This material is provided for informational purposes only and not for the purpose of providing legal advice. You should contact an attorney to obtain advice with respect to any particular issue or problem. (Updated 5/16/2019)
Can Cannabidiol Derived Products be Sold in the Pharmacy?
With the recent proliferation of products and therapies derived from cannabidiol (CBD), many pharmacies have been contacting IPA to determine whether CBD products can be sold in their stores. Until recently, the question was answered with an unequivocal “no” from both the Iowa Board of Pharmacy and Iowa Department of Public Health. However, with the passage of Iowa’s Hemp Act, the question has again been brought to the forefront.
What did the Iowa Hemp Act change?
During the 2019 Legislative Session, lawmakers cleared a bill allowing for the growth and sale of industrial hemp in Iowa. Included in the bill were changes to Iowa’s controlled substance law, which removed CBD products derived from hemp from the Schedule I controlled substance list, as long as the THC level is below 0.3%.
How does the change in Iowa’s law conform with federal law?
At the federal level, the Agriculture Improvement Act of 2018, Pub. L. 115-334, (the 2018 Farm Bill) was signed into law on Dec. 20, 2018. Similar to Iowa’s Hemp Act, the 2018 Farm bill included removing hemp from the CSA, which means that cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under federal law.
The 2018 Farm Bill, however, explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the Food, Drug, and Cosmetic (FD&C) Act and section 351 of the Public Health Service Act (PHS Act). The FDA treats products containing cannabis or cannabis-derived compounds as it does any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of whether the cannabis or cannabis-derived compounds are classified as hemp under the 2018 Farm Bill.
What CBD products has the FDA approved?
Currently, the FDA has only approved one-cannabis-derived (Epidiolex) and three cannabis-related drug products (Marinol, Syndros, and Cesamet), all of which require a prescription. There are no other FDA-approved drug products that contain CBD. Furthermore, federal policy maintains that adding CBD oil to food products is the same as adding a prescription drug.
However, under the FD&C Act, cosmetic products and ingredients are not subject to premarket approval by FDA. Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients, such as topical creams, patches and sprays that do not include THC. Still, ingredients not specifically addressed by regulation must comply with all applicable requirements, and no ingredient – including a cannabis or cannabis-derived ingredient – can be used in a cosmetic if it causes the product to be adulterated or misbranded in any way.
What does this mean for my pharmacy?
This article does not constitute legal advice and pharmacists must ensure they do their due diligence before stocking any CBD oil product on their shelves. CBD oil products present the opportunity to expand profitability on OTC products. However, choosing which CBD product to sell in your pharmacy can be a complicated decision, involving both the legality of the product and its clinical effectiveness. To fully ensure compliance with all state and federal regulations, it is recommended you consult with an attorney prior to deciding to sell CBD oil products.
How does this impact hospital, long-term care, and other health facilities?
While both the federal and state bills do not legalize the sale or manufacturing of all hemp-derived products, they do decriminalize possession of CBD products derived from hemp. This should enable health facilities to define more clearly their policies and procedures when determining how to handle patients who are in possession of CBD products.