FDA Proposes Rule To Advance Consumer Access To OTC Drugs

The U.S. Food and Drug Administration is proposing a rule that will broaden the range of nonprescription or over-the counter drugs available to consumers.

The rule titled, “Nonprescription Drug Product with an Additional Condition for Nonprescription Use,” is intended to increase options for the development of safe and effective nonprescription drugs. This will enable more people to self-treat certain common conditions and thus improve public health.

Nonprescription or OTC drug products are used by consumers without the supervision of a health care professional. These OTC products play a vital role in America’s healthcare system helping millions to determine their conditions and self-manage them every day.

The “Drug Facts Labeling” on nonprescription drug packaging is the primary source for information for consumers about a product’s intended use, directions for use, and important safety information.

The agency noted that the proposed rule, if finalized, would establish the requirements for a drug company that submits a new application to bring a nonprescription drug product to market with an additional condition for nonprescription use.

When the FDA finds that labeling alone is not sufficient for consumers to appropriately self-select and use a drug product in a nonprescription setting, an application can be submitted proposing an additional condition for nonprescription use that a consumer must successfully fulfill to obtain the nonprescription drug product.

The federal agency noted that public can comment on the proposed rule in the next 120 days after the date of publication in the Federal Register. Following this, FDA will review them and move to develop the final rule.

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