J&J Pays $511K Fine For Pfizer Blunder
1 CommentBy Ed Silverman // August 5th, 2008 // 5:26 pm
The healthcare giant coughed up the money in order to settle federal allegations that a plant in Lititz, Pennsvylvania, which it acquired in 2006 as part of its purchase of Pfizer’s consumer health care business, violated paperwork regulations for controlled substances, according to the US Attorney in Philadelphia (read the statement).
The manufacturing plant was accused of importing controlled substances - in this case, Benadryl-D - from Canada without filing a notification with the US Drug Enforcement Agency between 2001 and 2005. The med contains pseudophedrine, which is a controlled substance pseudophedrine.
The Controlled Substances Act requires anyone who imports, distributes and dispenses controlled substances to report to the DEA any importation. The reports allow the agency to track drugs that, although legal when prescribed by a physician, are often abused and sold illegally. The Act imposes civil penalties for violations of its record keeping and filing requirements as incentive for importers to help the DEA combat illegal diversion. However, Pfizer’s consumer unit never filed the required forms.
Dan
Half a million doesn’t seem like much, in perspective.
Speaking of which, when are the on line internet sources for controlled substances going to be addressed?