Did you know that the current regulations for labeling of Over-the-Counter (OTC) drug products were initiated in 1972 as part of the OTC Drug Review? That’s over 50 years ago and the monograph system that arose from that process has not yet come to completion in terms of finalizing regulations for all OTC products.
The monographs establish conditions (for each therapeutic category) under which OTC drug products are generally recognized as safe and effective. These conditions include labeling requirements such as indications, warnings, directions as well as any required testing.
Some monographs are final and codified in the regulations while others are “tentative” in that the monograph was proposed but has not yet been finalized. Marketing a product under a tentative monograph is allowed through FDA’s enforcement discretion as long as it meets the conditions in that monograph. OTC drug products that do not meet the requirements under the monograph system are considered new drugs and must be submitted to FDA through the application process for approval to market.
In addition to the requirements of the monographs, numerous other laws have passed over time and new regulations issued further complicate your labeling.
These myriad requirements can make compliance confusing, not to mention that the industry is still awaiting Senate passage of the Over-the-Counter Monograph Safety, Innovation, and Reform Act which may address some of these issues.
EAS offers review of OTC product ingredients and claims to ensure they are in compliance with Federal regulations. Our experts are also able to assist with the required drug listings and registrations for OTC products. To learn more about our services visit our webpage. You may also wish to view our On-Demand webinars on OTC regulations, also found on our webpage under the Resources tab.