Posted on 06/11/2006 7:12:13 PM PDT by neverdem
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.
Dr. Randall Lutter, the F.D.A.'s associate commissioner for planning and policy, said many participants at a February hearing on the issue told the agency that the regulations were needed to spur investment in the radio tagging technology. "This decision to lift the stay is intended to provide that push," Dr. Lutter said at a news conference yesterday.
The F.D.A. had projected, based on industry forecasts in 2004, that the new technology would be widely deployed by 2007. But that timetable has fallen by the wayside. Only a handful of major pharmaceutical companies currently use radio tags on their products, and even in those cases the technology has not moved much beyond pilot programs. Pfizer has been applying the...
(Excerpt) Read more at nytimes.com ...
This is like the program Walmart has used for several years to track all its goods including the drugs that are sold in their pharmacies. This program has been available for several years and will prove to be invaluable in the 'shrinkage' department as well as in the area of counterfeit drugs.
The reality is a ton of drugs are manufactured, and sold, off label, and without valid prescriptions. ie. ritalin, and the one Limbaugh was taking. There has been no interest in pursuing this on the part of the pharma co's and pharmacies. Pharma's because it will result in lower sales, and Pharmacies because of lower sales and possible professional penalties.
If you like prescripton drug prices now, just wait till this program gets implemented.
RFID tracking. One way to see what's in your medicine cabinet...or on your person, as well as an efficient way to track inventory. It just validates the container, though, not necessarily the contents.
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