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

help me understand telehealth, I have read the wiki twice

Regulatorybranch of 14 comments

help me understand telehealth, I have read the wiki twice. Searched first, found three threads that contradict each other, hence the post. Compounded preparations are not approved products and carry no bioequivalence claim. That is a statement about regulatory category, not about quality. Why "compounded" is not…

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14 comments, started 1 year ago
u/camila_sandvik0 points·1 year 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/kian_ferreira1 point·1 year ago

Careful. Naming a clinic without describing what actually happened turns this into a different kind of thread.

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u/yannick_petrov1 point·1 year ago·edited

Correction: patient-specific refers to the prescription, not to a bespoke formulation. Common misreading and it changes the argument.

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u/honest_syringe_20251 point·1 year ago

the pharmacy and the prescriber are two separate questions

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u/tobias_vukovic1 point·1 year ago

ask what the beyond-use date is based on

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u/prior_auth_painappeals1 point·1 year ago

Agreed on potency testing of the finished preparation. That is a different question from the purity of the starting material.

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u/ignacio_vanhecke1 point·1 year ago

Disagree — a 503B being registered does not make its preparations equivalent to an approved product. Different regulatory category entirely.

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u/rt_shift_reggieOP1 point·1 year ago

Concentration on the compounded vial was different from what I had been using and I nearly did the arithmetic on autopilot.

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[removed]1 point·1 year ago

[removed by moderator]

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u/rt_shift_reggieOP1 point·1 year ago

Is the compound still on the shortage list where you are?

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u/hassan_chowdhury1 point·1 year ago

Not convinced. You are comparing a compounded concentration with a branded one and assuming they match.

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u/step_therapy_s1 point·1 year ago

Potency and sterility testing on the finished preparation are separate from any certificate covering the starting material.

camila_sandvik is right about the concentration trap. It breaks arithmetic that has been reliable for months.

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u/sofia_danquah1 point·1 year ago

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

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u/camila_mensa1 point·1 year ago

compounded is not generic, there is no equivalence claim

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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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