Shedding Light on Legal, Regulatory Issues Surrounding CBD

As the use of cannabidiol (CBD) becomes more frequent and perceptions of marijuana change—along with its legal status—across much of the country, pharmacists and other health care providers face many questions regarding the use of CBD, which leads to a gray area for pharmacists.

Bill Lee, DPh, MPA, FASCP, is the senior director of pharmacy system innovations at Carilion Clinic in Riner, Virginia, and his presentation on CBD at the APhA 2022 Annual Meeting & Exposition shed some light on this substance that is often used as a treatment, but which is not considered a medication or nutritional supplement.

During the session, Lee shared information about the latest legal and regulatory CBD updates in order to keep pharmacists and other professionals informed on how to stay in compliance.

Lee addressed professionals in the pharmacy, hospital, and cannabis industries on the legal differences between medical and recreational CBD products. He also talked about the FDA-approved indications for CBD and identified concerns related to CBD products from the patient perspective, as well as his perspective as a Board of Pharmacy representative.

The goal, said Lee, was for participants to be able to recognize regulatory and legal issues regarding the sale of CBD products in drugstores and to learn how the pharmacy industry is dealing with these issues.

Lee noted that the earliest FDA approvals for CBD were limited to epilepsy, and that questions have been raised as to whether it’s effective as an appetite suppressant or an anti-anxiety treatment.

The discussion also included safety concerns regarding CBD.

“Do you know how [the] CBD is prepared?” Lee asked. “Are

manufactured in an FDA-approved facility? What about pesticides? If it’s pure, if it’s truly organic… what kind of pesticides? How do they test for pesticides? What are some drug interactions? How do they test for it and what is the standard?”

According to Lee, many people are unsure as to the differences between CDB and marijuana, how the 2018 Farm Bill affects the legality of marijuana, and how hemp is being promoted.

“You have hemp in so many industries, it’s crazy now,” Lee said. “It’s been even introduced into nutrition [and] nutrients.”

Lee added that research on CBD has been ongoing since 2019 in unrelated studies on anxiety, cognition, pain, and movement disorder.

One important factor in CBD is the amount of tetrahydrocannabinol (THC) it contains. “When people say, ‘I’m taking CBD,’ do they really know how much THC is in there?” he said. “And what kind of THC? I kept thinking, ‘They have THC in there. Are we talking about just THC delta-9?’ No, there’s THC delta-8, there’s THC delta-10, and there are other terpenes that [we] are still discovering.”

There also are concerns in the hospital industry because of the potential of false positive on urine tests if someone is using CBD. “How do we handle that? Those are becoming HR issues now,” Lee said.

Then, there are the safety factors that Lee said pharmacists need to be aware of, including side effects and drug interactions with both prescribed and OTC products.

“In the community pharmacy or in the hospital pharmacy, we’re doing a medication reconciliation or history when the patient walks up to the counter,” he said. “How many of you actually ask, ‘Are you taking any CBD?’ Because a lot of patients don’t consider CBD a medication. Is it a medication? If they don’t tell you, what happens?”

“We know some things that are very common,” he continued. “CBD is going to cause drowsiness, it’s going to lower blood pressure; it also affects the P450 cytochrome. So, there are numerous drugs that are going to be affected by the P450. There are even reports of liver damage as well.”

Lee wrapped up his presentation by stressing the importance of long-term studies and continued research before taking questions and concluding his talk.

This was originally posted by our sister publicatoin Drug Topics.

Reference

Lee B. Your CBD guide part 1: Legal and regulatory concerns. Presented at: American Pharmacists Association 2022 Annual Meeting & Exposition; March 18-21, 2022; San Antonio, TX