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c/compounding·submitted 2 years ago by u/marit_mwangi

three years of 503B threads, summarised so you do not have to read them

Pricingbranch of 6 comments

three years of 503B threads, summarised so you do not have to read them. I have gone back and forth on this for months. A beyond-use date derived from published stability data means something different from one assigned by default rule. Asking which is a fair question and the answer is usually available. A 503A…

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6 comments, started 2 years ago
u/bilal_osei37 points·2 years ago

Asked for potency testing on the finished preparation. They had it. I had assumed they would not.

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u/camila_sandvik54 points·2 years 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/rania_diallo42 points·2 years ago

Potency and sterility testing on the finished preparation are separate from any certificate covering the starting material. Ask which you are being shown.

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u/ismael_pires15 points·2 years ago

compounded is not generic, there is no equivalence claim

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u/usp_appendixMOD19 points·2 years ago

Removed the staff name. Facilities and clinics can be named here; individuals cannot.

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u/lift_heavy_thingsresistance training30 points·2 years ago

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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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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