FDA Decides To Track Pharmaceuticals

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FDA Decides To Track Pharmaceuticals

http://www.medicalnewstoday.com/healthnews.php?newsid=44938

The FDA has decided to track pharmaceuticals from the factory, to

wholesaler to pharmacy. In fact, there is an 18-year-old law that

requires wholesalers to track drugs from the factory to the retail

outlet - the pharmacy. The FDA will now enforce this law.

This move is aimed at stamping out the traffic of counterfeit drugs -

drugs that look the same as the real thing, but either do not contain

the essential active ingredient or have some contaminants. If a drug

does not have the essential active ingredient it is completely

useless.

The number of cases involving counterfeit drugs has been growing over

the last few years. In 2000 the FDA had to investigate 2000 cases, in

2004 58 cases and in 2005 32 cases.

This new move makes it easier to stop the traffic of fake

prescription drugs lower down the chain, rather than trying to catch

people in back alleys at the end of the supply chain. It will make it

more difficult for the criminal to slip his/her fake products into

the supply chain.

Why hasn't the FDA been enforcing this law for the last 18 years? The

main reason was that wholesalers said they would fold up if the law

were enforced.

With Radio Frequency Identification (RFID), which is available today,

it is much easier now to track drugs as they make their way up the

chain from production, wholesale to retail.

Randy Lutter, FDA, Associate Commissioner for Policy and Planning,

said there is an arms race between authorities and counterfeiters.

The counterfeiters are forever trying to discover some new way of

fooling investigators, public health authorities the FDA, and

manufacturers He said his job is to make sure the authorities are

always one step ahead of them.

Drug manufacturers and pharmacies don't have to have the new tracking

technology in place, said the FDA. This would delay the

implementation of the law even more. However, secondary wholesalers

will have to have adopted the new technology by the beginning of

December, 2006.