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    Controlled Substance Schedules

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    Definition of Controlled Substance Schedules

    Lists of Scheduling Actions, Controlled Substances, Regulated Chemicals (PDF) (June 2022)

    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.

    Scheduling Actions Controlled Substances List I and II Regulated Chemicals

    Alphabetical Order Alphabetical Order Alphabetical Order

    Chronological Order DEA Drug Code Number DEA Number

    CSA Schedule List Number

    Illicit Uses and Threshold Quantities

    Exempted Lists

    Exempt Anabolic Steroid Products

    Exempt Anabolic Steroid Products Procedures

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

    Exempt Chemical Preparations

    Exempt Chemical Preparations (§1308.23 (a))

    Exempt Chemical Preparation Application Process (§1308.23 (b-d))

    Processing Exempt Chemical Preparation Application (§1308.23 (e-f))

    Relevant Application Information (§1308.24)

    Exempt Chemical Preparations List (PDF) (April 22, 2022) For Application Dates Through December 31, 2021

    Exempted Prescription Products

    Exempted Prescription Products Application

    Table of Exempted Prescription Products (PDF) (April 29, 2022)

    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

    Defined

    Abbreviation Controlled Substance Analogue

    2C-B 4-Bromo-2,5-dimethoxyphenethylamine

    2C-T-7 2,5-Dimethoxy-4(n)-propylthiophenethylamine

    BZP N-Benzylpiperazine

    DMT Dimethyltryptamine

    DOM 4-Methyl-2,5-dimethoxyamphetamine

    GBL Gamma butyrolactone

    GHB Gamma hydroxybutyric acid, gamma hydroxybutyrate, 4-hydroxybutanoic acid, sodium oxybate

    LAAM Levo-alphacetylmethadol

    LSD Lysergic acid diethylamide, lysergide

    MDA 3,4-Methylenedioxyamphetamine

    MDE 3,4-Methylenedioxy-N-ethylamphetamine

    MDMA 3,4-Methylenedioxymethamphetamine

    MPPP 1-Methyl-4-phenyl-4-propionoxypiperidine

    P2P Phenyl-2-propanone, phenylacetone

    PCC 1-Piperidinocyclohexanecarbonitrile

    PCE N-Ethyl-1-phenylcyclohexylamine

    PCH 1-Phenylcyclohexylamine

    PCP 1-(1-Phenylcyclohexyl)piperidine, phencyclidine

    PEPAP 1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine

    PHP 1-(1-Phenylcyclohexyl)pyrrolidine

    SPA (-)-1-Dimethylamino-1,2-diphenylethane

    TCP 1-[1-(2-Thienyl)cyclohexyl]piperidine

    Source : www.deadiversion.usdoj.gov

    The Controlled Substances Act

    The Controlled Substances Act (CSA) places all substances which were in some manner regulated under existing federal law into one of five schedules.  This placement is based upon the substance’s medical use, potential for abuse, and safety or dependence liability.  More information can be found in Title 21 United States Code (USC) Controlled Substances Act. Alphabetical listing of Controlled Substances CONTROLLING DRUGS OR OTHER SUBSTANCES THROUGH FORMAL SCHEDULING The CSA also provides a mechanism for substances to be controlled (added to or transferred between schedules) or decontrolled (removed from control). The procedure for these actions is found in Section 201 of the Act (21U.S.C. §811). Proceedings to add, delete, or change the schedule of a drug or other substance may be initiated by the Drug Enforcement Administration (DEA), the Department of Health and Human Services (HHS), or by petition from any interested party, including: The manufacturer of a drug A medical society or association A pharmacy association A public interest group concerned with drug abuse A state or local government agency An individual citizen In determining into which schedule a drug or other substance should be placed, or whether a substance should be decontrolled or rescheduled, certain factors are required to be considered. These factors are listed in Section 201 (c), [21 U.S.C. § 811 (c)] of the CSA as follows: (1) Its actual or relative potential for abuse. (2) Scientific evidence of its pharmacological effect, if known. (3) The state of current scientific knowledge regarding the drug or other substance. (4) Its history and current pattern of abuse. (5) The scope, duration, and significance of abuse. (6) What, if any, risk there is to the public health. (7) Its psychic or physiological dependence liability. (8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter. More information on the Drug Scheduling process

    The Controlled Substances Act

    The Controlled Substances Act (CSA) places all substances which were in some manner regulated under existing federal law into one of five schedules.  This placement is based upon the substance’s medical use, potential for abuse, and safety or dependence liability.  More information can be found in Title 21 United States Code (USC) Controlled Substances Act.

    Alphabetical listing of Controlled Substances

    CONTROLLING DRUGS OR OTHER SUBSTANCES THROUGH FORMAL SCHEDULING

    The CSA also provides a mechanism for substances to be controlled (added to or transferred between schedules) or decontrolled (removed from control). The procedure for these actions is found in Section 201 of the Act (21U.S.C. §811).

    Proceedings to add, delete, or change the schedule of a drug or other substance may be initiated by the Drug Enforcement Administration (DEA), the Department of Health and Human Services (HHS), or by petition from any interested party, including:

    The manufacturer of a drug

    A medical society or association

    A pharmacy association

    A public interest group concerned with drug abuse

    A state or local government agency

    An individual citizen

    In determining into which schedule a drug or other substance should be placed, or whether a substance should be decontrolled or rescheduled, certain factors are required to be considered. These factors are listed in Section 201 (c), [21 U.S.C. § 811 (c)] of the CSA as follows:

    (1) Its actual or relative potential for abuse.

    (2) Scientific evidence of its pharmacological effect, if known.

    (3) The state of current scientific knowledge regarding the drug or other substance.

    (4) Its history and current pattern of abuse.

    (5) The scope, duration, and significance of abuse.

    (6) What, if any, risk there is to the public health.

    (7) Its psychic or physiological dependence liability.

    (8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter.

    More information on the Drug Scheduling process

    Source : www.dea.gov

    4 Controlled Substance Laws and Regulations You Should Know

    Pharmacists have a great responsibility to stay current with the laws and regulations governing the profession.

    4 Controlled Substance Laws and Regulations You Should Know

    July 24, 2017

    Jennifer Gershman, PharmD, CPh, PACS

    Pharmacists have a great responsibility to stay current with the laws and regulations governing the profession.

    Pharmacists have a great responsibility to stay current with the laws and regulations governing the profession. The Controlled Substances Act (CSA) places all regulated substances under existing federal law into 1 of 5 schedules. Additionally, it outlines manufacturing, dispensing, and distributor requirements such as record keeping provisions.

    It is important to note that states may establish stricter laws than the CSA, and pharmacists must keep abreast of the information. State boards of pharmacy also may require that electronic or print copies of the current laws and regulations be maintained in the practice setting, which is especially important when it comes to inspections. If you are in search of your state laws, then look no further than the National Association of Boards of Pharmacy, which maintains links to the state boards of pharmacy websites.1

    Controlled substance prescriptions have specific requirements.

    All prescriptions for controlled substances must include the following:2

    Date prescription was issued

    Prescriber’s signature

    Patient’s full name and address

    Medication name Strength Dosage form Quantity prescribed Directions for use

    Prescriber’s name, address, and registration number.

    Pharmacists should consult their state rules to determine whether other prescription requirements exist.

    Schedule III and IV controlled substances expire after 6 months.

    Schedule III and IV controlled substances cannot be filled or refilled more than 5 times or more than 6 months after the date the prescription was issued, whichever occurs first.3 Schedule II prescriptions cannot be refilled. Under federal law, there is no expiration for a Schedule II prescription. However, many states have established time restrictions. In states with no expiration this becomes a tricky situation and the pharmacist’s professional judgement is extremely important.

    Pharmacists have a corresponding responsibility.

    Prescriptions must be issued for a legitimate medical purpose, and pharmacists have a corresponding responsibility to determine this when dispensing controlled substances.4 Essentially, this means that pharmacists must use their professional judgement and verify controlled substance prescriptions. Pharmacists should consult their state prescription drug monitoring program (PDMP) when verifying controlled substance prescriptions. Missouri has just become the last state to enact legislature to establish a PDMP, as the governor recently signed an executive order.5 Currently, 49 states, the District of Columbia, and Guam have operational PDMPs.6

    Schedule II controlled substances can be dispensed through an oral prescription for emergencies.

    The following requirements must be followed when dispensing Schedule II controlled substances for emergency situations:7

    The quantity prescribed and dispensed must be limited to an adequate amount to treat the patient during the emergency.

    The pharmacist must document the oral prescription information and verify the identity of the prescribing practitioner.

    The pharmacy must receive the written prescription within 7 days, and it must state on the face “Authorization for Emergency Dispensing” with the date of the oral order.

    The pharmacist must attach the paper prescription to the emergency oral authorization. Pharmacists must document electronic prescriptions with the original authorization and date of the oral order.

    Pharmacists must notify the Drug Enforcement Administration if a prescriber fails to deliver the written or electronic prescription on time.

    Pharmacists should consult their state laws and regulations to determine if there are more stringent requirements for emergency Schedule II oral prescriptions.

    Hopefully, these laws will assist you in your pharmacy practice setting and serve as a starting point for your pharmacy law toolbox.

    References

    Boards of pharmacy. NABP website. https://nabp.pharmacy/boards-of-pharmacy/. Accessed July 21, 2017.

    Title 21 Code of Federal Regulations 1306.05 manner of issuance of prescriptions. DEA website. https://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_05.htm. Accessed July 23, 2017.

    Title 21 Code of Federal Regulations 1306.22 refilling of prescriptions. DEA website. https://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_22.htm. Accessed July 23, 2017.

    Title 21 Code of Federal Regulations 1306.04 purpose of issue of prescription. DEA website. https://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_04.htm. Accessed July 23, 2017.

    Governor Eric Greitens announces statewide prescription drug monitoring program. Missouri Governor website. https://governor.mo.gov/news/archive/governor-eric-greitens-announces-statewide-prescription-drug-monitoring-program. Accessed July 23, 2017.

    Status of PMP’s. PDMP TTAC website. http://www.pdmpassist.org/pdf/pdmpstatustable.pdf. Accessed July 23, 2017.

    Title 21 Code of Federal Regulations 1306.11 requirement of prescription. DEA website. https://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_11.htm. Accessed July 23, 2017.

    Source : www.pharmacytimes.com

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