F.D.A. Imposes Long-Delayed Rule to Require Tracking of Prescription Drugs
By BARNABY J. FEDER
Long-delayed federal rules requiring most wholesalers to be able to track prescription drugs from factory floor to pharmacy door will finally take effect in December, the Food and Drug Administration said yesterday.
The regulations, stemming from a 1988 law intended to combat counterfeiting by verifying a drug's pedigree, were originally drafted in 1999. But the F.D.A. had repeatedly put a stay on the rules because the drug industry said it lacked practical methods for tracking and tracing all of its products. Now, though, the agency said further delay of the "pedigree" rules as they are known was no longer justified because of the development of electronic tracking technology, particularly digital identification tags that can be scanned with radio waves.
Such tags have become small enough to embed in the labels of individual drug bottles and packages. The tags can store more information than bar codes and can be scanned from farther away. And in contrast to bar codes, bunches of them can be scanned simultaneously. Still, development and adoption of radio tags have been slowed by concerns on cost, reliability and security.
