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Regulation of OTC (over-the-counter) Drugs

Development and Regulation of OTC (over-the-counter) Drug Products

Over-the-counter (OTC) drugs are developed under the OTC Monograph Process or through the New Drug Application (NDA) Process. FDA's review of OTC drugs is primarily handled by the Center for Drug Evaluation's Office of Drug Evaluation IV.

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. These cases are primarily handled by DNDP unless consultation with the Division of Unapproved Drugs and Labeling Compliance or another review division is necessary. If a drug cannot comply with the drug monograph, an IND and approved NDA is necessary before the drug product may be marketed.

OTC Drugs Developed Through the NDA Process

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 Drug Products (DNDP) in the Office of Drug Evaluation IV. DNDP 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, DNDP reviews the consumer studies, the post marketing safety data, the OTC labeling, and any regulatory issues. The SSMRD collaborates with DNDP 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 DNDP, including clinical pharmacology, statistics, and chemistry.

OTC Drugs Developed Under the OTC Drug Monograph Process

The Over-the-Counter (OTC) Drug Review was established to evaluate the safety and effectiveness of OTC drug products marketed in the United States before May 11, 1972. It is a three-phase public rulemaking process (each phase requiring a Federal Register publication) resulting in the establishment of standards (drug monographs) for an OTC therapeutic drug class.

The first phase was accomplished by advisory review panels. The panels were charged with reviewing the active ingredients in OTC drug products to determine whether these ingredients could be generally recognized as safe and effective for use in self-treatment. They were also charged with reviewing claims and recommending appropriate labeling, including therapeutic indications, dosage instructions, and warnings about side effects and preventing misuse.

According to the terms of the review, the panels classified ingredients in three categories as follows:

Category I: generally recognized as safe and effective for the claimed therapeutic indication;

Category II: not generally recognized as safe and effective or unacceptable indications;

  • Category III: insufficient data available to permit final classification

The second phase of the OTC Drug Review is the agency’s review of active ingredients in each class of drugs, based on the panel’s review of ingredients, on public comment, and on new data that may have become available. The agency, in turn, publishes its conclusions in the Federal Register in the form of a tentative final monograph (TFM). After publication of the TFM, a period of time is allotted for interested parties to submit comments or data in response to the agency’s proposal.

The publication of final regulations in the form of drug monographs is the third and last phase of the review process. The monographs establish conditions under which certain OTC drug products are generally recognized as safe and effective. Products containing active ingredients or indications that are nonmonograph require an approved New Drug Application for marketing.

After publication, a final monograph may be amended, either on the Commissioner’s own initiative or upon the petition of any interested person. OTC drug monographs are continually updated to add, change, or remove ingredients, labeling, or other pertinent information, as needed.

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