Drug Facts for Convenience-Size Packaging

Convenience-size drug products can and should comply with FDA's Drug Facts rule.

Gary L. Yingling, Esq.
Kirkpatrick & Lockhart LLP

Responding to a citizen petition from Lil' Drug Store Products Inc. (Cedar Rapids, IA), a distributor of convenience-size over-the-counter (OTC) drug products, FDA agreed to delay its Drug Facts rule compliance date for convenience-size OTC drug product retail packaging and to consider a proposed modification of that rule as it would apply to these package sizes. While calling for the inclusion of full drug labeling information inside the drug packaging, the petitioner requested truncated versions of warnings, directions, and other drug information on the outer retail drug package. It suggested that the need for the modification is due to cost control.

Mechanical Servants Inc. (Chicago), also a convenience-size drug distributor, strongly disagrees with the proposed modifications. The company expressed legitimate concerns that consumers who are denied important drug labeling information at the point of purchase will be inconvenienced and possibly put at risk of physical harm.

Among other drug labeling information modifications, Lil' Drug Store seeks deletion of preexisting-condition and symptoms warnings from the outer retail package of convenience-size drug products. The petitioner stated that these warnings, which direct certain predisposed consumers to contact a doctor before use of the product, are less important because negative side effects are unlikely to be associated with the low drug dosages delivered in these package sizes.

Mechanical Servants does not agree. Preexisting-condition warnings identify persons who are more susceptible to adverse effects associated with a particular OTC drug product. At the very least, a consumer will be greatly inconvenienced to discover, after purchasing the convenience-size drug package and reading the full labeling information inside the package, that he or she should refrain from use of the drug product.

There is no need for the proposed modification. Convenience-size drug packaging can meet the current Drug Facts requirements through a number of packaging options, including the multipart resealable label option used by Mechanical Servants. While allowing consumers to read all Drug Facts information at the point of purchase, this type of label also maintains complete labeling and package integrity for the retailer if the consumer decides not to purchase the product.

Certainly, the benefits of purchasing a product that can be safely used by the consumer outweigh the miniscule increase in cost associated with Drug Facts–compliant packaging. In fact, the use of the petitioner-proposed truncated version of the Drug Facts panel could very well increase the cost to a purchasing consumer who later finds out, from the full labeling inside the drug product, that the product should not be used.

While Mechanical Servants does not support a truncated Drug Facts panel on the outer retail packaging, it does support a socially responsible mechanism for decreasing package costs while maintaining consumer safety. One possibility would be to limit the information that must appear on the inner package (e.g., often a small pouch or blister package) of a convenience-size OTC drug product.

Because such drug products are generally intended for immediate use, there is little concern that the inner package will become separated from the outer retail packaging. With no safety benefit derived from duplicative labeling, Mechanical Servants believes it is time for FDA to acknowledge, through implementation of a guidance or policy statement, that the "inner package" labeling in most convenience-size drug products can be limited to identifying the proprietary name of the drug product, the lot number, and the expiration date where fully compliant labeling appears on the outer container of the retail package.

Gary L. Yingling, Esq., is a partner with the law firm of Kirkpatrick & Lockhart LLP. His practice focuses on regulatory and legal issues concerning food, drugs, medical devices, and cosmetics. He can be reached at gyingling@kl.com or (202) 778-9124.

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