Regulations and Regulatory Issues

An argument for moving away from traditional culture-based methods and towards employing methods with increased specificity and accuracy.

The U.S. Food and Drug Administration (FDA) recently released a draft guidance on developing cannabis-based drugs. These guidelines come weeks after the White House announced it had completed reviewing the draft guidance.

Here we examine the history of cannabis in the US, the role the USP played in that field, and the new role the USP is taking with cannabis for medical use.

In this article, you will learn about the GxP requirements for laboratories, production facilities, and distribution of cannabis.

The industry needs to address energy efficiency, plastic use, and wastewater to build a long-term reputation of accessibility, legitimacy, and sustainability.

The U.S. Department of Agriculture (USDA) recently issued a temporary delay regarding enforcement on two provisions of its hemp regulations (1).

A report on the findings from the initial field evaluation of a molecular DNA-based assay to distinguish the categories of fiber hemp, resin hemp, and THC cannabis based on genetics.

The U.S. Secretary of Agriculture, Sonny Perdue, announced the establishment of the U.S. Domestic Hemp Production Program on October 29, 2019.  

A number of causes of hemp testing insanity are documented such as different states using different THC measures to determine legality, lack of representative sampling, and more.

A review of the expert strategies and resources to streamline the laboratory accreditation process.

An explanation on the theory and measurement of water activity, its mode of action for microbial control, existing water activity regulations for cannabis, and more.

What changes need to be adopted in our industry to make the transition to the pharmaceutical industry testing paradigm?

Enterprise resource planning (ERP) helps provide control and visibility to critical cannabis business management issues, such as data, inventory, quality, and traceability. The author explains how it works.

Three former and current state regulators discuss their collaborative work in the cannabis industry.

Where does cannabidiol’s (CBD) legal status stand following the 2018 Farm Bill? One attorney looks at common misperceptions.

An outline of some of the current major challenges for both regulators and laboratories regarding the microbial testing of cannabis products.

This article is intended to spark conversations about measurement uncertainty that lead to the recognition and application of effective uncertainty budgets in the cannabis arena.

George Anastassov, the CEO of AXIM Biotech, recently spoke to us about the current good manufacturing methods (cGMPs) his company has developed, their significance to the market, and plans for the future.

The agencies sent warning letters to several companies that the agencies say are illegally marketing unapproved products to treat opioid addiction and withdrawal.