Pharmaceutical & Medical Packaging News - Pharma-Bio Transport Winter 2009

eling by ocean. Some have even had to guard against human traffickers that attempt to add a little extra to freight containers. Those risks underline the importance of this bit of FDA advice: “Know the risks and compliance history of the products you import, and of the firms that manufacture, distribute, or transport those products.”

FDA also emphasizes compliance with U.S. requirements during product travels throughout the supply chain.

“Know what preventive controls, if any, firms must institute at each critical point in the product’s life cycle, and the steps firms need to take to ensure that those controls are being appropriately applied,” FDA states. Do you need to employ robust temperature- or humidity-track-ing devices throughout your imports’ journey? What about tamper-evident cargo seals or even global-positioning systems to make sure your imports stay intact and on track?

Making information about imports readily available seems to be a common goal. It may even need to be available before imports reach

U.S. borders. “The more data that can be captured early in the supply-chain process, the better,” explains Donald P. Bliss, National Infrastructure Institute, who is quoted in the action plan. “If U.S.-based importers, retailers, and government agencies can identify product safety problems in the manufacturing or transportation stages before a product reaches the U.S. market, the public will be safer, and enforcement and recall costs will be significantly reduced.”

Track-and-trace technologies may have a role to play. “In order to identify the source and destination of a potentially violative product, the importer should consider whether it should be able to trace the product from its origin to its destination,” FDA

states in draft guidance. “This would facilitate the removal of the violative product from the marketplace as well as identify other implicated products. Importers should consider using contract provisions that require the use of track-and-trace technologies to accomplish these objectives.”

FDA believes that third-party support can be of assistance. It is seeking “legislative authority to accredit independent third parties to evaluate compliance with FDA requirements. . . . FDA will accredit third-party organizations, or recognize an entity

that accredits third parties. Third-party organizations could be, as appropriate, federal departments and agencies, state and local government agencies, foreign government agencies, or private entities without financial conflicts of interest. FDA would use information from these accredited third-party organizations in its admissibility decision making.” The group action plan lists this as a “short-term” goal.

In keeping with FDA’s now-typical risk-based focus, the import safety action plan “is built on the concept that focusing on risk is the most-effective way to address safety over the broad spectrum of products imported by the United States. Some areas

and products need more attention than others because of the potential risks they could present and because of differences in the product and the production environment. These differences include process controls, the history of compliance, the intended use of the product, the inherent risks of the product, and other factors demonstrated by science and experience to be valid predictors.”

Safe importing standards would
authorize border staff to destroy “med-
ical products refused admission into
the United States. The federal govern-
ment has had limited success in
stopping unsafe medical prod-
ucts for personal use from enter-
ing the United States because of
the statutory requirements that
must be met before those prod-
ucts are destroyed. Expedited
destruction of these products
would address this limitation but
would only apply to refused
shipments that are valued below
a certain threshold or which
pose a certain level of risk to
humans or animals. This is
intended to address problems,
such as personal shipments of
drugs being reimported after
they have been denied entry.”
FDA, along with other U.S.

government agencies, are definitely stepping up efforts to encourage import safety as the supply chain of almost every product stretches around the globe.

FDA calls its advice guidance, however. With a tight budget in a tough economy, FDA is expecting industry accountability when it comes to ensuring import safety. U.S. manufacturers can trust their overseas suppliers, but they also must verify that these supplies meet U.S. safety requirements, among other laws.