Randy Hoggle Advasur DSCSA Track and Trace

In my first article in this series in the May/June 2022 issue, I explained what the DSCSA (Drug Supply Chain Security Act) is and what pharmacy teams must do today to meet the additional five of 10 requirements.

Now I will outline the five new requirements that must be implemented by Nov. 27, 2023. These are summarized below.

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Requirement #6: Serialization codes validation, authentication, and documentation management

Dispensers may only buy and sell products encoded with product identifiers.

Requirement #7: Lot number validation, authentication, and documentation management

Dispensers must verify every product at the product package lot number level, including the SNI (serialized numerical identifier).

Requirement #8: Electronic advanced shipping notification (ASN) — 10 data sets for internal system integration

While the FDA (Food and Drug Administration) has a self-assigned deadline for providing Section 203 guidance with issuance by Nov. 27, 2022, for this requirement, most retail chains and large health systems have already embarked on meeting these system integration requirements — for example, ensuring that all orders are made using the NDC (national drug code) rather than UPC (universal product code) as commonly used by pharmacy/grocery chains.

Dispensers must validate the electronic shipment notification’s 10 data elements for accuracy of that data matched to suppliers’ 10 data elements, and where there are gaps in supplier prescription product data sets, correct those deficiencies.

Requirement #9: Interoperability of DSCSA compliance data exchange

While the FDA has a self-assigned deadline for providing Section 203 by Nov. 27, 2022, for this requirement, as well as for requirement #8, most retail chains and large health systems have already initiated work with their authorized trading partners and software vendors. At a minimum, the ASN 10 Rx product data points must be accurate and match your suppliers, as the Office of Inspector General (OIG) stated in its February 2020 report.

To meet requirement #9, the dispensers must have internal interoperability between ordering, the pharmacy management system, and the invoicing systems, and externally with trading partner data exchanges.

Requirement #10: Comprehensive DSCSA compliance reporting capabilities for government authorities

While the FDA had a self-assigned deadline for providing Section 203 guidance with issuance by Nov. 27, 2021, for this requirement, this guidance has not yet been issued. The requirements #8 and #9 guidance really depends on the delivery of requirement #10.

The FDA will still provide guidance on the development of regulations establishing comprehensive reporting requirements of enhanced drug distribution security (EDDS) interoperable electronic tracing of product at a package level.

Understanding What EDDS Means to Pharmacy Teams

Requirements #8 through #10 are designated the “enhanced drug distribution security” and have been depicted in a schematic developed by KPMG’s David Colombo, a director within its Life Science Advisory Practice, in an article titled, “Are You Prepared for the U.S. Enhanced Drug Distribution Security (EDDS) Requirements?,” at BioProcess Online, Oct. 5, 2020.

Summary of Requirements #6 Through #10 and Their Impact on Pharmacy Teams:

  • Requirement #6 and requirement #7: Pharmacy teams are currently receiving Rx product serialized codes and lot number information from over 90% of their direct-selling suppliers. Pharmacy teams are not currently receiving Rx product serialized codes and lot number information from the three largest wholesalers. These wholesalers may not start to transmit the serialized codes or lot number Rx product data until the Nov. 27, 2023, deadline. You should discuss with your prime wholesaler when you will receive the serialized code and lot number data transmissions on your ASNs.
  • Requirement #8 through requirement #10: The EDDS requirements are where the pharmacy teams’ responsibilities exceed those of your suppliers, as pharmacy is the only authorized trading partner that has responsibilities for dispensing the medication.

These are the most common pitfalls for pharmacies when inspected:

(a) Assumption that the wholesaler has you covered:

  • The primary wholesaler is just one supplier and does not have any of your other suppliers’ data.
  • The primary wholesaler, secondary wholesalers, and direct-selling generic suppliers should provide the 10 data ASNs, but portal access to an electronic packing slip or transaction history summary does not have all 10 data sets required on the ASN documentation.

(b) Belief that you don’t need to worry about federal DSCSA compliance until you hear about inspections occurring:

The FDA on Feb. 2, 2022, announced effective Feb. 7, 2022, that they were renewing their supply chain compliance inspections based on the COVID-19 pandemic subsiding.

Additionally, the FDA announced it will add nonphysical remote inspection tools like remote assessment auditing and monitoring systems. Our expectation is that these remote tools will include a tabletop electronic audit with the request of up to six years of data, as allowed under the law.

(c) Belief that you don’t need to worry about state DSCSA compliance inspections: The state boards of pharmacy have been the more active inspection authorities. Also, if the state boards of pharmacy use the remote assessment auditing and monitoring systems to be used on the federal level, then the number of pharmacies being inspected at a state level and the frequency of inspection could be greatly increased. CT

J. Randall Hoggle, B.Pharm., D.Ph., M.B.A., is the managing director of Advasur, LLC, the Advasur Audit & Supply Chain Resource Center in Rockville, Md. The author can be reached at r.hoggle@advasur.com.

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