Question: Since a cannabidiol (CBD) commercial product has been U.S. Food and Drug Administration (FDA) approved, can I compound with any CBD oil or product?

Answer: There is only one source of cannabidiol that can be used in compounding—Epidiolex.

A summary of Section 503A of the Federal Food, Drug and Cosmetic Act describes compounding as being allowed using drug substances that:

1. comply with standards of an applicable USP [United States Pharmacopeia] or NF [National Formulary] monograph, if a monograph exists, and the USP chapter on pharmacy compounding;
   
   
2. if such a monograph does not exist, are drug substances that are components of FDA-approved drugs; or
   
   
3. appear on a list developed by the FDA that:
   
   
   1. are manufactured by an establishment that is registered and
      
      
   2. that are accompanied by valid certificates of analysis for each bulk drug substance and does not appear on a list of drug products that have been withdrawn or removed from the market due to safety or effectiveness reasons and does not compound regularly or in inordinate amounts copies of any commercially available drug products.

There is only one source of CBD that fits the above requirements for compounding and that is Epidiolex (cannabidiol 100-mg/mL oral solution). Each bottle contains 100 mL of a clear, colorless to yellow solution.

Cannabidiol, the active ingredient in Epidiolex and only one of more than 80 active chemicals in marijuana, occurs as a white to pale-yellow crystalline solid that is insoluble in water and is soluble in organic solvents.

It is a strawberry-flavored, clear, colorless to yellow solution; each mL contains 100 mg of cannabidiol. Epidiolex also contains dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose.

There is a brief listing of the nervous system disorders related to Epidiolex in the "DID YOU KNOW?" section of this Newsletter.

More on this topic will be published in the Editorial in the March/April 2019 issue of the International Journal of Pharmaceutical Compounding.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

FDA Promoting Over-the-counter Naloxone Development
The FDA has, for the first time, proactively developed and tested a product label to encourage development of an over-the-counter version of the opioid overdose antidote "naloxone." This action removes the burden of creating these labels and conducting studies demonstrating consumer understanding and use without a healthcare professional from the companies. Labels for both auto-injector and nasal-spray forms of naloxone were created. "The AMA applauds the FDA and Commissioner Gottlieb," Patrice A. Harris, MD, AMA president-elect and chair of the AMA Opioid Task Force, said in a statement.
https://www.healio.com/family-medicine/pain-management/news/online/%7B4d173e14-4154-4fbd-80bd-716bfa86fe53%7D/fda-takes-unprecedented-step-to-spur-otc-naloxone-development

Walgreens to Pay $269 Million on Claims It Overcharged Federal Programs
Walgreen's Boots Alliance has agreed to pay more than $269 million to settle federal and state lawsuits that accused it of overbilling federal healthcare programs. Two separate settlements were approved. In the first settlement, Walgreens agreed to pay $209.2 million to the U.S. and several state governments for improperly billing Medicare, Medicaid, and other programs for hundreds of thousands of insulin pens it dispensed to program beneficiaries who did not need them. In the second settlement, Walgreens agreed to pay $60 million to settle claims that it overbilled Medicaid by failing to disclose and charge the lower drug prices it offered the public through a discount program.
https://www.wsj.com/articles/walgreens-to-pay-269-million-on-claims-it-overcharged-federal-programs-11548204714

Did You Know ...

�that there are side effects listed in the labeling (package insert) of Epidiolex?

Tip of the Week

Table 3 of the labeling (package insert) for Epidiolex lists the following Nervous System Disorders that are of interest, especially if an individual taking CBD drives or operates machinery.

Section 5.3 Suicidal Behavior and Ideation of the package insert (Table 2) provides a brief discussion of the relative risk for suicidal thoughts or behavior for patients on Epidiolex, which is similar to other antiepileptic drugs.

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Looking Back

Trainwrecks few,
Reason clear,
Fireman doesn't
Hug engineer!
     Burma Shave