The Controlled Substances Act (CSA) is the statute establishing federal U.S. drug policy under which the manufacture, importation, possession, use, and distribution of certain substances is regulated.
The legislation created five Schedules with varying qualifications for a substance to be included in each.
Two federal agencies, the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA), determine which substances are added to or removed from the various schedules.
Classification decisions are required to be made on criteria including potential for abuse and currently accepted medical use in treatment.
There is a DEA registration procedure to handle controlled substances.
All individuals and firms that are registered are required to maintain complete and accurate inventories and records of all transactions involving controlled substances, as well as security for the storage of controlled substances.
There are five different Schedules of controlled substances, numbered I–V.
The different schedules are based on three factors:
Potential for abuse
Accepted medical use
Safety and potential for addiction.
Schedule I High None Drug is not safe to use, even under medical supervision.
Schedule II High Yes; sometimes allowed only with severe restrictions.
Abusing the drug can cause severe physical and mental addiction
Schedule III Medium Abusing the drug can cause severe mental addiction, or moderate physical addiction
Schedule IV Abusing the drug may lead to mild mental or physical addiction
Schedule V Lowest
Abusing the drug may lead to mild mental or physical addiction.
Placing a drug or other substance in a certain Schedule or removing it requires finding and specifying the “potential for abuse” before a substance can be placed in that schedule.
The term “controlled substance” means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V.
Schedule I substances are described as those that have the following findings:
The drug or other substance has a high potential for abuse.
The drug or other substance has no currently accepted medical use in treatment in the United States.
There is a lack of accepted safety for use of the drug or other substance under medical supervision.
No prescriptions may be written for Schedule I substances.
Many states have made allowances for recreational and medical use of marijuana and/or have decriminalized possession of small amounts of marijuana – such measures operate only on state laws, and have no effect on Federal law.
Research that has found several substances on the list of Schedule I substances to have actual accepted medical uses and low abuse potential, despite the requirement for a Schedule I listing mandating that any substance so scheduled have both a high potential for abuse and no accepted medical use: example is the legalization of marijuana in some capacity in many states.
Schedule II substances are those that have the following findings:
The drug or other substances have a high potential for abuse.
The drug or other substances have currently accepted medical use in treatment in the United States, or currently accepted medical use with severe restrictions.
Abuse of the drug or other substances may lead to severe psychological or physical dependence.
No controlled substance in Schedule II, may be dispensed without the written prescription of a practitioner.
No prescription for a controlled substance in schedule II may be refilled.
Drugs in this schedule include:
Amphetamine drugs
Barbituates
Cocaine: used as a topical anesthetic and to stop severe epistaxis
Codeine (pure) and any drug for non-parenteral administration containing the equivalent of more than 90 mg of codeine per dosage unit;
Diphenoxylate
Fentanyl and most other strong pure opioid agonists.
Hydrocodone in any formulation.
Hydromorphone
Methadone
Methamphetamine
Methylphenidate
Morphine
Nabilone
Opium tincture
Oxycodone
Oxymorphone
Nembutal
Meperidine; Demerol
Phencyclidine (PCP)
Secobarbital (Seconal)
Tapentadol (Nucynta) – A drug with mixed opioid agonist and norepinephrine re-uptake inhibitor activity.
Schedule III substances are those that have the following findings:
The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II.
Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence.
No controlled substance in schedule III or IV, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic may be dispensed without a written or oral prescription.
Such prescriptions may not be filled or refilled more than six months after the date thereof or be refilled more than five times after the date of the prescription unless renewed by the practitioner.
A prescription for controlled substances in Schedules III, IV, and V issued by a practitioner, may be communicated either orally, in writing, or by fax to the pharmacist, and may be refilled if so authorized on the prescription or by call-in.
Drugs in this schedule include:
Anabolic steroids
Intermediate-acting barbiturates.
Buprenorphine
Dihydrocodeine when compounded with other substances,.
Ketamine
Xyrem
Marinol
Paregoric
Phendimetrazine Tartrate
Benzphetamine HCl (Didrex)
Fast-acting barbiturates such as secobarbital (Seconal) and pentobarbital (Nembutal)
Schedule IV controlled substances. The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III.
The drug or other substance has a currently accepted medical use in treatment.
Associated with limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III.
Control measures are similar to Schedule III.
Prescriptions for Schedule IV drugs may be refilled up to five times within a six-month period.
A prescription for controlled substances in Schedules III, IV, and V issued by a practitioner, may be communicated either orally, in writing, or by facsimile to the pharmacist, and may be refilled if so authorized on the prescription or by call-in.
Drugs in this schedule include:
Benzodiazepines such as alprazolam (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), diazepam (Valium), and Lorazepam (Ativan), as well as: temazepam (Restoril)
The benzodiazepine-like Z-drugs: zolpidem (Ambien), eszopiclone (Lunesta), and zaleplon (Sonata)
Chloralhydrate, a sedative-hypnotic
Long-acting barbiturates such as phenobarbital
Partial agonist opioid analgesics, such as pentazocine (Talwin)
The eugeroic drug Provigil and Nuvigil.
Difenoxin, an antidiarrheal drug, such as when combined with atropine (Motofen)
Tramadol
Carisoprodol (Soma)
Schedule V controlled substances
Schedule V substances are those that have the following findings:
The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule IV
The drug or other substance has a currently accepted medical use in treatment in the United States
Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV.
No controlled substance in schedule V which is a drug may be distributed or dispensed other than for a medical purpose.
A prescription for controlled substances in Schedules III, IV, and V issued by a practitioner, may be communicated either orally, in writing, or by facsimile to the pharmacist, and may be refilled if so authorized on the prescription or by call-in.
Drugs in this schedule include:
Cough suppressants containing small amounts of codeine.
Preparations containing small amounts of opium or diphenoxylate used to treat diarrhea
Some anticonvulsants, such as pregabalin (Lyrica)
Some centrally-acting antidiarrheals, such as diphenoxylate (Lomotil) when mixed with atropine.
Due to pseudoephedrine (PSE) and ephedrine being widely used in the manufacture of methamphetamine, the U.S. Congress passed the Methamphetamine Precursor Control Act which places restrictions on the sale of any medicine containing pseudoephedrine.