The International Pharmaceutical Excipients Council of the America (IPEC Americas) made the claim in a statement published on its website earlier this week, explaining that the comment was based on the finding of a survey of member organisations.
The industry group – which also said it has sent a letter detailing its findings to the US Food and Drug Administration (FDA) – said “many member companies are experiencing an increase in excipient products being held at ports of entry.”
It added that: “Unfortunately, items in hold status often result in monetary losses for the companies importing the products. In the worst case, these holds can prevent the excipient end-users from making the product on schedule and has, at least in one case, resulted in the shutdown of production of the drug product.”
The organisation called on US authorities to introduce a process by which “unnecessary holds” can be avoided and to develop a way of expediting the release of imports that are already being held.
“It is hoped that IPEC-Americas can engage with the FDA to understand the reason for this increase in holds, and discuss possible solutions to ensure that excipients with a long history of use and unimpeded import can continue to be efficiently processed at their port of entry, thus allowing them to reach their intended user without unnecessary delays.”
in-Pharmatechnologist.com would like to ask readers if the agree with the findings of the IPEC Americas survey.
Are US authorities holding more of your excipient imports at ports of entry?