Contract pharmaceutical manufacturers face a unique set of challenges under the Drug
Supply Chain Security Act.
Ashley Umberger, the manager of
engineering at Virginia-based Afton
Scientific, told Pharmaceutical Processing
that her company went above and beyond
the serialization required this year in an
effort to accommodate a wide range of
Afton's Charlottesville manufacturing
plant provides automated aseptic filling of
liquid drugs, as well as pre-sterilized and
packaged components, under the names
Afton Scientific and AnovaFill.
Explosion of Counterfeit Drugs
Although Afton is a relatively small CMO,
Umberger said, it provides services to
companies worldwide — from small drug
makers to industry giants Pfizer, Johnson
& Johnson and Takeda.
"The serialization needs for a company like
mine ... are definitely going to be a little bit
different," said Umberger, who is scheduled
to participate in a panel discussion on
serialization at INTERPHEX.
As counterfeit medications became
increasingly prevalent, the DSCSA — or
Title II of the Drug Quality and Security
Act — was signed into law in 2013 with
the goal of enabling the tracking of drugs
through the entire pharmaceutical supply
chain within 10 years.
The DQSA was crafted in response to a
deadly meningitis outbreak stemming from
a Massachusetts compounding pharmacy
in 2012, but the law also included measures
designed to crack down on the growing
problem of counterfeit drugs.
Some estimates indicate that more than 10
percent of all pharmaceuticals in the global
supply chain are counterfeit. The number
varies from country to country — the
percentage in the U.S. is much lower, while
the share of counterfeit drugs in other
countries could be as high as 70 percent —
but the proliferation of online pharmacies
facilitated their growth worldwide.
Contract Manufacturers Juggle
◗ By Andy Szal
Digital Reporter in
Advantage Business Media's
Drug companies, distributors and pharmacies are all
racing to comply with federal pharmaceutical identification
requirements ahead of a November deadline.