Manufacturers undergo intense scrutiny in the development, testing and distribution of pharmaceutical products. It is a natural progression to ensure that the end product is safely delivered into the patients’ hands. As counterfeit operations have ramped up in recent years, there has been a need to develop anti-counterfeit measures in the form of advanced directives by governments and regulatory bodies. While many countries have specific legislation for combating counterfeits, the US and EU have introduced robust regulations to address this issue: Drug Quality and Security Act (HR3204), followed by Title 11: Drug Supply Chain and Security Act (DSCSA), enforced in 2017. Provides specific directives for serialization of the individual salable unit, and went into enforcement in 2019 due to industry demand for additional time to implement processes. There is an anticipated aggregation requirement set to go into effect in 2023.    The EU Falsified Medicines Directive 2011/62, enforced in 2019. As European countries began to adopt their own requirements for serialization, the EU Commission saw a need for unified regulations to make transport and distribution easier.