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

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

Questionbranch of 10 comments

Genuine question, and the title is the question: Denmark — has anyone got a straight answer on 503B. The shortage list is the legal hinge: the permissions that allow certain compounding to happen at scale are tied to a drug’s shortage status, which changes. Compounded preparations are not approved products and carry…

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10 comments, started 2 years ago
u/solene_eriksen92 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/ahmed_okafor76 points·2 years ago

Nothing in this thread is medical advice, and the choice between arrangements is one for you and a prescriber who knows your history.

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u/solene_eriksen18 points·2 years ago

Switched between two compounded preparations and the concentration on the label was different. Redid the arithmetic on paper before drawing anything.

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u/usp_appendixcompendial22 points·2 years ago

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.

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u/ismael_pires5 points·2 years ago

ask what the beyond-use date is based on

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u/rania_diallo15 points·2 years 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/camila_mensa10 points·2 years ago

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

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u/kavya_kravchenko8 points·2 years ago

shortage status changes and the whole arrangement changes with it

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u/eu_apotheke_a7 points·2 years ago

potency testing on the finished preparation is the thing to ask for

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u/lift_heavy_thingsresistance training64 points·2 years ago·edited

the price difference is mostly the intake, not the vial

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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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