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CALIFORNIA ASSEMBLY URGES STUDY OF THIRD CLASS OF DRUGS

Executive Summary

CALIFORNIA ASSEMBLY URGES STUDY OF THIRD CLASS OF DRUGS to be sold without prescription in pharmacies only. Assembly Joint Resolution 63 passed by the state legislature in July exhorts FDA to study the pharmacy-only class of non-prescription drugs as a transition mechanism for products switching from prescription to OTC. The state resolution argues that the existence of a third class of drugs could take some of the pressure of an all-or- nothing decision off FDA and encourage the agency to move products more rapidly from prescription status. The halfway status of availability from a pharmacy without a prescription would provide a level of protection to the agency's initial switch decision, the resolution maintains. The resolution was sponsored by Assemblyman Bruce Bronzan (D- Fresno). The legislative action was backed by the California Pharmacists Association and the National Consumers League. California is the only state to have such a bill in support of studying a third class of drugs; no other legislative action on the subject is planned by the state. Bronzen may, however, ask for a hearing on the subject in the future. While a resolution without enforcement clout is not an immediate challenge to the OTC industry's long standing opposition to a restricted third class of drugs, the industry has had problems with state initiatives arising from California in the past. Most notably, the state forced a 1990 national relabeling of aspirin by proposing a state requirement to include a caution about use of the product in the third trimester of pregnancy.

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