FDA urges industry to take steps to prevent warehouse theft
Products stolen include prescription and otc medicines and medical devices
The US Food and Drug Administration (FDA) is urging the pharmaceutical industry to be more aware of the dangers of the theft of FDA-regulated products from cargo and warehouses.
Products stolen include prescription and over-the-counter medicines, medical devices and infant formula.
The FDA has sent a letter to pharmaceutical companies stating that it is each firm’s responsibility to review and strengthen its security practices. The letter outlines steps that firms should take in the event of large-scale theft and emphasises the importance of informing members of the supply chain and the public after thefts occur.
‘We do not want to see this increase in thefts continue. We would like to share our thoughts on steps that should be taken to minimise the risk of such thefts, as well as how FDA can work together with the industry when a theft has occurred to address the public health risks associated with the stolen products,’ the FDA said.
The US regulator says every company should have a clear plan on how to respond to these incidents, since swift action is essential. It says it will continue to work closely with manufacturers and wholesalers to find better ways to secure the supply chain.
The FDA asks pharmaceutical manufacturers to notify its Office of Criminal Investigations (OCI) as soon as possible after a theft has occurred by phoning +1 800 551 3989 or by accessing the OCI web site.
In some cases, the appropriate public health response may be a market withdrawal for product already in the supply chain with the same lot numbers as the stolen product.
‘We recognise the impact that such a withdrawal may have on consumers, the supply chain, and a firm’s business operations, and the agency is ready to work closely with firms to determine the appropriate steps to consider in order to protect the public,’ the FDA said.
‘Depending on the circumstances, a prompt and effective response to a theft will reduce the need for such a market withdrawal.’