FDA Proposes Amendments for OTC Drug Labeling Requirements

Rockville, MD (Dec. 12)-The US Food and Drug Administration (FDA, www.fda.gov) is proposing amendments to its final rule regarding labeling requirements for convenience-size over-the-counter human drugs. Drug packages are considered convenience sized if they contain no more than two doses of an OTC drug.

FDA published a final rule that established a standardized format and content requirements for the labeling of OTC drug products in the Federal Register on March 17, 1999. Soon after its publication, Lil’ Drug Store Products, Inc. (Cedar Rapids, IA, www.lildrugstore.com) filed a citizen petition requesting FDA modify the labeling and content requirements of the Drug Facts Rule for convenience-sized OTC drug products. Lil’ claimed that, because of the smaller size of convenience-sized packages, including all the drug information FDA required would consume more than 60% of the packages’ total surface area, thus necessitating an increase in the package size that might inhibit the sale of such packages from convenience stores and vending machines. In addition, Lil’ maintained that the amount of drug in each package was too low for many of the warnings commonly included on the outside of larger packages to be necessary. Lil’ proposed including the complete drug facts, such as title, active ingredients, purposes, uses, and inactive ingredients on the outside label, but including other information on an insert or on the inside of the package label.

In the amendments, FDA rejects Lil’s proposal that the warning to ask a doctor before use if you have certain pre-existing conditions be included inside the package. Lil’ claimed that the dosage being consumed was too low to result in the possible negative side effects, thus making the information unnecessary at point of sale.  FDA disagrees and maintains that such information, as well as information regarding drug–drug and drug–food interactions, be included on the outside of the label.

Nevertheless, FDA agreed that the section warnings regarding signs of toxicity or reactions could be addressed within the package, although warnings about allergic reactions should still appear on the outside. In addition, warnings about keeping the product away from children could appear inside, along with directions for use, provided there is a note on the outside stating where the directions can be found.

FDA also proposes two methods for including the information inside the package. Companies may choose to use a package insert or they may print the drug facts on the inside of the outer container or wrapper.

FDA is seeking comments on its proposed changes.  Any comments may be submitted to the Division of Dockets Management either written or electronically.