Editorial
Import with Care:
New Import Safety
Rules Put Forth by
Multiple Agencies
When you think of the government stepping in to tighten up supply-chain safety,
stories like that of convicted counterfeiter Ryan Wheele may come to
mind. In 2005 and 2006, hundreds
of prescriptions of Viagra, Cialis, and
Levitra were filled by an Internet pharmacy and shipped to patients in vials
with prescription labels. Trouble is,
there was no pharmacy, there were
no prescriptions, and there wasn’t
even any Viagra, Cialis, or Levitra.
In December 2007, Ohio resident
Wheele pleaded guilty to conspiracy
and trafficking in counterfeit prescription drugs. Wheele’s alleged operation? Shipments of counterfeit pills
from Pakistan, India, and Great Britain
were sent to Wheele by a coconspira-tor. He would then fill vials by hand
in a home basement shared with pet
cats and ship the vials out to unsuspecting patients, the U.S. Department
of Justice (DOJ) reported.
Feel like reading a little more true
crime? You’ll find countless reports of
counterfeit imports making their way
into the hands of crafty individuals
around the country at www.usdoj.gov.
But suspected counterfeits aren’t
the only imports the DOJ is eyeing
for increased scrutiny. The DOJ, the
Department of Health and Human
Services, the Department of Transportation, the Department of Homeland
Security, the Office of Management
and Budget, the Consumer Product
Safety Commission, and other agencies are banding together to form
the Interagency Working Group on
Import Safety.
The group will be looking at all
imports, even raw materials imported for manufacturing in the United States. “The import-safety chain
stretches from the point of foreign
origin, both of materials and finished
product, to domestic consumption or
use. All entities involved in the import
life cycle—foreign producers (growers
and manufacturers), governments, distributors, and exporters; U.S. importers, distributors, manufacturers and
retailers; testing and certification bodies and regulatory authorities at the
federal, state and local levels—must
work together to prevent unsafe products from entering the United States,”
reads the group’s action plan. It can
be found at www.importsafety.gov.
“The appropriate entities in the supply
chain must also take swift and effective
action when harmful products do enter
domestic commerce.”
Imported pharmaceutical and medical devices and any materials imported
to manufacture them are included in
the plan’s scope, but how their safety
will be ensured isn’t as spelled out as
much as are plans for food and toys,
for instance. Nonetheless, if you
import raw materials or ingredients,
your supply chains will be affected by
heightened scrutiny.
In its just-released “Good Importer
Practices” draft guidance, FDA states
that “importers should put into place
controls for known vulnerabilities, such
as microbiological contamination and
product defects, and monitor for other
risks, such as counterfeiting or intentional contamination.”
You may feel as though you have
those controls in place for your imports.
FDA wants to be doubly sure. In its
first guiding principle, titled “
Establishing a Product Safety Management
Program,” FDA advises firms to “assign
responsibility for product control and
compliance to specific individuals and
ensure they understand their role in the
organization.”
What transport packaging responsibilities come into play when importing
materials? “The importer should have
sufficient knowledge of the product . . .
its inherent vulnerabilities and risks,
and the methods by which it is . . .
packed, received, transported, stored,
imported, and distributed.”
For instance, when receiving
imported pharmaceutical goods, your
responsibility entails ensuring that the
ingredients are authentic and that they
have been packaged and handled in
such a way to maintain their safety and
efficacy. Temperature and humidity
control come to mind as two definite
musts when transporting pharma goods.
Also, I have had pharmaceutical packaging professionals tell me anecdotally
that they have had to protect shipments
against sunlight and salt air when trav-
