Medical Cannabis: Practical and Legal Implications LTC Providers

Gerald C. Canaan Hancock, Daniel & Johnson, P.C.

September 25, 2019

Road Map:

1. Federal laws surrounding CBD Disclaimer: This presentation is offered for discussion purposes only • The Farm Bill and shall not constitute legal advice. •DEA •FDA • Federal enforcement 2. Virginia state laws

3. Risks and Concerns of CBD in long-term care facilities

1 Virginia Law: CBD Distinctions • Over-the-counter CBD: CBD from hemp with TCH levels below 0.3% • Virginia Board of Pharmacy CBD: CBD/TCH-A

• Is either one “legal”? – Kind of legal?

Federal Law – The 2018 Farm Bill • The Agriculture Improvement Act of 2018 (“Farm Bill”) – established hemp is no longer included under the definition of marijuana – Hemp and hemp derivatives with THC concentrations of less than 0.3% are no longer a Schedule I substance – Hemp products are now classified as agricultural products – The Farm Bill provides U.S. Department of Agriculture (“USDA”) with the power of regulation over hemp products • States and USDA Hemp Regulations Overlap – USDA shares regulatory power over hemp with states – States must first demonstrate to USDA that it has a regulatory plan regarding licensing, cultivation, and production of hemp

2 Federal Law – The 2018 Farm Bill • Under federal law, industrial hemp can be legally grown and processed for commercial purposes in the United States • CBD oil is still illegal under federal law with very limited exceptions. Some examples include: – CBD derived from hemp that aligns with state and federal regulations and produced by a licensed grower – FDA approved Epidiolex • Unregulated CBD still constitutes a Schedule I substance under the Controlled Substance Act – This includes CBD from hemp that has over 0.3% of THC concentration or CBD from marijuana

U.S. Drug Enforcement Administration (DEA) • The DEA is the primary federal agency that handles enforcement and regulation of controlled substances • August 26, 2019: The DEA published a notice stating, “hemp, including hemp plants and cannabidiol (CBD) preparations at or below the .3 percent delta-9 THC threshold is not a controlled substance and the DEA registration is not required to grow or research it.” – The DEA clarified that hemp and hemp derivatives are not controlled substances as long as they comply with relevant regulations

3 U.S. Food and Drug Administration (FDA) • Under the Federal Food and Drug Act, hemp CBD products cannot be marketed as a drug or food ingredient • An FDA determination of a product as generally recognized as safe (GRAS) allows a product to be marketed in human food without food additive approval – Three recent GRAS notices by FDA: . (1) Hulled hemp seed . (2) Hemp seed protein . (3) Hemp seed oil • The FDA can take enforcement actions against companies illegally selling cannabis and cannabis derived products

Virginia Law – Over-the-Counter CBD • The Farm Bill allows individual states to develop their own regulatory scheme regarding hemp and hemp derivatives • Before 2019, the Commonwealth still considered hemp illegal outside of research programs • In 2019, Virginia passed the Virginia Industrial Hemp Law – This law abolished the previous restriction that hemp only be grown for research purposes – Commercial production of industrial hemp is now permitted in the Commonwealth – However, to legally possess hemp plants, growable hemp seed etc., you must be registered as an Industrial Hemp Grower, Dealer, or Processor

4 Virginia Law – Board of Pharmacy CBD/THC-A • Virginia offers legal protections for VA Board of Pharmacy CBD possession if an individual: – Obtains written certification from a registered practitioner – Registers certification with the Board of Pharmacy • If all requirements are met, the individual will have an affirmative defense against prosecution • In the next year, VA Board of Pharmacy will allow five companies to each open a dispensary in Virginia. Each dispensary will be located in one of Virginia’s five health services areas. – Dispensaries will distribute VA board of pharmacy CBD oil for those with written certification

Virginia’s 5 Health Service Areas

Photo courtesy Virginia NORML (Jenn Michelle Pedini)

5 Enforcement • Over-the-counter CBD products are everywhere! How? • The DEA and FDA have generally held back from strict enforcement action in this area – The FDA has issued Warning Letters but the letters have not affected CBD popularity • Federal and state laws are very complex and create many grey areas that make enforcement difficult

The Key Question:

• Should you or can you • Allow (OTC) or facilitate (CBD/THC-A) • the administration of a medication that • Is or may be “illegal”?

• If so, how?

6 Over-the-Counter CBD Concerns

Logistical Concerns Should LTC administer it? Store it?

Monitoring Concerns Should the LTC facility double check if patients are taking their over‐the‐counter CBD?

Clinical Concerns Should patient’s use of over‐the‐counter CBD affect the LTC facility’s treatment plan for patient? Will it interact with patient’s other medications? Interference with Resident Rights How to balance patient’s right to self‐determination Concerns with illegal gray areas? Can LTC facilities take away over‐the‐counter CBD from patients? Medicare Reimbursement Concerns ?

VA Board of Pharmacy CBD Concerns

Logistical Concerns Will you allow it in the building? How will patients obtain it from regional dispensaries? Where will you store it? Who will administer it?

Monitoring Concerns Monitored like any other drug? Will they oversee patient’s “prescription”, obtain refills? Will Medical Director prescribe it? Clinical Concerns How will it factor into a patient’s plan of care?

Interference with Resident Rights If patients have a written certification for CBD, can Concern the LTC facility interfere with patient taking that CBD?

7 Gerald C. Canaan [email protected]