Established name must accompany proprietary name each time featured in prescription drug ads

Rule

In an advertisement for a prescription drug (human or veterinary, as defined by 21 CFR 202.1 by reference to FD&C Act 503(b)(1) and 21 CFR 201.105), whenever the proprietary name is featured (e.g., in headlines, logos, or other prominent, non-running-text display), the corresponding established name must accompany it each time. This requirement applies only where an established name corresponding to the proprietary name actually exists ("if such there be"). Where no corresponding established name exists, separate requirements may apply under 21 CFR 202.1(c) (drugs containing two or more active ingredients) or 202.1(d)(1) (one proprietary name used for a combination of active ingredients present in more than one preparation); those paragraphs apply only on their own stated conditions.

Check

First confirm the piece is an advertisement (not promotional labeling or an OTC product) for a prescription drug, and that a corresponding established name exists for the featured proprietary name (if none exists, this rule does not apply — see (c) and (d)(1), which apply only on their own stated conditions). Then locate every instance where the proprietary name is "featured," meaning displayed prominently apart from running text (e.g., in a headline, logo, banner, or standalone prominent placement) — judgment is required to distinguish featured display from running-text use. For each featured instance, confirm the established name appears directly with it, in a type size at least half that of the proprietary name, with the relationship made clear (e.g., "brand of," brackets, or similar). Do NOT flag proprietary name mentions that occur only within the running text of the advertisement as violating this featured-use requirement; however, running text is still subject to the separate per-page requirement in 21 CFR 202.1(b)(1) that the established name be used at least once in the running text in association with the proprietary name, in the same type size used in that text, or at least half as large if the proprietary name appears in larger type — a reviewer should confirm running text is not being treated as unregulated.

Escalate when

Escalate when it is unclear whether a given use of the proprietary name (e.g., large type within a text block, a name appearing at the top/bottom of a column, or borderline typography/layout) constitutes a "featured" use versus running text, when it is unclear whether an established name corresponding to the proprietary name exists, or when it is unclear whether the material is an "advertisement" subject to 21 CFR 202.1 (as opposed to promotional labeling or an OTC product outside this section's scope).