In a direct response to concerns expressed by the Healthcare Distribution Management Association (HDMA) and others (see “HDMA Expresses Concerns About Industry Readiness for DSCSA” and “Will The DSCSA Cause Drug Shortages After January 1?”), the FDA posted new guidance that states their intention to postpone enforcement of just the requirements for manufacturers, wholesale distributors and repackagers to provide and capture Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS). That requirement was to take effect next Thursday for everyone except dispensers, who will still face the requirement on July 1.
The new guidance document can be found on the FDA’s website.
The core information is contained in the last paragraph:
“The product tracing requirements in sections 582(b), (c), and (e) of the FD&C Act take effect for manufacturers, wholesale distributors, and repackagers on January 1, 2015. However, some trading partners have expressed concern that unforeseen complications with the exchange of the required information may result in disruptions in the supply chain, and ultimately could impact patients’ access to needed prescription drugs. FDA recognizes that some manufacturers, wholesale distributors, and repackagers may need additional time beyond January 1, 2015, to work with trading partners to ensure that all of the product tracing information required under section 582 of the FD&C Act is provided to and captured by the recipient trading partner. To minimize possible disruptions in the distribution of prescription drugs in the United States, FDA does not intend to take action against trading partners who do not, prior to May 1, 2015, provide or capture the product tracing information required by section 582(b)(1), (c)(1), and (e)(1) of the FD&C Act. This compliance policy is limited to the requirements that trading partners provide and capture product tracing information; it does not extend to other requirements in section 582 of the FD&C Act, such as verification related to suspect and illegitimate product (including quarantine, investigation, notification and recordkeeping) and requirements related to engaging in transactions only with authorized trading partners.”
Technically, this is not a postponement of the requirement to collect and provide the transaction data, but in effect, it is, since the FDA says they will electively not enforce this requirement.
In my view, companies who are ready and able to pass the transaction data to trading partners who are able to receive it, should do so. You can consider this to be an extra four months of live testing to make sure there are no surprises in your data or the communications channel with your partners.
Companies who are not yet ready should keep moving forward as fast as they and their solution providers are able. Perhaps the new deadline will help to ensure that drug shortages do not occur as the result of the DSCSA.
This action (inaction?) by the FDA could be considered “enforcement discretion” since it does not change the law itself. Enforcement discretion is about the only option the FDA has at its disposal since only Congress can change the law (see “Will The FDA Delay The DSCSA?“).
It is a holiday gift to procrastinators, but it is also a gift to those who made every attempt to be ready on time but ran into unexpected complications and delays with their trading partners and solution providers. Getting every company in the supply chain aligned with a standardized data exchange approach is harder than most people assume. Take that as a small lesson toward the 2017 and 2023 requirements and give yourself plenty of testing time in advance of those deadlines. The FDA may not be as understanding about those dates.
If you are working this week, why not set aside a few minutes with your favorite hot caffeinated drink and fill out the 2015 RxTrace U.S. Pharma Traceability Survey, Sponsored by Frequentz? Start by clicking here. And watch for my analysis in 2015.