vet syndrome, it also treats other off-label conditions. In 2020, Epidiolex was approved to treat seizures associated with tuberous sclerosis complex (TSC) in one year and older patients. Under the CSA, CBD is currently a Schedule I controlled substance because it is a chemical component of the cannabis plant. The FDA has submitted a medical and scientific analysis of CBD, including data
from studies to assess the abuse potential of CBD, to the DEA to change the scheduling of CBD. In 2020, the DEA removed Epid- iolex from a downgraded Schedule V and descheduled it entirely, meaning Epidiolex is no longer subject to the CSA and its tracking and monitoring requirements (HB6095, 2021).
Table 1: Marijuana-Derived Pharmaceutical Products
FDA -Approved or Under Review Indications Appetite stimulant in the management of anorexia associated with AIDS. Treatment of chemotherapy-induced nausea/vomiting. Treatment and prevention of chemotherapy- induced nausea/vomiting. Treatment of Lennox- Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. Clinical trials for pain treatment in cancer patients who experience inadequate analgesia during optimized chronic opioid therapy.
Generic Name
Brand Name
FDA Status
Pharmacology
Dronabinol
Marinol
Synthetic delta-9- tetrahydrocannabinol (delta-9-THC) is the primary active compound of marijuana. Derivative of cannabinol, a nonpsychoactive constituent of marijuana. Plant-derived cannabidiol (CBD) accounts for 40% of cannabis extracts. Combination of delta‑9‑THC, the primary active compound, and cannabidiol, a nonpsychoactive component of marijuana.
FDA-approved controlled substance Schedule Ill.
THC
Syndros (capsules)
Nabilone
Cesamet (capsules)
FDA-approved controlled substance Schedule II. Descheduled by the DEA; no longer subject to the CSA.
Cannabidiol (CBD)
Epidolex (oral solution)
Cannabidiol (CBD) and delta-9- tetrahydrocannabinol
Sativex (oro-mucosal spray)
Under investigation in the United States, Phase II/III trials.
Healthcare Consideration: Although marijuana remains a federal Schedule I controlled substance, many states have approved or are considering supporting the medical and recreational use of marijuana. As these regulations differ from state to state, NPs must carefully review regulations and applicable requirements in their practice state. PRESCRIBING PRACTICES FOR CONTROLLED SUBSTANCES
A physician, dentist, podiatrist, veterinarian, or advanced prac- tice provider (i.e., chiropractor, nurse practitioner, midwife, op- tometrist, pharmacist) may issue a prescription for a controlled substance. Others may give a prescription under the following conditions: ● Authorized to prescribe controlled substances by the jurisdic- tion of practice. ● Registered with the DEA or exempted from registration (e.g., U.S. Public Health Service, Federal Bureau of Prisons, or mili- tary practitioners); to obtain a DEA registration, the clinician must complete DEA Form 224 (http://www.DEAdiversion.us- doj.gov). ● Effective May 11, 2022, DEA now requires all registration ap- plications and renewal forms to be submitted electronically. ● An agent or employee of a hospital or other institution acting in the normal course of business or employment under the registration of the hospital or other institution that is regis- tered instead of the individual practitioner being registered, provided additional requirements as outlined in the CFR (DEA, 2018c). DEA registration grants federal authority to practitioners to han- dle controlled substances as part of their professional practice or research. A clinician may prescribe controlled substances only under the state laws where their practice is located. When fed- eral and state laws differ, the practitioner should follow the more stringent aspects of both the federal and state requirements. This principle has led to much concern about the state legalization of medical marijuana, despite the DEA maintaining its controlled substance Schedule I status.
The DEA may deny, suspend, or revoke a clinician's DEA registra- tion upon finding the registrant has: ● Materially falsified any application filed. ● Been convicted of a felony relating to a controlled substance or a Schedule I chemical. ● Had their state license or registration suspended, revoked, or denied. ● Committed an act that would render the DEA registration in- consistent with the public interest. ● Been excluded from participation in the Medicaid or Medicare program. Clinicians who are agents or employees of a hospital or other insti- tution (e.g., interns, residents, staff physicians, advanced practice providers) may, in the normal course of their duties, administer, dispense, or prescribe controlled substances under the registra- tion of the hospital or other institution provided that: ● The dispensing, administering, or prescribing is in the ordinary course of practice. ● Practitioners are authorized by the state in which they practice. ● The hospital or institution has verified that the practitioner is permitted to dispense, administer, or prescribe controlled substances within the state. ● The practitioner acts within the scope of employment in the hospital or institution. ● The hospital or institution authorizes the practitioner to dis- pense or prescribe under its registration and assigns a specific internal code for each practitioner so authorized.
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Book Code: RPUS3024
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