On January 25, 2012, CPSC published a Proposed Rule in the Federal Register requiring use of child-resistant packaging for any over-the-counter (OTC) or prescription drug containing 0.08 milligrams or more of an imidazoline in a single package. Imidazolines, including tetrahydrozoline, naphazoline, oxymetazoline, and xylometazoline, are a class of vasoconstrictors indicated for nasal congestion and ophthalmic irritation. In making its determination, CPSC reviewed over 40 years of imidazoline data from FDA’s Adverse Event Reporting System and found numerous cases where imidazolines were associated with serious adverse reactions. CPSC believes that, in accordance with the Poison Prevention Packaging Act of 1970, packages containing 0.08 milligrams or more of an imidazoline should be packaged in special packaging to protect children under 5 years old from serious personal injury or illness due to handling, using, or ingesting such a substance. Comments to CPSC on the Proposed Rule are due by April 9, 2012.

For further information, please contact Georgia C. Ravitz or James R. Ravitz at Arent Fox, LLP. The Proposed Rule can be viewed here.