US Consumer Product Safety Commission Postpones Enforcement of Child-Resistant Packaging Requirements

January 14, 2015
Pharmaceutical Technology Editors

Child-resistant packaging requirements for products containing a specified imidazoline will come into effect June 10, 2015.

The US Consumer Product Safety Commission (CPSC) announced Nov. 20, 2014 that it would extend a conditional stay of enforcement of special, child-resistant (CR) 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. Products containing the drug include nasal and ophthalmic products. Enforcement was to begin Dec. 10, 2014, but firms that meet the conditions of the stay now have until June 10, 2015 to comply with the special packaging requirements.

The original stay of enforcement required companies to notify the Commission of their progress towards developing appropriate CR packaging. Because eight of 12 firms notified the Commission that they would not be able to meet the Dec. 10, 2014 deadline, the CPSC extended the stay by six months. Four of the five firms that manufacture ophthalmic products and that have met the requirements to participate in the stay have advised staff that the firms need additional time to produce their products in CR packaging, and four of seven firms that manufacture nasal products and that have met the requirements to participate in the stay have advised staff that the firms need additional time to produce either squeeze-spray or metered pump-spray bottles for their imidazoline products, the CPSC said in an announcement. Difficulties encountered in developing CR packaging included inability to obtain sufficient quantities of special packaging and prototypes that failed the test requirements either initially or when mass-produced. 

Source: US Consumer Product Safety Commission