The primary rules governing pharmaceuticals and cannabis packaging include the EU’s Falsified Medicines Directive, the US Drug Supply Chain Security Act, and country-specific cannabis regulations.
The EU’s Falsified Medicines Directive (FMD)
To protect consumers against the risks posed by counterfeit drugs, the European Union has mandated new safety features for most prescription and some over-the-counter medicines supplied within its jurisdiction.
In effect since February 2019, the EU’s Falsified Medicines Directive (FMD) stipulates that these products must have two key safety features: a unique identifier in the form of a two-dimensional barcode and some form of tamper-evident feature on the outer packaging.
In line with this directive, manufacturers are required to upload information from the unique identifier of each medicine to a central EU repository, forming a comprehensive track-and-trace mechanism across the entire supply chain.
In addition, the tamper-evident features would reveal whether the packaging has been altered or opened since its manufacture, safeguarding the integrity and authenticity of the contents from its point of origin to its destination.
It is worth noting that while the EU’s FMD mandates the use of tamper-evident features, it does not specify the type of tamper-evident solution. This lack of specificity allows brands some flexibility in choosing what best suits their needs while ensuring compliance with the law.
US Drug Supply Chain Security Act (DSCSA)
In 2013, the United States Congress enacted the Drug Supply Chain Security Act, which comprises two key components: the enforcement of a robust tracking mechanism and the incorporation of physical security features on outer packaging.
The tracking mechanism requires all participants in the US pharmaceutical distribution channel to adopt a secure and interoperable electronic exchange of transaction information. This includes affixing precise product identifier details—such as the National Drug Code, serial number, lot number, and expiration date—to each package. Initially slated for November 27, 2023, the enforcement deadline has been extended to November 27, 2024.
The DSCSA also recommends using physical security features on drug packaging. These may include tamper-evident tape, color-shifting inks, holograms, and anti-counterfeiting technologies to signal potential tampering or damage to shipping units. Unlike the EU’s FMD, the DSCSA suggests the use of tamper-evident tape without making it a requirement.
Together, these components strengthen the security and integrity of the pharmaceutical supply chain, providing protection against counterfeit, stolen, or adulterated drugs.
Cannabis regulations in Canada and the US
When it comes to cannabis, things get even more complicated: first, because cannabis warrants its own set of regulations; second, because they vary significantly from one country to another; and third, because they are subject to continuous updates.
In the United States, cannabis regulations differ at the federal and state levels. While cannabis remains illegal at the federal level, many states have legalized it for medical and/or recreational purposes. All these variations impact the requirements for packaging safety, labeling clarity, and child-resistant packaging.
In Canada, cannabis regulations are governed by the Cannabis Act. The Act imposes stringent requirements on packaging and labeling to ensure consumer well-being. Key aspects include clear and standardized labeling, child-resistant packaging, and restrictions on promotional elements. Essentially, the objective is to provide consumers with accurate information while preventing access by minors and promoting responsible consumption.