New Rule for Drugs Containing Hydrocarbons

Some products that contain hydrocarbons are now required to have child-resistant/senior-friendly (CR/SF) packaging, according to a new rule issued by the Consumer Product Safety Commission (CPSC; Washington, DC). This applies to any drug meeting the rule's hydrocarbon threshold that is not already subject to CR/SF requirements.

The rule, published in the October 25, 2001 Federal Register [66 FR: 53951–53957], applies to certain prepackaged nonemulsion-type liquid products, including household chemicals, drugs, and cosmetics, that contain 10% or more hydrocarbons by weight and have a viscosity of less than 100 Saybolt Seconds Universal at 100°F. For products that contain multiple hydrocarbons, the total percentage of hydrocarbons in the product is the sum of percentages by weight of the individual hydrocarbon components. The rule is to take effect October 25, 2002.

CPSC passed the rule because direct aspiration into the lungs of even small amounts of petroleum distillates and similar hydrocarbon solvents can cause chemical pneumonia, pulmonary damage, and even death. The lower the viscosity of a hydrocarbon-containing product, the greater the risk for aspiration into the lungs.

Products using aerosol cans, mechanical pumps, or trigger sprayers are exempt provided that the product is expelled as a mist and the spray mechanism is permanently attached to the bottle or has a CR attachment. Potential coverage of aerosol, pump, and trigger sprayers will be addressed separately in a future proceeding.

For further information, contact Geri Smith, Office of Compliance, CPSC, Washington, DC 20207; 301/504-0608, ext. 1160.

Erik Swain

No votes yet