Yesterday the U.S. FDA posted the first issue of the wholesale distributor and third-party logistics provider (3PL) database as mandated by the Drug Supply Chain Security Act (DSCSA). Through this webpage, you can either download the entire database (in .XLS form), or enter a specific query and then download that result set if desired. I couldn’t get the result set download to work, so there are obviously some bugs that need to get worked out, but this is still an important step in the implementation of the DSCSA.
With this posting, anyone who buys drugs from wholesale distributors should include a step in their “purchasing” Standard Operating Procedure (SOP) to check this database to confirm that the company they are placing an order with is properly licensed in the jurisdiction they are located in. According to the FDA, this database will be updated every day, so even if a wholesale distributor was licensed yesterday, and their license wasn’t due to expire for another year, you should check this database again today, before placing a new order, because some action may have caused their license to be revoked last night. In that case, you would be violating the DSCSA if you buy from them today. Further, any drugs that were shipped to you by that wholesale distributor after their license was revoked may be viewed as “suspect product” under the DSCSA.
The list of companies who must check the license status of wholesale distributors they buy from, includes, other wholesale distributors, repackagers and dispensers.
The 3PL license database is for drug manufacturers to check whenever they distribute their product through one of these companies. These manufacturers should regularly check this database to ensure that their contracted 3PL is still licensed to distribute drugs in the target jurisdictions. Contracts with 3PL’s should probably include an escape clause for the manufacturer if the 3PL loses it’s licenses in one or more of the target markets.
The DSCSA requirements I refer to above that require companies to only buy from companies who are licensed, went into effect on January 1, 2015. These particular requirements were not included in those that the FDA has delayed their enforcement of, so you should begin using this database immediately!
As I said, these requirements are an important part of the DSCSA protection of patients. They are intended to quickly shutdown any company that loses their license, for any reason. Of course, those reasons may include problems with inappropriate sourcing, poor storage or handling, and other issues that may impact the quality and safety of the drugs they sell or distribute. Don’t let their violation extend to include you and your company. Check this database before you buy–especially in drug shortage situations.