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
14 of 251 rules — including rules the source does not limit to any one scope
US-NAME-001·21 CFR 202.1(a)(1)AI-verified
Ingredient info block must be unbroken when 502(n) data is shown
blockercheckable
US-NAME-002·21 CFR 202.1(a)(2)AI-verified
Ad ingredient order must match order on product label
blockercheckable
US-NAME-003·21 CFR 202.1(a)(2)AI-verified
Ingredient quantity in Rx drug ad must match product label
blockercheckable
US-NAME-020·Section II.ADisputed
Trademark and controlled-substance symbols do not count as intervening matter
notecheckable
US-NAME-021·Section II.AAI-verified
Established name should sit directly right of or below proprietary name
warningcheckable
US-NAME-024·21 CFR 201.10(g)(1) and (2) and 202.1(b)(1) and (2); Section II.BAI-verified
Established name must be at least half size when proprietary name is enlarged in running text
blockercheckable
US-NAME-025·21 CFR 201.10(g)(1) and (2) and 202.1(b)(1) and (2); Section II.BAI-verified
Established name outside running text must be at least half the proprietary name's size
blockercheckable
US-NAME-026·Section II.BDisputed
Type size is measured by actual letter height, not point size
notecheckable
US-NAME-029·21 CFR 201.10(g)(1) and 202.1(b)(1); Section II.DAI-verified
Established name required once in running text when proprietary name is not featured
blockercheckable
US-NAME-030·21 CFR 201.10(g)(1) and 202.1(b)(1); Section II.DAI-verified
Established name required once per detailed-information column
blockercheckable
US-NAME-032·Section II.D.1AI-verified
Print: established name required once in running text when proprietary name only in text
blockercheckable
US-NAME-037·Section II.D.2AI-verified
Bottom-of-screen supers do not require the established name
notecheckable
US-NAME-038·Section II.D.2Disputed
Audio portion of audiovisual/broadcast material need not include established name
notecheckable
US-NAME-041·21 CFR 201.10(g)(1) and 202.1(b)(1); Section II.D.3AI-verified
Digital: established name required once in running text when proprietary name not featured
blockercheckable