FDA Issues Guidance for Use of PCIDs for Anti-counterfeiting Applicable to ®mark® On-Dose ID Covert Markers
GLEN ROCK, Pa., (July 15, 2009) – ARmark Authentication Technologies, LLC, announced today that the Food and Drug Administration (FDA) issued draft guidance on July 13, 2009 covering the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) by manufacturers to make drug products more difficult to duplicate by counterfeiters, and to make it easier to identify the genuine version of the drug. The company’s ®mark® On-Dose ID covert marker technology is a Physical Chemical Identifier (PCID) which has been designed for application to solid oral dose drug products.
The draft guidance outlines regulatory filing requirements (NDA, ANDA and postapproval) for usage of ®mark On-Dose ID covert markers for unit-level, on-dose authentication of oral solid dose pharmaceuticals for the prevention of counterfeiting. The on-dose form of the covert marker technology was developed through an alliance between ARmark Authentication Technologies, LLC, a developer of custom authentication systems, and Colorcon, Inc., a world leader in the development of formulated coatings and other excipients for the pharmaceutical industry. The ®mark® On-Dose ID covert marker technology is formulated from ingredients listed in the FDA’s Inactive Ingredient Guide (IIG) and is applied via incorporation into the tablet film coating.
®mark On-Dose ID covert markers are custom-developed from approved excipient materials and are manufactured under cGMP conditions. These markers can contain multiple levels of security with brand-owner specific, encrypted information such as lot and batch ID numbers, logos and other text, patterns, shapes and symbols, in a particle smaller than the diameter of a human hair. Nearly impossible to replicate or reverse engineer, the markers are compatible with other covert/overt identification technologies and can also be incorporated as part of labels, bottles, paper and blister packaging.
The covert markers are applied directly to pharmaceutical tablets during existing tablet coating processes, not as an additional step, which offers manufacturers total reliability for placement of the markers on each and every tablet. This compatibility with existing manufacturing processes also allows for no additional process changes and no new capital equipment or expenses.
According to the World Health Organization, the US-based Center for Medicines in the Public Interest predicts that counterfeit drug sales will reach $75 billion globally in 2010, an increase of more than 90% from 2005.
“Counterfeit drugs are a multi-billion dollar industry and the problem reaches across the globe,” said Jeff Robertson, Director/GM of ARmark. “®mark covert markers offer pharmaceutical manufacturers a safe method to protect their products from counterfeiters, while also protecting their customers.”
®mark On-Dose ID markers are identified using ARmark’s ®vision™ detection systems, easy-to-use digital micro-imaging systems that are customizable to each brand-owner-specific marker. ®vision systems can be portable, handheld devices that offer immediate on-site detection and authentication of the markers without destroying the product.
Based in Glen Rock, PA, ARmark Authentication Technologies, LLC develops custom authentication systems for brand protection, product surety and risk mitigation to fight global counterfeiting. Our technologies protect our clients’ products with brand-owner-specific information so that the authenticity of these products becomes “indisputable”. ARmark Authentication Technologies, LLC services a variety of industries, including but not limited to: pharmaceutical, medical devices, luxury goods, electronics, secure documents, food and apparel. ARmark Authentication Technologies, LLC is a wholly-owned subsidiary of Adhesives Research, Inc.
For more information on ARmark Authentication Technologies, LLC and its products, call 1-717-227-5920 or visit www.rmark.org.
®vision™ is a trademark and ®mark® is a registered trademark of ARmark Authentication Technologies, LLC. ARvision® and ARmark® are registered trademarks of Adhesives Research, Inc. Adhesives Research® is a registered trademark of Adhesives Research, Inc., for engineering and design services in the field of pressure-sensitive adhesive systems.
Media Contact: Anne Marie Swinehart
Scheffey Integrated Marketing
aswinehart@scheffey.com
(717) 569-8274 ext. 14