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The Food and Drug Administration offered a reminder to the pharmaceutical industry that by December companies will be required to provide pedigree tracking for prescription drugs all the way along the supply chain from manufacture to consumer sale.
Along that route, drugs can change hands as many as 10 times.
To aid in compliance, the FDA committed to releasing technical guidance to the industry within the next few weeks.
The agency also said that a final version of the policy compliance guidelines will be issued before prescription drug pedigrees must be implemented in December.
This past June, the FDA released a draft version of the guidelines for comment and is currently working to address the 11 responses it received.
IBM took advantage of the FDAs reminder by releasing information on its pharmaceutical RFID initiative.
It unveiled a system for tracking and tracing prescription drugs.
The IBM RFID system is currently being tested by three companies, including medical product distributor Cardinal Health.
The IBM system uses blended RFID software and services to capture and track the movement of drugs through the supply chain.
RFID tags are embedded on products at the unit, case and pallet level and authenticate the product from manufacturer to wholesalers to hospitals and pharmacies.
Each tag contains a unique identifier that can be linked back to descriptive product information such as dosage and strength, lot number, manufacturer and expiration date.
Although the FDA has not specifically required RFID technology, it has repeatedly encouraged it as a means of fulfilling the requirements for a pedigree in the Prescription Drug Marketing Act.
The need for a pedigree will be “best implemented through electronic track and trace technology,” according to FDA associate commissioner for policy and planning Randy Lutter.
IBM argues that its solution goes one big step beyond the FDA requirements for drug pedigree.
“A lot of other companies are focused on pedigree, so the receiver can look back and see transaction history,” said Paul Chang, RFID pharma executive, IBM Software Group. “Thats tracing, but no one else has been focused on looking back up the supply chain.”
IBM is looking beyond pedigree, to focus on supply chain management.
“The pharmaceutical industry as a whole is very interested in learning how to share their data in order to wring out some of the fat thats built into the industry,” Chang said.
IBMs RFID system is a “step in the right direction,” according to Forrester Research vice president and research director Ellen Daley.
She argues that pharma RFID options are usually highly fragmented, but that IBMs will “provide support across the lifecycle—including business case development, integration with existing infrastructure and tags/readers.”