Published June 5th, 2021

As the community prepares for the GS1 Connect 2021: Digital Edition conference next week, the FDA issued new guidance to further enhance the security of prescription drugs in the supply chain. This guidance is intended to assist trading partners in complying with the law and achieving a safer, more secure, and more trusted drug supply chain.

The Drug Supply Chain Security Act (DSCSA), enacted by Congress on November 27, 2013, outlines steps to build an electronic, interoperable system to identify and trace U.S. prescription drugs. The regulation has a ten-year horizon with requirements and applicable standards unfolding in several phases.

As the industry struggles to meet specific milestones, FDA periodically delays regulatory enforcement. Six months ago, FDA surprised many by delaying enforcement of salable returns verification by an additional three years, until November 27, 2023.

New guidance on enhanced drug distribution security establishes an integrated view of drug traceability requirements, commonly referred to as the “enhanced system.” In this guidance, FDA makes clear that salable return verification should be considered an integrated capability of enhanced verification, as opposed to developing separate processes and systems dedicated just to salable returns verification.

For the first time, the FDA clarifies the enhanced system requirements and provides recommendations on system attributes necessary for enabling secure tracing of product at the item level. The FDA establishes a blueprint for a comprehensive approach to drug traceability and sharpens the focus on specific aspects (e.g. aggregation, inference, physical security, data and system security, errors and other discrepancies) deemed important to implementing a robust enhanced system envisioned under DSCSA.

November 2023 seems far away; do I need to worry?

Traceability requires that an extensive amount of item-level information be captured and exchanged at each ownership change. Successfully establishing traceability therefore requires each trading partner within the drug supply network to connect and exchange drug product information.

Most wholesalers are looking for the majority of their customers to be onboarded in the first half of 2023. Realistically, most industry trading partners have 18 months from today to get connected and share item-level transaction record information, consistent with DSCSA data content requirements and GS1 application standards.

Expect the onboarding process to be delayed the longer one waits to engage with trading partners. According to industry surveys, only 10-20% of the manufacturers are currently connected to their trading partners, which means sharing scarce resources with hundreds of companies and thousands of products. Recognize that few onboardings succeed initially, many require multiple iterations, so plan accordingly. What seemed to be off into the future, is now around the corner.

Since the FDA expects the product tracing information to be true, accurate, and complete, consider Gateway Checker’s conformance certification and establishing an automated approach to drug traceability integrity.

To learn more about how Gateway Checker is testing and certifying traceability conformance, join our virtual presentation An Automated Approach to Drug Traceability Readiness at GS1 Connect 2021: Digital Edition, taking place June 8-10, 2021. You will lean about an automated solution that can achieve accurate, rapid, robust and reliable connectivity with minimal errors, conformance to accepted standards, and identify gaps in preparedness.

We look forward to assisting the pharmaceutical industry on its path to traceability and we hope you will journey with us! If you like what you read, please share our newsletter and invite others to subscribe.

Click on the links below for additional information:

• Enhanced Drug Distribution Security as defined by DSCSA
• How to Ensure Conformance to EPCIS Standards in Drug Traceability
• How to become DSCSA Conformance Certified
• FDA provides new guidance to further enhance the security of prescription drugs

Gary Lerner,
President and Founder
Gateway Checker

Published June 4th, 2021

On June 3rd, 2021, the FDA provided new guidance to further enhance the security of prescription drugs in the U.S. supply chain. To help stakeholders understand the emerging DSCSA requirements FDA published four guidance documents to assist trading partners in complying with the law and achieving a safer, more secure, and more trusted drug supply chain.

Three of the published documents either finalize or revise guidance on suspect product and product identifiers. From an industry participant perspective there is not much new as most of the content has already been published.  See: FDA provides new guidance to further enhance the security of prescription drugs

The fourth guidance, Enhanced Drug Distribution Security at the Package Level under DSCSA, is new and brings into focus the interoperable, electronic, package level product tracing systems, and processes required by section 582(g) of the F D & C act which go into effect on November 27, 2023.

For the first time FDA clarifies the enhanced system requirements and provides recommendations on system attributes necessary for enabling secure tracing of product at the item level. FDA establishes a blueprint for a comprehensive approach to drug traceability and sharpens the focus on specific aspects (e.g. aggregation, inference, physical security, data and system security, errors and other discrepancies) deemed important to implementing a robust enhanced system envisioned under DSCSA.

The new guidance on enhanced drug distribution security establishes an integrated view of drug traceability requirements, commonly referred to as the “enhanced system.” In this guidance FDA makes clear that salable return verification should be considered an integrated capability of enhanced verification, as opposed to developing separate processes and systems dedicated just to salable returns verification.

Furthermore, FDA expects the product tracing information to be true, accurate, and complete.  Consider Gateway Checker’s conformance certification and establishing an automated approach to drug traceability integrity to ensure continuous content verification.

Some content of the guidance represents more specific or new requirements that trading partners need to consider when making plans to support the Enhanced System.

Enhance System Elements

The FDA mandated the use of product identifiers to verify the product at the package level and enable prompt response when suspect and illegitimate products were found.

DSCSA included a ten-year timeline culminating in the building of “an electronic, interoperable system to identify and trace prescription drugs as they are distributed in the United States.”

DSCSA “Enhanced System” requires trading partners to exchange drug product tracing information (TI) and a transaction statement (TS) whenever there is a transaction that involves a drug product change of ownership.

The inclusion of both a TI and a TS represents a Transaction Record (TR).  Per the DSCSA, this information, the Transaction Record, must be exchanged in electronic form.

In short, the enhanced drug distribution security aspect of DSCSA mandates the exchange of a Transaction Record it each change of ownership.

Specifically referenced in this guidance, the Enhanced System includes the following:

(A) the exchange of transaction information and transaction statements in a secure, interoperable, electronic manner;

(B) transaction information that includes the data elements of the product identifier at the package level for each package included in the transaction;

(C) systems and processes for verification of product at the package level;

(D) systems and processes necessary to promptly respond with the relevant transaction information and transaction statement for a product upon request by FDA or other appropriate Federal or State official in the event of a recall or for the purposes of investigating a suspect product or an illegitimate product;

(E) systems and processes necessary to promptly facilitate the gathering of the information necessary to produce the transaction information for each transaction going back to the manufacturer upon request by FDA or other appropriate Federal or State official in the event of a recall or for the purposes of investigating a suspect product or an illegitimate product, or upon request of an authorized trading partner for the purposes of investigating a suspect product or an illegitimate product or assisting FDA or other appropriate Federal or State official with a request; and

(F) systems and processes to associate a saleable return product with its applicable transaction information and transaction statement to allow a trading partner to accept the returned product.

Other aspects of the Enhanced System requiring further review and scrutiny:

• Physical Security Features – FDA recommends the use of security features on shipping units (such as homogeneous cases or pallets) of product to help indicate when product may have been tampered with, previously unsealed, or damaged, rendering it suspect.
• A trading partner should only use inference when it receives pallets or homogeneous cases with aggregated data if the integrity of the unit is intact—in other words, the tamper-evident tape or wrap, or other security seal, has not been broken. If the receiving trading partner determines that the product is suspect, it should not use inference for the aggregated data.
• Although under section 582(k) of the FD&C Act the requirement to provide and receive transaction history sunsets November 27, 2023, the enhanced system must include the ability to promptly facilitate the gathering of information necessary to produce the transaction information for each transaction going back to the manufacturer.
• The enhanced system should permit only an authorized trading partner to request relevant data related to a product the authorized trading partner sold or purchased
• The Selling Trading Partner Should Ensure that the Transaction Information and Transaction Statement Accurately Reflect the Product it Sells to a Purchasing Trading Partner
• The product tracing information that will be provided to the purchasing trading partner in an electronic format should be checked to ensure that it accurately reflects the product that will be physically shipped.
• A purchasing trading partner should undertake reconciliation upon physical receipt of the product and then before selling the product to help confirm the veracity of the inbound and outbound transactions.
• If a wholesale distributor, dispenser, or repackager purchases product and identifies a potential clerical error or other discrepancy in the product tracing information it received, that trading partner should FDA expects the product tracing information to be true, accurate, and complete. resolve the error or discrepancy within 3 business days.
• Examples of how trading partners may resolve errors:
  • The selling trading partner may provide new and revised product tracing information that reflects the products received by the purchasing trading partner.
  • The selling trading partner may provide new product tracing information only for the extra product received by the purchasing trading partner.
  • Either trading partner may use internal resources for identifying trading partners and their contact information to fill in such gaps in product tracing information received.

Click Here to review the DSCSA Enhanced System guidance