Pharmaceutical wholesalers and distributors must refuse products from non-compliant manufacturers as of August 27, with serialization and verification systems now mandatory. Non-compliance risks FDA 483s, product seizures, warning letters, and potential lawsuits.
- Distributors cannot accept non-serialized products from manufacturers after August 27 of this year, making supplier compliance mandatory.
- Penalties for non-compliance include FDA Form 483 observations, public warning letters, and product seizures by regulators.
- Companies must maintain written verification procedures and documented evidence of compliance to receive FDA credit during inspections.
- FDA enforcement on DSCSA violations is increasing significantly, with inspections now a high priority for regulatory agencies.
- Non-compliance creates contractual risks with trading partners, state inspection liability, and exposure to private lawsuits from patients and competitors.
Key takeaways:
- If a manufacturer is not complaint, a wholesaler or distributor should not accept product until it has been updated with serialized data.
- Not complying, or participating in prohibited behavior, will result in a 483. Also, the FDA can seize product that is not compliant and in your possession.
- While DSCSA hasn’t been a focus of FDA inspections, it is becoming increasingly so.
The latest HDA’s Traceability Webinar Series featured a panel discussion on the phased Drug Supply Chain Security Act (DSCSA) implementation process.
HDA’s Liz Gallenagh, Jaidalyn Rand and Tim Stearns, and legal experts Tish Pahl and Brian Waldman examined how the multiphase exemptions will impact operations across the pharmaceutical supply chain.
The fact is that the distributor exception ends August 27 of this year. If a manufacturer is not complaint, a wholesaler or distributor should not (may not) accept product until it has been updated with serialized data.HDA
If a manufacturer is not complaint, a wholesaler or distributor should not (may not) accept product until it has been updated with serialized data. In other words, if a supplier isn’t compliant, the company can no longer be a supplier.
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.HDA
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.
