Alert: Packaging World now enhanced for the iPad and iPhone. Watch a quick video preview
 
Download Download this free, 150-page Pharmaceutical Serialization Playbook jam-packed with strategies for success and pitfalls to avoid.  Learn more >>
Article |

USP guidelines aim to combat counterfeit meds and medical devices

USP to seek public feedback, and input at May 2012 workshop regarding its new guidelines for supply chain integrity and the role of packaging technologies.
Print Reprint
     

As the pharmaceutical supply chain grows increasingly complex, and the risks to drug quality and safety correspondingly proliferate—new draft guidelines will be proposed this spring by the U.S. Pharmacopeial Convention to help ensure the integrity of the supply chain. A significant component of the guidelines, which will be contained in General Chapter 1083 of the USP-NF compendia, is best practices to combat counterfeit drug and medical devices.

The U.S. Pharmacopeia, as its Web site says, “is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are developed and relied upon in more than 130 countries.”

The chapter notes that combating counterfeit drugs and medical devices requires a combination of strategies that involve the cooperation of pharmaceutical or device manufacturers, supply-chain entities, regulatory authorities, law enforcement and patients. No single approach or party can be successful working in isolation. Within the chapter, USP looks at topics including packaging technologies (tamper-evident designs, authentication technologies and serialization); establishment of drug pedigrees; application of machine-readable data carriers to drug products (2D bar codes and RFID tags); repackaging guidance, information retention and security; international standards and global approaches to establishing drug pedigrees; combating illegal internet pharmacies; and best anti-counterfeiting practices.

Other key areas the chapter covers include good importation practices, diversion and theft, and natural disasters.

The chapter will be published in the Pharmacopeial Forum, the vehicle through which USP accepts public comment on its standards, in March-April 2012. This is available free to all parties. USP expects the chapter to evolve significantly based on public feedback, and will further solicit input at a Supply Chain Integrity Workshop that the organization is convening May 22-23, 2012, at its headquarters in Rockville, MD.

Comments(0)

Add new comment

ADVERTISEMENT
E-BOOK SPECIAL REPORT
42 Best Package Designs
Sign up to receive timely updates from our editors and download this e-book consisting of our editors' picks of most notable package designs. Updated for 2014!
x

 

Newsletters
Don’t miss intelligence crucial to your job and business!
Click on any newsletter to view a sample. Enter your email address below to sign up!
GENERAL INTEREST

New Issue Alert

Packaging World Magazine

eClip

Breaking packaging news

Packaging Insights

Pertinent packaging issues

On the Edge Blog

Workforce Development

PACKAGE DESIGN/
DEVELOPMENT

Greener Package

Sustainable packaging

Shelf Impact

Package design strategies

Each newsletter ranges in frequency from once per month to a few times per month at most.