Clarification of Recent FDA Initiatives Affecting OTC Drugs

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FDA/Center for Drug Evaluation and Research

FDA recently announced implementation of two statutory amendments affecting over-the-counter (OTC) drug products.

Because there has been some confusion expressed by stakeholders over these two actions, FDA is issuing this clarification.

Action 1 — On December 22, 2007, FDA’s Center for Drug Evaluation and Research published a notice in the Federal Register announcing the availability of a draft guidance for industry entitled Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. This document was intended to assist stakeholders in complying with the labeling requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 (DSNDCPA).

Section (d) of this law added section 502(x) to the Federal Food, Drug, and Cosmetic Act (FDCA), which requires the label of an OTC drug marketed in the United States without an approved application to include:

a domestic address or domestic phone number through which the responsible person [i.e., the manufacturer, packer, distributor, or retailer identified on the drug label]... may receive a report of a serious adverse event associated with the use of the drug product.

This new statutory provision (and draft guidance) applies to OTC drug products that are marketed without applications (new drug applications (NDAs) or abbreviated new drug applications (ANDAs)) approved under section 505 of the FDCA, including those marketed under the OTC Monograph Drug Review. Section 502(x) of the FDCA does not apply to OTC drug products marketed under approved NDAs or ANDAs.

Action 2 — In an unrelated action, on January 3, 2008, FDA published an interim final rule (the toll-free number interim final rule) to comply with section 502(f) of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Although the toll-free number interim final rule largely applies to pharmacy distribution of prescription drugs, it also has some provisions applicable to the labeling of OTC drug products that are approved under an NDA or ANDA. Under the toll-free number interim final rule (21 CFR 201.66(c)(5)(vii)), OTC drug products that (1) are marketed pursuant to an application approved under section 505 of the FDCA and (2) do not include on their packaging a toll-free number through which consumers can report complaints to the manufacturer or distributor must include a specified label statement in the OTC drug facts format containing the toll-free number for reporting adverse events to FDA (FDA’s MedWatch telephone number). The label statement reads, in pertinent part: “You may report side effects to FDA at 1-800-FDA-1088.”

The following table clarifies the type of OTC drug products affected by each statutory provision and answers specific questions about each of the requirements.

	Toll-Free Number Interim Final Rule	Draft Labeling Guidance
To which OTC drug products does this initiative apply?	OTC products marketed pursuant to applications approved under section 505 of the FDCA	OTC drug products marketed without an approved application
What must be on the drug product’s label?	Unless the packaging includes a toll-free number through which consumers can report complaints to the manufacturer or distributor, the drug facts label must contain a statement including FDA’s toll-free MedWatch telephone number in the content and format specified in 21 CFR 201.66(c)(5)(vii).	The domestic address or phone number at which the manufacturer or other “responsible person” may receive a report of a serious adverse event associated with the use of a drug product.
What is the legislative origin of this initiative?	Best Pharmaceuticals for Children Act of 2001 & Food and Drug Administration Amendments Act of 2007 (FDAAA)	Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 (DSNDCPA)
What is the effective date of these requirements?	The toll-free number interim final rule became effective January 1, 2008	The DSNDCPA requirements became effective December 22, 2007
Will FDA exercise enforcement discretion regarding these requirements?	FDA will exercise enforcement discretion regarding the requirements of the toll-free number interim final rule until January 1, 2009.	FDA will exercise enforcement discretion regarding the labeling requirements of the DSNCDPA until January 1, 2009.

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Date created: January 25, 2008