HCPC Requests CR Protocol Review

Erik Swain

In a letter to the new chairman of the Consumer Product Safety Commission (CPSC; Washington, DC), The Healthcare Compliance Packaging Council (HCPC; Falls Church, VA) calls for the commission to "seriously review" its child-resistance (CR) testing protocol.

"Under your leadership, the HCPC is hopeful that CPSC will recognize that the time has come to explore significant changes to the existing protocol," HCPC stated in its October 21, 2002, letter to Harold Stratton. "We are further hopeful that a primary objective of this effort will be the removal of impediments to greater use of unit-dose blister and strip packaging that exist under the current protocol."

Citing CPSC data obtained by HCPC via the Freedom of Information Act (and reported in the January 2001 issue of PMP News), the letter argued that "unit-dose formats are superior to cap-and-vial closures when it comes to protecting small children from accidental poisonings due to ingestion of drug products." However, unit-dose formats are not favored by U.S. pharmaceutical manufacturers because "it is far easier, and less expensive, for them to meet protocol requirements by using cap-and-vial closures."

As a result, the CR protocol for non-reclosable pharmaceutical packaging should be made less subjective than it is now. HCPC also suggested that CPSC review the British and German protocols, which have "objective pass/fail criteria" and "are 'type' tests that preclude the need to retest the same packages over and over again."

The letter led to a meeting between CPSC officials and HCPC's board of directors on November 18, 2002. At the meeting, HCPC asked for either the toxicity element to be removed from the non-reclosable packaging CR protocol or for blisters to be made "comparable with bottles in their ability to bypass CR features" at a patient's request. HCPC executive director Peter Mayberry said the CPSC representatives seemed receptive to HCPC's concerns.

The full text of the letter is available at www.unitdose.org.

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