Industry Recommends Antidote For Preventing Prescription Counterfeiting
ALEXANDRIA, Va. - In response to the growing problem of counterfeit drugs introduced in the U.S. drug supply system, the National Association of Chain Drug Stores (NACDS) submitted a report to the Food and Drug Administration as a commentary on policy issues surrounding prescription drug counterfeiting.
The report, called Industry Points of View on Counterfeit Prevention, includes short- and long-term recommendations on anti-counterfeiting measures, including:
-- A classification system to prioritize and focus resources on the drugs most vulnerable to counterfeiting;
-- Tracking and tracing, similar to imported food regulations already in place. The temporary procedure would implement a "one-step-back, one-step-forward" record-keeping system, ensuring drug authenticity for very high-risk drugs to be utilized by every member of the supply channel to track the immediate source and recipient of drug products;
-- Anti-counterfeiting packaging, whereby the FDA would provide industry guidance on facilitating multi-level measures built into packaging to help combat counterfeiting of high-risk drugs;
-- Strict licensing for states and the FDA to implement more stringent requirements on wholesalers and drug re-packagers, including tougher penalties and frequent inspections for all distributors in the prescription drug channel;
-- Importation law enforcement for state and federal agencies to work in conjunction with the FDA to enforce existing importation laws.
NACDS president and c.e.o. Craig Fuller said the association would continue working with the FDA to find the best ways to combat prescription drug counterfeiting. "NACDS is pleased to submit this report and offer continuing assistance to the FDA. Our report represents the thinking of the U.S. drug distribution system's leaders," said Fuller. "The recommendations -- if implemented -- are the first steps in providing enhanced protections to the integrity of prescription drug supply."
The report, called Industry Points of View on Counterfeit Prevention, includes short- and long-term recommendations on anti-counterfeiting measures, including:
-- A classification system to prioritize and focus resources on the drugs most vulnerable to counterfeiting;
-- Tracking and tracing, similar to imported food regulations already in place. The temporary procedure would implement a "one-step-back, one-step-forward" record-keeping system, ensuring drug authenticity for very high-risk drugs to be utilized by every member of the supply channel to track the immediate source and recipient of drug products;
-- Anti-counterfeiting packaging, whereby the FDA would provide industry guidance on facilitating multi-level measures built into packaging to help combat counterfeiting of high-risk drugs;
-- Strict licensing for states and the FDA to implement more stringent requirements on wholesalers and drug re-packagers, including tougher penalties and frequent inspections for all distributors in the prescription drug channel;
-- Importation law enforcement for state and federal agencies to work in conjunction with the FDA to enforce existing importation laws.
NACDS president and c.e.o. Craig Fuller said the association would continue working with the FDA to find the best ways to combat prescription drug counterfeiting. "NACDS is pleased to submit this report and offer continuing assistance to the FDA. Our report represents the thinking of the U.S. drug distribution system's leaders," said Fuller. "The recommendations -- if implemented -- are the first steps in providing enhanced protections to the integrity of prescription drug supply."
