Over the Counter Drugs

Over-the-counter (nonprescription) drug products play an increasingly vital role in America's health care system. OTC drugs are defined as drugs that are safe and effective for use by the general public without seeking treatment by a health professional.

Over-the-counter (OTC) drugs are developed under the OTC Monograph Process or through the New Drug Evaluation (NDA) Process.  OTC monographs represent regulatory standards for the marketing of non-prescription drug products not covered by new drug applications. These standards provide the marketing conditions for some OTC drug products including the active ingredients, labeling, and other general requirements.  Data presented to support the safety and efficacy of different active ingredients in a particular drug monograph are reviewed by appropriate scientific personnel. Although pre-approval by FDA for drugs marketed under a drug monograph is not required, many companies seek assurance that the product they intend to market under the drug monograph complies with the regulations.

A sponsor seeking to market its product OTC, either as a new NDA or as a switch from a prescription product, applies to the Division of Nonprescription Clinical Evaluation (DNCE) in the Office of Drug Evaluation IV. DNCE will oversee drug development, including the review and regulatory action on Investigational New Drugs (INDs), and may obtain input from the specific subject matter review division (SSMRD) during the development process. After a sponsor submits an NDA, DNCE reviews the consumer studies, the post marketing safety data, the OTC labeling, and any regulatory issues. The SSMRD collaborates with DNCE and typically provides review of the efficacy and safety data related to controlled clinical trials. Additional input is obtained as needed from other disciplines outside of DNCE, including, clinical pharmacology, statistics, and chemistry.

The attorneys of Rick Ruz, PLLC provide its clients with advice on all aspects of the regulations pertaining to Over-the-counter drug products.  To obtain additional information regarding how our firm can help your business navigate through the complex regulatory maze pertaining Over-the-counter drug products, please contact our firm to arrange a consultation.

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300 Sevilla Avenue, Suite 301
Coral Gables, Florida 33134
(P) 1 (305) 921-9326
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