Rule CG-CMP-001

Regulatory status: what rule CG-CMP-001 checks

Rule CG-CMP-001 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-001 · Warns · Citation checked against stored text
A pharmacy or physician that compounds under section 503A may advertise the compounding service but not the compounding of a particular drug, class of drug or type of drug, or it loses the section 503A exemptions. Promoting a named compounded drug is the pattern FDA warns about.
Source: 21 U.S.C. 353a(c) - a pharmacy, pharmacist or physician may not advertise or promote the compounding of any particular drug, class of drug or type of drug, but may advertise the compounding service
Safer wording: Describe the compounding service in general terms, for patients with a valid prescription, and do not name the compounded drug in the promotion. Have counsel review before publishing.
21 U.S.C. 353a · Needs counsel review

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