Pharmaceutical packaging compliance, including safety and supply chain visibility, is an area that demands secure packaging and label identification. Many new compliance regulations are designed to verify the authenticity and origin of raw materials and ingredients, and to effectively, quickly, and accurately track and trace the products as they move across a global supply chain of manufacturers, packagers, distributors, and retail outlets both online and in-person. These identification requirements provide the regulators and, more importantly, the manufacturers the tools needed to understand where problems may lie, remove
the offending product from the supply chain, and quickly notify the consumer to mitigate risk and negative effects.

The Drug Supply Chain Security Act (DSCSA) was enacted by the U.S. Congress on Nov. 27, 2013. It requires that there is an ability to track and trace all products in the pharmaceutical distribution supply chain. Critical steps are outlined in the DSCSA to build an electronic, “interoperable” system by Nov. 27, 2023, and improve detection and removal of counterfeit and potentially harmful products from the pharmaceutical distribution supply chain. According to the law, as of July 1, 2015, dispensers were required to comply with the new regulations. Compliance with the regulations means maintaining what is known as the 3Ts: transaction information (TI), transaction history (TH) and transaction statement (TS). These records must be maintained for six years. All manufacturers, distributors and dispensers of prescription drugs in the supply chain in the U.S. market are required to comply, and other countries are implementing similar programs.

Recent tangible efforts and results, such as in controlled substance monitoring, have shown that these systems work. The federal government increasingly is holding the pharmaceutical industry responsible for monitoring the supply chain for the illegal and out-of-pattern ordering of Schedule II drugs (opioids) and is penalizing distributors and manufacturers as seen recently in the Purdue Pharma and McKinsey settlement.