Are You Complying with the DSCSA?

Although the Drug Supply Chain Security Act (DSCSA) was passed 13 years ago and applies to eyecare practices, many remain in the dark regarding its effect on them, says the founder of a company that delivers readiness audits for regulated medical environments.

“What the FDA wants is everyone to be good stewards of their part of the supply chain,” says James Strafuss, founder of the company Claritas Axis. “I’m seeing a lot of people who are at risk of inspection failure just out of ignorance of the law because no one’s educated them. The practices that can get ahead of this become the standard in their market.”

DSCSA OVERVIEW

The DSCSA was created to aid in the detection and prevention of harmful drugs entering the country’s drug supply chain and allows for a fast response to remove such drugs, so patients and practices alike are protected, according to the FDA. The guidelines require drug dispensers, such as ODs, to “achieve an interoperable and electronic way of both identifying and tracing certain prescription drugs at the package level as they move through the supply chain,” says the FDA. Failure to supply this drug documentation can result in license suspension, practice closure, and fines.

COMPLIANCE RESOURCES

Claritas Axis offers a free tool to help eyecare practices determine whether they are in compliance with the DSCSA requirements: a 10-question Drug Supply Chain Readiness Snapshot, available on the company’s website.¹

In reviewing DSCSA warning letters sent to practices at risk of failing inspection, Mr. Strafuss says he was able to boil down what the FDA is looking for during drug inspection. He notes that eyecare practices must:

1. Confirm every drug supplier holds a valid license in both the state they are shipping from and the state they are shipping to.
2. Maintain transaction documentation for every drug for 6 years.
3. Quarantine any suspect or potentially illegitimate product while it is under investigation.
4. Notify the FDA and relevant trading partners within 24 hours if a product is confirmed illegitimate.
5. Have a system to receive recall alerts, pull affected lots, and respond with records on request.
6. Document every drug administered in-office and reconcile it against what was purchased.

Mr. Strafuss says he then converted these findings into the company’s Snapshot to help eyecare practices pinpoint potential gaps in their drug documentation process. He adds that a more extensive paid questionnaire containing action-based solutions is also offered for those who want to take a deeper dive.

Also available as resources to help guide an eyecare practice are independent FDA/DSCSA consultants, pharmacy compliance consulting firms, healthcare accreditation and audit-readiness providers, and specialty practice compliance services.