CONTROLLED SUBSTANCES ACT

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CONTROLLED SUBSTANCES ACT

• Pharmacy 151
• Introduction to Pharmacy Law
• Wayne Brown, Ph.D.

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Controlled Substances

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

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Closed System

• Manufacturing
• Distributing
• 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

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Drug Enforcement Administration (DEA)

• An agency of the United States Department of
  Justice
• US Attorney General has authority for scheduling
  and unscheduling drugs

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Symbols

• C-I
• C-II
• C-III
• C-IV
• C-V

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Schedule I Substances (C-I)

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

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Schedule II Substances (C-II)

• High abuse potential with severe psychological or
  physical dependence liability
• Accepted medical use in the United States
• Available for practitioners to prescribe,
  dispense and administer
• 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)

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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

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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

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Schedule IV Substances (C-IV)

• Abuse potential less than those listed in
  Schedule III and more than substances in Schedule
  V
• 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).

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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)

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Registration

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

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FORMS

• Pharmacies Form 224
• Manufacturers or Researchers Form 225
• Narcotic Treatment Programs Form 363

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DEFINITIONS

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

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DEFINITIONS (Cont)

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

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DEFINITIONS (Cont)

• Dispenser
• A practitioner who so delivers a controlled
  substance to an ultimate user

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DEFINITIONS (Cont)

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

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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

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Opioid Treatment Program

• 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

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Controlled Substance Registrant Protection Act of
1984

• Mandates federal investigation if
• Theft is 500 or greater
• Significant injury or death results
• Interstate or foreign commerce involved in crime

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

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Anabolic Steroids Act

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

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Comprehensive Methamphetamine Control Act of 1996

• Regulates the sale of large amounts of OTC
  ephedrine, pseudoephedrine, and
  phenylpropanolamine (PPA)