CR Packaging for OTC Switches
Agency aims to protect children from the entire OTC product.
Starting in 2002, any oral prescription drug that switches from prescription to over-the-counter (OTC) status will have to remain in child-resistant packaging, says a rule recently finalized by the Consumer Product Safety Commission (CPSC).
Newly switched OTC oral drug products containing an ingredient that was previously available by prescription must continue to have child-resistant packaging, which is required for all prescription drugs, even if the OTC dosage is lower than the prescription strength. "This recognizes the reality that absent child-resistant packaging, the 'dose' potentially available to a child is the entire package contents," the agency states in the rule, published in the August 2, 2001, Federal Register [66 FR:40111–40116]. Previously, child-resistant packaging was determined for switched products on a case-by-case basis.
The rule applies even if the OTC product is a new use or a dose that was not approved when the drug product was available only by prescription. It applies only to products for which the OTC-switch application is submitted to FDA on or after the effective date, January 29, 2002. It does not apply to nonoral formulations, even if they contain any of the same active ingredients as an oral preparation. A list of drugs affected by the rule will be maintained as an appendix to the regulation.
If a manufacturer with an affected product believes its product does not pose a threat of injury or illness to children, or if it finds that child-resistant packaging is not technically feasible, practicable, or appropriate for the product, it can apply to CPSC for exemption. These applications are now allowed to be made before FDA approval of the product's switch to OTC, as the new rule revokes a provision banning the submission of petitions before FDA approval. Firms should be aware, however, that the exemption procedure involves public notice and comment, and a petitioner must be willing to make toxicity and safety information available to the agency and the public.
One trade organization, the Healthcare Compliance Packaging Council (HCPC; Falls Church, VA), which promotes patient compliance through increased use of unit-dose packaging, was highly critical of the new rule.
"The HCPC is disappointed by CPSC's decision," says Peter Mayberry, the organization's executive director. "The CPSC's premise—that all they are doing is extending a requirement that has been in place for nearly 30 years—is just not the case. What this rule actually does is eliminate a system that has been in place for decades whereby CPSC staff reviews the potential toxicity of each OTC-switched drug, and then requires child-resistant packaging only for those products that can pose a risk to small children. While this is what the commission is supposed to do under the Poison Prevention Packaging Act, this rule turns congressional intent on its head by requiring that manufacturers prove to CPSC's satisfaction that their packaging should not be required to pass protocol."
Mayberry took particular exception to CPSC's dismissal of comments filed by the HCPC and the Consumer Healthcare Products Association (CHPA; Washington, DC) regarding the need to address provisions within the child-resistant protocol for unit-dose formats. According to both organizations, the protocol places unit-dose packages at a disadvantage and should be remedied before CPSC requires that more products be subject to it. For more on this issue, see the editorial, "A Way to Unite Industry on the Divisive Issue of CR/SF Packaging," (PMP News, January 2001). The agency, however, declared that HCPC's and CHPA's comments on this issue were "beyond the scope of this rule making" because "the child-resistant unit packaging regulations are not part of this rule making."
"To say that the protocol is beyond the scope of rule making on child-resistant packaging is counterintuitive," says Mayberry. "In the United States, child-resistant packaging is defined by the CPSC protocol. There is no such thing as child-resistant packaging other than packaging that complies with the protocol."
Of the five comments CPSC received on the rule, however, three supported adopting it as proposed. Of those, the National Association of Chain Drug Stores and a group of students from Florida International University both expressed general support for the rule but suggested revisions that CPSC says were not necessary for the final rule. The agency says those issues were already addressed in the proposed rule or in other existing regulations. No comments were filed by manufacturers of prescription drugs or the associations that represent them.
For further information, contact Suzanne Barone, PhD, Directorate for Health Sciences, CPSC, 301/504-0477, ext. 1196, or Geri Smith, Office of Compliance, CPSC, 301/504-0608.