Help FDA regulate OTC drugs


Nonprescription drugs play an increasingly vital role in America’s health care system, providing easy access to drugs that can be used safely without the help of a health care practitioner. This enables consumers to take control of their own health care in many situations.

Because of consumer demand and accessibility of the pharmacist, our profession typically gets many questions from patients asking when certain drugs will be available without a prescription. We also get questions regarding the safety of these products.

Since pharmacists receive many nonprescription product questions, we can advise FDA. As with prescription products, FDA reviews and evaluates nonprescription products, which have benefits outweighing their risks, low potential for misuse and abuse, and adequate labeling; can be used for self-diagnosed conditions; and do not require health professionals for safe and effective use.

The FDA Center for Drug Evaluation and Research (CDER) oversees these drugs. The two divisions within CDER that regulate all nonprescription drug products marketed in the United States are the Division of Nonprescription Regulation Development and the Division of Nonprescription Clinical Evaluation.

The Division of Nonprescription Regulation Development is primarily responsible for updating OTC drug monographs, which are like recipe books covering acceptable ingredients, doses, formulations, labeling, and testing. Products conforming to a monograph may be marketed without FDA preapproval, while those that do not must undergo separate review and approval through the New Drug Application (NDA) process. NDAs involving nonprescription products are primarily handled by the Division of Nonprescription Clinical Evaluation. The NDA process is also used for new ingredients entering the OTC marketplace for the first time.

CDER relies on scientists and regulators to assist in the review process within these two divisions. FDA’s Nonprescription Drug Advisory Committee also meets one to four times per year to assist the agency in evaluating issues surrounding these products.

In general, advisory committees include a chair and several members, as well as consumer, industry, and sometimes patient representatives. Nominations originate from professional societies, industry, consumer and patient advocacy groups, individuals, or other interested persons. Advisory committee members serve overlapping 4-year terms, and new vacancies become available throughout each year. For information about vacancies, visit For information about joining an advisory committee, visit

Pharmacists have a wealth of information about nonprescription products and the needs of our patients. For this reason, we should assist FDA in making decisions affecting our patients and public health. Please consider joining an advisory committee to advocate for patients and the profession.

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