Excipients industry faces bioterrorism law deadline
the US must step up their compliance with new legislation or risk
having shipments turned back at the border.
This was the stark warning delivered by Art Falk, chair-elect of the International Pharmaceutical Excipients Council of the Americas, at a meeting in France last week.
Last year, the US implemented two pieces of legislation designed to safeguard the country's food supply against bioterrorism. The first requires all food facilities to register with the Food and Drug Administration (FDA), while the second requires prior notice to US customs of any imported food shipments.
The relevance for the pharmaceuticals industry is that there are a number of food ingredients - such as gelatine and glycerine - that are widely used as excipients. But customs in the US have no mechanism to separate shipments intended for pharma use from those for food, and so excipients will be subject to the same legal requirements.
As of mid-January, said Falk, only half the 420,000 facilities expected to need registration for importing under the scheme had done so. To date this has not been a problem because, since the legislation was implemented 12 December last year, US customs and the FDA have been exercising a degree of tolerance for shipments which arrive without the correct documentation. But this grace period is set to end.
From March, warned Falk, the US will start rejecting shipments that do not have the right paperwork, and this will mean that an application to import will have to be re-submitted. And this could spell significant delays for customers waiting for the goods, he noted.
Feedback needed now
Falk told the IPEC Europe seminar in Cannes, France, that as the legislation is currently officially only an interim final rule, the FDA is still welcoming comments on it and this is imperative if any teething troubles are to be sorted out.
Carl Mroz, vice chairman of IPEC Europe and an executive at excipient company Colorcon, commented at the meeting that 90 per cent of all excipients come under the food additive category, so this will have a significant impact on those companies doing business in the US.
Mroz also said that there are difficulties associated with the rules on prior notice. For example, at present, this requires notice of import to be served no more than five days prior to shipment and no less than eight hours before arrival by ship. This is difficult to achieve if your shipment is on a ship leaving Singapore and bound for the Eastern seaboard, he pointed out.
Other problems raised at the meeting included the issue of the supplier's FDA registration number, awarded upon registration of a facility and supposed to be confidential. One delegate at the meeting said that his company was routinely asked to reveal this by customers, and was unsure of the legalities of doing so.
Finally, there are certain issues that will appear as the legislation becomes established. Falk pointed out that one requirement of the legislation is that any change in situation - such as a change in ownership - must be registered with the US authorities. This could create an ongoing administrative burden, he noted, adding that there are also outstanding questions about how this might be audited.
