BRINGING YOU INFORMATION.  PROVIDING YOU A PLATFORM.

 

 
THE PHARMA REVIEW (JANUARY - FEBRUARY 2018)

Rx to OTC: Regulatory Requirements in US

S. Suman Shekar, Balamuralidhara V.*, M. P. Venkatesh & Abhishek B.V.

Introduction: Rx-to-OTC (Over the Counter) switch refers to the switch of proven prescription drugs (Rx) to non-prescription, OTC status. Rx-to-OTC switch is a data-driven, scientifically rigorous, and highly regulated process that allows consumers to have OTC access to a growing range of medicines. For a medicine to be granted OTC status, it must have a wide safety margin and be effective, and must bear understandable labelling to ensure proper use.

 
Self-care is becoming increasingly popular among health care consumers. The availability of over-the-counter medications makes it possible for consumers to treat numerous ailments without the supervision of a health care professional. The U.S. Food and Drug Administration has procedures in place that allow prescription products to be reclassified as over-the-counter medications if certain criteria are met. Reclassified products have had clinical and economic effects on the U.S. health care system and have led to concerns among health care professionals. Patient education and counselling are particularly important to promote safe and effective use of over-the-counter products. switching of drugs from prescription to OTC have pointed to several benefits of this switch, including lower health care costs, expanded pharmaceutical markets, and greater consumer reliance on self-care.
.
 

 

Go to Content Index Page

PHARMA REVIEW - ARTICLES ARCHIVE ( COMPLETE LIST)

 

The above content is an abstract only. For the full Article please contact:
KONGPOSH Publications Pvt. Ltd.
ICS House, C-19, Commercial Complex, SDA, Opp. IIT Gate, New Delhi, India -110016
Tel.: 26855839, 9811195411
Email: kongposhpub@gmail.com, Website: http://www.kppub.com

 
 
 
 

Copyright KONGPOSH PUBLICATIONS Pvt. Ltd.