Medical cannabis companies developing a new product or redesigning packaging for an existing one may want to look beyond today’s cannabis packaging requirements and consider what could be required in the years ahead.
Pharmaceutical packaging has spent decades addressing many of the same issues medical cannabis companies face, including child resistance, tamper evidence, and product traceability. As medical cannabis markets develop and regulatory requirements become more sophisticated, some pharmaceutical standards offer a useful reference point for packaging R&D.
Germany’s medical cannabis market operates under pharmaceutical manufacturing and distribution requirements, while Australia’s Therapeutic Goods Administration regulates medicinal cannabis within its therapeutic-goods framework. In the U.S., cannabis packaging requirements remain largely state-based, but companies developing products today are making packaging decisions that could remain in place for years.
Changing a package later can mean new tooling, stability testing, supplier qualification, artwork and labeling changes, along with additional cost. Looking at established pharmaceutical requirements during development can help companies decide which safeguards make sense to incorporate before a package reaches production.
Three areas are particularly relevant.
Child-Resistant Packaging Has Decades of Testing Behind It
Child-resistant packaging in the U.S. is governed by a federal law that predates the modern cannabis industry by half a century.
The Poison Prevention Packaging Act gave the Consumer Product Safety Commission authority to require special packaging for hazardous household substances. The testing protocol, codified at 16 CFR 1700.20, sets specific performance requirements. Packaging must resist opening by at least 80 to 85% of children tested and must be opened successfully by at least 90% of adults.
The standard relies on a pass/fail laboratory test using children and adults, with statistical thresholds the packaging must meet before it can legally hold a regulated substance.
Pharmaceutical child-resistant requirements developed over several decades. Aspirin was the first drug required to ship in child-resistant packaging in 1972. Iron-containing products followed in 1978, acetaminophen in 1980, diphenhydramine in 1984, and ibuprofen in 1992. Regulators added substances as poisoning risks were identified.
Cannabis packaging requirements have developed along a similar path. Industry reporting has documented a shift away from bulky exit bags secured at the register toward child-resistant mechanisms built into primary packaging, including push-and-turn caps, slide-lock tins, and heat-sealed pouches.
Medical cannabis companies designing packaging can use the pharmaceutical standard as a benchmark rather than focusing only on whether a package satisfies today’s state requirement. During development, teams can consider closure selection, ease of use for adult patients, repeatability, and validated child-resistant testing.
Accessibility is particularly important for medical products. A package must prevent children from opening it while remaining usable by adults, including patients with limited dexterity. Pharmaceutical packaging testing already accounts for both sides of the equation.
Tamper Evidence Became a Baseline Safety Requirement
Modern tamper-evident drug packaging emerged from the 1982 Tylenol poisonings.
Someone placed cyanide in Tylenol capsules after the products had left the manufacturer and reached retail shelves in the Chicago area. Seven people died. The FDA subsequently established tamper-evident packaging requirements for over-the-counter drugs, now codified at 21 CFR 211.132.
The regulation requires one or more indicators or barriers that provide visible evidence to consumers when tampering may have occurred.
Congress followed in 1983 with the Federal Anti-Tampering Act, making product tampering a federal crime. Pharmaceutical packaging requirements were designed both to make interference visible to consumers and to establish consequences for tampering.
Some medical cannabis markets have incorporated comparable safeguards. Australia’s TGA applies therapeutic-goods packaging requirements to medicinal cannabis products, including requirements intended to protect products from contamination and degradation.
Tamper evidence is worth considering during package development because it can affect the package itself as well as the manufacturing process. Seals, closures, films, and other indicators may need to work with filling equipment, package materials, and production speeds.
Adding those features after a product has entered commercial production can require changes to packaging components or equipment. Evaluating them during R&D gives companies more flexibility to determine how tamper evidence fits into the package and production process.
Packaging ID for Track-and-Trace
Track-and-trace provides another useful comparison between pharmaceutical and cannabis packaging.
Passed in 2013 with a phased implementation schedule, the Drug Supply Chain Security Act (DSCSA) established package-level identification and electronic tracing requirements for prescription drugs. Product identifiers include the National Drug Code, serial number, lot number, and expiration date, typically encoded in a two-dimensional data matrix barcode.
Manufacturers, wholesale distributors and dispensers use this information to identify and trace prescription drugs as they move through the supply chain.
The law followed years of concerns about counterfeit and diverted pharmaceuticals entering legitimate distribution channels. In 2012, for example, counterfeit versions of the cancer drug Avastin reached U.S. medical practices. Serialization gave trading partners a way to identify individual packages and investigate suspect or illegitimate products.
Legal cannabis markets also use track-and-trace systems, generally requiring cultivators, processors and retailers to report inventory movements through seed-to-sale software. Cannabis tracking, however, has often centered on plants, batches, packages and transactions rather than the pharmaceutical model of serializing individual saleable units.
Some international medical cannabis markets are adding more detailed product identification and traceability requirements. QR codes and other machine-readable identifiers are also appearing on cannabis packaging, giving manufacturers and regulators additional ways to connect an individual package with product and production information.
Companies considering package-level identification need to think beyond where a QR code or data matrix will appear. Serialization can affect packaging equipment, printing capabilities, data management, and the connection between a physical package and its manufacturing records.
A company developing packaging now should plan for enough printable space for variable data, confirm production equipment can accommodate it, and ensure identifiers can connect to existing quality and inventory systems. Retrofitting those capabilities after commercialization can be considerably more complicated.
Pharma Offers a Packaging R&D Roadmap
Medical cannabis companies do not need to adopt every pharmaceutical packaging requirement before regulators require it. Pharmaceutical standards are a useful reference when a company is developing a new product, selecting packaging, or updating an existing package.
Child-resistant performance can influence the closure and container. Tamper evidence can affect materials and filling equipment. Serialization can require different printing technology, data systems, and package layouts. Understanding and weighing the packaging options early in development can reveal how difficult and expensive those capabilities are to add later.
The regulatory path for medical cannabis will continue to vary by country and, in the U.S., by state. Companies working on products today can still review packaging standards already tested in another highly regulated medical market.
A package developed today may remain in production for years. Looking at pharmaceutical standards during R&D gives medical cannabis companies a chance to account for child resistance, tamper evidence, and traceability while they are already making decisions about materials, equipment, and package design, rather than revisiting each one after the product reaches the market.
The post What Medical Cannabis Packaging Can Learn from Pharma appeared first on Cannabis Industry Journal.
