Gerry Letendre, RPh, MBA, CHt
Sarasota Specialty Pharmacy and Wellness Center are proud members with PCCA (Professional Compounding Centers of America), which means they have access to and use the highest-quality ingredients for all of their compounded pharmaceutical formulations. Only members of PCCA have access, and they are one of very few in the area that have access via PCCA. This includes their prescription Cannabidiol. Why should you care? Well, the answer to that question will most likely enlighten you and make you think twice about where and who you buy your “CBD” products from.
Numerous individuals using Cannabidiol for specific health needs and personal health goals find it to be beneficial for a gamut of conditions, but a few common uses for cannabidiol are as follows:
• Crohn’s Disease
Sarasota Specialty Pharmacy and Wellness Center uses Pure Cannabidiol that is closely monitored and regulated at >98% powder. It’s critical to know what you’re getting when you purchase CBD products. For example, when buying CBD Oil at a gas station or hair salon, purity of product is very questionable. They may contain harmful contaminants, chemicals and fungi. The majority of CBD products on the market are not regulated, so the manufacturer can essentially label the bottle any way they want to in order to market or commercialize the product and potentially use false claims.
With Sarasota Specialty Pharmacy and Wellness Center, you can always trust quality, dose and usage are pure and correct, and their products are prescribed specific to each patient’s needs, not a one size fit all in a bottle.
If you are a physician and would like to know more about prescribing CBD for your patients, please contact Gerry (owner and lead pharmacist) directly for more information or recommendations on formulas.
WARNING: NOT ALL CANNABIDIOL IS THE SAME
Details on the Differences in CBD Products
The following information is provided by the Professional Compounding Centers of America(PCCA):
What Is Cannabidiol?1
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 (active pharmaceutical ingredients) in compounded preparations because they did not meet the requirements of section 503A of the FD&C Act — until now.1
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”)1
PCCA Cannabidiol (>98% Powder) is an API that can be used in prescription compounding because it fulfills these requirements:
• It is made by an FDA-registered and -inspected manufacturer in full compliance with CGMPs
• It is contained within an FDA-approved product (Epidiolex®)
• It is a pharmaceutical-grade, high-purity, synthetic cannabidiol powder with a minimum assay (purity) of 98% that is accompanied by a valid certificate of analysis1
Additionally, it is not a controlled substance according to the U.S. DEA, and it has a delta-9-tetrahydrocannabinol (THC) content specification of less than 0.1%. Because our cannabidiol powder is synthetic, there is not a concern that it would contain pesticides or other plant components. The assay on our most recent lot showed 100.3% cannabidiol. Because PCCA’s Cannabidiol (>98% Powder) is a drug, it is for prescription compounding only.1
For the purposes of clarity, PCCA’s Cannabidiol (>98% Powder) is:
• Not hemp oil
• Not medical marijuana and is not extracted from marijuana
• Not a full-spectrum mixture of cannabinoids
• Not an over-the-counter (OTC) drug and not for OTC compounding
• Not a dietary supplement1
It is an API, just like any of the other prescription drugs used as active ingredients in compounding.1
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.1
To find out more, please contact Sarasota Specialty Pharmacy and Wellness Center today at 941.366.0880, or visit www.sarasotarx.com
Cannabidiol is by Prescription ONLY
1. Gus Bassani, PharmD, PCCA Chief Scientific Officer, Cannabidiol Is Now Available For Pharmacy Compounding, https://pccarx.com/Blog/cannabidiol-is-now-available-for-pharmacy-compounding, 4/9/20, Houston, TX