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FDA Outlines Guidelines for Developing Cannabis and Cannabis-Based Products

A small jar of lotion on top of cannabis leaves

Earlier this year, the FDA released a draft that provides guidance for companies who are interested in developing drugs containing cannabis or cannabis-derived products. The document contains recommendations pertaining to how a company can source their marijuana, quality considerations, and how to properly calculate the THC levels in products.

With more and more local and state governments regulating marijuana, many businesses are making the leap into the marijuana industry. As an emerging enterprise, it should be anticipated that several local laws and regulations will impact how marijuana is sold. By utilizing Agenda Discovery, you can stay on top of the latest policies that could hinder your success in this market.

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Sources of Cannabis For Clinical Research

For years, the National Institute on Drug Abuse (NIDA) provided the only domestic federally legal source of marijuana for clinical research. It wasn’t until the 2018 Farm Bill that hemp could be served as a source of cannabis and marijuana-based compounds. As a result, hemp could be used in drug development if it did not contain THC more than 0.3% by dry weight. The new outline states that marijuana at or under 0.3% THC can now be used for clinical research without NIDA interference. 

Ensuring The Quality of Product

For businesses entering the industry, they must provide information such as the identity, quality, purity, and potency or strength of the marijuana and the product they are planning to sell. This is meant to ensure the manufacturer is consistently meeting the FDA’s quality standards. Some of the requirements include:

  • Adequate characterization of cannabis and cannabis-derived compounds
  • Drug scheduling considerations under the CSA for applicants pursuing FDA approval of an NDA for a drug that contains cannabis or cannabis-derived compounds
  • Choosing containers that provide adequate characterization and safely hold the product

Delta-9 and the Controlled Substances Act (CSA)

Under the FDA’s new guidelines, it would remove any marijuana-derived compound with delta-9 THC levels above 0.3% by dry weight from the controlled substance list. The guidelines will also remove any marijuana product and derivatives with 0.3% or less from the list as well.

Keep Up With The Latest Cannabis Policies with Agenda Discovery 

If you are thinking of entering the cannabis market you need to stay on top of the policies that are impacting your industry. With it being a new venture, policymakers are making laws to regulate the manufacturing of marijuana products. By using Agenda Discovery’s local government tracking tool, you can easily keep up with them. Contact us to request a demo today!


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