Transcript Schedule I Substances (CI)

CONTROLLED SUBSTANCES ACT
Pharmacy 151
Introduction to Pharmacy Law
Wayne Brown, Ph.D.
Controlled Substances
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Controlled or scheduled because of their
potential for addiction and abuse
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

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)
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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®)
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)
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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)
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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®).
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
FORMS
Pharmacies
 Manufacturers or Researchers
 Narcotic Treatment Programs
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Form 224
Form 225
Form 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® 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
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
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Regulates the sale of large amounts of
OTC ephedrine, pseudoephedrine, and
phenylpropanolamine (PPA)