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Regulatory Affairs

Is RFID the only answer?

The pharmaceutical industry has quickly embraced the use of Radio Frequency Identification Devices (RFID) as a way to protect consumers. Yet, preventing counterfeit drug products from reaching consumers is not a simple task and the implementation of RFID is only part of the solution. Another part is the development and utilization of pedigrees. A pedigree is a tracking mechanism, either paper or electronic, that identifies the path a drug product has taken from the manufacturer. Pedigrees were required by the Prescription Drug Marketing Act enacted in 1988. However, the pedigree requirements have yet to be fully defined by the Food and Drug Administration.

Another method to protect consumers is to increase the number of inspections for imported drug substances and products. Both consumers and businesses are purchasing drug substances and products from firms outside of the United States. More inspectors must be available from the Department of Homeland Security and the FDA, in order to increase the inspections.

There are many ways to prevent counterfeit drug products from reaching consumers, including RFID. Please remember that RFID is not the only answer.

Looking for a flexible packaging vendor?

In its 2004-2005 Flexible Packaging Buyers Guide, the Flexible Packaging Assn. lists flexible packaging material suppliers by product lines/end-use categories. Under Medical & Pharmaceutical, vendors are listed for biologicals, dental supplies, diagnostics, disposable products, medical devices, pharmaceuticals, and veterinarian supplies. See buyer's guide.

--By Linda McBride, Registered Pharmacist

Linda McBride is the director, regulatory affairs for Medi-Flex, Inc. Her 16 years of pharmaceutical industry experience include positions with Bayer HealthCare, Oread, and Novartis Consumer Health. She holds a B.S. in pharmacy and is a member of the International Society for Pharmaceutical Engineering and the Regulatory Affairs Professionals Society.

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