LABELING OPTION PROPOSED FOR 'CONVENIENCE-SIZE' OTC DRUG PACKAGES
OTC drugs in very small "convenience-size" packages could qualify for "optional alternative labeling" under a proposed amendment to the FDA's 1999 final rule on standardized format and content requirements for OTC drug labeling in general.
The agency proposes to define a convenience-size OTC drug package as one containing no more than two doses of an OTC drug. For products marketed for both adults and children, a dose would be defined as a child's dose. In addition, packages would have to be "so small that they cannot accommodate the modified drug facts labeling" set forth in the current regulation "with 60 percent or less of their available labeling space."
However, manufacturers of several OTC drug products, such as syrup of ipecac and activated charcoal, which are used for poison treatment and marketed in single-dose containers, would not be allowed to use the optional alternative labeling "for public health reasons."
The optional alternative labeling would have to include a "Drug Facts" title, active and inactive ingredients, purpose, use, warnings and some of the other information required on other OTC drug labels. The FDA is considering various ways to present that information inside the package.
The announcement of the proposed amendment can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/1998N-0337C-npr0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/1998N-0337C-npr0001.pdf). Public comments can be submitted for 120 days following the Dec. 12 publication date of the proposed amendment in the Federal Register.