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Recall notification bill

This article was originally published in The Rose Sheet

Executive Summary

Posting in-store notices of OTC product Class I and Class II recalls would be required of pharmacies under a bill introduced March 12 by Rep. Christopher Shays (R-Conn.) and Sen. Christopher Dodd (D-Conn). In line with FDA classifications, the bill defines a Class I recall as one with a reasonable probability the violative product may cause serious adverse health consequences or death and a Class II recall as one that may cause temporary or medically reversible adverse health consequences. Class III recalls (no adverse health effects likely) would not be affected by the Drug and Device Recall Reporting Act. Of four Class II cosmetics recalls reported in 1997, one was also an OTC product ("The Rose Sheet" Jan. 12, p. 9). The measure would subject pharmacies selling OTC products that failed to post notices to a minimum fine of $10,000. Drafted in the House Government Reform & Oversight/Human Resources Subcommittee, the bill will be referred to the House Commerce Committee and the Senate Labor Committee...
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