FDA Offers Suggestions & Seminar on Preventing Cargo/ Whse Theft
The Food and Drug Administration and the Drug Information Association are announcing a May 13, 2011 seminar in Washington D.C. on the prevention of cargo and warehouse theft of FDA-regulated products, including prescription and over-the-counter medicines, vaccines, medical devices, and infant formula, as theft of these types of products pose a significant public health risk resulting from improper storage, etc. FDA also has a webpage dedicated to informing the public of cargo theft of FDA-regulated products and issued a letter to stakeholders in April 2010 suggesting steps for the trade to follow to prevent and/or respond to such threats.
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Seminar Will Discuss Best Practices to Prevent and Respond to Theft
The seminar will discuss current best practices to ensure progress in reducing the number of cargo thefts by enhancing storage and intransit security practices and providing a prompt and effective response when a cargo theft occurs.
The program has been designed for senior-level management of manufacturing and distribution, law enforcement, wholesalers, transportation companies, logistics and security providers, insurance companies, and federal, state and local regulators.
FDA Highlighted Concern in 2010 Stakeholder Letter, Suggested Certain Controls
In the April 2010 letter to stakeholders, FDA said that it was very concerned about the increase in cargo and warehouse thefts of FDA regulated products and suggested the following;
Continuously review security. The agency said that firms engaged in providing medical products and infant formula to the public have a fundamental responsibility to continuously review their warehouse physical security and security practices and procedures for transporting products to ensure that measures are in place to minimize the risk of warehouse and cargo theft.
Measures throughout supply chain. These measures are important throughout the supply chain-starting from the point of manufacturing, continuing through the distribution of the product and to the retail outlet or other point where the product will be sold. Companies should ensure that their business partners and carriers review and have strengthened their storage and in-transit security practices as well. Companies also need to be one-step ahead of thieves in securing their warehouses and product transport.
Contact FDA if theft occurs. The trade should promptly notify FDA's Office of Criminal Investigations (OCI) as soon as possible when a theft has occurred. The agency has developed streamlined procedures to rapidly respond to reports of theft and to ensure consistency as it works with firms that have experienced a cargo or warehouse theft.
Notify public. Prompt public notification of the theft is a critical step in protecting the public health because it alerts others in the supply chain and the public to look out for the stolen products and to be skeptical of offers for these products at unusually low prices or from a person outside the legitimate distribution chain.
FDA Webpage Tracks Stolen Products & Batch Numbers, Etc.
FDA’s webpage on cargo theft contains information on:
- what products were stolen;
- which lot or batch numbers to look for;
- what consumers should do to check a product to see if it is a stolen product;
- what consumers should do if they have a stolen product;
- how to report adverse events related to the use of or exposure to a stolen product;
- what pharmacies, retailers or distributors should do if they have stolen product;
- how to report suspected criminal activity to FDA's Office of Criminal Investigations.
(FDA also tracks the number of cargo thefts resulting in public notifications each month through its “Dashboard” project available here.)
FDA list of drug-related meetings, conferences and workshops events available here.
FDA letter to stakeholders, dated 04/28/10, available here.