It was fairly easy to predict the FDA would invoke enforcement discretion for the wholesale distributor’s saleable returns requirement of the Drug Supply Chain Security Act (DSCSA), as they announced last Tuesday (see “Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?”). The deadline for the mandate was originally this November 27, but with the announcement, will not be enforced until November 27, 2020.
The new guidance containing enforcement discretion is “final” rather than “draft” as earlier delays in enforcement have been, because the timing doesn’t really work if you have to accept comments before you can make it final. The time is just too short. The full new guidance document is available here.
The DSCSA will trigger multiple requirements for wholesale distributors on November 27, 2019 and the only one this guidance offers enforcement discretion for is the requirement to verify at the SNI-level all saleable drugs returned, before they are redistributed. Here is how the FDA says it:
“FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2020, verify a product identifier prior to further distributing returned product as required under section 582(c)(4)(D) of the FD&C Act. This represents a one-year delay in enforcement of the requirement for wholesale distributors to verify a product identifier prior to further distributing that returned product.”
Here is FDA’s justification for invoking enforcement discretion:
“…FDA has received comments and feedback from wholesale distributors as well as other trading partners and stakeholders expressing concern with industry-wide readiness for implementation of the verification of saleable returned product requirement for wholesale distributors. Specifically, stakeholders have described challenges with implementation of verification of the product identifier on saleable returned drug product packages or sealed homogenous cases due to a number of factors, including: (1) the very large volume of saleable returned product requiring verification; (2) the need to refine and test verification systems during actual production using real-time volumes of saleable returned product rather than simply in pilots; and (3) the complexities of building an interoperable, electronic system with the capabilities to timely and efficiently verify the large volume of saleable returned products amid immature technologies.”
The guidance make a passing reference to the development of the Verification Router Service (VRS), without using its name, but acknowledging that more time is necessary to get it fully operational.
Probably the most important part of the guidance is where the FDA lists what it NOT covered by the enforcement discretion. Here is a breakdown of that part:
- “…[I]t does not affect the requirement that a wholesale distributor must have verification systems in place to determine whether a returned product is a suspect product”;
- “…[It] does not affect the requirement that beginning November 27, 2019, a wholesale distributor may engage in transactions involving a product only if such product is encoded with a product identifier (except as provided pursuant to section 582(a)(5) of the FD&C Act)”;
- “[It] does not relieve a manufacturer of its verification obligations pursuant to section 582(b)(4)(C) of the FD&C Act upon receiving a request for verification from a wholesale distributor”;
- “Further, beginning November 27, 2019, wholesale distributors must only accept returned product from a dispenser or repackager if the wholesale distributor can associate returned product with the transaction information and transaction statement associated with that product”.
The delay is only for the verification of saleable returns using the Standardized Numerical Identifier (SNI). The wholesale distributors and their trading partners now have another year to get the VRS working smoothly and connected to their largest suppliers.
BERNSTEIN DEPARTS FDA
As Pharmaceutical Commerce reported three weeks ago, Dr. Ilisa Bernstein has departed the FDA to work as a senior executive at the American Pharmacists Association (APhA), after a 30-year career with the FDA. She leaves the position of deputy director of FDA’s Office of Compliance in CDER.
In the quest for elevated pharmaceutical supply chain security and efficiency, I like to think we all play a role. You have a role, I have a role and lots of other people have roles. The people at the FDA have some of the most important and challenging roles. The role Dr. Bernstein filled over the years I have known her was well executed. In my experience with her as the key person at the FDA responsible for implementing the DSCSA, she was always open, knowledgeable, cheerful and in control. It was always my pleasure to hear her speak and to discuss various challenges of the DSCSA in one-on-one interviews or conversations. I am sorry to see her go at such a critical point in the path to 2023 but I wish her well at APhA. So far there is no word on her replacement.