Regulatory Affairs Certification (RAC) Practice Exam

In the context of regulatory requirements for over-the-counter (OTC) monograph drugs, the correct approach when a company changes a supplier moving production of an OTC monograph drug substance is indeed to conclude that there is no need to report the change. This is because OTC monograph products are governed by a regulatory framework that allows for variations in manufacturing without the need for immediate notifications for certain changes. OTC monographs include provisions for the manufacturing processes and ingredient standards that do not require pre-market approval like prescription drugs. Once a company complies with the monograph, they can change suppliers or make other production adjustments as long as the final product remains within the established standards and specifications outlined in the monograph. Such changes are often considered operational rather than regulatory. Reporting requirements are stricter for prescription drugs and other regulated products, where changes to suppliers can impact patient safety and efficacy, necessitating immediate communication with the FDA. However, for OTC monograph drugs, as long as quality and compliance with the monograph specifications are maintained, these operational changes do not trigger a formal reporting obligation to the FDA.