The DEA has moved cannabidiol (CBD) drugs (prescription products) with a THC content below .01% to a Schedule 5 (V) drug, provided the drug has been approved by the FDA. This was prompted by the FDA's approval of Epidolex, a drug intended to be used for rare forms of epilepsy. This means that medical cannabis facilities will not be able to distribute these types of CBD products and that they will instead have to go through a physician/prescription process like any other prescription product.
The DEA has five schedules for drugs. Each schedule takes into account the drug’s acceptable medical use and the potential for abuse or dependency. The more acceptable the drug and lower the potential for abuse or dependency, the less restrictive the scheduling will be. Drugs scheduled as a Schedule 1 (I) have no accepted medical use and have the highest potential for abuse. Schedule 5 drugs are those with the lowest potential for abuse but that may contain very limited quantities of certain narcotics or, in the case of Epidolex, THC.
The DEA describes the schedules as follows:
Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse. Some examples of Schedule I drugs are:
- Lysergic acid diethylamide (LSD)
- Marijuana (cannabis)
- 3,4-methylenedioxymethamphetamine (ecstasy)
Schedule II drugs, substances, or chemicals are defined as drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous. Some examples of Schedule II drugs are:
- Combination products with less than 15 milligrams of hydrocodone per dosage unit (Vicodin)
- Hydromorphone (Dilaudid)
- Meperidine (Demerol)
- Oxycodone (OxyContin)
Schedule III drugs, substances, or chemicals are defined as drugs with a moderate to low potential for physical and psychological dependence. Schedule III drugs abuse potential is less than Schedule I and Schedule II drugs but more than Schedule IV. Some examples of Schedule III drugs are:
- Products containing less than 90 milligrams of codeine per dosage unit (Tylenol with codeine)
- Anabolic steroids
Schedule IV drugs, substances, or chemicals are defined as drugs with a low potential for abuse and low risk of dependence. Some examples of Schedule IV drugs are:
Schedule V drugs, substances, or chemicals are defined as drugs with lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics. Schedule V drugs are generally used for antidiarrheal, antitussive, and analgesic purposes. Some examples of Schedule V drugs are:
- Cough preparations with less than 200 milligrams of codeine or per 100 milliliters (Robitussin AC)
Although the cannabis industry sees this as move towards rescheduling cannabis or even possibly de-scheduling cannabis, the future of cannabis in the eyes of the FDA and DEA remains at risk. This rescheduling is a fairly limited move by the DEA, and, as it did when denying the rescheduling petitions for cannabis in the past, signals that the DEA is still only prepared to follow the FDA’s lead on cannabis.
Diane Romza-Kutz is an attorney in the firm's Health Care practice.