First, the FDA issued its 10-year implementation plan for the Drug Supply Chain Security Act. This includes estimated timeframes and target dates based on the requirements set forth in the law. These dates will interest IWLA members:
- Issue notice of public docket to collect stakeholder comments on standards for interoperable exchange of transaction information/history/statement in paper or electronic format (2/20/2014)
- Publish draft guidance establishing standards for interoperable exchange of transaction information/history/statement in paper or electronic format (11/27/2014)
- Establish a system for third-party logistic provider reporting to FDA (11/27/2014)
- Develop regulations establishing standards for licensing of third-party logistic providers (11/27/2015)
Second, the FDA issued a request to stakeholders to comment about the interoperable exchange of transactions. As you may recall, information is not required to be passed when transferring possession of a product or when a product is transferred to a corporate affiliate. Fortunately, the act defines 3PL as providing and coordinating warehousing and other logistics services of the product in interstate commerce, relieving the industry from assuming ownership. But, this is not necessarily out of the 3PL’s hands as customers may look to their warehouse to aid in compliance of this law.
The FDA has opened the gates for stakeholders and other interested parties to comment on the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format, for each transfer of product in which a change of ownership occurs.
To continue IWLA’s proactive approach to working with the FDA to develop effective solutions for compliance, please provide your feedback to the IWLA Government Affairs Committee by the April 21, 2014 deadline. You can do so via IWLA Washington Representative Pat O’Connor.