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

help me understand 503B, I have read the wiki twice

Regulatory Receipts ×6 Cold Box ×1 Well Actually ×1

503B. That is the whole post, but I will justify it.

Everything else people worry about in c/t2dglp1 is downstream of it. Titration speed, reflux, the endless dose arguments — most of it resolves if you sort 503B out first, and almost nobody does.

I say this having got it wrong for 2 months. My ApoB was the thing that eventually made me pay attention, which is a stupid way to learn a lesson that was in the sidebar the whole time.

2,931 up / 311 down90% upvoted43 commentsid 1nz0b225 Aug 2024

43 comments

24 in this archive, depth 6

best — the order this archive was captured in

u/usp_appendixcompendial253 points·1 year ago

Mechanistically the bit that matters is 503B. It explains most of the early profile and a decent chunk of the outcome.

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u/ahmed_fonseca159 points·1 year ago

state board rules differ, say which state

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u/niels_roos97 points·1 year ago

Yeah, 503A and 503B are different regulatory animals.

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u/vikram_mbeki36 points·1 year ago

API transparency is the question that separates good compounders from sketchy ones

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u/rt_shift_reggieOP-8 points·1 year ago

shortage list status is state board, check the actual list

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u/tove_ogunleye1 point·1 year ago

shortage list status is state board, check the actual list

Yes, exactly this, and it is the bit that took me 36 weeks to accept.

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u/solene_eriksen1 point·1 year ago

the shortage list is temporary, it ends and compounding becomes illegal again

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u/dario_stanescu1 point·1 year ago

You have restated the marketing copy. What is the actual substance here.

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u/sigrid_kaufmann1 point·1 year ago

API transparency is the question that separates good compounders from sketchy ones

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u/ismael_pires41 points·1 year ago

Are we talking 503A or 503B?

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u/naomi_erdogan53 points·1 year ago

shortage list status is compounding, check the actual list

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u/camila_sandvik175 points·1 year ago

Half-life is about 168 hours, so steady state lands around week 10–5. Practical consequence: what you feel in week 1 is not what that dose does.

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u/kian_ferreira94 points·1 year ago

503B compounding is different from 503A, different rules, different legality

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u/yannick_petrov73 points·1 year ago

This is correct. The shortage list does expire and the rules change.

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u/honest_syringe_202540 points·1 year ago

I am going to push back on this slightly.

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u/tobias_vukovic32 points·1 year ago·edited

no pharmacy referral codes, naming is fine, recruiting is not

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u/prior_auth_painappeals13 points·1 year ago

telehealth prescriber models exist, pricing differs by state

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[removed]28 points·1 year ago

[removed by moderator]

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u/julia_erdogan107 points·1 year ago

Mechanistically the bit that matters is shortage list. It explains most of the early profile and a decent chunk of the outcome.

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u/tobias_vukovic85 points·1 year ago

the the UK situation is different from the US, different regulations

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u/enzo_ferrari58 points·1 year ago

API transparency is the question that separates good compounders from sketchy ones

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u/hugo_bergstrom40 points·1 year ago

the 503A/503B distinction is load-bearing, do not blur it

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u/quiet_moderatorMOD93 points·1 year ago

Removed a chain here. The rule is one line long and it is not negotiable.

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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.
  2. No pharmacy referral codes. Naming a pharmacy is fine; recruiting for it is not.
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