Bioterrorism Rules Impact Distributors

The new bioterrorism rules implemented by the Food and Drug Administration (FDA) will certainly impact distributors by requiring record keeping and trace back systems, but some distributors say it really isn’t that big of a deal.

Brian Conley of B&W Wholesale said it’s a matter of "adding a few fields to a software program that most distributors already have in place."

Under the new rules, large distributors must comply by December 2005; everyone else, except very small companies (10 or fewer employees), must comply by June of next year.

Basically the rules require that companies, when questioned by the FDA, must be able to provide supplier and customer details about a shipment of product, including the transporter, within 24 hours. On the bright side, said John Thomas of the law firm Luman, Lange, Thomas & McMullen, the session’s moderator, the government did listen to industry when developing the final rules and did not require companies to provide lot numbers.

Thomas also addressed Drug Enforcement Agency (DEA) requirements in regard to the sale of common cold medicines that are sometimes used to make illegal drugs. He said distributors have "a legal obligation not to engage in a transaction that appears suspicious." One distributor said he posts the DEA hotline number in the lobby of his business, which he feels deters any potential illegal purchases.