During the last year, the FDA has held a number of public meetings to focus on strategies and issues related to the enhanced drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA).
The DSCSA outlines critical steps to build an electronic, interoperable system by November 2023, to identify and trace certain prescription drugs as they are distributed within the U.S. This system will enhance the FDA’s ability to protect U.S. consumers from exposure to drugs that may be counterfeit, diverted, stolen, intentionally adulterated or are otherwise harmful by improving the detection and removal of potentially dangerous drugs from the drug supply chain.
During a February 2018 public workshop, FDA Commissioner Scott Gottlieb stated that reaching full implementation of the DSCSA by November 2023 is a high priority for the agency.
“Patient safety is at the core of [the] FDA’s public health mission; and ensuring reliable patient access to safe and effective medicines requires maintaining a closed, secure U.S. drug supply chain for the distribution and delivery of finished drug products,” Gottlieb stated. “… Reaching true interoperability for systems and processes that can produce full information for each transaction going back to the manufacturer – down to the individual package level, in near real time – is challenging.”
Full implementation of the DSCSA will create a safe, secure pharmaceutical supply chain that will pay dividends for decades to come, including enhanced patient confidence.”
– Scott Gottlieb, FDA Commissioner
To that end, the FDA has so far released 11 guidance documents for industry related to the DSCSA, covering topics such as standards for the interoperable exchange of product tracing information; annual reporting by wholesale distributors and third party logistics providers; product identifier requirements; and identifying trading partners.
“Full implementation of the DSCSA will create a safe, secure pharmaceutical supply chain that will pay dividends for decades to come, including enhanced patient confidence,” Gottlieb said.
FDA hosts public workshops
Last summer, the FDA hosted a series of three public workshops related to the DSCSA. Via these meetings, the FDA intended to provide members of the pharmaceutical distribution supply chain, and other interested stakeholders, an opportunity to discuss, and provide input on, provisions of the act. Meetings were held in August and December 2017 and February 2018, and more meetings are planned ahead of the 2023 deadline.
During these public meetings, participants focused on what supply chain security should look like in the future, as well as what is needed for enhanced drug distribution security and electronic interoperability. Stakeholders also discussed standards for product tracing, data architecture options, management and maintenance of product tracing data, and the use of aggregation and inference for enhanced product tracing and verification.
At the August 2017 FDA-sponsored public meeting, the director of the agency’s Center for Drug Evaluation and Research (CDER) Office of Compliance, Donald Ashley, stated that though the U.S. is among the safest countries in the world with regard to drug supply, there are still problems with the system. The Office of Compliance leads efforts to protect the public from unsafe, ineffective and low-quality drug products through measures designed to assist industry-wide compliance with federal standards for quality and safety, as well as regulatory and enforcement measures to address violations of those same standards.
Ashley said criminal organizations are often behind breaches in the U.S., and these organizations have no regard for the safety of the products they are peddling or the harm they cause when the drugs they introduce have too much or not enough of an active ingredient, for example.
History of DSCSA
The DSCSA was signed into law on Nov. 27, 2013 as Title II of the Drug Quality and Security Act; section 202 of the DSCSA added sections 581 and 582 to the Federal Food, Drug, and Cosmetic Act (FD&C Act), establishing new definitions and requirements related to product tracing.
Requirements for the tracing of products through the pharmaceutical distribution supply chain under section 582(d)(1) of the FD&C Act went into effect on July 1, 2015. The FDA’s Guidance for Industry: DSCSA Implementation: Product Tracing Requirements for Dispensers-Compliance Policy addresses the readiness of dispensers in the pharmaceutical distribution supply chain to comply with the provisions related to the exchange of transaction information, transaction history and transaction statements (product tracing information), and informs on the FDA’s enforcement intention.
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Editor’s note: This analysis was developed with data from Cortellis Regulatory Intelligence.