Catching Up on DSCSA as the Deadline Looms

Direct Access | Randy Hoggle talks about the steps to be taken to ensure compliance and his take on quality-of-data issues that still need to be addressed.

This interview by PTMR Publisher Bill Lockwood with Randy Hoggle, B.Pharm., Dr.PH., M.B.A., CEO of the DSCSA Compliance Services Resource Center, brings us up to date on the steps to be taken to ensure compliance and his take on quality-of-data issues that still need to be addressed.

PTMR: Now that we are closing in on the new deadline for DSCSA (Drug Supply Chain Security Act) compliance, what must pharmacies have in place to ensure compliance? Can you provide a checklist?

Randy Hoggle: Yes, the pharmacies must be able to meet five requirements, and they only need to look to their state boards of pharmacy to see DSCSA compliance-related actions taken against in-state or out-of-state pharmacies that sell product to other pharmacies and are thus acting as wholesalers in that state, where the board has met and made decisions on fines or taken other action steps against those parties transacting these illegal sales. Federal or state government authorities can inspect pharmacies’ capabilities to meet the following first five DSCSA compliance requirements: