u/neha_krastev13 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/lukas_vermeulenOP11 points·1 year ago

Asked for the beyond-use date basis and got a real answer with a stability reference attached. Not universal, apparently.

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u/lukas_vermeulenOP6 points·1 year ago·edited

Small fix — 503B facilities register with the regulator; 503A pharmacies are licensed by the state board. Different mechanisms.

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[removed]2 points·1 year ago

[removed by moderator]

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u/step_count_stan4 points·1 year ago

ask which facility, then ask for their testing

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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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