Bob's Pharmacy Stocks Its Shelves With CBD Oil

MAY 18, 2019
Ned Milenkovich, PharmD, JD
Editor’s note: The characters in this article are a work of fiction. Names, characters, businesses, places, events, locales, and incidents either are the products of the author’s imagination or used in a fictitious manner. Any resemblance to actual persons, living or dead, or actual events is purely coincidental.


The agriculture improvement act of 2018 legalized industrial hemp under federal law after hemp and its derivative products were removed from the Drug Enforcement Administration’s schedule I list of controlled substances. The law also reclassified hemp as an industrial plant, permitting its commercial cultivation and use.

Bob, a congenial and conscientious neighborhood pharmacist, is the proprietor of Bob’s Pharmacy in Small Town, USA, which he operates with his wife, Sally, who is also a pharmacist. Their good advice over the years has won their customers’ trust and earned them a solid reputation.

A man in his mid-30s, wearing a conservative suit, enters the pharmacy. Sally recognizes him as Joe, an occasional customer. He is usually cheerful, but today he appears uncertain and worried.

“Do you have hemp CBD oil?” Joe asks Sally, who is behind the counter.

“I think so,” replies Sally, who turns and calls into the back room, “Hey, Bob. Did we get that delivery today?”

“Yep,” he answers. Joe explains that his daughter, Hayden, is having recurring epileptic seizures. Many have been brief, with just a half-minute of her staring into space, but other episodes have been more severe, with his daughter collapsing and sometimes hurting herself. Bob, emerging from the back room, joins the conversation.

“Did you get a helmet for her?” he asks.

“Had to,” Joe answers. “She was bruising her head when she fell.”

Joe says that Hayden was hospitalized several times. He took her to different doctors, who prescribed various medications, but she began to experience numerous adverse effects.

“Can hemp oil help her?” Joe asks.

HEMP: ROPE, NOT DOPE
Cannabis is a family of plants. Hemp and marijuana are 2 different species of the plant within that genus (Cannabis sativa L). One of the major components derived from hemp is cannabidiol (CBD), and it does not produce a high. The tetrahydrocannabinol (THC) in marijuana, rather, produces a psychoactive effect. CBD has proven antiseizure benefits, among others. It can induce analgesic, antianxiety, anticonvulsive, anti-inflammatory, and anti–muscle spasm effects.

Marijuana refers to the psychotropic drug that is the subject of much current legal debate. It is a schedule  I drug and illegal under federal law. However, many states have allowed the possession and use of marijuana for medicinal and recreational purposes.

HEMPSEED OIL VERSUS HEMP CBD OIL
Hempseed oil is extracted by cold-pressing hemp seeds. The oil is a good source of protein and counteracts aging, has omega-3 and omega-6 fatty acids, and promotes cardiovascular health. Hemp CBD oil is produced from the flower of the plant. CBD, though it has limited federal FDA approval (eg, Epidiolex), is thought anecdotally to have treatment benefits in a variety of illnesses.

Hemp is available for ingestion both as a capsule and an oil. Joe purchased a tincture-size bottle and capsules. Hayden can ingest the oil in droplet form after mixing it with a vehicle or as an oral capsule.

CHALLENGES AND OBSTACLES
The Agricultural Improvement Act drastically reworked federal hemp policy, but legalization carries with it some remaining regulatory restrictions. Moreover, federal and state barriers to the sale of hemp products have not completely disappeared. First, the bill permits the sale of only those hemp products that have been specifically authorized by applicable laws. These products must be made from “industrial hemp,” and any cannabis plant that contains more than 0.3% will be considered marijuana, so it would have no legal protection under this new legislation.

Next, the FDA still considers hemp to be a drug and categorizes it as an illegal controlled substance. On the same day that the act was passed, the FDA issued a statement advising that despite hemp’s new legal status, the agency’s opinion on the matter had not changed. The FDA is the subject of severe criticism for taking this position, which is largely seen as an aggressive action to prevent hemp from being legally sold in drug outlets and the marketplace in general.

GUIDELINES FOR PHARMACIES
A pharmacy that handles hemp products must carefully review the definition of marijuana in its state to determine whether it excludes hemp and whether it lists THC as a controlled substance. Knowing whether hemp and its production quality are legal and legitimate should be a vital part of a pharmacy’s due diligence. Even though hemp is legal under federal law, some state boards of pharmacy have still not taken a position on hemp sales in pharmacies because of state laws that have not been modified to conform with the Agricultural Improvement Act. As a result, pharmacies should consult a legal adviser before stocking their shelves with hemp.

A month later, Joe returned to Bob’s Pharmacy and gave Bob and Sally a big hug. Joe told them that Hayden had experienced a sharp decline in the number of seizures during the past 4 weeks since she started taking hemp oil. The duration of her seizures had also decreased.

“Most of all, I’m grateful for being able to see my daughter grow, develop, and smile again,” Joe said.
 
Ned Milenkovich, PharmD, JD, is chairman of the health care law practice at Much Shelist PC in Chicago and former vice chairman of the Illinois State Board of Pharmacy.


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