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Two U.S. Bills Might Lead to RFID Mandates

If they pass into law, the proposed legislation could result in RFID-tagging requirements for drugs sold via the Internet and for all tobacco products.
By Beth Bacheldor
Mar 07, 2007Two proposed federal bills—though not naming RFID specifically—could become legislative catalysts for the technology's use in government regulation.

In an effort to shutter disreputable Internet pharmacies and help improve drug safety for consumers, U.S. Senator Judd Gregg (R-N.H), a member of the Senate Health, Education, Labor and Pensions Committee, along with Senator Gordon Smith (R-Ore.), introduced a bill mid-February that calls for track-and-trace technologies to be used on drug shipments. The Safe Internet Pharmacy Act of 2007, S.625, seeks to amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of Internet pharmacies.

Though it doesn't specifically mention RFID, the bill will likely be influenced by the U.S. Food and Drug Administration, which is urging pharmaceutical companies to use RFID to track drugs within the supply chain in order to fight drug counterfeiting and create electronic pedigrees, or e-pedigrees (see FDA Issues New 'Counterfeit Drug Task Force' Report). E-pedigrees record where a drug is manufactured and how it is distributed.

Specifically, the bill would require Internet pharmacies "to affix to each shipping container of drugs to be shipped in the United States such markings as the Secretary [of Health and Human Services] determines to be necessary to identify that the shipment is from a licensed Internet pharmacy, which may include anticounterfeiting or track-and-trace technologies."

The Safe Internet Pharmacy Act would also require, among other things, that all Internet pharmacies that dispense prescription drugs in the United States be licensed by the Food and Drug Administration, and requires them to display a tamper-resistant "seal of approval" on their Web sites to help consumers determine if they are licensed by the FDA.

The legislation addresses concerns that Internet shoppers may be buying unsafe or counterfeit pharmaceuticals from unregulated and unscrupulous Internet vendors, according to Doug Farry, managing director and chair of the RFID practice at McKenna Long & Aldridge, a nationwide law firm that focuses on public policy and technology. Farry also oversees McKenna Long's RFID Law Blog.


Damon McDaniel 2007-03-08 09:55:38 AM
Proposed Laws The S625 is NOT the Safe Internet Pharmacy Act but is the Proposed legislation for regulating the tobacco industry further. I thought I was going to get the details for the one since you mentioned the act & link together at the beginning of the article. FYI. Regards.

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