As FDA Guideline Calls For More Secure Pharmaceutical Supply Chain, COVECTRA Offers Robust Solutions
Official FDA Guidance Document Includes Standardized Numerical Identification (SNI) on Prescription Packaging to Combat Counterfeiting
Southborough, MA – COVECTRA, a multi-layered brand
protection solutions provider offering serialization,
authentication, and track and trace technology services, announces
the availability of easy-to-implement technology solutions to
support pharmaceutical companies in quickly responding to an FDA
guideline issued last week, for regulatory standards in developing
a secure pharmaceutical supply chain. In addition to offering
affordable solutions for FDA’s suggested guidance that all
pharmaceutical companies print SNI (Standardized Numerical
Identification) codes on all secondary packaging, COVECTRA uniquely
provides unit dose identification technology that further secures
prescription drugs and medical devices traveling through the
complex supply chain to consumers, making each pill or medical
device verifiable as an authentic product.
In an effort to contribute to anti-counterfeiting initiatives in
the United States, as the first of several guidances and
regulations that the FDA plans to issue and implement, the
“Standards for Securing the Drug Supply Chain –
Standardized Numerical Identification (SNI) for Prescription Drug
Packages” document indicates that standards must be developed
for identification, validation, authentication, and tracking and
tracing of prescription drugs. It also recommends that an SNI be
applied to a prescription drug at the point of manufacturing and
repackaging, at the package or pallet level. This SNI, which should
be applied to each new package in both human-readable and
machine-readable forms, will be linked back to the
manufacturer’s SNI for the container. In this document, the
FDA recommends specifically that the SNI for most prescription drug
packages should be a serialized National Drug Code (sNDC) that
corresponds to the specific drug product combined with a unique
serial number, generated by the manufacturer or re-packager for
each individual package, which should have no more than 20
characters.
COVECTRA offers pharmaceutical manufacturers the technology to
support these newly identified standards, while also providing the
ability to apply even more significant security and integrity
measures which uniquely allow traceability down to the unit and
dosage level. COVECTRA’s security offerings are applied in
layers, from simple labels and cartons with proprietary taggants,
to sophisticated web-based serialization solutions that provide the
brand with “end-to-end” knowledge of the
product’s life history and disposition. By combining these
various layers of security, a product travels from manufacturing,
through packaging, into distribution through multiple wholesalers,
to the retailer’s point of sale, and into the hands of the
consumer with maximum traceability, safety and integrity.
“With up to 90% of Internet drug sites selling adulterated
drugs, diversion control and counterfeiting are concerns that
substantially impact the pharma industry,” stated COVECTRA
President and CEO, Steve Wood. “With applications providing
the opportunity for traceability throughout the supply chain,
manufacturers, customs officials and law enforcement can identify
counterfeit and diverted product and detect how and where the
product entered the supply chain,” stated COVECTRA President
and CEO, Steve Wood.”
The COVECTRA methodology creates a sophisticated, streamlined
capability to identify and prevent product diversion and
counterfeiting, which, coupled with its AuthentiTrack™
software platform, provides a complete portfolio of software and
packaging security solutions to protect as well as enhance consumer
loyalty to any valuable brand. Additionally, the companies’
unique smartphone application can application can be used to input
serialized human readable codes that are unique to a unit package.
Once the code is entered into the smartphone, the application
checks it against COVECTRA's AuthentiTrack™software platform
which can be used to track the product through all levels of
distribution from the point of packaging throughout the supply
chain, and ultimately to the consumer. The consumer is then able to
verify authenticity, communicate directly with the manufacturer,
and enroll in product promotions programs.
About COVECTRA
Uniquely, COVECTRA provides solutions from unit package
authentication and verification to serialization of all levels of
packaging. COVECTRA’s products include security labels with
overt and covert security feature serialization, authentication and
track-and-trace software applications. COVECTRA also provides
professional services to assist clients with brand protection
strategies, security label designs, and printing and packaging
material and equipment specification. In cooperation with its
strategic partner, MSO Group, Ltd, of Belfast, Ireland, a
manufacturer of specialty, high quality labels and cartons,
COVECTRA provides technology that simultaneously secures integrity,
brand imaging and brand loyalty for prescription drugs, medical
devices, and luxury products.
Posted: April 2010
