FDA seeks to secure supply chain

The US Food and Drug Administration is seeking 100 companies to volunteer to join the Secure Supply Chain pilot programme. The programme aims to promote the safety of drugs and active drug ingredients produced outside the US. Applicants will need to meet the programme's criteria, including a requirement that they maintain control over the drug products from the time of manufacture through entry into the country. The FDA hopes the programme will expedite the entry of products meeting the pilot's criteria into the US and allow it to focus its resources on foreign-produced drugs that fall outside the programme and that may not be compliant.
Regulatory Focus