Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Etienne Nichols
What’s the difference?
Liza Dzhezhora
How to ensure the integration of IoMT devices in your practice
Del Williams
Options to address the risk of combustible dust explosions for NFPA 61 compliance
Doug Folsom
Unpatched vulnerabilities will become increasingly susceptible to cyberattacks
Del Williams
Mitigate risk, prevent safety issues by utilizing closed conveyor systems designed with sanitation in mind

More Features

FDA Compliance News
Creates one of the most comprehensive regulatory SaaS platforms for the industry
Company’s first funding round will be used to accelerate product development for its QMS and MES SaaS offerings
Showcasing tech, solutions, and services at Gulfood Manufacturing 2022
Easy, reliable leak testing with methylene blue
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community

More News

Quality Digest

FDA Compliance

Report: RFID on Packaging Secures Pharmaceutical Supply Chain

Published: Tuesday, May 24, 2005 - 22:00

According to research from the Pharmaceutical Research and Manufacturers of America, the use of an electronic system that authenticates individual packages while they’re on the supply chain protects both the industry and patients. The use of radio frequency identification chips (RFID) on pharmaceutical packaging has been identified by the Food and Drug Administration as the most promising technological approach to deterring counterfeit drugs. PhRMA recently released a position paper that strongly recommends advancing technology that would check if a pharmaceutical package originated with the manufacturer before it’s dispensed to a patient.

“Making double sure that a drug is authentic before a patient gets it and takes it home is vitally important,” says Billy Tauzin, PhRMA president and CEO. “And we’re close to having the technology to do it.”

According to Tauzin, this could be accomplished through mass serialization, bar coding or radio-frequency identification tags. However, the PhRMA paper determined that fully operational trace-and-track technology likely won’t be implemented for another five or more years. It supports implementing the paper pedigree requirements as outlined in the Prescription Drug Marketing Act as an interim step until a broad-based electronic system is established. It also recommends requiring that packages, pallets and cases of certain prescriptions contain a machine-readable serial number.

“America’s biopharmaceutical companies are deeply concerned that the drugs they produce not be compromised by breakdowns in the distribution system,” says Alan Goldhammer, PhRMA associate vice president for regulatory affairs. “PhRMA is prepared to collaborate with federal and state policy makers to set uniform electronic track-and-trace standards throughout the United States.”

The pharmaceutical industry has been holding discussions with wholesalers, pharmacies, and federal and state regulators on the feasibility of a nationwide electronic pedigree system to stymie counterfeiters. Pharmaceutical companies currently use a variety of counterfeit-resistant technologies. These include color-shifting inks, holograms, microprinting and chemical agents embedded in the drugs. They need to be changed regularly because some can be duplicated by counterfeiters as quickly as 12–18 months after they come out.

For more information, visit www.phrma.org.


About The Author

Quality Digest’s picture

Quality Digest

For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.