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LOPERAMIDE CHILD-RESISTANT PACKAGING REQUIREMENT IS CODIFIED

This article was originally published in The Tan Sheet

Executive Summary

LOPERAMIDE CHILD-RESISTANT PACKAGING REQUIREMENT IS CODIFIED by the Consumer Product Safety Commission in a final rule published in the July 21 Federal Register. Using authority granted by the Poison Prevention Packaging Act of 1970 to establish "special packaging" standards for any household product, CPSC is mandating "child-resistant packaging for products containing more than 0.045 mg of loperamide in a single package." CPSC initially proposed child-resistant packaging for OTC loperamide products in October 1992. The commission noted that "even though the OTC loperamide preparations currently on the market are voluntarily sold in [child-resistant] packaging," the regulation is "needed to ensure that those that are now in child resistant packaging and future products containing loperamide . . . will be subject to [child- resistant packaging] requirements." The notice adds that since currently marketed loperamide products are already complying with the child-resistant packaging requirement, the regulation will carry an accelerated effective date of Aug. 21, one month after publication of the final rule. The Poison Prevention Packaging Act usually stipulates that "no regulation shall take effect sooner that 180 days" from the date a regulation is issued. However, "the commission may establish an earlier effective date if it determines an earlier date to be in the public interest," the notice sums up. CPSC explained that child-resistant packaging for loperamide- containing products is needed because of the potential toxicity of the antidiarrheal drug in high doses. For instance, CPSC noted that animal and human pharmacological and toxicological data show that "overdosage of loperamide can cause stomach and intestinal irritation"; "abdominal distention and obstruction of the bowel"; central nervous system effects such as drowsiness, dizziness, muscular spasms and convulsions; respiratory depression; and death. However, CPSC noted that the majority of cases of loperamide toxicity reported in scientific literature "occurred in foreign countries and involved the intentional administration of loperamide to children." In addition, the CPSC Children and Poisoning database for 1978 through April 1993 observed 12 ingestions of loperamide by children under 5 years of age treated in hospital emergency rooms, according to the notice. Four of these children were admitted to the hospital. The notice points out that, under the Poison Prevention and Packaging Act, a single size of a product may be packaged without child-resistant packaging only if it is available with child- resistant closures in its most popular sizes. In containers without safety devices, however, the product is required to bear a conspicuous label warning stating: "This package for households without young children." An alternate caveat of "Package not child-resistant" is allowed in cases where the packaging is too small to accommodate the longer statement. CPSC underscored in the final reg that it may "restrict the right to market a single size in noncomplying packaging if the commission finds that the substance is not also being supplied in popular size packages that comply with the standard." Other items on the commission's regulatory agenda include requiring child-resistant packaging for topical lidocaine- and dibucaine-containing products as well as for mouthwashes containing more than 5% alcohol. A briefing packet on topical lidocaine/dibucaine child-safety caps is expected to be issued to CPSC commissioners for consideration in September, while a packet on mouthwash safety devices will reach the commissioners in October ("The Tan Sheet" May 3, p. 14). In February, a coalition of 29 attorneys general petitioned CPSC to establish child- resistant packaging for ethanol-containing mouthwashes. As a pre-emptive strike, the Nonprescription Drug Manufacturers Association and the Cosmetic, Toiletry and Fragrance Association jointly issued voluntary child-resistant packaging guidelines for mouthwashes containing more than 5% alcohol in June ("The Tan Sheet" June 7, p. 17).
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