In a bid to beat counterfeit drugs long-delayed federal rules requiring most wholesalers to track prescription drugs from factory floor to pharmacy door is prposed to take effect in December 2006.
The issues holding up introduction are, agreeing the tracking frequency, ensuring the selected frequency radio waves have no effect on the drugs and the biggest stumbling block, the cost of introduction and compliance. The cost of course will be bourne by tax payers and consumers when they go to purchase the products. You are invited to keep up to date on which, of the brand and generic suppliers that are reliable and who to avoid by joining a free subscription to
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The regulations, stem 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.
The development and adoption of radio tags have been slowed by concerns on cost, reliability and security.
The F.D.A. had projected, based on industry forecasts in 2004, that the new technology would be widely deployed by 2007. That timetable was binned as 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.
The F.D.A. is an advocate for radio frequency identification, after major consumer retailers, manufacturers and the Department of Defense agreed to back standards for tagging in 2003 and to push for widespread adoption. The retail industry and Defense Department have focused primarily on tagging pallets and cartons of goods in their supply chains to avoid shortages and to increase efficiency.
The drug industry faces a more difficult challenge in tagging individual items as a way to fight counterfeiting and aid in product recalls. The biggest questions are not whether the technology can meet the drug industry's needs but which of two competing frequency standards to use and how fast it can be cost-effectively rolled out.
Most of the drug industry testing has been with older, so-called high frequency HF systems, but Wal-Mart and other major customers for the new technology have been supporting still higher-powered systems in the ultra high-frequency or UHF bandwidths.
A remaining uncertainty the F.D.A. noted yesterday is the effect of the radio signals on biological drugs, which consist of purified proteins. While there is not yet evidence of such problems with the technology, the testing has been limited.
The F.D.A. said that its new regulations could be met with bar codes or even written documents as well as the radio tags, although it expects that the industry will eventually adopt the radio tags almost universally. States like Florida and California that have been introducing their own drug-authenticity rules have taken a similar position.
Counterfeiting is roughly a $30 billion global problem for the drug industry, involving 8 to 10 percent of drugs sold. Federal regulators say it is relatively rare in the United States but still a concern because the drug distribution system is far more convoluted and open to corruption than most Americans realize, and the sophistication of the counterfeiters has been growing.
To appreciate the difference between counterfeiting, generic and brand name drugs you can follow the debate on
DrugStoreBestBuys.com While some drugs move relatively directly to consumers from manufacturers through major wholesalers, several thousand secondary wholesalers and repackagers that break down bulk shipments into smaller containers play a major role in drug distribution. Such middlemen also buy overstocks from retailers and other wholesalers to resell. In some cases, they buy stolen drugs, supplies accumulated by addicts or drugs from patients who obtain more from their doctor than they need.
The F.D.A. regulations, as specified by Congress, exempt major wholesalers who get drugs directly from manufacturers through established contractual relationships. But if the exempt wholesalers buy the drugs from any nonexempt source, they must obtain the pedigree information and pass it on when they sell the drugs.
