CONTROLLED SUBSTANCES CONTROLLED SUBSTANCES ACTACT

Pharmacy 151Pharmacy 151

Introduction to Pharmacy LawIntroduction to Pharmacy Law

Wayne Brown, Ph.D.Wayne Brown, Ph.D.

Controlled SubstancesControlled Substances

Controlled or scheduled because of Controlled or scheduled because of their potential for addiction and their potential for addiction and abuseabuse

Closed SystemClosed System

ManufacturingManufacturingDistributingDistributingDispensingDispensing

Only those persons or entities registered Only those persons or entities registered with DEA may legally engage in these with DEA may legally engage in these activitiesactivities

Intent is to reduce the diversion of Intent is to reduce the diversion of controlled substances to illicit marketscontrolled substances to illicit markets

Drug Enforcement Drug Enforcement Administration (DEA)Administration (DEA)

An agency of the United States An agency of the United States Department of JusticeDepartment of Justice

US Attorney General has authority for US Attorney General has authority for scheduling and unscheduling drugsscheduling and unscheduling drugs

SymbolsSymbols

C-IC-IC-IIC-IIC-IIIC-IIIC-IVC-IVC-VC-V

Schedule I Substances (C-Schedule I Substances (C-I)I)

High abuse potential and no accepted High abuse potential and no accepted medical use in the United States medical use in the United States

Include heroin and propiram. Some Include heroin and propiram. Some hallucinogenic substances found in hallucinogenic substances found in Schedule I include LSD, marijuana and Schedule I include LSD, marijuana and MDMA (Ecstasy).MDMA (Ecstasy).

Other examples of Schedule I substances Other examples of Schedule I substances are the depressant methaqualone, and are the depressant methaqualone, and gamma hydroxybutyric acid (GHB) and the gamma hydroxybutyric acid (GHB) and the stimulant methcathinone stimulant methcathinone

Schedule II Substances (C-Schedule II Substances (C-II)II)

High abuse potential with severe psychological or High abuse potential with severe psychological or physical dependence liabilityphysical dependence liability

Accepted medical use in the United StatesAccepted medical use in the United States Available for practitioners to prescribe, dispense Available for practitioners to prescribe, dispense

and administer and administer Narcotics include morphine, codeine, Narcotics include morphine, codeine,

hydrocodone and opium. hydrocodone and opium. Other Schedule II narcotic substances and their Other Schedule II narcotic substances and their

common name brand products include: common name brand products include: hydromorphone (Dilaudid®), methadone hydromorphone (Dilaudid®), methadone (Dolophine®), meperidine (Demerol®) (Dolophine®), meperidine (Demerol®) oxycodone (Percodan®) and fentanyl oxycodone (Percodan®) and fentanyl (Sublimaze®) (Sublimaze®)

Schedule II Substances (C-II) Schedule II Substances (C-II) [CONT][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-Schedule III Substances (C-III)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-Schedule IV Substances (C-IV)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 SubstancesSchedule V Substances (C- (C-V)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®)

RegistrationRegistration

Eight groups of activities are independent of Eight groups of activities are independent of each other and require registrationeach other and require registration

ManufacturingManufacturing DistributingDistributing DispensingDispensing Conducting ResearchConducting Research Conducting a Narcotic Treatment CenterConducting a Narcotic Treatment Center Conducting Instructional ActivitiesConducting Instructional Activities Importing and ExportingImporting and Exporting Conducting Chemical AnalysisConducting Chemical Analysis

FORMSFORMS

PharmaciesPharmacies Form 224Form 224 Manufacturers or ResearchersManufacturers or Researchers Form 225Form 225 Narcotic Treatment ProgramsNarcotic Treatment Programs Form 363Form 363

DEFINITIONSDEFINITIONS

Individual PractitionerIndividual Practitioner

A physician, dentist, veterinarian, or A physician, dentist, veterinarian, or other licensed or registered to other licensed or registered to dispensedispense

Does not include a pharmacist, Does not include a pharmacist, pharmacy, or institutional pharmacy, or institutional practitionerpractitioner

DEFINITIONS (Cont)DEFINITIONS (Cont)

DispenseDispense

To deliver a controlled substance to To deliver a controlled substance to an ultimate user pursuant to the an ultimate user pursuant to the lawful order of a practitionerlawful order of a practitioner

DEFINITIONS (Cont)DEFINITIONS (Cont)

DispenserDispenser

A practitioner who so delivers a A practitioner who so delivers a controlled substance to an ultimate controlled substance to an ultimate useruser

DEFINITIONS (Cont)DEFINITIONS (Cont)

PractitionerPractitioner

A physician, dentist, veterinarian, A physician, dentist, veterinarian, pharmacy, hospital licensed to pharmacy, hospital licensed to distribute, dispense, administer a distribute, dispense, administer a controlled substancecontrolled substance

DEFINITIONS (Cont)DEFINITIONS (Cont)

Institutional PractitionerInstitutional Practitioner

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

Opioid Treatment ProgramOpioid Treatment Program

Metadone (DolophineMetadone (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 Controlled Substance Registrant Protection Act of 1984Protection Act of 1984

Mandates federal investigation if:Mandates federal investigation if:Theft is $500 or greaterTheft is $500 or greaterSignificant injury or death resultsSignificant injury or death results Interstate or foreign commerce Interstate or foreign commerce

involved in crimeinvolved in crime

Chemical Diversion and Chemical Diversion and Trafficking Act of 1988Trafficking Act of 1988

Lists chemicals and the tableting and Lists chemicals and the tableting and encapsulating machined known to be encapsulating machined known to be used in illegal manufacture of used in illegal manufacture of controlled substancescontrolled substances

Manufacturers and suppliers of these Manufacturers and suppliers of these items must verify legitimate use and items must verify legitimate use and keep recordskeep records

Anabolic Steroids ActAnabolic Steroids Act

Anabolic steroids for human use are Anabolic steroids for human use are C-III substancesC-III substances

Some examples are:Some examples are:

Oxymetholone (AnadrolOxymetholone (Anadrol®), Oxandrolone (Oxandrin®), Methandrosterolone (Dianabol®), Stanozolol (Winstrol®), Fluopxymesterone (Halotestin®)

Comprehensive Comprehensive Methamphetamine Control Act of Methamphetamine Control Act of

19961996Regulates the sale of large amounts Regulates the sale of large amounts

of OTC ephedrine, pseudoephedrine, of OTC ephedrine, pseudoephedrine, and phenylpropanolamine (PPA) and phenylpropanolamine (PPA)