Life Sciences Blog

Over-the-Counter Drug Product Monographs: What you need to know

by | Jun 3, 2021

Reed Tech recently hosted the first in a series of OTC-focused webinars featuring Reed Tech subject-matter experts and some of our industry friends and colleagues. The series is scheduled to take place throughout the summer. This first webinar, featuring Gary Saner and David Wilson of Reed Tech, included an overview of OTC drug listings including the key differences between OTC monographs and unapproved homeopathics and the requirements of each.

According to the FDA, “An OTC monograph is a ‘rule book’ for each therapeutic category establishing conditions, such as active ingredients, uses (indications), doses, labeling and testing, under which an OTC drug is Generally Recognized As Safe and Effective (GRASE) and can be marketed without a New Drug Application and FDA pre-market approval.” Whereas, Homeopathy is an alternative medical practice that was developed in the late 1700s and is generally based on two main principles. First, that a substance causing symptoms in a healthy person can be used in diluted form to treat symptoms and illnesses, a principle known as “like-cures-like”; and secondly, the more diluted the substance, the more potent it is, which is known as the “law of infinitesimals.”

The main takeaway from this webinar is this side-by-side comparison chart created by Reed Tech and detailing the similarities and differences between OTC Drug Monographs and Homeopathic Products.

 

The webinar also previewed Reed Tech Navigator™ for Drug Labels to show how you can investigate and learn more about published drug labels. Learn more about Navigator for Drug Labels or sign up for a free trial.

Register here for the next webinar in our Over-the-Counter Drug Monograph series.

To learn more, please call us at +215-557-3010 or email us at [email protected].

 

Questions? We are here to help. Visit our Knowledge Center or Contact Us. 

Reed Tech Life SciencesJoin us for our OTC drug product monograph webinar series!

Register here for the next webinar in an ongoing series of OTC-focused webinars featuring Reed Tech subject-matter experts and some of our industry friends and colleagues.