Drug Facts for Small Packages


Erik Swain


The smallest over-the-counter (OTC) drug packages have received a temporary reprieve from compliance with FDA's new "Drug Facts" labeling format, which went into effect on May 16, 2002.

The agency intends to amend the labeling requirements for "convenience-size" OTC drug products and is postponing compliance dates for such products until the amendment is published.

The delay applies to products that contain no more than two doses of an OTC drug and that would re-quire using more than 60% of the total surface available to bear labeling for the "Drug Facts" format.

The move follows years of debate between industry and FDA over the rule's impact on the smallest drug packages, as industry believes it will lead to some products being discontinued. The Consumer Healthcare Products Association (CHPA; Washington, DC) had proposed class exemptions for "convenience-size" products, but FDA did not agree with CHPA's proposed definitions of "convenience-size." Subsequently, Lil' Drug Store Products Inc. (Cedar Rapids, IA), a distributor of single-dose medicines, filed a citizen petition asking FDA to define "convenience-size" and requesting the rule be modified for such products. The petition asked for a reduced version of the "Drug Facts" format to appear on the outside, while still having the full version appear on the inside, via inner-package printing or package inserts.

FDA has agreed to publish a definition of "convenience-size" and to address labeling requirements for those packages in a future edition of the Federal Register. In the meantime, packages likely to fall under that rule can continue to use their old labeling formats. (The two-dose maximum that FDA is using for the time being was suggested in the Lil' Drug Store petition.)

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