The June 2019 Edition of the Kansas State Board of Pharmacy Newsletter reprinted an article written by compounding expert Loyd Allen, Jr., PhD, RPh in the International Journal of Pharmaceutical Compounding (IJCP, Vol. 23, No. 2).
The original Kansas BOP and IJCP article describe the requirements pharmacists should follow if compounding with cannabidiol (CBD).
In the article authored by Professor Allen, he describes the current FDA guidance on compounding in general and how that applies to compounding with CBD.
To summarize, pharmacists are permitted to compound medications written for specific patients using drug substances that comply with FDA compounding law:
(1) the drug substance complies with current USP or NF monographs, if a monograph exists;
(2) if a monograph does not exist, are drugs that are components of FDA-approved drugs; OR
(3) appear on a list developed by the FDA that: (a) are manufactured by an establishment that is FDA registered and (b) are accompanied by a valid certificate of analysis for each bulk drug substance; and
(4) do not appear on a list of drugs that have been withdrawn or removed fomr the market due to safety or efficacy concerns; and
(5) the pharmacy does not compound regularly or in inordinate amounts any drug products are essentially copies of commercially available drugs.
Professor Allen points out that CBD does NOT currently have a USP or NF monograph, does NOT appear on the list of bulk substances approved for use, nor is CBD on the list of removed or withdrawn drugs. It DOES, however, have an FDA approved source marketed under the brand name Epidiolex.
Because Epidiolex is approved, it is reasonable for pharmacists to use Epidiolex as a source for CBD compounds.
If you have questions about compounding, please contact our firm for a consult.
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