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.
These two documents, released early in September 2023, include:
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.
Assigning a unique product identifier or serial number to each individual package of prescription drugs they manufacture. The identifier must include:
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.
Ensuring transparency and security when transferring ownership of products to authorized trading partners, by providing:
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:
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.
Verifying the authorization of trading partners to ensure their legitimacy before engaging in transactions with other entities in the supply chain.
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:
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:
Keeping accurate records for:
Complying with the serialization and product tracing requirements established by the drug sponsor, including:
Exchanging transaction information, history, and statements (TIHRS) when transferring products to trading partners.
Collaborating with drug sponsors to ensure that the products they manufacture meet the serialization and traceability requirements set by the sponsors.
To prepare your Quality and Compliance program for that November deadline, you will want to make sure you have these elements in place:
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:
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!
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