CPSC Proposes Child-Resistant Packaging for Certain OTC Drugs
All oral prescription drugs that switch to OTC would be subject to the commission's CR packaging requirements.
Child-resistant (CR) packaging will be required on oral over-the-counter (OTC) drugs with active ingredients previously available only by prescription if a rule proposed by the Consumer Product Safety Commission (CPSC) goes into effect.
Under the proposal, published in the August 30, 2000, Federal Register [65 FR:52678–52684], the OTC versions of oral drugs would be subject to the same CR packaging requirements as their prescription versions. That is, they would have to pass a test protocol to ensure that children of a certain age cannot gain access to a toxic dose.
"Our main concern is to protect children," says Suzanne Barone, PhD, CPSC's product manager for poison prevention.
The rule would not apply to non-oral drugs, nor to oral OTC drugs whose active ingredients do not have ethical equivalents. The rule is proposed to take effect 180 days after it becomes final.
CPSC regulations currently require CR packaging of all oral prescription drugs that have not been otherwise exempted. There is no such blanket requirement for oral OTC drugs, though 12 have that mandate on an individual basis. "This rule will provide children with the same protection when a drug product is more widely available as an OTC preparation that they had when it was available only by prescription," the agency states in the proposal. "The need to continue to protect children does not diminish when an oral prescription drug product is granted OTC status."
In deciding whether to grant OTC status to a prescription drug, FDA does not consider whether it would be toxic if a child unintentionally ingested it. That, plus an influx of drugs that will be switching from ethical to OTC in the near future, prompted CPSC to decide that a blanket CR requirement is needed.
Since 1976, there have been 22 oral prescription active ingredients that have also been approved for OTC sale, and CPSC has required six of them to have CR packaging. The rule calls for CPSC to maintain a list of all such products.
In recent years, CPSC has evaluated the potential toxicity of oral OTC-switched products, rather than waiting for reports of deaths or injuries before mandating CR packaging. But this evaluation has had to come after FDA approval of the switch to OTC, because CPSC cannot afford to expend resources on reviewing products whose switches end up not getting approved.
Therefore, there is a lag between an FDA approval of an OTC switch and a CPSC mandate to use CR packaging. That means if a product receives the mandate, its manufacturer has to change its packaging (and conduct the relevant stability tests) early on in its OTC incarnation, unless the manufacturer voluntarily uses CR packaging to begin with. The proposal would eliminate this lag, and the manufacturer would know right away that CR packaging is required.
If, after the OTC switch, other forms, dosages, or combinations containing some or all of the active ingredients also get approved for OTC sale, they would be covered by the proposed rule, even if they did not exist when the drug was only available by prescription.
The rule would also apply even if the OTC dosage is lower than prescription strength. "This recognizes the reality that absent CR packaging, the 'dose' potentially available to a child is the entire package contents," the proposal states.
The rule also calls for the elimination of 16 CFR 1702.16(b). That regulation specifies that CPSC must deny a petition for exemption from CR packaging if FDA has not approved the new drug product. So if an exemption is sought, the manufacturer must market in CR packaging until there is
a decision on the exemption, delay marketing until the decision is made, or request a stay of enforcement. By revoking the regulation, CPSC can consider exemptions before FDA approval, and manufacturers will know what kind of packaging they need before they go into the approval process.
Peter Mayberry, executive director of the Healthcare Compliance Packaging Council (HCPC; Falls Church, VA), questions whether CPSC has the legal authority to impose such a sweeping mandate. The Poison Prevention Packaging Act gives CPSC the responsibility to determine which products pose a significant enough risk to children to require special packaging, but the proposed rule would apply even to some products with a low level of toxicity to small children.
"We are definitely on the side of child safety, and when CR packaging is needed, we do not want to stand in the way," Mayberry says. "But if CPSC exceeds its legal authority, that can't be allowed."
CPSC is accepting comments on the proposal until November 13, 2000. They can be sent by mail to the Office of the Secretary, Consumer Product Safety Commission, Washington, DC 20207; by fax to 301/504-0127; or by e-mail to firstname.lastname@example.org.
For further information, contact Barone at 301/504-0477, ext. 1196.