If you’re a new company, or an existing one with a new OTC drug product, you may be considering giving away free samples to entice customers into a future purchase. Or perhaps you just want to sell your product in a small convenience-size pack so it can be displayed in a grocery store or gas station check-out location. Marketing small packs such as these presents difficulties in terms of accommodating all of the label information required to meet FDA compliance.
When the FDA published the final rule establishing the standardized format and content (“Drug Facts”) regulations in 1999, it made no exceptions for these small packs. Indeed, in the Comments section of the Federal Register notice, the agency specifically stated that it considered the Drug Facts information essential for safe use of the product, irrespective of the size or shape of the package, and advised manufacturers to reconfigure their packaging to meet the requirements of the regulation.
Fast forward to 2002, at about the time that the Drug Facts requirements were to become effective, the FDA issued a partial delay of compliance for “convenience-size” OTC drug products in response to a citizen petition that had been submitted to the agency. The FDA agreed that some accommodation may be appropriate for these products based on their limited use. At that time, the FDA defined convenience-size package as one that (1) contains no more than two doses of the drug product and (2) because of its limited available labeling space, would require more than 60 percent of its total surface area available to bear labeling to meet the labeling requirements of 21 CFR 201.66 and therefore qualify for the modified labeling format. To clarify further, the agency defined dose as the maximum single-serving for an adult (or child for products marketed only for children) as specified in the product's directions for use. For products marketed with directions for both adults and children, dose would mean a maximum single serving for a child as specified in those same directions.
As a result of this stay, manufacturers selling convenience packs were allowed to continue to market their product in a labeling format different from that specified in the regulation, although the labeling would still have to comply with all other regulatory requirements (e.g., statement of identity, declaration of quantity, name and place of business, etc.)
The issue was next addressed by the FDA in the form of a proposed rule published in the Federal Register in December 2006, in which the agency retained the definitions noted above and outlined alternative labeling requirements that would allow for certain information to be omitted from the outer package, provided it was available inside the package (and the consumer directed to “See information inside before using.”) It was noted at the time that “the proposed definition of ‘dose’ would also apply to sample and trial-sized packages that contain only one or two dosage units of an OTC drug.”
As with any proposed rule, the FDA invited specific comments from industry and other interested parties, but to date no final rule has been published. In the meantime, for those companies wishing to market convenience- or trial-size packages, these proposed rules provide guidance as to how the products should be labeled to meet the requirements of the Drug Facts regulation and provide consumers with the information that they need for safe use of the drugs.