The Controlled Substances Act (CSA)
In 1970, the United States Congress formulated the Controlled Substance Act to regulate the manufacture, distribution, import or export, and drug dispensing. The Act was effected starting May 1, 1971. According to the Act, drug manufacturers, distributors, and sellers should be registered with the Drug Enforcement Administration (DEA).
Drugs are classified into schedules as per the national classification system. The scheduling system protects the public's safety and health by controlling the availability of medicines and poisons to the general public. The classification is based on the medicine's safety, with low safety risk drugs being tightly controlled compared to medicines with higher safety risk.
Drug schedules provide detailed information on how medicines or poisons in a particular schedule should be stored, labeled, bought, sold, or thrown. The schedules also offer information on whether the medicines need prescriptions when dispensing or not.
There are currently 10 drugs schedules organized from the least tightly controlled to the most tightly controlled. However, not all medicines fall in drug schedules. Some, like cold remedies, are not scheduled, although they can be sold to the public. Therapeutic medicines fall in schedules 2, 3, 4, or 8.
How Many Drug Schedules Are There?
There are 10 drugs schedules. Here's a brief description of each schedule.
Schedule 1
Schedule 1 is no longer available, so currently not in use.
Schedule 2
Schedule 2 is also called pharmaceutical medicines. It refers to preparations and substances used to treat different medical conditions. The preparations or substances are safe to use, don't need a doctor's prescription, and are readily available over the counter.
Schedule 3
This category involves preparations and substances used to treat specific diagnosed medical conditions. Schedule 3 medicines don't need doctor's prescriptions, although they are available behind the counter. The medicines are also called Pharmacist Only Medicine.
Schedule 4
Also called Prescription Only Medicine, schedule 4 are preparations and substances used to treat medical conditions. The preparations or substances are available only upon a doctor's/veterinary's prescription and may be bought from a pharmacy or supplied in a hospital.
Schedule 5
These are preparations and substances with low toxicity levels, thus need to be handled, used, and stored with caution.
Schedule 6
Preparations and substances that are moderate to highly toxic belong to this category. When schedule 6 medication is inhaled, eaten, or comes in contact with the skin, it may cause severe injuries or lead to death.
Schedule 7
Schedule 7 is a dangerous poison and refers to preparations and substances that are substantially toxic. The substances/preparations can lead to death or cause serious injuries even in low doses. As such, its use, availability, and possession are strictly regulated. When using, manufacturing, or handling schedule 7 drugs, special safety measures should be put in place.
Schedule 8
These are controlled drugs and include preparations and substances that can be used to treat different medical conditions but have a likelihood of causing dependence or being abused. Schedule 8 drugs can be prescribed by an authorized professional doctor who may need a special prescribing permit.
Schedule 9
Drugs in this category are also called prohibited substances. Using, manufacturing, selling, or distributing schedule 9 drugs is strictly prohibited unless done for research purposes only.
Schedule 10
Schedule 10 drugs refer to preparations and substances that are extremely harmful to health. These medications are banned, and the law strictly prohibits using, supplying, or selling them.
What Are Drug Schedules?
Drugs, certain substances, and chemicals used to manufacture drugs are classified into different categories called schedules. The classification is based on the drugs' safety, the potential for abuse, and dependency. These drugs are available on prescription drug schedules.
Drug schedules are made to protect the public's health and safety since there are toxic medicines. Some medicines, such as those causing addiction or dependence, are prone to be misused.
The drug schedules further provide a baseline on which substances or preparations need to be closely monitored and those that don't.
What Do Controlled Drug Schedules Mean?
According to the Controlled Substances Act (CSA), controlled drug schedules control the use and distribution of drugs that have a high abuse and dependency potential.
These drugs are ranked according to their abuse risk and then grouped into schedules as per the Federal Drug Enforcement Administration (DEA). Drugs with the highest abuse potential fall in schedule I, while those with the lowest abuse potential fall in schedule V.
It's important to note that practitioners registered with the DEA are the only ones allowed to provide prescription drug schedules. Prescriptions for drugs in schedule II ought to be physical or transmitted by a computer system approved for EPCS (electronic prescribing of controlled substances). In case of emergencies, schedule II drug prescription may be done through a phone call with a registered professional, followed by a physical prescription form within 7 days.
What Are The Five Controlled Drug Schedules?
The five controlled drug schedules are C-I, C-II, C-III, C-IV, and C-V. Below is a brief description of each schedule:
Schedule I
Drugs in schedule I are the most dangerous, with the highest abuse and dependency potential. According to FDA and DEA, these drugs have no medicinal use. Examples include:
- Marijuana
- Heroin
- Hallucinogens
- Ecstasy
- LSD
- Quaaludes
Note:
Marijuana is legal in many states. It is the only schedule I drug legalized for recreational and medicinal uses. That's why, many professionals believe that the drug should be made fully legal to allow room for thorough research on its medicinal benefits.
Schedule II
Schedule II drugs are also considered to have a high addiction and abuse potential and are accepted for use (medically) in special circumstances. For instance, in treating chronic addiction or pain.
As such, getting schedule II drugs is only possible with a doctor's prescription. Abusing schedule II drugs may lead to serious physical or psychological dependence. Examples of schedule II drugs are:
- Morphine
- OxyContin
- Methadone
- Fentanyl
- Demerol
- Methamphetamine
- Cocaine (anesthesia)
Schedule III
According to DEA, any drug with low to moderate potential for psychological and physical dependence fall in schedule III. Misusing schedule III drugs can lead to addiction and abuse. The drugs are dangerous but not as much as schedule I and II drugs. They are also available without a doctor's prescription, although found behind the counter. Examples are:
- Anabolic steroids
- Ketamine
- Vicodin
- Suboxone
- Tylenol with Codeine
- Buprenorphine
Schedule IV
The DEA considers drugs falling in this schedule to be having viable medical use. They also have a low probability of abuse and misuse compared to Schedule III substances. However, when misused or combined with other substances of abuse, schedule IV drugs could lead to addiction. Below are examples:
- Valium
- Soma
- Xanax
- Ativan
- Tramadol
- Ambien
- Sonata
- Lunesta
Schedule V
The DEA terms drugs in this schedule as the least addictive. However, when misused to high amounts, they could lead to psychological or physical dependency. One example is Imodium, a harmless anti-diarrheal agent. However when taken in large doses one can get high on Imodium.
Most schedule V preparations are made by mixing the drug with some narcotic. For example, cough suppressant Robitussin AC, a schedule V substance, contains Codeine in extremely low amounts.
Other examples include Lomotil, Motofen, Lyrica, Parepectolin, and prescriptions used to manage conditions like fibromyalgia and irritable bowel syndrome.
Vicodin Drug Schedule
Vicodin, a prescription tablet containing Hydrocodone and Acetaminophen, is a painkiller used to relieve moderate to severe pain. The drug belongs to the Opiate drugs category.
Before October 2014, Vicodin belonged to schedule III. However, due to the drug's high abuse potential, the DEA agreed to restrict its use. As such, the drug was transferred from schedule III to schedule II. This was mainly done to protect the public from misusing or abusing Vicodin.
Abusing Vicodin involves using the drug for means not as directed by a professional or using the drug without a doctor's prescription, which often leads to serious health complications.
For example, liver damage/failure can be brought about by abusing Vicodin containing more than 4000 mg of acetaminophen a day.
The drug's abuse potential and health complications made the FDA ban manufacturers from advertising products containing more than 325 mg of acetaminophen in March 2014. Previously, the drug had about 500 to 750 mg acetaminophen.
Percocet Drug Schedule
Percocet, belonging to the Opioid group, is a prescription-only medicine used to relieve acute and moderate to severe pain. It may be used alone or combined with other medicines. The drug contains hydrocodone and acetaminophen substances which are shown to have high abuse potential.
Currently, Percocet is classified as schedule II. This is per the DEA and the Controlled Substance Act (CSA), which issued a final rule stating that drugs containing hydrocodone fall in schedule II, starting October 2014.
Earlier on, hydrocodone was classified by the Controlled Substances Act as Schedule II in 1971. But, when the drug was mixed with certain amounts of non-narcotic ingredients, like acetaminophen, it became schedule III, given that the pill's hydrocodone content doesn't go beyond 15 mg. The final rule changed this and categorized hydrocodone back to schedule II drugs.
The rule now restricts patients from refilling their drugs without physical prescriptions. Moreover, more restrictions are expected on Percocet to prevent further drug abuse and misuse.