Drug Industry Faces New DSCSA Regulations
Though numbers vary widely depending on country of origin, the World Health Organization estimates that between 1 and 10 percent of drugs sold around the world today are counterfeits.
Additionally, around 50 percent of medicines purchased from illegal sites without a published physical address feature counterfeits. This has broad implications for the pharmaceutical industry, especially inpatient safety.
Pharmaceutical manufacturing and packaging companies are grappling with compliance challenges. More countries implement serialization and tracking regulations to ensure the safety and quality of prescription drugs sold within their borders. In this way, they can facilitate quick recalls or alerts.
In the United States, the Drug Supply Chain Security Act (DSCSA) signed by President Obama in 2013 demands error-free serialization and tracking of pharmaceutical products throughout the entire supply chain. The intent is to collect data to illustrate the who, what, when, where, and why of any interaction with a container of medicine from the time it is manufactured until it lands in a consumer’s hands.
From the consumer’s point of view, these regulations will enhance product safety. You can feel more confident that the medicine you purchased first came from a legitimate chain of custody, then continued into a legal flow. Consumers will be better protected against substandard, falsely labeled or counterfeit medical products. In addition, when a problem arises, subsequent recalls will be more comprehensive and methodical. The specific locations of affected medicines will be more quickly known and notified.
Complying with serialization regulations in a forward-thinking way takes serious effort. Evolving guidance and regulation definitions from the Food and Drug Administration (FDA) make keeping up difficult. Contract manufacturers, contract packagers, distributors, and pharmacies must examine their compliance status. Additionally, they should take note of upcoming deadlines, and formulate future plans.
Requirements for the DSCSA regulations come phased incrementally through 2023. The regulations will increase in complexity as time goes on, culminating with full item-level traceability from the individual bottle, syringe, carton, etc., back to the initial manufacturer. According to the FDA, the auditable serialization data will encompass billions of transactions captured in a “secure, computer-generated, time-stamped electronic record”. Companies should store these in accordance with current good manufacturing process (cGMP) standards.
Currently, all pharmaceutical manufacturers, repackagers, wholesale distributors and dispensers (such as pharmacies) must have appropriate licenses and registrations. Second, these trading partners must also have systems in place to correctly exchange product lot information to enable tracing of each product’s transactions in the supply chain. The third requirement for DSCSA regulations notes these supply chain participants must respond to verification requests or product alerts. Also, they must investigate and quarantine suspected products, as well as notify any trading partners of illegitimate products found.
In November 2017, pharmaceutical manufacturers must comply with item-serialization requirements, and requirements on repackagers will follow in 2018. Wholesaler and logistics companies will begin with lot-level traceability in 2019, with pharmacies and other dispensers affected in 2020. Finally, in 2023, all these entities will need to communicate with each other and with regulatory bodies regarding the supply chain history of each saleable pharmaceutical package.
For pharmaceutical companies, DSCSA regulations affect operations in an extreme way. Virtually every area of the company will feel affected. While IT faces an obvious challenge of data management and software integration, other impacts seem more subtle. Examples of areas affected by these changes include manufacturing equipment, packaging artwork, legal agreements, standard operating procedure (SOP) documentation, logistics resources, and government relations.
When evaluating options, organizations should make sure their solutions can grow with the business, as well as to adapt to the upcoming requirements. To avoid missteps and wasted resources, it’s essential to take a holistic view of the implications of this regulatory change. Successful companies involve internal function experts in vendor interviews and implementation of the serialization process. Learning from experienced peers can also provide valuable insight.
With the goal of helping pharmaceutical companies learn from their peers and other experts about how to comply with the DSCSA regulations, Bell and Howell is hosting a free Traceability and Serialization Forum in Durham on Nov. 17.
Editor’s Note: This blog post originally ran in the Triangle Business Journal on Oct. 28, 2016.