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CPSC Again Delays Enforcing Child-Resistant Packaging for Products with Decongestant Substance

Thursday, November 20, 2014
Sandler, Travis & Rosenberg Trade Report

The Consumer Product Safety Commission has extended again, through June 10, 2015, the conditional stay of enforcement of special packaging requirements for over-the-counter and prescription products containing the equivalent of 0.08 milligrams or more of a specified imidazoline in a single package. This requirement was included in a Dec. 10, 2012, final rule that was effective as of Dec. 10, 2013, but gave firms meeting certain conditions until Dec. 10, 2014, to comply.

Imidazolines are a family of drugs that are used as decongestants in eye drops and nasal products. Products containing imidazolines can cause serious adverse reactions, such as central nervous system depression, decreased heart rate and depressed ventilation, in children who accidentally ingest them. Eye drops and nasal sprays containing imidazolines, which include tetrahydrozoline, naphazoline, oxymetazoline and xylometazoline, are widely available at drug, grocery and mass market retailers.

The CPSC states that firms that meet the following conditions now have until June 10, 2015, to comply with the special packaging requirements specified in the December 2012 rule.

- provide notice to the CPSC of their intent to receive the benefit of the conditional stay of enforcement, which includes a detailed timeline setting forth the steps necessary for the firm to produce child-resistant packaging for its products and a range of time anticipated for completion of each step

- submit during the stay of enforcement for each affected product quarterly status reports that provide (1) proposed packaging specifications, (2) estimated initial production date, (3) progress made and/or steps completed during the quarterly reporting period, and (4) reports of any incidents or exposures involving the firm’s imidazoline-containing products subject to the rule

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