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Single comment threadYou are looking at one branch of someone explain telehealth to me like I have not read a paper in years — 17 comments in the full submission. View in context.
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c/compounding·submitted 1 year ago by u/lukas_vermeulen

someone explain telehealth to me like I have not read a paper in years

Regulatorybranch of 7 comments

someone explain telehealth to me like I have not read a paper in years. 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…

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This branch

7 comments, started 1 year ago
u/discount_math_dm23 points·1 year ago

Same view. If the intake asked you nothing, the intake was a formality and you should factor that in.

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u/gallbladder_gary18 points·1 year ago

Same view.

This is the distinction the whole board runs on. Everything else follows from it.

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u/julia_erdogan22 points·1 year ago

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

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u/lift_heavy_thingsresistance training5 points·1 year ago

A 503A pharmacy compounds for an identified patient against a prescription. A 503B outsourcing facility registers with the regulator, may produce without patient-specific prescriptions, and is subject to current good manufacturing practice requirements. The two are governed differently and the difference is not cosmetic.

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u/sofia_nascimento1 point·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/rania_diallo1 point·1 year ago

shortage status changes and the whole arrangement changes with it

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u/yannick_petrov2 points·1 year ago

ask which facility, then ask for their testing

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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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c/compounding rules
  1. Regulatory claims need a citation to the actual rule, notice or docket.
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