By: Jaqueline Corrigan-Curay, J.D., M.D., Office of the Center Director, Center for Drug Evaluation and Research (CDER) and Jill Furman, J.D., Office of Compliance, CDER
Ensuring reliable patient access to safe and effective medicines requires every link in the supply chain to be secure: from the moment a drug leaves the manufacturer until it reaches a pharmacy or health care professional’s offices. Since 2013, the U.S. Food and Drug Administration has been implementing the Drug Supply Chain Security Act, a law known as DSCSA. This law gives the FDA more regulatory tools to detect and help ensure the removal of dangerous drugs from the supply chain, such as those that may be counterfeit, stolen, contaminated, or otherwise harmful.
Requirements of this law improve supply chain security activities by trading partners, for example, prescription drug manufacturers, repackagers, wholesale distributors, third-party logistics providers (3PLs), and dispensers, primarily pharmacies. Gradual implementation of the requirements for product tracing, product identification, authorized trading partners, and verification, is helping trading partners develop required systems for interoperable, electronic tracing of products down to the package level. Interoperable electronic systems are those that can exchange data accurately, efficiently, and consistently about each package (i.e., smallest individual saleable unit) as it is distributed in the U.S.
Implementing the Drug Supply Chain Security Act
The FDA has been working to implement DSCSA since it became law, and the 10-year anniversary is a good time to recognize our work with industry and other stakeholders thus far and the initiatives in store for the future:
- Since 2013, the FDA has issued more than 20 DSCSA guidance documents.
- In 2014, the FDA established a public database for reporting requirements for wholesale distributors and 3PLs to help stakeholders check that they are appropriately licensed.
- Since 2015, the FDA and trading partners have implemented lot-level product tracing and verification, which increased our abilities to trace products and investigate those that are suspect or illegitimate.
- In 2019, we launched the DSCSA Pilot Project Program to help understand the technical capabilities of the supply chain and system attributes needed to fully implement DSCSA requirements. Twenty industry-led pilot projects were selected to participate; the final program report provides details.
- The FDA has been improving the oversight of entities that warehouse and distribute prescription drugs by working to establish national standards through rulemaking. The proposed rule, when finalized, will harmonize licensure requirements across U.S. states to provide certainty and clarity for wholesale distributors, 3PLs, and state regulators.
- Over the past decade, the FDA has held multiple public meetings on DSCSA implementation, which have allowed us to gather different perspectives. We also have a public-private partnership with the Partnership for DSCSA Governance, a collaborative forum that is dedicated to developing, advancing, and sustaining an effective and efficient model for interoperable tracing and verification of prescription drugs in the U.S.
Stabilization Period for Industry
DSCSA requires trading partners to provide, receive, and maintain documentation about prescription drugs and their chain of ownership from manufacturer to dispenser. Recently, the FDA announced in two compliance policy guidance documents its intent to not take action to enforce certain DSCSA requirements until November 27, 2024; this 1-year “stabilization period” will accommodate trading partners’ ability to implement, troubleshoot, and mature their interoperable electronic systems and processes.
This stabilization period will support successful implementation and lead to a stronger and safer drug supply chain. It will help avoid supply chain disruptions due to technical issues and ensure continued patient access to drugs as trading partners work to fully implement the enhanced drug distribution security requirements. We expect trading partners to use this time to continue building and validating their systems and processes. To that end, we:
- Finalized two guidance documents that identify necessary standards to facilitate interoperable data exchange and clarify the enhanced drug distribution security requirements.
- Finalized the guidance document that outlines the factors the FDA intends to consider when evaluating requests for waivers, exceptions, or exemptions from certain DSCSA requirements.
To help small dispensers (25 or fewer full-time employees) meet requirements, we will conduct a technology and software assessment that examines the feasibility for these businesses to conduct interoperable, electronic tracing of products at the package level.
Collaboration to Implement Supply Chain Interoperability
Together, we have made considerable progress in securing the supply chain, but there is still work to do. The FDA continues to gather feedback regarding industry readiness to ensure supply chain integrity and the availability of prescription drugs to U.S. patients. We will keep working with industry as well as other stakeholders, and plan on robust engagement leading up to November 27, 2024.
We are working on finalizing the remaining DSCSA guidance documents and will continue to implement requirements to achieve interoperable, electronic tracing of products at the package level. In addition, we have launched a DSCSA Portal through the FDA’s CDER NextGen that trading partners can use to submit electronic DSCSA documentation in response to FDA inquiries regarding suspect or illegitimate products, such as counterfeits.
By fully implementing the DSCSA, together with industry and other stakeholders, we will create a more secure pharmaceutical supply chain that will assure the continued distribution of safe prescription drugs for the benefit of public health.