Navigating the Drug Supply
Chain Security Act: A Guide
for US Dispensers

DSCSA

Executive Summary


The Drug Supply Chain Security Act (DSCSA), enacted in
November 2013, aims to enhance the security of the
pharmaceutical distribution supply chain in the United States.
It introduces strict requirements to allow for better tracking
and tracing of prescription drugs as they move through the
supply chain. Pharmacies and dispensers have a crucial role in
this process.

Here’s how DSCSA requirements affect pharmacies and dispensers.

PRODUCT VERIFI CATION: PHARMACIES MUST
  • Pharmacies must verify the legitimacy of the prescription drugs they receive. This means they need to ensure that drugs have come from authorized trading partners who are registered and compliant with FDA standards.
  • Retail and health system pharmacies must authenticate serialized product identifiers for products in the event of a suspect product or an investigation into illegitimate products.
TRACEABILITY AND PRODUCT TRACING:
  • Pharmacies are required to receive and store Transaction Information (TI), and
  • Transaction Statements (TS) from their suppliers for each drug product received. This information should be maintained for at least six years. Transaction Information includes details such as the proprietary or established name or names of the product, the strength and dosage form, the National Drug Code (NDC) number, container size, number of containers, lot number, transaction date, shipment date (ifdifferent from the transaction date), and the business name and address of the person from whom and to whom ownership is being transferred.
  • The Transaction Statement includes a statement by the seller that they are authorized, received the product from an authorized trading partner, received transaction information and transaction statement from the prior owner, did not knowingly ship a suspect or illegitimate product, and has systems and processes in place to comply with verification requirements under the law.
SUSPECT AND ILLEGITIMATE PRODUCTS:
  • Pharmacies must have processes in place to identify, investigate, and report suspect and illegitimate products to the Food and Drug Administration (FDA) and communicate such findings with trading partners ifnecessary.
  • They are required to quarantine and investigate any product they have reason to believe is suspect, including verifying the product identifier.
LICENSING:
  • Pharmacies must engage with trading partners that are properly licensed. Dispensers need to ensure that they only transact with entities that are authorized under DSCSA guidelines.
RECORD KEEPING:

All documentation related to product tracing must be retained in either electronic or paper format for at least six years from the date of the transaction. This requirement ensures that there is accountability and transparency within the supply chain.

ELECTRONIC SYSTEMS AND INTEROPERABILITY:
  • By 2023, the act aimed to implement an interoperable electronic system for product tracing across the drug supply chain. Pharmacies need to be prepared to integrate such systems to comply with future standards.
  • The FDA delayed enforcement of the DSCSA until November 27, 2024. The FDA also announced exemptions for specific dispensers and, in certain cases, their trading partners, from particular mandates outlined in section 582 of the Food Drug and Cosmetic Act (FD&C Act), See section Understanding the FDA’s Small Dispenser Exemption
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Compliance with DSCSA requirements is crucial for maintaining the integrity of the drug supply chain. Pharmacies and other dispensers must apply these regulations to help prevent counterfeit, stolen, or contaminated drugs from entering the market, thereby ensuring patient safety and maintaining the quality of drugs within the pharmaceutical distribution network. The integration of these practices not only meets legal obligations but also contributes to higher industry standards and patient trust.

Major check points

Your business needs a trustworthy solution provider that will navigate your through complexities of the regulation and mitigate the risks. Here are the the major check points you need to consider choosing a partner:

DSCSA EXPERTISE:
Choose a provider with a comprehensive understanding of the DSCSA regulations and a track record of success fully helping pharmacies comply with them.
END-TO-END TRACEABILITY:
Ensure the provider offers systems capable of managing Transaction Information (TI), and Transaction Statements (TS), essential for compliance.
INTEROPERABILITY:
Possibly consider a solution that is fully interoperable with existing pharmacy systems and other supply chain partner systems, facilitating seamless data exchange.
AUTOMATED VERIFI CATION PROCESSES:
Look for solutions with automated suspect product verification and notification processes, making it easier to identify and handle suspicious or illegitimate drugs.
SECURE AND EFFI CIENT RECORD-KEEPING:
Ensure the solution provides robust record-keeping capabilities to store necessary compliance data securely for at least six years.
SUSPECT PRODUCT MANAGEMENT:
Choose a provider offering comprehensive tools for the identification, quarantine, and investigation of suspect and illegitimate products, along with reporting capabilities to the FDA.
REGULATORY REPORTING AND ALERTS:
Select a provider that offers real-time regulatory updates and alerts to keep your pharmacy informed of any changes to the DSCSA requirements.
TRAINING AND SUPPORT:
Look for a provider that offers comprehensive training for your staff and ongoing support to ensure all team members are well-equipped to use the compliance tools effectively.
FLEXIBLE AND SCALABLE SOLUTIONS:
Ensure that the solution can grow with your pharmacy, allowing for scalability as your needs evolve and as regulatory requirements become more stringent.
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By taking these steps, your pharmacy can confidently choose a solution provider equipped to ensure compliance with the DSCSA, maintaining the integrity of your operations and safeguarding your patients.

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SMALL DISPENSER

EXEMPTION!

Understanding the FDA’s Small Dispenser Exemption

On June 12, 2024, the Food and Drug Administration (FDA) announced exemptions for specific dispensers and, in certain cases, their trading partners, from particular mandates outlined in section 582 of the Food Drug and Cosmetic Act (FD&C Act) until November 27, 2026.

What/Who is a “small” dispenser

For the purpose of this exemption, a “small dispenser” is defined as one whose owning corporate entity employs 25 or fewer full-time pharmacists or certified pharmacy technicians. These exemptions pertain to certain aspects of section 582 of the FD&C Act, mainly focusing on enhanced distribution security requirements, as detailed in the FDA’s communication on this issue.

Recently, the FDA has clarified that they do not plan to extend the one-year Stabilization Period, which was originally introduced in August 2023. This period was meant to give trading partners additional time to adapt to, troubleshoot, and develop the necessary systems and procedures to comply with the Drug Supply Chain Security Act (DSCSA) enhanced security requirements. The FDA advises any trading partners, including manufacturers, repackagers, distributors, and dispensers, who might be concerned about meeting these demands to submit a waiver request using the WEER process by August 1, 2024.

Industry Recommendation

The industry strongly recommends that any dispensers not covered by the small pharmacy exemption and who are unsure about their compliance capability with DSCSA by November 27
should consider submitting a WEER request to the FDA as soon as possible. Large retail pharmacies and health systems across the U.S. report receiving only a fraction of the expected
serialization data files (GS1 EPCIS), sometimes as little as 20-30%. With less than four months remaining before the stabilization period ends on November 27, 2024, even the largest
dispensers might not be fully prepared.

ARE SMALL DISPENSERS EXEMPT FROM ALL DSCSA REQUIREMENTS?

No, the exemptions do not negate small dispensers’ existing commitments under DSCSA. For instance, small dispensers must still:

  • Identify and verify their drug suppliers as authorized trading partners per Section 581 of the FD&C Act.
  • Know where their product tracing data is stored and how to access it.
  • Be equipped to identify potentially harmful products, with procedures in place to quarantine, investigate, and report as needed.
  • Develop and adhere to comprehensive drug purchasing policies and procedures (P&Ps) that are accurate to their location’s operations.
WHAT ARE SMALL DISPENSERS ACTUALLY EXEMPT FROM?

Exemptions concern the enhanced drug distribution security requirements stated in sections 582(g)(1) and 582(d)(4) of the FD&C Act. Specifically, small dispensers are exempt from using electronic and interoperable methods to:

  •  Exchange transaction information and statements with trading partners.
  • Conduct verifications of suspect and illegitimate products.
  • Collect transaction data for package-level recalls.
  • Gather information to respond to regulator inquiries about suspect or illegitimate products.
DISPENSERS ARE STILL LIABLE FOR THESE TASKS BUT CAN EMPLOY MANUAL OR EXISTING METHODS. HOW TO DETERMINE IF YOU ARE EXEMPT?
  • Identify your parent company.
  • Count the number of pharmacies under the parent company.
  • Calculate the number of full-time pharmacists and technicians across all pharmacies owned by the parent company, based on November 2024 filings.
  • Document this information and evaluate whether your company needs to apply for a waiver, exemption, or exception as suggested by the FDA if the total full-time employees exceed 25.
HOW TO INFORM TRADING PARTNERS ABOUT YOUR EXEMPTION?

Inform all direct trading partners if your organization qualifies for an exemption. The FDA does not publicly provide information on granted waivers or claimed exemptions. Organizations receiving a waiver or exemption should notify their trading partners, and NABPTM’s Pulse directory will include optional fields for this purpose.

WHAT IF I DON’T QUALIFY FOR THE EXEMPTION AND AM UNSURE ABOUT COMPLIANCE BY NOVEMBER 27, 2024?

NABP recommends submitting an FDA WEER promptly. The FDA advises all trading partners, including those not qualifying for the exemption, to submit waiver or exemption requests by August 1, following published guidelines on preparing these requests. The process involves detailing your current compliance efforts, why readiness may be unachievable, and your strategy for achieving compliance eventually. Although durations for WEERs vary, the FDA may request regular updates on compliance progress.

WHAT IF I HAVE SYSTEMS IN PLACE BUT ONLY RECEIVE PARTIAL DATA FROM SUPPLIERS?

Even if pharmacies have electronic and interoperable systems and connections with trading partners, incomplete data from upstream partners means non-compliance with DSCSA. Filing a WEER should be considered in these situations.