What Pharmaceutical Companies Can Expect from the New DSCSA Pilot Program
One of the main purposes of the U.S. Food and Drug Administration (FDA) is to ensure that every product we regulate are high in quality and safe – and this includes pharmaceuticals. This works to produce accountability in our national drug supply chain.
In February of 2019, the FDA launched a pilot project in which drug supply chains’ representatives can use innovative methods for verifying and tracing prescription drugs in the United States. Representatives include repackagers, manufacturers, and other stakeholders. The ultimate goal is to make sure that illegitimate, illegal, and suspect products never make it into the national drug supply chain.
The pilot run will help shape the enhanced track-and-trace system for the industry that is set to go into effect in 2023, which is an important part of the Drug Supply Chain Security Act (DSCSA). The entire program is meant to pilot a variety of technologies that could become part of the final system, which will be aimed at reducing counterfeit drugs being able to ultimately reach patients.
FDA Commissioner Scott Gottlieb, M.D. explained, “As part of our ongoing efforts to protect our nation’s drug supply, today, we’re giving industry an opportunity to test new technologies that can help spur greater accountability for participants in the supply chain and improve our ability to trace prescription drugs at every point in the distribution chain. Using new innovations, we believe we can improve the overall security of our closed system and improve our ability to prevent the introduction of illegitimate products, better detect the introduction of illegitimate products, and enable stakeholders and the FDA to respond more rapidly when such products are found.”
Tracing and tracking is vital to the industry’s ability to find and remove potentially dangerous products from the drug supply chain. The pilot is a step toward innovation in improving not just the security around new products coming into the chain, but also in making improvements across the products that already are within the drug supply chain.
The FDA recently brought on board Frank Yiannas, an expert in traceability technologies in global food supply chains, to work with Gottlieb on the expansion efforts of methods, including blockchain technology. Blockchain technology uses lists of records, known as blocks, that are linked together using cryptography. Blocks include a timestamp, transaction data, and a cryptographic hash of the previous block, which makes the information resistant to tampering and modification.
The new pilot system will provide a step-by-step account of the location of a drug product, who has handled it, and information on any quarantines activated regarding a drug. In addition to this program, the FDA recently issued draft guidance on using product identifiers with a unique serial number to enhance verification all the way down to the package level.
The Drug Supply Chain Security Act was launched originally on November 27, 2013 by Congress. The FDA is charged with the duty of protecting public health by ensuring the effectiveness, safety, and security of drugs, vaccines, and other biological products, as well as medical devices. It is also responsible for the safety of the country’s food supply, dietary supplements, cosmetics, and any products that emit electronic radiation. Finally, the FDA is also responsible for regulating tobacco products in the United States.
For more information on the Drug Supply Chain Security Act and recent news and updates regarding developments in the tracking and regulation of products that fall under the FDA’s regulation, visit our Research & Trials page.