The Future of Cannabis Packaging in a Schedule III Era
March 26, 2024
A Director of Regulatory Compliance From Pharma Unpacks Schedule III Implications for the Cannabis Industry with AssurPack®.
The recent news of the potential rescheduling of cannabis to Schedule III could be a massive shift in the cannabis industry, with profound implications for all stakeholders, including packaging companies. In this blog, we delve into the insights from an interview with a seasoned Pharmaceutical Director of Regulatory Compliance who brings over two decades of experience navigating pharmaceutical and nutraceutical manufacturing regulatory frameworks with the FDA. Our inside expert sheds some light on what Schedule III means for the cannabis industry, what it means for the packaging industry, and how to prepare for what’s to come.
AssurPack® Interviews Pharma Regulatory Expert About Schedule III and Cannabis
AP: Will cannabis brands still be able to use their current packaging under Schedule III?
Expert: That depends on whether their current packaging allows their product to meet cGMP guidelines, such as stability data to support shelf life. Some cannabis packaging in the market is made in ways that would work within a Schedule III framework, and other companies will need to change what and how they meet these new standards.
AP: What do operators need to look for in a packaging supplier?
Expert: Cannabis packaging suppliers must operate under the same cGMP guidelines as the manufacturer’s operations.
AP: How do we know if suppliers are operating to meet cGMP requirements?
Expert: You need an individual experienced in regulatory quality who is familiar with cGMP guidelines to help you develop a GMP audit questionnaire that you can send to your suppliers to complete. An in-person audit of your supplier’s manufacturing facility would be the next step to ensure they adhere to proper guidelines.
AP: What documentation will we need from your suppliers under Schedule III?
Expert: First, you must establish specifications and release requirements for your specific cannabis package. These documents ensure traceability in packaging to understand where product batches are should there be a recall. You will need a Certificate of Compliance (CofC) release document for all packaging materials you receive manufactured. Also, you will need to get their material CofC from the raw material manufacturer. These documents verify what is used to create the packaging to ensure it meets FDA guidelines.
AP: We work with global packaging manufacturers. How can we ensure they meet cGMP?
Expert: Packaging companies worldwide should work to an ISO standard and certification since the FDA does not audit packaging companies overseas. This applies to the raw materials manufacturer to get materials tested to FDA standards at a 3rd party certified lab.
ISO certification is the gold standard internationally for compliance standards. At AssurPack®, we ensure all of our manufacturing partners have ISO certification so we can ensure the safety and compliance behind every product made.
In a regulatory landscape that is constantly changing, AssurPack® works to stay ahead of the curve by providing cannabis packaging that is accessible, sustainable, and compliant with regulatory standards. We are constantly working to maintain and uphold compliance standards, so there is no doubt in anyone’s mind about where to find quality cannabis packaging.
Contact us to prepare now for the future of Cannabis Packaging.
