Important takeouts:
If the manufacturer is not a complaint, the wholesaler or distributor should not accept the product until it has been updated with serialized data. Additionally, you will be 483 to not comply with or participate in prohibited conduct. Additionally, the FDA is not compliant and you can grab the products you own. DSCSA has not been the focus of FDA testing, but it is increasing.
The latest HDA traceability webinar series featured a panel discussion on the Phased Drug Supply Chain Security Act (DSCSA) implementation process.
HDA's Liz Gallenagh, Jaidalyn Rand, Tim Stearns, and legal experts Tish Pahl and Brian Waldman looked into how multiphase exemptions affect operations across the drug supply chain.
In fact, the distributor exception ends on August 27th of this year. If the manufacturer is not a complaint, the wholesaler or distributor should not accept the product until it is updated with serialized data.HDA“What if my supplier is not compliant?” And while it may be a question that may increase emotions and stress, the answer is very simple. In fact, the distributor exception ends on August 27th of this year.
If the manufacturer is not a complaint, the wholesaler or distributor should not accept the product until it is updated with serialized data. In other words, if the supplier is not compliant, the company is no longer a supplier.
Brian Waldman, the company managing partner at Arentfox Schiff, also answered another common question: “Why do you follow?”
“There are now many requirements and exemptions don't affect these, so keep an eye on the ball. You can only trade with a certified trading partner,” Waldman says.
・Can only be traded on serialized products.
– A robust lot level verification system must be in place.
– You must record a documenting procedure.
If you do not participate in any prohibited actions, you will be 483. Additionally, the FDA is not compliant and can grab products you own. Waldman went on to explain that the lack of a verification system is a top priority for the FDA. If you create a policy, you will get credits, but you will need to follow them and create a document that shows you are following them.
“There are now many requirements and exemptions don't affect these, so keep an eye on the ball. You can only trade with a certified trading partner,” Waldman says.HDAHow does FDA enforcement come about? Through routine or causal testing. The FDA will be in and inspected, then a 483 will be issued (observation results), which could be a warning letter. Side notes: All warning letters are published on the FDA site, and the presence of the company in the letter may affect your relationship with your trading partner.
DSCSA has not been the focus of testing, but it is becoming more and more common, says Waldman. A great source of information companies can access about what the FDA is looking for is the form of warning letters. For example, the FDA issued 483 in June 2023 to companies that reportedly sold counterfeit HIV drugs and employ inappropriate verification systems. The pharmacy had been bringing attention to the issue, but the company had not investigated the issue.
If FDA compliance is not sufficient, know that the state will also perform inspections and audits. Also, contracts and partners have contractual risks. Finally, patients and private litigation are real possibilities.
