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Efforts to stop counterfeit and contaminated pharmaceutical drugs entering the US have been announced by the country’s Food and Drug Administration (FDA).
A cornerstone of the Secure Supply Chain scheme is that companies must have complete control over products – from manufacture to entry into the country.
As well as policing the quality of drugs, it will also expedite the importation of those products that can prove they meet the FDA’s criteria.
These include approval for all imported pharmaceutical ingredients, and the requirement that foreign manufacturers and US receiving companies must be FDA-registered and comply with Good Manufacturing Practices.
Deborah Autor, an FDA compliance director, said that a prime objective is to ensure that drug makers develop and maintain secure supply chains.
FDA regulatory spokesman Michael Chappell added: “It is critical that the FDA concentrate its resources on companies that pose the highest risk of importing products that don’t meet the FDA’s standards and violate US laws.”
Copyright Press Association 2009
