FDA Starts Secure Supply Chain Pilot Programme

According to a press release, the American Food and Drug Administration (FDA) starts a pilot programme to improve the safety of imported medicinal products and active pharmaceutical ingredients, which is called Secure Supply Chain Pilot Programme. For this task, the authority intends to select 100 voluntary applicants who will monitor up to 5 selected products throughout the supply chain until being imported into the USA. The aim is to obtain information in order to develop a Secure Supply Chain Programme meant to support the FDA in its efforts to exclude those products that do not comply with the FDA requirements from being imported. For those products that fulfil the requirements, the import procedure is intended to be facilitated. In doing so, the FDA is supported by the U.S. Customs and Border Protection. The pilot programme is planned to run for 2 years.

More information can be found in the Federal Register.

The programme may be a first step into the direction outlined by FDA Commissioner Robert A. Friedman. Friedman thinks it will be possible that supplier qualification and control could be explicitly included into the FDA regulations, especially into the CFR, and also mentions excipients manufacturers in this context (The Gold Sheet Vol.42, No.10).

What has also been published is a draft for a Guidance for Industry : Good Importer Practices. It is the objective of the guidance to give further recommendations regarding the safety of imported products to importers. The contents include among others:

  • a Product Safety Management Programme
  • verification that manufacturer and product comply with the US requirements
  • corrective and preventive action in case of deviations

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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