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Over-the-Counter and Prescription Drug Manufacturers are Granted a One Year Reprieve from the Burdensome Requirements of the Consumer Product Safety Improvement Act

Porzio Pharmaceutical Alert

by Frank Fazio and Anne E. Wagstaff

On August 12, 2008, Congress passed the Consumer Product Safety Improvement Act (“CPSIA”), which amended the Consumer Product Safety Act (“CPSA”). One of the more noteworthy requirements imposed by these amendments is a certification standard that would directly impact manufacturers subject to the revised Act, including manufacturers of prescription and over-the-counter drugs. Confronted
with the overwhelming task of enforcing these new certification standards the Consumer Product Safety Commission (the “Commission”) published a Notice of Stay of Enforcement of Testing and Certification Requirements in the February 9, 2009 Federal Register. 74 Fed. Reg. 6396 (2009). The partial stay effectively delays enforcement of the revised Act until February 10, 2010.

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