Electronic Drug Tracking System Could Be Put on Hold in California
Today the California Board of Pharmacy will vote on whether to delay a first-in-the-nation law that requires drug manufacturers, wholesalers and pharmacies to electronically track their drugs to fight drug counterfeiting, USA Today reports (Appleby, USA Today, 3/25).
The law, enacted in 2004, required that tracking systems be instituted by Jan. 1, 2007, but the California Legislature in 2006 extended the deadline to Jan. 1, 2009.
Pharmaceutical companies, drug wholesalers and retail pharmacy chains say that they cannot meet the 2009 deadline and are asking for an extension until 2011.
When the Legislature postponed the deadline in 2006, it also created tougher restrictions that mandate the industry to install electronic readers to track serial numbers on each unit of a drug at key points in the manufacturing, distribution and sales processes (Lifsher, Los Angeles Times, 3/25).
FDA began national efforts to electronically track all prescription drugs in 1988, but the agency has never implemented the requirement.
A similar effort in Florida was dropped in the face of serious opposition (Robertson, Sacramento Business Journal, 3/24).
Some drug makers say they are not sure if they can meet the deadline even if the compliance deadline is pushed back to 2011. Pharmaceutical companies also are sponsoring a bill that would indefinitely delay the date for electronically tracking drugs (Los Angeles Times, 3/25).
If the board retains the January 2009 deadline, Californians might face obstacles filling prescriptions because there would be a limited supply of medications available that comply with the law's requirements, the San Diego Union-Tribune reports.
Pharmacists and drug suppliers that do not properly tag medicines for sale would be violating state law, although enforcement measures are still unclear.
Several industry sources also said that the Legislature will take up the law this year no matter what action the state Board of Pharmacy takes today (Darcé, San Diego Union-Tribune, 3/25).