Manufacturers largely met May DSCSA deadline without major issues, experts say

Supply chain experts said that most manufacturers successfully implemented the enhanced tracing requirements outlined in the Drug Supply Chain Security Act (DSCSA) by the 27 May deadline without significant issues. In addition, they said that wholesalers are optimistic about meeting the upcoming deadline of 27 August, which marks the end of the exemption period.

Eric Marshall, executive director of the Partnership for DSCSA Governance (PDG), and Tish Pahl, an attorney with Olsson Frank Weeda Terman Matz PC, spoke with Focus to share their insights on the current status of DSCSA compliance.

In October 2024, the US Food and Drug Administration (FDA) announced that it will give firms additional time before it begins enforcing its enhanced distribution security requirements under the Drug Supply Chain Security Act (DSCSA), heeding calls from industry and lawmakers to delay certain aspects of the law’s implementation to avoid potential shortages. (RELATED: FDA announces broad DSCSA exemptions for trading partners, Regulatory Focus 9 October 2024)

Under the policy, manufacturers and repackagers had until 27 May 2025 to comply with the enhanced distribution security provisions of the law, while wholesale distributors and dispensers with 26 or more full time employees will have until 27 August 2025 and 27 November 2025, respectively, to comply.

Both Marshall and Pahl said that for the most part, manufacturers were ready by the May deadline.

“It did come and go. There were no fireworks. In many ways, it was uneventful. Many folks felt like manufacturers were pretty prepared,” said Marshall. “I am aware of two or three exceptions that were issued to individual manufacturers, but generally it went off pretty quietly.”

Marshall noted that a “few issues” have cropped up. These include an increase in bar code scanning issues over the past few weeks. This includes the printing of bar codes and bar code quality, and incorrect coding. Also there has been a “notable uptick” in equipment issues at the wholesale level, where scanners were incorrectly configured.

Pahl concurred that the deadline for manufacturers “came and went.”

“As far as I know, there were two exemptions for manufacturers that came out during that time. Otherwise, manufacturers seemed to think they were in compliance,” she said.

When asked to comment on the readiness of wholesalers ahead of the August deadline, Marshall said, “The word I’m hearing from wholesalers is that they are optimistic. Overall, there is a positive feeling about meeting the August deadline. There have been no calls from the wholesaler community to delay … While there are some nuanced issues, like bar code problems, most people are feeling pretty optimistic.”

Pahl added that wholesalers are using this exemption period to work through any glitches or bugs that may crop up. She said that the phased implementation timeline is “working as intended. My impression is that it's not easy, but trading partners are working through the problems.”

She further noted that “the recent report on that was pretty positive and that it is going pretty much according to plan.” Pahl was referencing a survey report issued by FDA and PDG, which summarized stakeholder comments from a town hall in June on DSCSA.

One looming “pain point” is the transition from the 10-digit NDC code format to a 12-digit format, according to Pahl. She mentioned that this change is “causing a lot of anxiety.”

In July 2022, FDA proposed an update to the National Drug Code (NDC), replacing the existing 10-digit format with a 12-digit format in anticipation of a looming exhaustion of these codes within the next ten to 15 years. A final rule is expected sometime next year, said Pahl. (RELATED: FDA announces plans to revamp national drug code, Regulatory Focus 26 July 2022)

Under DSCSA, trading partners have used the 10-digit NDC format as part of the DSCSA required product identifier. A change to a 12-digit code will necessitate changes to the product identifier as well as standards for exchanging data. Pahl added that “it will be a significant event for the pharmaceutical supply chain to deal with.”

Manufacturers largely met May DSCSA deadline without major issues, experts say

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