Extending Import Safety

Transporting pharmaceuticals and their packaging components is undoubtedly a hot topic for the National Wooden Pallet & Container Association’s (NWPCA). On its Web site (www.palletcentral.com), NWPCA reports that it has been fielding inquiries from pallet users concerned about the recent recall by McNeil Consumer Healthcare. The recall involved complaints of a moldy or mildewy smell; McNeil reportedly believes the smell was caused by the chemical 2,4,6 Tribromoanisole (TBA), a known degradant of 2,4,6 Tribromophenol (TBP) used in pallets that housed packaging supplies.

“Pallet users are alarmed and are calling NWPCA and pallet companies for assurance that U.S. wood pallets are safe,” NWPCA writes. To allay fears, the group offered a few “facts” on its site, such as “TBP is not a registered pesticide with the Environmental Protection Agency (EPA). Therefore, it is not legal for sale or use in the United States (it is also banned in Europe). The chemical is not recognized as a wood preservative by the American Wood Protection Association (AWPA). U.S. wood treatment facilities do not use this fungicide.”

I had called McNeil a while ago to learn more about the recall and its causes, but never did hear back, so I couldn’t ask about TBP. So I have no details to share on this recall or its causes.

But if you are a wooden pallet user and you accept the facts offered by NWPCA, sticking with U.S.-compliant pallets may make you feel better. NWPCA reports that some pallet users have been asking for pallet providers to self-certify that they are providing TBP-free materials, so you may want to consider a similar practice.

Ultimately, though, you are responsible for the materials you use to transport your products and components, at all stages of the supply chain.

NWPCA’s statements bring to mind something I included in last year’s Winter issue of Pharma-Bio Transport. I covered the then-new Interagency Working Group on Import Safety (www.importsafety.gov), which involved the Department of Health and Human Services, the Department of Transportation, the Consumer Product Safety Commission, and other agencies to ensure safe import of materials imported for manufacturing in the United States. Imported pharmaceutical and medical devices and any materials imported to manufacture them were included in the plan’s scope. And in its then-released “Good Importer Practices” draft guidance, FDA stated that “importers should put into place controls for known vulnerabilities, such as microbiological contamination and product defects, and monitor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.” In addition, “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.”

As I wrote then, 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.

And “ingredients” could very well include packaging materials.