RAC Chapter 18N (15)- OTC Drug Products Exam, Questions with Complete Answers 2023

In 1951 the Durham-Humphrey Amendment to the Federal Food, Drug,and Cosmetic Act (FD&C Act) established what three criteria that would limit a drug to prescription status: - Answer-• habit forming drugs • not safe for use unless supervised by a healthcare professional • limited to prescription use under a New Drug Application (NDA) What are the typical characteristics for OTC drugs? - Answer-• benefits clearly outweigh possible risks • potential for misuse and abuse is low • public can use them for self-diagnosed conditions • can be labeled to help assure appropriate use by the average person • healthcare practitioners are not needed for their safe and effective use In general, regulations that apply to prescription drugs also apply to OTC drugs (T/F)? - Answer-True - Regulations relating to all aspects of drug manufacture and testing (current Good Manufacturing Practices (CGMPs)), facility listing and inspection, drug registration, clinical trials and safety oversight apply equally to prescription and OTC drug products. The NDA route of approval for OTCs would involve submission to the agency by one of three processes. What are those processes? - Answer-A 505(b)(1) application; which contains full safety and efficacy trial reports. The trials included in this application are conducted either by or for the applicant, or rights have been obtained by the applicant to reference the data. A 505(b)(2) application; which relies on safety and efficacy data submitted from trials that the applicant did not conduct and did not obtain a right to reference. Essentially, this type of application relies on safety and efficacy data in either the published literature or from data that resulted in an approved NDA previously submitted by another applicant. A (505)(j) application; which is commonly referred to as an ANDA, is used to gain approval of a generic product.