Rules
Aboutfair balancerisk disclosureindication on labelsubstantiationcomparativemisleading presentationname ingredientsubmissionpre approvalscientific exchangedisclosure
Naturepromotional
Document typeadvertisement
Risk info placementdistinct-part
Communication typeadvertisement
Regulatory classprescription-drug
Drug classprescription
Rx statusprescription
Advertising typeprescription-drug-advertisement
Populationhuman-use
Content triggerliterature-or-study-effectiveness-claim
Materialadvertisement
Content typeadvertisement
Active ingredient counttwo-or-more
Proprietary name basismixture-designation
Established name statusnone-for-mixture-designation
Drug classificationprescription
Labeling scenariosingle-proprietary-name-multiple-preparations-no-established-name
Prescription statusprescription-drug
Ad formattelevision
Intended specieshuman
Exemption statusnon-exempt
Approval pathwayaccelerated
22 of 251 rules — including rules the source does not limit to any one scope
US-NAME-004·21 CFR 202.1(a)(3)AI-verified
No fanciful name implying unique effectiveness of a common substance
warningneeds human judgment
US-NAME-005·21 CFR 202.1(a)(4)AI-verified
Inert/inactive ingredients may not be featured to overstate their value
warningneeds human judgment
US-NAME-006·21 CFR 202.1(a)(5)AI-verified
No proprietary name confusable with another drug's name
warningneeds human judgment
US-NAME-007·21 CFR 202.1(b)(1)Disputed
Established name must accompany proprietary name each time featured in prescription drug ads
blockerneeds human judgment
US-NAME-008·21 CFR 202.1(b)(1)Disputed
Established name must appear with proprietary name in running text
blockerneeds human judgment
US-NAME-009·21 CFR 202.1(b)(1)AI-verified
Established name sizing in detailed running-text columns, incl. larger-type proviso
blockerneeds human judgment
US-NAME-010·21 CFR 202.1(b)(1)AI-verified
Relationship between proprietary and established name must be made clear
blockerneeds human judgment
US-NAME-011·21 CFR 202.1(b)(2)Disputed
Established-name lettering ≥ half size of featured proprietary name in Rx drug ads
blockerneeds human judgment
US-NAME-012·21 CFR 202.1(b)(2)AI-verified
Established name must have prominence commensurate with the proprietary name
warningneeds human judgment
US-NAME-013·21 CFR 202.1(c)AI-verified
Place quantitative ingredient info with prominent proprietary name for unnamed drug mixtures
blockerneeds human judgment
US-NAME-014·21 CFR 202.1(c)AI-verified
Quantitative ingredient info prominence must reasonably relate to proprietary name prominence
warningneeds human judgment
US-NAME-015·21 CFR 202.1(d)(1)AI-verified
Listing of established names required with prominent display of shared combination name
blockerneeds human judgment
US-NAME-016·21 CFR 202.1(d)(2), first sentenceAI-verified
Combination-ingredient ads: dosage form name and adjacent 502(n) quantities
blockerneeds human judgment
US-NAME-017·21 CFR 202.1(d)(2), read with 21 CFR 202.1(d)(1)AI-verified
Other dosage forms need quantitative info equal in prominence to name listing
warningneeds human judgment
US-NAME-022·Section II.AAI-verified
Avoid intervening matter that de-emphasizes or obscures the established name
warningneeds human judgment
US-NAME-027·21 CFR 201.10(g)(2) and 202.1(b)(2); Section II.CAI-verified
Established name prominence must be commensurate with proprietary name prominence
blockerneeds human judgment
US-NAME-031·Section II.D.1Disputed
Print: established name once per page or spread suffices for featured proprietary name
warningneeds human judgment
US-NAME-033·Section II.D.1AI-verified
Print: established name once per page or spread when running text spans multiple pages
warningneeds human judgment
US-NAME-034·Section II.D.1AI-verified
Print: multi-column use of proprietary name allows established name once per page or spread
warningneeds human judgment
US-NAME-047·Section IIIDisputed
Combination products: active ingredients should be placed directly right of or below proprietary name
warningneeds human judgment
US-NAME-048·Section IIIAI-verified
Combination products: avoid intervening matter between proprietary name and active-ingredient information
warningneeds human judgment
US-NAME-050·Section IIIAI-verified
Combination products: active ingredients should get commensurate emphasis and contrast
warningneeds human judgment