In setting out the requirements for cannabis, the issuing of the guidance document signals the wider acceptance of cannabis as a product that can be manufactured to scale for the mass market. The regulations proposed in the guidance document seek to apply the same regulatory standards to cannabis as would be applied to any other botanical raw material, botanical drug substance, or botanical drug product.
The first section of guidance looks at cannabis sources. Taking a legal position, the guidance notes that the cannabis source must meet the requirements of the U.S. Controlled Substances Act together with other provisions put in place by the Drug Enforcement Administration. These requirements come in to force when the cannabis material exceeds the limit of 0.3% Δ-9 THC, as assessed by dry weight at this level this excluded hemp).
At present, in the U.S., cannabis for medical research can only be obtained from the U.S. National Institute on Drug Abuse and Drug Supply Program. Other approved sources may emerge in the future.
The second substantial section looks at quality control, based around suitable scientifically based test procedures. The assessment of cannabis samples that the receiving laboratory must make include tests for the identity, quality, purity, and potency or strength. In addition, standards for microbiological contamination must be met.
The third area considers how cannabis will be delivered to the patient, such as via an inhaler. The holding materials must not adversely affect the cannabis material (as might occur through a reaction). The guidance also extends to the use of cannabis with another substance (this making it a combination medicinal product).
The fourth section looks at how the level of Δ-9 THC can be expressed. Different calculations will apply to the cannabis product in solution compared to the product in a solid oral dosage form (like a tablet). The suggested methods of assessing Δ-9 THC levels is based on the composition of the formulation with the amount of water removed.
It is recommended that the assessment is conducted as early as possible in the drug development process, in order to build in sufficient manufacturing controls.
The guidance concludes with advice on generating a suitable certificate of analysis, developing appropriate analytical methods, and filing instructions. The last aspect provides information about transportation.
