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From Products Liability Law Daily, November 20, 2014

OTC/prescription drug child-resistance packaging requirements enforcement stay extended

By Pamela C. Maloney, J.D.

The 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 (tetrahydrozoline, naphazoline, oxymetazoline, or xylometazoline) in a single package has been extended by the Consumer Product Safety Commission. The stay was set to expire on December 10, 2014. Firms that meet the conditions of the stay now have until June 10, 2015, to comply with the special packaging requirements. (CPSC Notice, 79 FR 69044, November 20, 2014).

Background. CPSC issued a rule (77 FR 73294, December 10, 2012) requiring special packaging (also called child-resistant or CR packaging) for any over-the-counter or prescription products containing the equivalent of 0.08 milligrams or more of a specified imidazoline in a single package (16 CFR 1700.14(a)(3)). The effective date of the rule was December 10, 2013; however, in consideration of concerns raised in comments on the proposed rule, the Commission gave imidazoline products manufacturers that are subject to the rule a 1-year conditional stay of enforcement.

Conditions of stay. In order to qualify for the stay, manufacturers of these products must: (a) provide notice to the Commission of 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 CR packaging for its products and a range of time anticipated for completion of each step; and (b) submit quarterly status reports during the 1-year stay of enforcement for each affected product. The reports must provide the following information: Proposed packaging specifications; estimated initial production date; progress made and/or steps completed during the quarterly reporting period; and reports of any incidents or exposures involving the firm's imidazoline-containing products subject to the rule.

Reasons for extension of stay. CPSC has granted the stay in response to notification by a number of firms that qualified for the stay that they would be unable to meet the CR packaging requirements before the expiration of the stay. The agency also concluded that the stay was justified based on a significant reduction in National Electronic Injury Surveillance System cases involving these products since the effective date of the final rule.

Firms could submit to CPSC a written request for additional time beyond the June 10, 2015, date. Such a request must specify the period of time needed to produce CR packaging, explain the reasons why additional time is needed and provide a timeline or schedule outlining what the firm will do to comply with the final rule.

MainStory: TopStory DrugsNews ChildrensProductsNews CPSCNews

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