Rules

Studies on normal subjects must disclose that fact unless drug is for normal individuals

Ingredient info block must be unbroken when 502(n) data is shown

Ad ingredient order must match order on product label

Ingredient quantity in Rx drug ad must match product label

Established name must be at least half size when proprietary name is enlarged in running text

Established name outside running text must be at least half the proprietary name's size

Established name required once in running text when proprietary name is not featured

Established name required once per detailed-information column

Print: established name required once in running text when proprietary name only in text

Digital: established name required once in running text when proprietary name not featured

Broadcast ads must include the major statement in audio (or audio/visual)

Reminder ads are not permitted for drugs with a boxed warning

Submit Promotional Labeling Specimens at Initial Dissemination

Submit Prescription Drug Ad Specimens at Initial Publication

Submit Sample-Carrying Mailers Complete, Minus the Physical Sample

Attach Completed Form FDA-2253 to Ad/Labeling Submissions

Include Current Professional Labeling With Ad/Labeling Submissions

Submit promo materials for FDA review if disseminated within 120 days of approval

After 120 days post-approval, submit promo materials 30 days before use

Submit pre-approval-window promotional materials during preapproval review

Submit post-approval promotional materials at least 30 days before use

Submit advertisements and promotional labeling to FDA per 314.81(b)(3)(i)

Continuing to share a retracted source publication is inconsistent with FDA's recommendation