FDA Advises Stakeholders about Preventing Cargo Theft

May 6, 2010
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration sent a letter to trade associations of manufacturers, wholesalers, and pharmacies to recommend procedures for preventing and responding to the theft of regulated products.

On Apr. 28, 2010, the US Food and Drug Administration sent a letter to trade associations of manufacturers, wholesalers, and pharmacies to recommend procedures for preventing and responding to the theft of regulated products. The letter follows recent thefts of prescription and over-the-counter medicines, vaccines, and infant formula. Products that have left the legitimate supply chain threaten public health by posing safety risks to consumers, FDA said in the letter.

Companies that provide regulated products to the public “have a fundamental responsibility” to review their warehouse physical security, security practices, and shipping processes continuously to minimize the risk of warehouse and cargo theft, according to the agency. The letter indicated that security measures are important from the point of manufacturing, through distribution, to the point of sale. FDA urged companies to confirm that their business partners and carriers review and strengthen their storage- and transportation-security practices.

The agency pledged to work with companies that experience theft to minimize public-health risks and ensure an appropriate response. In its letter, FDA asked firms to notify its Office of Criminal Investigations promptly when a theft occurs. After this notification, the agency’s District Office nearest to the company’s headquarters will request information about the stolen products, including a risk-assessment and an action plan. FDA also encouraged firms to report thefts to law-enforcement agencies immediately.

Prompt public notification of thefts protects the public health by spurring the supply chain and consumers to look out for the stolen products and to be wary of purchasing them. Public awareness also makes it difficult for thieves to sell stolen products back into the legitimate supply chain, FDA said in the letter.

Companies whose products are stolen should post public notices on their websites or publish press releases as soon as possible, according to the agency. If a company shares its notice with the agency before publication, FDA is willing to comment on it publicly and provide a link to the notice on its new Cargo Theft website.

In some cases, safeguarding the public health may require product already in the supply chain with the same lot numbers as the stolen product to be withdrawn from the market. In its letter, FDA stated its willingness to work closely with firms to determine the appropriate strategy to protect the public and minimize the effect of a product withdrawal on consumers, the supply chain, and a firm’s business operations.

The agency noted that it has been collaborating with manufacturers, wholesalers, and retailers to secure the supply chain, and that it had added stolen products as a threat to the supply chain alongside counterfeit, diverted, unapproved, and misbranded or adulterated products. In addition, FDA is working with the medical-products and infant-formula supply chain to identify best practices and provide guidance for preventing and responding to cargo and warehouse theft.