FDA Registration For OTC Drugs

Posted by Lisa Capote | Oct 12, 2011 | 0 Comments

OTC drugs are the most common forms of self-medication in the US. Since they are offered over the counter they do not require the client to present a doctor's prescription. Some people argue that this might be a rather unsafe procedure since after all these products are still drugs which need to be taken with care. However there are a number of processes and systems which are used to make such a request legal and safe. One such procedure is the FDA registration for OTC drugs.

Basically the FDA oversees the types of drugs which are allowed to be purchased over the counter. This regulatory body ensures that the products which fall in this category are relatively safe and can be purchased without a prescription.

The regulatory structure for FDA registration of OTC drugs mainly depends on the type of ingredients, the quantity of the active ingredients, and the labeling the particular product is composed of. In fact a study is carried out for each product so as to come up with the drug monograph. This will govern the FDA's decision as to whether to register that particular product as an OTC.

Furthermore, there are a number of other regulations which need to be complied with prior to filing FDA registration and while marketing the OTC drug.

An OTC drug which has a monograph requires that the manufacturer comply with all aspects of the monograph as well as filing FDA registration through FDA's online system. In this application the manufacturer will delineate various aspects relating to the particular product, including active ingredients, inactive ingredients and labeling of the product.

FDA registration also requires annual renewal of registrations to keep track of which products are still in the US market.  The regulatory framework for OTC drug FDA registration can be cumbersome and difficult to maneuver.  Hiring an attorney well versed in the FDA registration process is vital to ensure compliance with FDA regulations.

About the Author

Lisa Capote

Ms. Capote is the founder and Managing Partner of Capote Law Firm. She founded the minority, woman owned law firm in 2006 with the goal to provide quality service to FDA regulated companies. Since that time her practice has grown to include other US federal agencies as well as an international trade component.


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