Electronic Tracking System Helps FDA Monitor Counterfeit Drugs
April 2, 2014 in News
An enhanced tracking system will help FDA track drug packages as they move throughout the distribution system, Roll Call reports.
The system came about as part of a 2013 law that details FDA’s oversight of compounding pharmacies (Ethridge, Roll Call, 3/31).
Background on the Law
The bill — called the Drug Quality and Security Act — will allow federal regulators to:
- Track drugs that compounding pharmacies are making;
- Receive reports about problems with the compounded drugs; and
- Have authority to conduct safety inspections.
It also will allow compounding pharmacies to register as outsourcing facilities and be subject to FDA oversight in a manner similar to traditional drug manufacturers.
Details of Tracking System
The electronic tracking system will be used to prevent counterfeited or stolen compounded prescription drugs from entering the U.S.
Within four years, drug manufacturers will be required to include serial numbers on all drug packages.
Within 10 years, the industry must include electronic codes to be able to track medicines from factories to pharmacies (iHealthBeat, 12/2/13).
According to Roll Call, FDA is working on an implementation schedule for the system. The goals of the system include:
- Providing FDA with an easier way to track drugs from manufacturer to distributor to pharmacy;
- Helping FDA identify counterfeit or contaminated drugs;
- Helping make recalls of drug products more efficient; and
- Creating a national, interoperable electronic tracking system of prescription drugs over the next decade.
Some of the entities that will be required to provide information about drugs and investigate any suspicious drug packages include:
- Repackagers; and
- Wholesale drug distributors.
The system will allow such entities to exchange information about a package’s location and how long a package has been in the distribution chain (Roll Call, 3/31).