Understanding security packaging regulations for pharmaceuticals and cannabis is like trying to solve a puzzle with pieces that keep changing.
Regardless of your role; manufacturer, distributor, or dispenser strict adherence to specific regulations is imperative to ensure compliance and maintain product integrity.
Here’s what you need to know.
The primary rules governing pharmaceuticals and cannabis packaging include the EU’s Falsified Medicines Directive, the US Drug Supply Chain Security Act, Australia’s Therapeutic Goods Act (TGA), and country-specific cannabis regulations.
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.
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.
Australia takes a risk-based approach to tamper evident packaging. The Therapeutic Goods Act (TGA) 1989 sets the overall framework for ensuring the safety and quality of therapeutic goods, which includes medicines (prescription and non-prescription, including medicinal cannabis), vitamins, and medical devices.
Instead of laws, the TGA publishes guidance documents outlining best practices for tamper evident features. The specific requirements depend on the risk level of the product. Higher-risk products, such as potent medications or narcotics, require more robust features, while lower-risk products, such as vitamins, might use simpler seals.
Manufacturers, in consultation with the TGA, determine the risk level based on factors like potential for misuse, severity of harm if tampered with, and the product’s active ingredients and potency.
These guidance documents are not strictly mandatory, but manufacturers are expected to follow them to ensure compliance with the Act. The TGA can take action against manufacturers who do not meet their expectations for tamper evident packaging.
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.
Australia’s cannabis regulations fall somewhere between the US and Canada. The Australian Capital Territory (ACT) legalized recreational possession of small amounts of cannabis for adults over 18 in September 2019. This allows for growing a limited number of plants and possessing a small amount for personal use. Recreational sale and commercial production of cannabis are still illegal throughout Australia.
This brief overview of key regulations in the pharmaceuticals and cannabis sectors underscores that while specific requirements vary based on industry regulations, product types, and regional standards, the consensus is clear.
Security packaging involves implementing measures to safeguard package contents, provide evidence of tampering, and ensure the authenticity of the product. This may include tamper-evident features, unique identifiers, tracking mechanisms, holograms, and child-resistant packaging.
Tamper-evident features are mechanisms designed to show when a package has been opened or tampered with. Common examples include security seals, tapes, or labels that break or leave a visible mark when an attempt is made to open the packaging.
Unique identifiers, such as barcodes, QR codes, or serialized numbers, are applied to products to distinguish them individually. These identifiers play a crucial role in track-and-trace systems, allowing for the monitoring of a product’s journey through the supply chain.
Tracking mechanisms involve the use of technology to monitor and trace the movement of products. This can include RFID tags, GPS tracking, or other technologies that enable real-time visibility into the location and status of the packaged items.
Holograms and specialized security labels are used to provide a visual authentication feature. They typically incorporate intricate designs, holographic images, or color-shifting elements that are challenging to replicate.
RFID tags use radio-frequency technology to store and transmit data. They are generally used for inventory management, asset tracking, and product authentication.
Child-resistant packaging requires a specific mechanism (e.g. that must be pushed down and turned) to open, in order to prevent accidental ingestion by children.
It is also important to keep in mind that one option doesn’t exclude another. In fact, it is often the combination of specific package design features and tracking mechanisms that offers the best protection. When tamper-evident security packing tape contains authentication capabilities, it adds an extra layer of security against counterfeiting and unauthorized access.
While brands enjoy significant flexibility in choosing how to secure their products, they bear a crucial responsibility.
Despite concerted efforts to protect citizens from the threat of falsified medicines, fraudulent products continue to circulate in the gray market. For instance, in December 2023, the FDA seized thousands of units of counterfeit Ozempic, a popular diabetes drug also widely used for weight loss. Although such incidents are relatively rare, they underscore the need for continuous vigilance.
Hopefully, as secure packaging becomes the norm, consumers will develop a greater awareness, instinctively associating it with safety and becoming more cautious about products that lack these protective measures.
Remaining compliant isn’t a one-time achievement; it’s an ongoing commitment. Let’s become partners on this journey. Contact us to discuss and request a quote.
Graduate from the Chemical Engineering Department at McGill University, Jesse has been with the Tamperguard team since 2016 and has helped develop novel chemistries for the security of Tamperguard’s products. He also helps on articles for the Tamperguard website!