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Controlled Substances Act
The Controlled Substances Act (CSA) was signed into law by President Nixon in 1970. This legislation created five classes of drugs with the DEA (Drug Enforcement Agency) determining the placement of any given substance into one of five categories (schedules). This placement is based upon the substance’s accepted medical use, its potential for abuse, and liability for safety and dependence. The Act also provided the mechanism for a substance to be added, removed, or transferred to a different schedule.
The meaning of “accepted medical use” is obvious in most cases. However, the term “potential for abuse” is not clearly defined in this Act and the following are clues for a drug having the potential to be abused:
- Use of a substance independent of advice from a medical practitioner
- Use of a substance in amounts that are hazardous to one’s health
- When there is a significant diversion of the substance from legitimate drug channels because of illegitimate use
- When the substance is new but similar to other substances having abuse potential
“Physical dependence” is defined as the development of tolerance (increasing doses necessary to achieve the same effect) and withdrawal (symptoms occurring with the cessation of use of the substance). “Psychological dependence” is defined as the craving that occurs when one becomes physically addicted.
The cornerstone of the Controlled Substances Act is the registration of anyone authorized by the DEA to handle controlled substances. A unique DEA number is assigned to anyone involved in the handling of these substances, including the importer, exporter, manufacturer, distributor, hospital, pharmacy, practitioner, and researcher. Every physician has a unique DEA number.
Substance Categorization
The categorizations of controlled substances range from Schedule I (high potential for psychological and physical dependence and abuse) to Schedule V (low potential).
Schedule I
Heroin, LSD, marijuana, MDMA (ecstasy), peyote, quaaludes, psilocybin (psychedelic mushrooms)
Schedule II
Vicodin, cocaine, methamphetamine, methadone, Dilaudid, Demerol, OxyContin, Percocet, fentanyl, Dexedrine, Adderal, Ritalin, PCP (angel dust), Opium
Schedule II prescriptions must be written and signed by the practitioner using a prescription pad and cannot be phoned in except in an emergency and cannot be refilled.
As a urologist, I occasionally prescribe Vicodin or Percocet for post-operative pain or pain related to a kidney stone.
Schedule III
Tylenol with codeine, ketamine, anabolic steroids, testosterone
As a urologist, I occasionally prescribe Tylenol with codeine for post-operative pain and often prescribe testosterone for men with symptomatic hypogonadism.
Schedule IV
Xanax, Valium, Librium, Klonopin, Ativan, Soma, Darvon, Darvocet, Talwin, Tramadol, Ambien, Lunesta, Provigil
Schedule III and IV drugs may be prescribed by phone or written prescription and may be refilled up to five times within the six-month period dating from the time of the prescription.
As a urologist, I occasionally prescribe Tramadol for post-operative pain and occasionally prescribe Xanax or Valium for pre-procedure or pre-imaging anxiety or for insomnia.
Schedule V
Anti-diarrheal medications, analgesics, anti-cough medicines: Robitussin A-C, Lomotil, Motofen, Lyrica, Parepectolin
Schedule V drugs face restrictions above and beyond over-the-counter medications, including the requirement that the patient must be at least 18 years of age, must have identification, and must have their name entered into a special pharmacy log.
Why Isn’t Alcohol on the Schedule?
Interestingly, alcohol is not regulated under the Controlled Substances Act. Alcohol is so deeply ingrained (no pun intended) into our society that it gets a pass. Clearly, alcohol has limited medical use, a high potential for abuse, and concerns for safety and dependence. The National Institute for Health (NIH) estimates that there are about 15 million Americans with alcohol abuse disorder.
Why is Marijuana on the Schedule?
Marijuana is listed as a schedule I drug — the same category as heroin! — when clearly it has acceptable medical value and a low potential for abuse, and it has been decriminalized or legalized in many states. Go figure! Currently, medical marijuana is legal in 38 states and recreational marijuana is legal in 18 states. On April 21 New Jersey commenced sales of recreational marijuana.
