Office of Nonprescription Products What We Do
Over-the-counter (OTC) drug products are those drugs that are available
to consumers without a prescription. There are more than 80 classes
(therapeutic categories) of OTC drugs, ranging from acne drug products to
weight control drug products. As with prescription drugs, CDER oversees OTC
drugs to ensure that they are properly labeled and that their benefits
outweigh their risks.
OTC drugs play an increasingly vital role in America's health care system
by providing easy access to certain 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. There are more
than 100,000 OTC drug products marketed, encompassing about 800 significant
active ingredients.
Most OTC drug products have been marketed for many
years, prior to the laws that require proof of safety and effectiveness
before marketing. For this reason, FDA has been evaluating the
ingredients and labeling of these products as part of "The OTC Drug
Review Program." The goal of this program is to establish OTC drug monographs for each class of products.
OTC drug monographs are a kind
of "recipe book" covering acceptable ingredients, doses,
formulations, labeling, and testing. OTC drug monographs are
continually updated to add additional ingredients and labeling as needed.
Products conforming to a monograph may be marketed without FDA pre-approval,
while those that do not, must undergo separate review and approval through
the New Drug Application (NDA) process. The NDA
process, and
not the monograph process, is also used for new ingredients entering the OTC
marketplace for the first time. For example, the newer OTC drug
products (previously available only by prescription) are first approved
through the NDA process and their "switch" to OTC status is
approved via the NDA process.
FDA's review of OTC drugs is primarily handled by CDER's Office of
Nonprescription Products. However, scientists and regulators throughout CDER, the Office of General
Counsel, and other Centers within FDA are routinely asked to assist in this
massive effort. There is also an advisory committee, the "Nonprescription Drug Advisory
Committee," which meets regularly to assist the agency in evaluating issues surrounding these products.
This interactive chart
provides an overview of the OTC drug review process and how CDER determines the safety and effectiveness of OTC drug products. |
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Date updated: May 29, 2003
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