By Gus Bassani, PharmD, PCCA Chief Scientific Officer

There has been a considerable amount of interest over the past few years regarding the potential clinical use of various cannabinoids found in Cannabis sativa L. (hemp). The body’s endocannabinoid system, and the receptors associated with it, present an opportunity for health care practitioners to impact the progression of a number of medical conditions. However, until now, there was not a legal avenue for a cannabinoid to be used in pharmacy compounding as a bulk drug substance — or active pharmaceutical ingredient (API) — other than dronabinol, which has not really been a molecule of interest.

That’s why we at PCCA are excited to announce the availability of Cannabidiol (>98% Powder) for use as an API in pharmacy compounding. It is produced by an FDA-registered manufacturer in full compliance with current good manufacturing practices (CGMPs), and meets all of the requirements of section 503A of the U.S. Food, Drug and Cosmetic Act (FD&C Act) for use as a bulk drug substance in compounding.

What Is Cannabidiol?
It is important to have a clear understanding of what this API is, and what it is not. There have been so many nomenclature errors in the media, various industries and medical literature with regard to cannabinoids that it is easy to get confused. Much of the confusion comes from the misuse of the term “CBD.” Technically, “CBD” refers only to cannabidiol, which is a single cannabinoid among a sea of cannabinoids. Unfortunately, so many hemp-based products on the shelves of stores prominently display the term “CBD,” despite the fact that they are not just cannabidiol, but contain a mixture of cannabinoids and other phytochemicals found in the hemp plant. Additionally, the FDA views CBD as a drug and thus not legal to be marketed in the manner most of these retail products are marketed. Compounding pharmacists were also not allowed to use any of these cannabinoids as an API in compounded preparations because they did not meet the requirements of section 503A of the FD&C Act — until now.

As a refresher, Section 503A of the FD&C Act states that a bulk drug substance can be used in compounding if:

• It is manufactured by an FDA-registered manufacturer
• It is accompanied by a valid certificate of analysis 
• It is contained within an FDA-approved product, has an applicable USP/NF monograph or is on one of the bulk drug substance lists generated by the FDA (Category 1 of the interim list or the official “positive list”)

Having cannabidiol powder available for use as an API in compounding is valuable to patients, prescribers and pharmacists. Finally, prescribers can have confidence in the quality and dosing accuracy of the cannabidiol being used by their patients, and can be more personalized in their approach. Most importantly, the patient will be treated under medical supervision and can be monitored appropriately.

Cannabidiol Formulas
PCCA’s Formulation Development team has been hard at work on a variety of cannabidiol formulas, including capsules, troches, topical creams and gels, permeation-enhancing creams and gels, and suppositories. We will be assessing the physicochemical stability of this new active under a variety of conditions. As we’ve seen from early testing, and from a review of the literature, cannabidiol is light sensitive. Pharmacists need to protect the final preparation from light and not allow the API to be exposed to excessive light during compounding. One of the nice attributes of PCCA’s Cannabidiol (>98% Powder) is that it is nearly tasteless, and is very soluble in oils and organic solvents. PCCA members with Clinical Services access should check our Members-Only Website for the latest cannabidiol formulas.

When working with this API, it is important to remember that section 503A of the FD&C Act prohibits compounders from making what is considered to be “essentially a copy” of a commercially available product. The commercial solution must never be copied, unless there is a drug shortage or unless the patient has a documented allergy or sensitivity to an ingredient in the commercial product.

If compounders work with prescribers who have an interest in the use of cannabidiol for their patients, there is now a high-quality, FDA-registered and -inspected source of the API that can legally be used in compounding!*

Gus Bassani, PharmD, PCCA Chief Scientific Officer, has been with PCCA since September 2002. Prior to that, he was a formulation pharmacist in the product development lab of a veterinary pharmaceutical company. He has worked in multiple pharmacy practice settings in Alaska, Iowa and Kansas, and has taught extemporaneous compounding principles to pharmacy students in Drake University's Pharmaceutics Laboratory course. Gus earned his Doctor of Pharmacy degree from the Drake University College of Pharmacy and Health Sciences. He is a member of the 2015–2020 United States Pharmacopeia Council of Experts – Compounding Expert Committee, and served on the 2012–2014 Drake University College of Pharmacy and Health Sciences National Advisory Council. He is a member of the American Pharmacists Association (APhA), Alliance for Pharmacy Compounding (APC), and American Association of Pharmaceutical Scientists (AAPS).

*Cannabidiol is currently listed as a controlled substance and is not eligible for pharmacy compounding in the states of Idaho (Statute 37-2701), Nebraska (Revised Statute 28-401) and South Dakota (Statute 34-20B). To PCCA’s knowledge, all other states have adopted the DEA’s definition of cannabidiol as not a controlled substance.