Phased DSCSA Implementation: A Discussion with Industry Experts

Brian Waldman, Firmwide Managing Partner at ArentFox Schiff, also answered another common question, ‘why comply?’

“Don’t take your eye off the ball because there are many requirements in effect now and the exemptions do not affect these: you can only transact with authorized trading partners,” says Waldman.

·     You can only transact with serialized product.

·     You should have a robust lot level verification system in place.

·     You should records documenting your procedures.

Not complying and participating in prohibited behavior will result in a 483. Also, the FDA can seize product that is not compliant and in your possession. Waldman went on to describe that the absence of verification systems is a high priority for FDA. You get credit if you have written policies in place, but you must follow them and have documents that demonstrate you’re following them.

“Don’t take your eye off the ball because there are many requirements in effect now and the exemptions do not affect these: you can only transact with authorized trading partners,” says Waldman.HDAHow does FDA enforcement come about? Through routine or for-cause inspection. The FDA come in and inspects, then a 483 is issued (listing out observations) that could then become a warning letter. Side note: all warning letters are publicly available on the FDA’s site, and the presence of your company in a letter could affect your relationship with your trading partners.

While DSCSA hasn’t been a focus of inspections, it is becoming increasingly so, says Waldman. A good source of information that companies have access to in terms of what the FDA might look for is in the form of warning letters. For example, the FDA issued a 483 in June 2023 to a company allegedly selling counterfeit HIV medications and with inadequate verification systems in place. Pharmacies were calling attention to the problem, but the company was not investigating the problem.  

If complying with the FDA isn’t enough motivation, know that states will be doing inspections and audits, too. There are also contractual risks with your contract and partners. Finally, patients and private lawsuits are a real possibility.