GMP and Schedule III

With recent rumors swirling about the Department of Health recommending a rescheduling of cannabis to Schedule III, operators have been considering what the future of cannabis might look like, ranging from facility design to packaging. The most significant benefit of rescheduling is that IRC 280e would no longer apply to cannabis businesses, meaning that cannabis operators could write off business expenses, like packaging.

Schedule III drugs are “accepted medical benefits with a moderate to low potential for physical and psychological dependence.” Drugs that fall in this category include ketamine and Tylenol with codeine. This classification would impact every facet of the industry, enforcing pharmaceutical regulations requiring manufacturing practices, storage, packaging, and facility requirements. AssurPack® brings over 100 years of pharmaceutical packaging experience to ensure that every facet of your packaging complies with the Schedule III code while allowing you to function in the market just as you were before. 

AssurPack® and GMP

Good Manufacturing Practices (GMP) are a multipart system that ensures products consistently meet quality and safety standards. It applies to both products and the manufacturing process to create them. GMP is made to ensure that quality standards are built into every area of a manufacturing process to ensure a quality product is the end result. AssurPack® ensures we use GMP across our production of cannabis packaging: from the materials we use, the records we keep, and the certifications, our packaging is ensured by knowing that you have top-quality practices in making your packaging.

Cannabis companies are not currently held to a standard for GMP, but with rescheduling, there’s potential for Medical GMP to be enforced in medical facilities. If the FDA takes the same approach to cannabis that they do to tobacco, regulations for manufacturing will be unique to the nature of the product. Tobacco is not a scheduled drug, which paints a picture for the different pathways that exist for cannabis depending on the path of rescheduling or descheduling. If cannabis were to be descheduled, the FDA would prescribe unique regulations around the methods for preproduction design, manufacturing, packaging, and storage of cannabis products.

Schedule III Packaging Requirements

Requirements for Schedule III are as follows:

• Child-Resistance (According to CPSC guidelines)
  • As with cannabis packaging, Schedule III drugs require child resistance to prevent children from ingesting the drug.
• Tamper Evidence
  • Tamper-evident features are necessary to ensure product integrity and assure patients that their drugs have not been opened or tampered with.
• Protectiveness
  • Protective features should ensure the product is safe from contamination and light, depending on the drug. For cannabis, features that protect from oxidation and light are most necessary to ensure product integrity.
• Proper Container Materials and Testing
  • Proper materials are defined as materials that prevent interaction between the drug and packaging materials to ensure there isn’t product degradation.
  • Testing must be done from outside 3rd party labs to ensure proper materials were used on the packaging.
    • Other forms of testing need to be done to ensure other packaging factors are satisfactory to safety and freshness standards. (Ex: USP 671 testing is done to ensure the highest level of tightness available for packaging products.)

AssurPack® complies with and can handle all requirements set out by the FDA for Schedule III packaging. These specifications are outlined and necessary to protect patients.

Schedule III Labeling Requirements

With Schedule III drugs, certain labeling requirements are necessary to sell these products commercially, with the main component being identification of the drug being Schedule III. Aspects necessary to Schedule III drug labeling are as follows:

• Drug Name
• Dosage Information
• Active Ingredients
• Manufacturer Information
• Controlled Substance Information
• Expiration Date
• Necessary Warnings and Precautions
• Storage instructions
• Batch Number
• Barcode or Serial Numbers (where applicable)

Though it may seem like a lot, working with a proper packaging provider can ensure that all of this information is placed in its proper place and planned correctly. With our previous experience in Pharma packaging, we can help you prepare for Schedule III label requirements.

What does this mean for you?

There is a lot of speculation regarding cannabis being rescheduled to Schedule III, with the foremost concern being the state-sanctioned legal system and how that’s affected by legality changes.

By working with a packaging partner well-versed in pharmaceutical packaging and regulatory landscapes, you are in the best position to be compliant, with top-line quality control and attention to every detail. 

Work with AssurPack® today to prepare for Schedule III compliance!