CONTROLLED SUBSTANCES ACT Pharmacy 151 Introduction to Pharmacy Law Wayne Brown, Ph.D.

Controlled Substances Controlled or scheduled because of their potential for addiction and abuse Controlled or scheduled because of their potential for addiction and abuse

Closed System Manufacturing Manufacturing Distributing Distributing Dispensing Dispensing Only those persons or entities registered with DEA may legally engage in these activities Intent is to reduce the diversion of controlled substances to illicit markets

Drug Enforcement Administration (DEA) An agency of the United States Department of Justice An agency of the United States Department of Justice US Attorney General has authority for scheduling and unscheduling drugs US Attorney General has authority for scheduling and unscheduling drugs

Symbols C-I C-I C-II C-II C-III C-III C-IV C-IV C-V C-V

Schedule I Substances (C-I) High abuse potential and no accepted medical use in the United States High abuse potential and no accepted medical use in the United States Include heroin and propiram. Some hallucinogenic substances found in Schedule I include LSD, marijuana and MDMA (Ecstasy). Include heroin and propiram. Some hallucinogenic substances found in Schedule I include LSD, marijuana and MDMA (Ecstasy). Other examples of Schedule I substances are the depressant methaqualone, and gamma hydroxybutyric acid (GHB) and the stimulant methcathinone Other examples of Schedule I substances are the depressant methaqualone, and gamma hydroxybutyric acid (GHB) and the stimulant methcathinone

Schedule II Substances (C-II) High abuse potential with severe psychological or physical dependence liability High abuse potential with severe psychological or physical dependence liability Accepted medical use in the United States Accepted medical use in the United States Available for practitioners to prescribe, dispense and administer Available for practitioners to prescribe, dispense and administer Narcotics include morphine, codeine, hydrocodone and opium. Narcotics include morphine, codeine, hydrocodone and opium. Other Schedule II narcotic substances and their common name brand products include: hydromorphone (Dilaudid®), methadone (Dolophine®), meperidine (Demerol®) oxycodone (Percodan®) and fentanyl (Sublimaze®) Other Schedule II narcotic substances and their common name brand products include: hydromorphone (Dilaudid®), methadone (Dolophine®), meperidine (Demerol®) oxycodone (Percodan®) and fentanyl (Sublimaze®)

Schedule II Substances (C-II) [CONT] Some examples of Schedule II stimulants include amphetamine (Dexedrine®, Adderall®), methamphetamine (Desoxyn®) and methylphenidate (Ritalin®) Other Schedule II substances include cocaine, amobarbital, glutethimide, pentobarbital and secobarbital

Schedule III Substances (C-III) Abuse potential less than those in Schedule II, but more than Schedule IV substances Schedule III narcotics include products containing less than 15 milligrams of hydrocodone per dosage unit (Vicodin®, Lorcet®, Tussionex®), and products containing not more than 90 milligrams of codeine per dosage unit (codeine with acetaminophen, aspirin, or ibuprofen) Other Schedule III substances include anabolic steroids, benzphetamine (Didrex®), phendimetrazine, and any compound, mixture, preparation or suppository dosage form containing amobarbital, secobarbital, pentobarbital, dronabinol (Marinol®) or ketamine

Schedule IV Substances (C-IV) Abuse potential less than those listed in Schedule III and more than substances in Schedule V Propoxyphene ( Propoxyphene (Darvon®), butorphanol (Stadol®) and pentazocine (Talwin-NX®). alprazolam (Xanax®), clonazepam (Klonopin®), clorazepate (Tranxene®), diazepam (Valium®), flurazepam (Dalmane®), halazepam (Paxipam®), lorazepam (Ativan®), midazolam (Versed®), orazepam (Serax®), prazepam (Verstran®), temazepam (Restoril®), triazolam (Halcion®), and quazepam (Doral®). Other Schedule IV substances include barbital, phenobarbital, chloral hydrate, ethchlorvynol (Placidyl®), chlordiazepoxide (Librium®), ethinamate, meprobamate, paraldehyde, methohexital, phentermine, diethylpropion, pemoline (Cylert®), mazindol (Sanorex®), and sibutramine (Meridia®).

Schedule V Substances (C-V) Abuse potential less than those listed in Schedule IV Cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC®, Phenergan with Codeine®) and buprenorphine (Buprenex®)

Registration Eight groups of activities are independent of each other and require registration Manufacturing Manufacturing Distributing Distributing Dispensing Dispensing Conducting Research Conducting Research Conducting a Narcotic Treatment Center Conducting a Narcotic Treatment Center Conducting Instructional Activities Conducting Instructional Activities Importing and Exporting Importing and Exporting Conducting Chemical Analysis Conducting Chemical Analysis

FORMS PharmaciesForm 224 PharmaciesForm 224 Manufacturers or ResearchersForm 225 Manufacturers or ResearchersForm 225 Narcotic Treatment ProgramsForm 363 Narcotic Treatment ProgramsForm 363

DEFINITIONS Individual Practitioner A physician, dentist, veterinarian, or other licensed or registered to dispense Does not include a pharmacist, pharmacy, or institutional practitioner

DEFINITIONS (Cont) Dispense To deliver a controlled substance to an ultimate user pursuant to the lawful order of a practitioner

DEFINITIONS (Cont) Dispenser A practitioner who so delivers a controlled substance to an ultimate user

DEFINITIONS (Cont) Practitioner A physician, dentist, veterinarian, pharmacy, hospital licensed to distribute, dispense, administer a controlled substance

DEFINITIONS (Cont) Institutional Practitioner A hospital or other person (other than an individual) licensed to dispense a controlled substance in course of practice, but does not include a pharmacy

Opioid Treatment Program Metadone (Dolophine Metadone (Dolophine® and Methadose®) Physicians can not detoxify patients unless in detox program Physicians can treat patient in hospital for medical condition and hospital can supply methadone doses Methadone can be used for analgesia in non-addictive patients

Controlled Substance Registrant Protection Act of 1984 Mandates federal investigation if: Theft is $500 or greater Theft is $500 or greater Significant injury or death results Significant injury or death results Interstate or foreign commerce involved in crime Interstate or foreign commerce involved in crime

Chemical Diversion and Trafficking Act of 1988 Lists chemicals and the tableting and encapsulating machined known to be used in illegal manufacture of controlled substances Lists chemicals and the tableting and encapsulating machined known to be used in illegal manufacture of controlled substances Manufacturers and suppliers of these items must verify legitimate use and keep records Manufacturers and suppliers of these items must verify legitimate use and keep records

Anabolic Steroids Act Anabolic steroids for human use are C-III substances Anabolic steroids for human use are C-III substances Some examples are: Some examples are: Oxymetholone (Anadrol Oxymetholone (Anadrol®), Oxandrolone (Oxandrin®), Methandrosterolone (Dianabol®), Stanozolol (Winstrol®), Fluopxymesterone (Halotestin®)

Comprehensive Methamphetamine Control Act of 1996 Regulates the sale of large amounts of OTC ephedrine, pseudoephedrine, and phenylpropanolamine (PPA) Regulates the sale of large amounts of OTC ephedrine, pseudoephedrine, and phenylpropanolamine (PPA)