DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)

With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two new compliance policy guidance documents, establishing an additional year (until November 27, 2024) for stabilization of complete implementation, troubleshooting, and maturing electronic, interoperable systems, you do not need to wait any longer to start preparing to meet the regulatory expectations. As a matter of fact, the FDA cautioned industry that these new compliance policies are "not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements." Also, FDA "strongly urges" continued efforts to implement requirements in Section 582(g)(1) of the FDCA.

[Learn More: What is the Drug Supply Chain Security Act (DSCSA)?]

These two documents, released early in September 2023, include:

• DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry and
• Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies.

At ProPharma, we understand that pharmaceutical distributors and dispensers bear the responsibility of authenticating their drug products by confirming the validity of serialized identifiers and scrutinizing the product's transaction history to ensure that drugs are safer from counterfeiting or compromise. In specific instances where suspected counterfeit or compromised drugs are identified, investigators are better able to trace the drug's movement and identify potential points of supply chain integrity breaches; however, they do not bear this burden alone.

Let's back up a little. Do you understand the responsibilities as a drug manufacturer? What about those as a contract manufacturer? Let's explore the similarities and differences.

Overall, both drug sponsors and contract manufacturers hold critical roles to maintain the security and integrity of the pharmaceutical supply chain under the DSCSA, with drug sponsors (manufacturers) shouldering most of the responsibilities related to product identification, tracing, and reporting.

DSCSA Requirements for Drug Sponsors (Manufacturers)

1. Product Serialization and Unique Identifier:

Assigning a unique product identifier or serial number to each individual package of prescription drugs they manufacture. The identifier must include:

• the National Drug Code (NDC),
• a serial number,
• a lot number, and
• an expiration date.

2. Product Tracing and Verification:

Establishing systems for tracing and verifying the authenticity of their products as they move through the supply chain with implementation of mechanisms to track each drug package from manufacture to dispensing.

3. Transaction Information, History, and Statements (TIHRS):

Ensuring transparency and security when transferring ownership of products to authorized trading partners, by providing:

• transaction information,
• transaction history, and
• transaction statements.

4. Notification of Suspected Illegitimate Products:

Quarantining and investigating promptly if becoming aware of a suspect or illegitimate product within their supply chain. If the product is confirmed to be illegitimate, they must notify:

• the FDA,
• trading partners, and
• other relevant parties.

5. Notification of Discontinuance or Interruption of Distribution:

Providing advance notification to relevant stakeholders and the FDA if they experience an interruption in supply or plan to discontinue the distribution of a product.

6. Verification of Authorized Trading Partners:

Verifying the authorization of trading partners to ensure their legitimacy before engaging in transactions with other entities in the supply chain.

Managing and Monitoring DSCSA Requirements

Note that while the sponsor holds primary responsibility for these tasks, they may also delegate some tasks, such as serialization, to the contract manufacturer (CMO). To make this work effectively, there must be a very close working relationship between the sponsor and CMO with very specific guidelines and detailed Quality Agreements in place. After all, regulatory agencies consider vendors to be an extension of the sponsor and strict controls must be in place to assure compliance.

Additionally, there are steps that must be taken to manage and monitor these processes, including:

• Maintaining a robust vendor qualification program:
• Initial qualification of your CMO should not be quick, forced, or decided "out of necessity."
• Periodic stringent requalification processes are vital to ensure that Quality Agreement requirements are being followed.
• Maintaining a diligent auditing program:
• Using a third-party, like ProPharma, for obtaining objective, non-biased evidence of conformance to regulatory guidelines and sponsor requirements
• Onsite, face-to-face audits to ensure appropriate preparation for new regulatory requirements and changes/upgrades to equipment and documentation
• Ensuring that equipment and process validations are performed appropriately
• Requiring periodic updates on specific critical indicators
• Maintaining a synergistic system for managing deviations, investigations, and changes:
• Processes are maintained per agreement specifications
• Trending is managed effectively for specific product processes and similar
• Investigations are conducted thoroughly, and effectiveness is evaluated successfully
• Changes in technology are evaluated carefully to ensure risk and impact are properly mitigated
• Staying current with those Quality Agreements to include all technology, communication, and expectation requirements.
• Requirements are met for notifications.
• Expectations for communication are clear and specific.
• Responsibilities are clearly defined.

DSCSA Requirements for Contract Manufacturers

For Contract Manufacturers, because they are manufacturing on behalf of drug sponsors (owners), their responsibilities are primarily focused on maintaining accurate records and complying with the requirements set by the drug sponsor:

1. Recordkeeping:

Keeping accurate records for:

• the products they manufacture, and
• the distribution of those products within the supply chain.

2. Compliance with Sponsor Requirements:

Complying with the serialization and product tracing requirements established by the drug sponsor, including:

• affixing the unique product identifier provided or delegated by the sponsor, and
• maintaining the integrity of the product's traceability data.

3. Transaction Information Exchange:

Exchanging transaction information, history, and statements (TIHRS) when transferring products to trading partners.

4. Collaboration with Sponsors:

Collaborating with drug sponsors to ensure that the products they manufacture meet the serialization and traceability requirements set by the sponsors.

Ensuring Compliance with DSCSA Requirements

To prepare your Quality and Compliance program for that November deadline, you will want to make sure you have these elements in place:

• Validated processes, equipment, and systems for the responsibilities listed above;
• A comprehensive Quality Management plan to ensure appropriate oversight of all those processes;
• A complete training program covering staff for the critical tasks involved in those processes;
• A robust program for approving and maintaining your vendors and suppliers; and
• A holistic and unbiased approach for qualifying your Contract Manufacturers.

If you find yourself thinking that you may not be adequately covered and want to ensure compliance with DSCSA regulations to provide enhanced patient safety within your supply chain, partner with ProPharma today. Does your organization want to be sure you are compliant before an Inspection? Our Audit Team and other Compliance Experts are ready to support you in meeting these requirements. We have the right people to help you with:

• Validation Programs (equipment, computer systems, and processes)
• Training Programs
• Quality Systems and procedure development
• Document Management
• Supplier Management Programs

Join us in safeguarding patient health and contributing to a secure pharmaceutical supply chain. Contact us now for preparatory audits, expert guidance, and seamless solutions!