HCPC's Petition to CPSC on Test Protocol
The Healthcare Compliance Packaging Council (HCPC; Falls Church, VA) has filed a petition asking the Consumer Product Safety Commission (CPSC; Bethesda, MD) to alter some provisions of the child-resistant/senior-friendly (CR/SF) test protocol in 16 CFR 1700–1750.
In a letter to CPSC secretary Todd Stevenson, dated March 17, 2003, the HCPC asked the commission to delete the subjective portions of the protocol for nonreclosable packaging and adopt type testing provisions allowing a package type to be considered compliant once it has passed, without being retested.
HCPC promotes the benefits of unit-dose packaging, and its membership consists of firms that make such packaging and its materials and machinery. The council argues that the current protocol creates a disincentive for U.S. pharmaceutical manufacturers to use unit-dose packaging, even though it is inherently safer than cap-and-vial closure systems.
“Unlike any type of closure system…unit-dose formats require that each unit be removed one at a time. This allows more time for children to lose interest, or for adults to intervene, should a child come into contact with a drug product,” the letter states. “In addition, unit-dose systems, by their design, do not need to be properly resecured after each use and, therefore, their CR properties are not dependent on repeated proper usage by adult consumers.”
HCPC noted that it has reviewed CPSC data from 1983 through 2002 and found “extremely compelling” evidence that child-resistant unit-dose packaging is less likely to be involved in poisoning incidents than cap-and-vial systems.
It said, however, that the CPSC protocol creates a disincentive to use unit-dose nonreclosable packages because it defines a failure as a child gaining access to at least eight units during the testing period, or fewer units if fewer would be a toxic dose to a child.
The problem, HCPC said, is that when a firm begins designing its CR protocol, it may not have enough data to determine how toxic the product is, and thus often defaults to an overly conservative number. This results in package designs that can be extremely difficult for seniors to open.
Thus, HCPC asked that all unit-dose nonreclosable packages be uniformly held to eight units as a failure standard, thus eliminating judgment calls by pharmaceutical manufacturers. Using eight as the standard “would require unit packaging to be fortified in such a way that would make it far more protective than a unit-dose package that has no CR feature at all,” but would not put children at risk. “CPSC’s own data show that children ingest very few dosage units when they gain access to unit-dose formats (even those that have no CR feature).”
HCPC also requested that CPSC allow a unit-dose package type that has successfully passed protocol testing to be used for other products without additional testing. Such type testing is currently allowed for cap-and-vial closures but not for unit-dose formats, creating another disincentive for their use, the council said.
The letter also urged action based on the January 21, 2003, decision by the U.S. Court of Appeals for the Second Circuit, which overturned an FDA regulation requiring many iron products to be packaged in unit-dose formats. If neither FDA nor CPSC can make such a mandate, the least CPSC could do is remove obstacles to the use of unit-dose packaging, HCPC stated.
Lastly, the letter stated that 16 CFR 1700–1750 was developed long before unit-dose packaging was in use in the United States, and “placed restrictions on the unit dose industry before it had a voice to speak, thereby denying it the due process to which it is entitled.” But now that there are data showing unit-dose formats are safer, it is time to remove those restrictions, it stated.
CPSC spokesman Ken Giles said there is no specific timetable for acting on the petition.
First, he said, the commission’s general counsel must verify that the letter meets the legal definition of a petition. If it does, it will be published in the Federal Register and public comments will be sought. At the same time, CPSC staff will look at all existing data related to the issue. It then will synthesize that data and the public comments, and recommend a course of action to the commission.
The commission will have three choices: to grant, deny, or defer, Giles said. Granting would mean a mandatory standard would be created. Denial would mean there would be no CPSC action, but voluntary standards could be issued elsewhere. Deferral would occur if it is determined that more research is needed.
“We certainly share the goal of preventing poisonings,” Giles said. “Our standards state that you can design a product any way as long as it promotes safety. In that framework, we will look at this.”