Revisions to CR Packaging Rules
CPSC is revisiting several requirements and adding others.
The Consumer Product Safety Commission (CPSC) will soon be revisiting certain regulations relating to child-resistant (CR) drug packaging and may be adding some new ones as well, says Suzanne Barone, project manager for poison prevention and scientific coordination at the agency.
Barone outlined upcoming developments in her presentation titled "Child-Resistant Packaging: Meeting the New CPSC Requirements," at the WorldPharm98 conference in Philadelphia held September 23. The packaging track of the conference was sponsored by PMP News.
On March 2, 1999, CPSC will add fluoride to the list of substances that must be marketed in CR packaging. But, Barone said, "the level is such that most toothpastes should not be included."
The rule will read as follows in the Poison Prevention Packaging Act, section 1700.14(a)(27): "Household substances containing more than the equivalent of 50 milligrams of elemental fluoride per package and more than the equivalent of 0.5 percent elemental fluoride on a weight-to-volume basis for liquids or a weight-to-weight basis for non-liquids shall be packaged in accordance with" poison prevention packaging standards.
Also, there may be some minor modifications in the test procedures for aerosols, Barone said. Currently, most packages required to be child resistant are tested to make sure children cannot get into them while adults between the ages of 50 and 70 can open and reclose them. But adult tests for aerosols and metal cans with metal closures use the old standard of testing people between the ages of 18 and 45 because the packages were considered incompatible with senior-friendly technology when the commission changed the protocol. "But now, there are some senior-friendly aerosols," Barone said.
The CPSC staff is also looking at whether to revise the CR standards for unit-dose packaging, she said. A unit-dose package fails the child test when enough children open either enough units that would cause serious injury or illness or more than eight units, whichever is less. But the staff is revisiting the issue to see whether another standard would be better, Barone said.
Also, she said, "we are in the process of clarifying test procedures for unit-dose, especially on the child test." One point that needs to be addressed is when the tester should demonstrate to the child how to open the unit-dose package after he or she has failed initially. Part of the child test protocol involves showing children how to open packages if they have failed to open them in the first five minutes of the test.
There have been many inquiries regarding prescription drug packages, she said, because drug companies have not had to worry about making them child resistant until the advent of unit-dose packaging. When prescription drugs are sent to pharmacists in big bottles for them to dispense in smaller vials, pharmacists are responsible for using CR packaging unless directed by the consumer or prescriber to do otherwise. But now, many drug companies package prescription drugs in unit-dose form. Because the unit-dose packages are meant to be sold directly to consumers and not repackaged by pharmacists, drug companies are now responsible for CR compliance.
Also in need of further investigation are physician samples, Barone said. Some drug companies make all their samples child resistant, but others leave it up to doctors. The distinction didn't matter when samples consisted of little more than a blister card with two pills. Now, some samples contain as much as 2–3 weeks' worth of drugs, and those may need a rule, she said.
Barone also said that a number of firms have approached CPSC in order to obtain CR exemptions for drugs that have not yet had new drug applications (NDA) submitted to FDA. Current CPSC policy dictates that there can be no exemptions for drugs not yet approved by FDA. Companies that have a new product that might qualify for an exemption and that do not want to develop a CR package must ask for a stay of enforcement between the drug's approval and the exemption ruling.
"But companies come to us before their NDAs and say, 'We want to be exempted now so we can do our stabilities knowing the exemption is in place,'" she said. "We're looking at how to handle this." Exemptions are granted when the drug in its particular package is proven not to be harmful to children, when it is impossible to make special packaging for it, or when special packaging is incompatible with its use.