HDA’s 2023 Distribution Management Conference Dives into DSCSA Specifics and More

The Healthcare Distribution Alliance (HDA)’s Distribution Management Conference (DMC) is considered to be the organization’s largest supply chain education event, one of several reasons that Pharmaceutical Commerce decided to attend.

Held this year in Indianapolis, the show was kicked off with a presentation from Moogega Cooper, PhD, who works as a planetary protection engineer with NASA’s Jet Propulsion Laboratory team. In a nutshell, one could describe her role as a “guardian of the galaxy,” keeping Mars safe from the contaminants produced by planet Earth. This, as one might assume, is no simple feat, but she left the audience with various pieces of inspiration, including one African proverb that reads: “Success in life largely depends on how you handle your failures.”

Once the conference was officially underway, the lineup featured—but was not limited to—Drug Supply Chain Security Act (DSCSA) coverage, environmental, social, and governance (ESG), EPCIS standards, and a 340B update, all of which were highly attended seminars. However, one topic of utmost popularity that perhaps some attendees would agree on would be the aforementioned DSCSA—an act whose goal is to lay the groundwork that establishes interoperable, electronic tracing at the unit level and helps protect consumers from counterfeit, stolen, and contaminated drugs—which was also recently referenced by Nicholas Basta, Pharma Commerce’s editor emeritus, and one that he will further expand upon in the publication’s April issue.

In essence, DSCSA aims to remove potentially dangerous drugs from the pharma supply chain.

During her "FDA DSCSA Overview and Update" presentation, Connie Jung, FDA’s senior advisor for policy, discussed various points, such as:

• Current product tracing and verification requirements
• Recent guidances for the industry as it related to implementing supply chain security requirements
• Enhanced drug distribution security requirements that will be going into effect this year
• Information surrounding proposed regulations for national standards for the licensure of both wholesale distributors and third-party logistics providers (3PLs)
• Proposed regulations that will revise the national drug code (NDC) format and barcode requirements

There are a multitude of tidbits to pull from Jung’s presentation, with one being the difference between a “suspect” product and an “illegitimate” product as it pertains to verification requirements. Basically, with a suspect product, there is reason to believe that the product is possibly counterfeit, diverted, or stolen, while an illegitimate one should contain credible evidence. If this is the case, companies are to notify their respective trading partners—along with FDA—of illegitimate product within 24 hours, and will need to fill out Form 3911.