Louisiana board report sheds light on DSCSA adoption

Editor's note: This article was updated on 4 October to clarify the number of facilities that responded to the survey.

A majority of facilities have the necessary electronic systems to exchange data with their trading partners under the Drug Supply Chain Security Act (DSCSA), which goes into effect this November, according to a recent survey by the Louisiana Board of Drug and Device Distributors. The report notes, however, that a minority of companies have processes in place to identify authorized trading partners (ATPs) or to manage waivers, exceptions and exemptions (WEEs).

In the survey, participants were asked six questions regarding their DSCSA readiness in the following areas: their processes for identifying ATPs, their verification systems, processes for identifying suspect and illegitimate products, their processes for managing WEEs, procedures for managing exceptions, and whether they have a data exchange in place with their trading partners.

The survey was sent to designated responsible persons (DRPs) at facilities that distribute pharmaceutical products to Louisiana and was conducted between 13 August to 23 September. The Board, which licenses distributors of drugs and devices, received responses from licensees in 40 states, as well as Canada and Puerto Rico. It heard back from 54% of the firms it reached out to, and out of the approximately 1,000 firms that responded, 273 facilities offered complete responses on the six policies and procedures outlined in the survey.

The survey sheds light on which supply chain trading partners are prepared for the impending DSCSA requirements and establishes a point of contact for the state to notify companies in case there is an identified suspect or illegitimate products at facilities, George Lovecchio, executive director of the Louisiana Board of Drug and Device Distributors, told Focus.

Of the 273 facilities that gave full responses, 77% reported having processes in place for identifying suspect and illegitimate products, 45% have a policy in place for managing exceptions such as missing data, 75% have procedures in place for verifying products, 43% have procedures in place for identifying ATPS, 74% have data exchange in place with their trading partners, and 29% have policies for managing WEEs.

When asked to comment on why more trading partners do not have procedures for designating ATPs, Lovecchio said there may still be “some confusion” around ATPs and the fact that “no one really knows how to check who is authorized.”

Lovecchio said the survey shows that a minority of trading partners have procedures in place to for managing WEEs, which he said was “the most disappointing number here. Because the 29% shows that people don’t know what to do to if they are on the receiving end” and is notified that the other party has a WEE. He said that there may be uncertainty on how this can be verified. He added that “we don’t have well defined process around WEEs on the receiving [end].”

The benefit of the survey is its “call to action” in raising awareness among trading partners on the policies and procedures that need to be in place under DSCSA, said Lovecchio.

“The emails have been flying around and people are asking questions. I think people are seeing this as valuable and showing that we can make this November deadline … I think this shows that we can do it if we work together.”

Lovecchio added that “I think the survey shows that the time for excuses is over and it is time for implementing.”

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Louisiana board report sheds light on DSCSA adoption

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