Manufacturers and distributors have 10 years to work with FDA to build an electronic, interoperable system able to trace prescription drugs to the package level in the United States market. The program is required by the Drug Quality and Security Act (DQSA), signed into law in November 2013, which also contains provisions reforming large drug compounding operations. Facing tight deadlines, FDA is beginning the complex task of implementing the law’s multiple track-and-trace requirements.
The larger goal is to remove counterfeit or unauthorized products from the supply chain and to better ensure that patients receive medicines that meet quality standards. Continuing concerns about substandard medicines from India and China and expanded drug counterfeiting operations have made more secure downstream drug distribution a top priority (1). The DQSA program, together with the upstream supply-chain measures in the FDA Safety and Innovation Act of 2012 (FDASIA), provide FDA and biopharmaceutical companies with additional tools and authorities for detecting, investigating, and challenging a full range of “suspect” products. Of immediate importance to manufacturers, DQSA also pre-empts the growing range of differing state pedigree and tracking requirements, which would have been a nightmare for the industry to implement.
In establishing systems and processes for verifying drug packages and for secure exchange of transaction information, the program will help manufacturers investigate problematic products and conduct product recalls, notes Elizabeth Jungman, director of drug safety and innovation at the Pew Charitable Trusts. Although the final law contains numerous caveats and exceptions and a long phase-in period, Jungman acknowledged at a February conference sponsored by the Food and Drug Law Institute (FDLI) that, in the end, it should lead to a more efficient system for keeping harmful medical products from reaching consumers.
Multiple FDA offices and working groups are beginning to tackle a 15-point implementation plan for the drug supply chain portion of DQSA, explained Ilisa Bernstein, deputy director of the Office of Compliance (OC) in the Center for Drug Evaluation and Research (CDER), at the FDLI meeting. Bernstein heads up the implementation effort, together with OC’s Office of Drug Security, Integrity, and Recalls. The plan lists the many guidance documents, rules, and standards needed to establish electronic track-and-trace by 2022 (2, 3).
Implementation got off the ground with a February Federal Register entry seeking comments on setting standards for establishing an interoperable drug tracing system (4). FDA wants input by April 21, 2014 on the scope of transaction information needed for such a program; whether current systems can exchange lot level data; how participants will shift from paper to electronic tracking in the future; and what new standards, technologies, and models will help build the new process. FDA also is interested in current practices for providing notification of supply problems, for verifying product identity, and for recalling suspect or illegitimate drugs. The comments will help FDA develop guidance by November 2014 on interoperable data exchange and to clarify which situations could increase the risk of suspect products. These processes are key for manufacturers to meet a January 2015 deadline for establishing and testing systems for data exchange.
Meanwhile, FDA is tackling an initial guidance, due in May 2014, designed to help manufacturers identify suspect and illegitimate products. Drug makers are busy refining unique identifiers for each drug product and package that can verify the product and trace it as it changes hands.
At some point, manufacturers and FDA will have to deal with data aggregation and inference, pointed out Jungman of Pew, who regards the capacity to link serial identifiers from palettes to cases to drug packages as key to establishing a functional, interoperable tracking system. DQSA acknowledges the need to address this issue, but leaves it to FDA to work out the specifics. Different approaches to data aggregation are in use around the world, and manufacturers want FDA rules to support a practical, common solution.
A related issue is whether and how manufacturers will “decommission” product serial numbers no longer in use, also important for blocking counterfeit and substandard products from entering the US supply chain. Without some system for retiring obsolete serial numbers, says Jungman, criminals can use old numbers to bring in illegitimate drugs without detection.
A parallel task for FDA is to issue national standards for licensure of supply-chain participants such as wholesalers, distributors, and third-party logistics providers (3PLs). FDA is establishing databases for wholesalers to report licensing information and for 3PLs reporting. New regulations, which will establish standards for wholesalers, distributors, and 3PLs, are due by November 2015, and will take effect the following year. Those states that license wholesalers can continue to do so under DQSA, provided their rules are consistent with FDA rules.
Despite its broad scope, DQSA largely exempts pharmacists from end-point verification of serial numbers before drug dispensing, along with physicians that dispense drugs. The tracking system will help pharmacies verify package receipt and account for returns, expired items, destruction, and pilferage. These significant exemptions were necessary political compromises, and the rules could be strengthened as an efficient data-tracking system emerges.
Implementing DQSA builds on supply-chain provisions in FDASIA, which requires registration of all drug manufacturers and importers that supply drugs in the US, authorizes greater exchange of drug quality information, and expands FDA inspections for foreign manufacturers. FDA is testing how well these initiatives can improve the oversight of the ever-rising volume of drugs and APIs imported into the US through a two-year pilot program for expediting drug imports from prequalified manufacturers. Thirteen pharmaceutical companies are participating in this Secure Supply Chain Pilot Program (SSCPP), much fewer than the hundred firms initially sought by FDA, but considered sufficient to test the program. Each manufacturer will select up to five products to be exempt from border inspections, based on the firm’s record for drug quality control, validated security systems, and ability to correct problems and to initiate recalls when needed. FDA hopes to determine if reduced oversight for lower-risk drugs can save resources—and permit the agency to focus more on preventing the entry of violative products.
FDA will be gathering more specific information and opinions on how the new track-and-trace program should operate at a series of public meetings over the next few years. These meetings will help the agency finalize initial guidance documents on transaction processes, with an eye to harmonizing with existing international programs. The process also will set the stage for FDA-sponsored pilot programs to test new initiatives.
Meanwhile, manufacturers are re-engineering their business processes to establish or refine systems for fast product verification based on serial number identifiers; for data aggregation, quarantine, and investigation of suspect products; and for speedy notification of FDA and trading partners of problem situations. In six years, wholesalers and manufacturers will need to be able to verify legitimate returns. The 10-year timeframe for establishing a fully operational tracing system will fly by quickly.
1. J. Wechsler, “Track-and-Trace Not Enough to Halt Drug Counterfeiters,” PharmTech Talk, (March 4, 2014), accessed Mar. 6, 2014.
2. FDA, Drug Supply Chain Security Act, Title II of the Drug Quality and Security Act of 2013, accessed Mar. 6, 2014.
3. V. Ventimiglia and E. Marshall, FDLI’s Food and Drug Policy Forum, What are the Key Implementation Challenges in the Supply Chain Security Provisions of the Drug Quality and Security Act? (FDLI, Dec. 20, 2013), accessed Mar. 6, 2014.
4. FDA, Federal Register, Vol. 79, No. 34, pp. 9745-9747 (Feb. 20, 2014), accessed Mar. 6, 2014.