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The FDA has issued a warning letter to California-based drug repackaging firm PharmPak, after discovering that deficiencies in the firm’s repackaging process may have resulted in cross-contamination between penicillin and nonpenicillin products.
In an effort to address mounting concerns over counterfeiting, the FDA's Counterfeit Drug Task Force issued a final report last month urging drugmakers to adopt electronic track-and-trace technology and other authentication tools by 2007.
An estimated 3,995 packaging lines at 1,447 facilities nationwide will be expected to affix linear bar codes to the labels of their prescription drug products used in hospitals under a new FDA final rule that could cost industry participants more than $28 million in compliance costs during the first two years of implementation.
The FDA has ignored pleas from PhRMA to implement paper pedigree requirements in the Prescription Drug Marketing Act of 1987 (PDMA) immediately, announcing it will continue to stay the requirements for another 32 months while it oversees industry’s adoption of electronic pedigrees using track-and-trace technologies.
To thwart drug counterfeiting, the FDA wants drugmakers and distributors to implement electronic tracking systems within the next three years, according to the final report of the agency's Counterfeit Drug Task Force released Feb. 18.