Controlled Substance Act and Schedules of Controlled Substances | Tammy Nguyen, PharmD | RxEconsult
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Controlled Substance Act and Schedules of Controlled Substances Category: Pain Management by - November 6, 2013 | Views: 18836 | Likes: 0 | Comment: 0  

Schedule of Controlled Drugs

What is the Controlled Substance Act (CSA)

The Controlled Substances Act (CSA) was passed as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. It was signed into law by President Richard Nixon and effective since October 27, 1970. The Controlled Substance Act is a federal drug policy that was placed in order to regulate the manufacturing, possession, distribution, and use of certain drugs or substances. The act was established to help prevent drug abuse and dependence through stricter regulation of drugs or substances with a potential for abuse.

The legislation established five Schedules (I, II, III, IV, and V) for controlled substances. Both the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) determined which drugs and substances should be added and removed from the schedule of controlled substances. The determination of which schedule a drug or substance is classified under depends on the potential for abuse, current accepted medical use in the United States, and the likelihood of physical or psychological dependence. These schedules are updated and republished on an annual basis.

 

Related: FDA Recommends Reclassifying and Restricting Hydrocodone Combination Drugs to Schedule II

 

What are the definitions for each Schedule

Schedule I: Drugs or substances that have a high potential for abuse and are not currently accepted for medical use in the US due to a lack of safety for use under medical supervision.

Schedule II: Drugs or substances that have a high potential for abuse. However, they are currently accepted for medical use in the US with severe restrictions. Abuse of a drug or substance in this schedule may lead to severe psychological or physical dependence.

Schedule III: Drugs or substances that have less of a potential for abuse than drugs or substances in Schedules I or II. They are currently accepted for medical use in the US Abuse of a drug or substance in this schedule may lead to moderate or low physical dependence or high psychological dependence.

Schedule IV: Drug or substances that have a low potential for abuse when compared with those in schedule III. They are currently accepted for medical use in the US Abuse of a drug or substance in this schedule may lead to limited physical dependence or psychological dependence relative to the drugs or substances in schedule III.

 Schedule V: Drug or substances that have a low potential for abuse when compared with those in schedule IV. They are currently accepted for medical use in the United States and consist mainly of preparations containing limited quantities of certain narcotics. Abuse of a drug or substance in this schedule may lead to limited physical dependence or psychological dependence relative to the drugs or substances in schedule IV. These drugs are commonly used for anti-diarrheal, antitussive, and analgesic purposes.

 

Related: New FDA Opioid Pain Killer Label Change

 

What are some examples of the types of drugs or substances in each Schedule

Below is a list of some drugs or substances that are classified under each Schedule. For complete list of all of the drugs and substances, please visit the DEA website here.

Schedule I:

  • Heroin
  • Lysergic acid diethylamide (LSD)
  • marijuana (cannabis)
  • 3,4-methylenedioxymethamphetamine (Ecstasy)

Schedule II:

  • Narcotics : hydromorphone (Dilaudid), methadone (Dolophine), meperidine (Demerol), oxycodone (OxyContin, Percocet), methylphenidate (Concerta), dexmethylphenidate (Focalin), oxymorphone (Opana), fentanyl (Sublimaze, Duragesic). 
  • Other Narcotics:
    • Morphine
    • Opium
    • Pure Codeine and any drug for non-parental administration containing the equivalent of more than 90 mg of codeine per dosage unit
    • Pure hydrocodone and any drug for non-parenteral administration containing no other active ingredients or more than 15 mg per dosage unit
  • Stimulants: amphetamine (Dexedrine, Adderal®), methamphetamine (Desoxyn), Lisdexamfetamine (Vyvanse), and methylphenidate (Ritalin).
  • Other: amobarbital (Amytal), secobarbital (Seconal), tapentadol (Nucynta), and pentobarbital (Nembutal).  These do not include suppositories since those are considered Schedule III.

Schedule III:

Any compound, mixture, or preparation containing limited quantities of any of the following narcotic drugs, or any salts that are not in another schedule:

  •  No more than 1.8 grams of codeine per 100 ml or not more than 90 mg per dosage unit, with either an equal or greater quantity of an isoquinoline alkaloid of opium or with one or more active, non-narcotic ingredients in recognized therapeutic amounts.
  • No more than 300 mg of dihydrocodeinone per 100 ml or not more than 15 mg per dosage unit, with a four-fold or greater quantity of an isoquinoline alkaloid of opium or with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
  • No more than 1.8 grams of dihydrocodeine per 100 ml or not more than 90 mg per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
  • No more than 300 mg of ethylmorphine per 100 ml or not more than 15 mg per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
  • No more than 500 mg of opium per 100 ml or per 100 grams, or not more than 25 mg per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
  • No more than 50 mg of morphine per 100 ml or per 100 grams with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
  • Narcotics:
    • Combination products containing hydrocodone and acetaminophen (Vicodin, Lorcet, Norco, Xodol) (soon to be moved to schedule II)
    • Combination products containing not more than 90 mg of codeine per dosage unit (Tylenol with Codeine No. 3 and 4),
    • buprenorphine (Suboxone)
  • Anabolic Steroids (also known as “body building drugs”): fluxymesterone (Halotestin), methyltestosterone (Oreton, Android, Testred), nandrolone (Durabolin), oxymetholone (Anadrol), testosterone (Delatestryl) and stanozolol (Winstrol).
  • Others: aprobarbital ( Alurate), butabarbital (Butisol), ketamine (Ketalar), metharbital (Gemonil), and thiopental (Pentothal).

Schedule IV:

  • Benzodiazepines:  alprazolam (Xanax), clonazepam (Klonopin), diazepam (Valium), lorazepam (Ativan), midazolam (Versed), temazepam (Restoril), and triazolam (Halcion).
  • Others:  zolpidem (Ambien, eszopiclone (Lunesta), zaleplon (Sonata), modafinil (Provigil), carisoprodol (Soma), and tramadol (Ultram)
  •  Long-acting barbiturates: phenobarbital (Luminal) and mephobarbital (Mebaral). 

Schedule V:

Any compound, mixture, or preparation containing limited quantities of any of the following narcotic drugs, which shall include one or more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal qualities other than those possessed by the narcotic drug alone:

  • No more than 200 mg of codeine per 100 ml or per 100 grams.
  • No more than 100 mg of dihydrocodeine per 100 ml or per 100 grams.
  • No more than 100 mg of ethylmorphine per 100 ml or per 100 grams.
  • No more than 2.5 mg of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit.
  • No more than 100 mg of opium per 100 ml or per 100 grams.
  • Cough suppressants: quaifenesin with codeine (Robitussin AC) and promethazine with codeine.
  • Anticonvulsants:  pregabalin (Lyrica), lacosamide (Vimpat) and retigabine (ezogabine).
  • Antidiarrheals:  diphenoxylate with atropine (Lomotil) and difenoxin with atropine (Motofen).  Note: Without atropine, these drugs are in Schedule II.

Here is a table of drugs in each schedule

What are some exceptions?

There are certain drugs that are not classified as a federally controlled substance but are considered a control substance under state law. An example of this would be tramadol (Ultram). Tramadol is not under a schedule under federal law but is classified as a schedule IV in some states such as California, New York, Illinois, Arkansas, Kentucky, North Dakota, Oklahoma, Tennessee, West Virginia, and Wyoming. This is a case where the state law is more stringent than federal law.

References

US Food and Drug Administration. Controlled Substance Act. 2009.

US Department of Justice, Drug Enforcement Administration. List of Controlled Substances. 2013.

US Department of Justice, Drug Enforcement Administration. Title 21 Code of Federal Regulations: Part 1308-Scedules of Controlled Substances. 2013.

US Department of Justice, Drug Enforcement Administration. Tramadol. 2013.

Article: Updated 8/18/2014

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