Abstract
In the United States, nonprescription drug products are regulated through implementation of laws enacted by Congress. The Food and Drug Administration (FDA) follows specific procedures that allow for public notice and comment when promulgating implementing regulations. Drug products may be marketed directly to consumers, unless they are limited to prescription use only because they meet certain criteria. Nonprescription drug products are marketed over the counter (OTC) pursuant to drug ingredient-use monographs or as approved new drugs for an OTC use. These United States regulatory pathways require evidence of safety, efficacy, and labeling that consumers can understand that renders the product not adulterated or misbranded. All new drugs are required to comply with specific postmarketing surveillance practices.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
