The FDA has issued a proposed rule to establish requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU), which might include a questionnaire administered via a website, a mobile application, or a display screen at a pharmacy kiosk. The proposed rule, if finalized, would establish additional application requirements, labeling requirements, and post-marketing reporting requirements that an applicant must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a health care practitioner. The FDA believes that this proposed rule would increase options for applicants to develop and market safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers. Comments are due to FDA by Oct. 26, and NCPA plans to comment.
NCPA
