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List of Controlled Substances

Lists of Scheduling Actions, Controlled Substances, Regulated Chemicals (PDF) (December 2020)

This document is a general reference and not a comprehensive list. This list describes the basic or parent chemical and does not describe the salts, isomers and salts of isomers, esters, ethers and derivatives which may also be controlled substances.

Exempted Lists

The drugs most commonly shown in films are cocaine, heroin, LSD, cannabis (see stoner film) and methamphetamine. There is extensive overlap with crime films, which are more likely to treat drugs as plot devices to keep the action moving. The following is a partial list of drug films and the substances involved. The FDA granted emergency authorization to a new treatment for patients with the COVID-19 coronavirus infection this week. The drug is a monoclonal antibody therapy approved for mild to moderate infections in patients over the age of 12.

International Drug Names. The Drugs.com International Drug Name Database contains information about medications found in 185 countries around the world. The database contains more than 40,000 medication names marketed outside the USA and is presented in multiple languages. Only brand names of products subject to a new drug application or an abbreviated new drug application must be approved by the FDA first. This requirement distinguishes them from generic names. According to a report in the January-February 2004 issue of the Journal of the American Pharmacists Association, there are more than 9,000 generic drug. List of Generic Drug suffixes. Recognizing a drug name or class by Suffix makes it easier to memorize. Another helpful tip for learning the top 200 drugs. Drug Class Definitions Drug Class Definitions and descriptions from the Top 200 drugs. Knowing which class a drug is will help you memorize drug names. DEA Controlled Drugs from the top 200.

Exempt Anabolic Steroid Products

Exempt Anabolic Steroid Products Procedures

Exempt Anabolic Steroid Products List (PDF) (November 5, 2020)

Exempt Chemical Preparations

Exempt Chemical Preparations List (PDF) (November 7, 2017) For Application Dates Through December 31, 2016

Exempted Prescription Products

Exempted Prescription Products Application

Exempted Prescription Products List (PDF) (January 11, 2021)

Lists of Controlled Substances Disclaimer

Section 812 of the Controlled Substances Act (21 U.S.C. §801 et seq.) (CSA) lists substances which were controlled in 1970 when the CSA was enacted. Since then many substances have been added, removed, or transferred from one schedule to another. The current list of controlled substances can be found in section 1308 of the most recent issue of Title 21 Code of Federal Regulations (CFR) Part 1300 to end (21 CFR §1308) and the final rules which were published in the Federal Register subsequent to the issuance of the CFR.

These lists describe the basic or parent chemical and do not describe the salts, isomers, salts of isomers, esters, ethers, and derivatives which may be controlled substances. These are not comprehensive lists so please note that a substance need not be listed as a controlled substance to be treated as a scheduled substance for criminal prosecution. The 'Other Names' column, provides some examples of alternate names for certain compounds, and in some instances provides examples of 'positional isomers'. If outside parties want to ensure that a compound is not considered a scheduled substance or listed chemical, they should write the DEA, Drug and Chemical Evaluation Section (DRE), Diversion Control Division, 8701 Morrissette Drive, Springfield, Virginia 22152, for an official determination.

A substance (not included on these lists) may also be regulated as a controlled substance analogue. A controlled substance analogue is a substance which is intended for human consumption, is structurally substantially similar to a schedule I or schedule II substance, is pharmacologically substantially similar to a schedule I or schedule II substance, or is represented as being similar to a schedule I or schedule II substance and is not an approved medication in the United States. See 21 U.S.C. §802(32)(A) for the definition of a controlled substance analogue and 21 U.S.C. §813 for the schedule.

Defined Abbreviations

Definition of Controlled Substance Schedules

Drugs and other substances that are considered controlled substances under the Controlled Substances Act (CSA) are divided into five schedules. An updated and complete list of the schedules is published annually in Title 21 Code of Federal Regulations (C.F.R.) §§1308.11 through 1308.15. Substances are placed in their respective schedules based on whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential, and likelihood of causing dependence when abused. Some examples of the drugs in each schedule are listed below.

Schedule I Controlled Substances

Substances in this schedule have no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.

Some examples of substances listed in Schedule I are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), peyote, methaqualone, and 3,4-methylenedioxymethamphetamine ('Ecstasy').

Schedule II/IIN Controlled Substances (2/2N)

Substances in this schedule have a high potential for abuse which may lead to severe psychological or physical dependence.

Examples of Schedule II narcotics include: hydromorphone (Dilaudid®), methadone (Dolophine®), meperidine (Demerol®), oxycodone (OxyContin®, Percocet®), and fentanyl (Sublimaze®, Duragesic®). Other Schedule II narcotics include: morphine, opium, codeine, and hydrocodone.

Examples of Schedule IIN stimulants include: amphetamine (Dexedrine®, Adderall®), methamphetamine (Desoxyn®), and methylphenidate (Ritalin®).

Other Schedule II substances include: amobarbital, glutethimide, and pentobarbital.

Schedule III/IIIN Controlled Substances (3/3N)

Substances in this schedule have a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence.

Examples of Schedule III narcotics include: products containing not more than 90 milligrams of codeine per dosage unit (Tylenol with Codeine®), and buprenorphine (Suboxone®).

Examples of Schedule IIIN non-narcotics include: benzphetamine (Didrex®), phendimetrazine, ketamine, and anabolic steroids such as Depo®-Testosterone.

Schedule IV Controlled Substances

Subject: New Drug Names Types

Substances in this schedule have a low potential for abuse relative to substances in Schedule III.

Examples of Schedule IV substances include: alprazolam (Xanax®), carisoprodol (Soma®), clonazepam (Klonopin®), clorazepate (Tranxene®), diazepam (Valium®), lorazepam (Ativan®), midazolam (Versed®), temazepam (Restoril®), and triazolam (Halcion®).

Schedule V Controlled Substances

Substances in this schedule have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.

Subject: New Drug Names In America

Examples of Schedule V substances include: cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC®, Phenergan with Codeine®), and ezogabine.

Demonstration of safety and efficacy of the drug product for use in humans is essential before the drug product can be approved for import or manufacturing and marketing in the country. The Rules 122A, 122B, 122 DAB, 122DAC, 122 DD and 122E of Drugs and Cosmetics Rules and Appendix I- XII of Schedule Y, describe the information/data required for approval of clinical trial and/or to import or manufacture of new drug for marketing in the country.

New drugs as define under Rule 122-E of Drugs and Cosmetics Rules as drug, including bulk drug substance or phytopharmaceutical drug which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labeling thereof and has not been recognized as effective and safe by the licensing authority mentioned under rule 21 for the proposed claims. A drug already approved by the Licensing Authority mentioned in Rule 21 for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration. fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration. All vaccines and Recombinant DNA (r-DNA) derived drugs shall be new drugs unless certified otherwise by the Licensing Authority under Rule 21. A new drug shall continue to be considered as new drug for a period of four years from the date of its first approval.

RULES GOVERNING CLINICAL TRIALS

1. Rule 122-A -Application for permission to import new drug
2. Rule 122-B -Application for approval to manufacture new drug
3. Rule 122-DA-Mandatory requirement of permission from DCG (I) for conduct of clinical trial of new drug;
4. Rule 122 DAB -Provision for examination of serious adverse event (SAE) of injury and death and payment of compensation in clinical trial related cases. Provision for debarment of the applicant in case of failure to pay compensation;
5. Rule 122 DAC -Conditions of permission for conduct of clinical trial which includes mandatory requirement to follow Good Clinical Practice (GCP) guidelines, guidelines and requirements specified in Schedule Y of Drugs and Cosmetics Rules and other applicable regulations. Provision for debarment of applicant and investigator in case of non- compliance
6. Rule 122 E-Definition of new drug
7. Schedule Y-Detailed guidelines and requirements for conduct of clinical trial and approval of new drug
8. Good Clinical Practice Guidelines -issued by CDSCO, Directorate General of Health Services, Govt. of India