Enacts new GS 106-138.1 in Article 12 of GS Chapter 106, the North Carolina Food, Drug and Cosmetic Act. Violations of this Article are a Class 2 misdemeanor and violators may be assessed a civil penalty of not more than $2,000.
Sets out requirements for advertisements by a manufacturer of prescription drugs or biological products or an affiliate of the manufacturer or a labeler that receives prescription drugs or biological products from a manufacturer or wholesaler and repackages those drugs or biological products for later retail sale and that has a specified labeler code from the FDA. Defines prescription drug as a drug that under federal law is required, prior to being dispensed or delivered, to be labeled with the following statement: "Caution: Federal law prohibits dispensing without a prescription." Requires that a manufacturer include the following in any regulated advertisement: (1) the date the prescription drug or biological product received approval from the FDA for the advertised use of the drug or product; (2) the date the prescription drug or biological product was first available for purchase by consumers in the US; (3) for any side effect that must be included in an advertisement for a prescription drug or biological product under section 352(n) or 353(c) of Title 21 of the US Code, or any federal regulation or rule issued pursuant to Title 16 of the US Code, the regulated advertisement must include at least the following for any clinical trial which evidenced the side effect that must be listed: a. the length of the trial; b. the number of trial participants; and c. the frequency of the listed side effect, expressed by the number or percentage of participants experiencing the side effect. Defines regulated advertisement as a presentation made to consumers located in North Carolina of a commercial message regarding a prescription drug or biological product by a manufacturer made through any media, including television, radio, internet, and print advertisements. Also defines biological product and clinical trial. Applies to advertisements for a prescription drug or biological product published in this state on or after October 1, 2025.