Rule CG-CMP-002

Regulatory status: what rule CG-CMP-002 checks

Rule CG-CMP-002 is one of the checker's regulatory status rules. It cites 21 U.S.C. 353a. The reason, source and safer wording are below.

CG-CMP-002 · Warns · Citation checked against stored text
Section 503A covers drugs compounded for an identified individual patient on a valid prescription. Copy that offers compounded drugs with no prescription, or the same product for everyone, signals compounding outside that exemption.
Source: 21 U.S.C. 353a(a) - compounded for an identified individual patient based on a valid prescription order or notation
Safer wording: Say that compounded medicines are prepared for a specific patient after a prescriber's evaluation, and remove any no-prescription or for-everyone language.
21 U.S.C. 353a · Needs counsel review

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