Originally Published PMPN February 2005
NEWS
CPSC Advises No Action on HCPC CR Packaging Petition |
| Drug makers do not need to determine toxic levels when using CR cap-and-vial packages. |
Staff at the U.S. Consumer Product Safety Commission (CPSC) has recommended that no action be taken in response to a petition on child-resistant (CR) packaging filed by the Healthcare Compliance Packaging Council (HCPC).
In a briefing package released on November 23, 2004, CPSC formally responded to an HCPC petition that was filed on March 17, 2003. The petition sought a change in the pass-fail criteria for unit-dose packaging under CPSC’s long-standing test protocol currently used to determine whether packaging is legally considered to be child-resistant.
Specifically, HCPC requested that a straight numerical standard be used such that, if children were able to open or gain access to more than eight dosage units during the entire 10-minute test, the package would be considered a failure. This would be a change from current regulations that require the toxicity of the drug to be considered. HCPC argued that this provision deters manufacturers from using unit-dose formats because they do not have to make such a determination when they use cap-and-vial closures, and that manufacturers sometimes do not know the amount of drug product that could cause serious personal injury or serious illness to a small child.
In its review of the petition, CPSC staff determined that granting HCPC’s request would lower the level of protection offered under the existing protocol. “The CPSC staff does not agree with the HCPC’s assertions regarding the safety of unit packaging,” the staff wrote. “If the change that the petitioner requested is adopted, children would have no protection from the most toxic products, that is, those that can result in serious injury or serious illness following access to eight or fewer units.”
The CPSC staff also noted that there are several unit-dose formats on the market that have an “F1” rating (i.e., children cannot gain access to even a single dosage unit during the 10-minute test), and firms could use any of these formats if they cannot determine harmful dosage levels. “Child-resistant unit packaging providing the most protective levels of child resistance is technically feasible, practicable, appropriate, and commercially available,” the briefing concludes.
The CPSC staff does concede, however, that it can be difficult to determine harmful dosage levels, and indicates that it may be worthwhile to study the feasibility of determining whether an equation could be developed to make such calculations. The CPSC briefing also validates that HCPC’s interpretation of data regarding incidents in which children were either sickened or killed after defeating CR cap-and-vial closures is plausible.
In a response letter dated December 13, 2004, HCPC executive director Peter Mayberry wrote, “The point here is that staff did not even address the primary reason why the HCPC filed the petition in the first place: pharmaceutical manufacturers have repeatedly stated that they do not use unit-dose formats as original packaging in the United States due to concerns with PPPA compliance. CPSC staff also failed to note in the briefing packaging that pharmaceutical manufacturers routinely avoid PPPA compliance by shipping product in bulk containers which are exempted from the Act.” Mayberry concludes his letter by stating that “after carefully considering this portion of the briefing package, we simply have no idea what sort of additional data could be presented to CPSC staff that would allow them to concede the obvious: that unit-dose formats are inherently safer than cap-and-vial closures when it comes to protecting small children from accidental ingestion of drug product.”
HCPC will have an opportunity to challenge the recommendation when it is formally presented to the CPSC commissioners during a public hearing that, at press time, was still yet to be scheduled. Copies of the CPSC recommendation can be found at www.cpsc.gov/library/foia/foia05/brief/childresistpt1.pdf.
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