Article Summary

NOTICE: Information update regarding DSCSA regulations that will impact Dispensers and Pharmacies beginning in November 2023. *Updated* to include August 25 notice regarding delayed enforcement until November 2024.

The pharmaceutical industry is on the cusp of a significant regulatory change that will impact dispensers and pharmacies across the United States. Over the past 10 years, The Drug Supply Chain Security Act (DSCSA) has set forth a series of deadlines aimed at enhancing the security and traceability of pharmaceutical products as they move through the supply chain, with the final deadline approaching on November 27, 2023. In this article, we'll discuss the upcoming DSCSA deadline and its implications for dispensers and pharmacies.

Understanding the DSCSA

Enacted in 2013, the Drug Supply Chain Security Act was designed to ensure the integrity of the pharmaceutical supply chain, from manufacturers to patients. The DSCSA has introduced a comprehensive set of regulations and requirements to track and trace prescription drugs, thereby reducing the risk of counterfeit, adulterated, or stolen medications entering the market.

Upcoming DSCSA Deadline for Dispensers

Starting from November 27, 2023, dispensers will be required to comply with the DSCSA's requirements related to product tracing, verification, and quarantine of suspect products. Below you'll find the Key Requirements your organization needs to be prepared for.

Key Requirements for Dispensers

Interoperability:

This upcoming deadline requires trading partners to create interoperable point-to-point connections to conduct transactions, using systems that can import and process one another's data. Once the deadline is in effect, dispensers will only be able to receive shipments with serialized data. The industry has largely adopted GS1's EPCIS standard for interoperable data.
The EPCIS onboarding process must be completed between each pair of trading partners; each implementation can take a few weeks, so it's a good idea to start on this with ample time to be prepared for the deadline.
Dispensers must be able to exchange serial data in a secure, interoperable, and electronic manner.

Serialization:

Dispensers will only be able to buy prescription drug products that use serialized product identifiers that can be barcode scanned and are in a human-readable text format. Although barcode scanning must be an option, it is not required that dispensers scan barcodes to dispense.
Dispensers will need to be able to handle suspect or illegitimate products by:
- Being able to verify suspect products using serialized data
- Being able to quarantine suspect products until they are either cleared to be dispensed or removed from the supply chain
- Being able to resolve discrepancies in transaction information vs. physical product received within three business days
- Being able to report findings to the FDA and trading partners, including notifying the agency and trading partners of illegitimate product within 24 hours

Product Tracing:

Dispensers must be ready to receive or send transaction data with specific serialized product identifiers for each saleable unit of prescription drug products. This must happen before or at the time of a given transaction.
Dispensers need to establish processes for verifying the legitimacy of prescription drugs they receive. This involves checking the unique serialized identifier against the product's transaction history to ensure that it has not been compromised, counterfeited, or otherwise tampered with.
Dispensers must maintain transaction information for at least six years after a transaction.
Dispensers must be able to accept salable returned products only if they can associate the appropriate transaction information and transaction statement to that product.

Benefits of DSCSA Compliance

Complying with the DSCSA is not just about meeting regulatory requirements, it also offers several benefits to dispensers:

Patient Safety: By ensuring the authenticity and integrity of pharmaceutical products, dispensers contribute to patient safety by reducing the risk of counterfeit or unsafe drugs reaching consumers.
Streamlined Operations: Implementing robust tracking and tracing systems can lead to improved inventory management, reduced errors, and enhanced operational efficiency.
Enhanced Trust: DSCSA compliance demonstrates a commitment to transparency and safety, which can enhance trust among patients, healthcare professionals, and trading partners.
Preparedness for Future Regulations: The pharmaceutical industry is evolving, and compliance with DSCSA sets a precedent for adapting to future regulatory changes.

MDScripts / USMeds Readiness for DSCSA Compliance

MDScripts has been working for the past several years to implement solutions within the MDScripts dispensing platform as well as our drug supply chain platform, USMeds, to support DSCSA compliance. Much of that work centers around tracking and managing serialized product data, GS1 2D barcodes and GS1 GLN location details. Outlined below are the solutions currently in place or currently in development within each platform to support our clients.

MDScripts Dispensing Readiness

Support for serialized inventory and capturing of serial numbers at the time of dispense [Implemented in 2018]
Support for 2D serialized barcodes on shipment imports and dispensing processes [Implemented in 2018 and continuing to work with vendors to add support for their shipment data]
Availability of of pedigree (T3) data within MDScripts for sites purchasing from wholesalers and repackagers utilizing USMeds for pedigree tracking [Implemented 2010 - addition of EPCIS data format available soon]
Quarantine and Verification process for suspect inventory [In development currently]

USMeds Pedigree Readiness

Implementation of EPCIS data protocol to support serialized transaction data for incoming and outgoing transactions.
GS1 2D barcode scanning support for generating outgoing orders to clients to capture serialization data at the point of shipment.
Conversion of existing ASN/856 interfaces to EPCIS format to support serialization.
Additional support for serialization added to ANSI 856 format for vendors choosing that route over EPCIS.
Workflow improvements for Verification, Quarantine, and Returns management.
SSCC package level tracing capabilities
Improvements to interface with MDScripts to support delivery of serialized pedigree data along with existing DSCSA T3 Pedigrees.

Next Steps for Dispensers preparing for DSCSA

As the November deadline approaches dispensers will continue to receive more communications from wholesalers and manufacturers with regards to DSCSA readiness. This may include requests for location "Master Data" such as GLN & sGLN to identify dispensing locations within L4 Pedigree data platforms. MDScripts is working directly with many wholesalers and repackagers to mitigate this requirement within the MDScripts / USMeds environment. Dispensers who purchase from wholesalers and repackagers who currently do not utilize USMeds may need to register their own GLN through GS1 or request that the wholesaler provide one for them. Many L4 Pedigree systems require GLN/sGLN values in order to route pedigree data properly. Many L4 systems provide login portals where dispenser can access their Pedigree data and remain in compliance even if they don't implement an L4 system themselves. Dispensers can also opt to establish an account with USMeds to act as their L4 provider and be able to receive serialized shipment data regardless of whether they use MDScripts dispensing system or not.

It is recommended that dispensers should spend time educating themselves on the requirements of DSCSA and take part in feedback sessions with DEA and professional organizations such as NABP.

Future of DSCSA Regulations

NOTICE: August 25, 2023: FDA Announces Delayed enforcement of DSCSA Regulations until November 27, 2024

"Section 582(g)(1)(B) of the FD&C Act requires that, as of November 27, 2023, the transaction information required to be exchanged under section 582 include the product identifier (i.e., the standardized numerical identifier consisting of the NDC and serial number, lot number, and expiration date) at the package level for each package included in the transaction. FDA does not intend to take action to enforce this requirement until November 27, 2024. FDA is issuing this compliance policy to accommodate the additional time (beyond November 27, 2023) that may be needed by trading partners to achieve compliance and to help ensure continued access to prescription drugs as trading partners continue to refine processes for the inclusion of the product identifier at the package level for each package in a transaction into the transaction information in accordance with section 582(g)(1)(B).

In addition, FDA does not intend to take action to enforce the requirement under section 582(g)(1)(B) of the FD&C Act with respect to product that is introduced in a transaction into commerce by the product?s manufacturer or repackager before November 27, 2024, and for subsequent transactions of such product through the product?s expiry. This means that FDA does not intend to take action if the transaction information for product introduced in a transaction into commerce by the product?s manufacturer or repackager before November 27, 2024, does not incorporate?at the package level for each package in the transaction?the product identifier. This policy will facilitate the use and exhaustion of product supply already in the supply chain prior to November 27, 2024."

Industry Groups Providing Feedback to FDA

As the November 2023 deadline approaches, there are many industry partners that are proposing a cancellation of the regulation or at a minimum, postponement, since wholesalers and manufacturers still have not fully implemented their DSCSA solutions. Dispensers will have very little time to implement their solutions once their upstream partners finalize their implementations. In February 2023, the Healthcare Distribution Alliance (HDA) issued a number of comments and recommendations to the FDA regarding the looming DSCSA deadline. These included delayed enforcement of the regulation, further clarification on published guidance documents, and alternatives to several of the mandates.

https://hda.org/getmedia/c1deccbd-3dfd-4765-bbe6-126deaccafaa/HDACommentsonFDAMeetingFollowUp262023.pdf

FDA Requesting Feedback from Impacted Entities

FDA is requesting comments on the development of a technology and software assessment that examines the feasibility of small dispensers (businesses providing drugs to patients with a prescription) with 25 or fewer full-time employees conducting interoperable, electronic tracing of products at the package level (i.e., small dispensers assessment).

In the notice, FDA requests comments on proposed questions which cover subjects such as readiness, technology, and staffing capabilities that will impact small dispensers. FDA is interested in receiving feedback on the questions themselves and whether they should be edited to be more useful for the assessment.

FDA is also interested in any new questions that commenters may recommend. Commenters may provide other relevant information that may inform the development of the small dispensers assessment under the DSCSA.

Link to review request and submit comments - due by 30 days after the notice is published.

Industry Experts and Law Makers issue warnings for DSCSA impacts on supply chain

MDScripts / USMeds will continue to monitor FDA updates on DSCSA as well as industry recommendations and work with our clients and downstream partners to ensure compliance with regulations as well as continued data interoperability. Feel free to open a help desk ticket or contact MDScripts or USMeds support staff with any questions you may have.

DSCSA Information Update for Dispensers and Pharmacies - August