The document discusses the history and classification of controlled substances in the United States. It begins with a brief history of increasing drug regulation since the early 1900s, culminating in the 1970 Controlled Substances Act (CSA) which established five drug schedules based on a drug's medical use, abuse potential, and safety. The CSA contains laws governing the manufacture, distribution, and possession of controlled substances. The document then outlines the five drug schedules, providing examples of drugs in each schedule. It concludes by discussing prescribing, procurement, storage, dispensing, inventory control, and disposal of controlled substances in accordance with the CSA.

1. Controlled Drugs
DARYA OSMAN HUSSEIN DAOUD

2. Objective
 Brief History of controlled drug use
 Define Controlled Drugs
 Different classifications of controlled drugs
 Prescribing of controlled drugs
 Procurement, Storing and Dispensing of controlled drugs
 Disposing of controlled drugs

3. History
 The FDA has been overseeing drugs
in the US since the beginning of the
20th century
 Before the 1970’s there were very
little if any laws on the use and
control of many drugs
 This meant many dangerous drugs
were sold without any control

4. History Cont.
 During the 1970s recreational drug use
began becoming a huge problem in the
USA
 President Nixon recognized this as a
problem and encouraged his
administration to act on this issue
 In 1970 the FDA released the Controlled
Substance Act (CSA)

5. The CSA
 This act contains “schedules” which are
classifications of drugs based on risk of
abuse or harm
 It contains laws on the manufacture,
import, export, distribution and
possession of controlled substances
 It also contains the fines and prison
terms for violations of the laws

6. Controlled drugs
 “Controlled substance” is a legal term referring specifically to substances controlled
by federal or state laws.
 CSA Definition: The term "controlled substance" means a drug or other substance,
or immediate precursor, included in schedule I, II, III, IV, or V …… The term does not
include distilled spirits, wine, malt beverages, or tobacco,….”
 Substances are placed in their respective schedules based on:
 Whether they have a currently accepted medical use in treatment in the United States,
 Their relative abuse potential, and
 Likelihood of causing dependence when abused.

7. Classification: Schedule I drugs
 Drugs or other substance with high
potential for abuse
 Have no currently accepted medical
use in treatment
 Lack of accepted safety for use of the
drug or other substance under
medical supervision

8. Classification: Schedule I drugs
Examples
 Heroin
 lysergic acid diethylamide (LSD)
 marijuana (cannabis)
 Peyote
 methaqualone
 3,4-methylenedioxymethamphetamine
(“Ecstasy”).

9. Classification: Schedule II Drugs
 Drug or other substances has high
potential for abuse
 Has currently accepted medical use in
treatment in the USA with severe
restrictions
 Abuse of drug or other substances
may lead to severe psychological or
physical dependence

10. Classification: Schedule II Drugs
Examples
 hydromorphone (Dilaudid®)
 methadone (Dolophine®)
 meperidine (Demerol®)
 oxycodone (OxyContin®,
Percocet®),
 fentanyl (Sublimaze®,
Duragesic®).
 morphine, opium, and
codeine
 amphetamine (Dexedrine®,
Adderall®),
 methamphetamine
(Desoxyn®)
 methylphenidate (Ritalin®).
 Amobarbital
 Glutethimide
 pentobarbital.

11. Classification: Schedule III Drugs
 Drug or substance has a potential for abuse less
than those in schedule I and II
 Drug or substance has currently accepted
medical use in the USA
 Abuse of drug or substance may lead to
moderate or low physical dependence or high
psychological dependence

12. Classification: Schedule III Drugs
Examples
 combination products containing less than 15
milligrams of hydrocodone per dosage unit (Vicodin®)
 products containing not more than 90 milligrams of
codeine per dosage unit (Tylenol with Codeine®)
 buprenorphine (Suboxone®).
 benzphetamine (Didrex®)
 phendimetrazine
 anabolicsteroids such as Depo®-Testosterone.

13. Classification: Schedule IV Drugs
 Drug or other substance has a low potential
for abuse relative to those in schedule III
 Drug or substance has currently accepted
medical use in treatment in the USA
 Abuse of may lead to limited physical
dependence or psychological dependence
relative to schedule III drug

14. Classification: Schedule IV Drugs
Examples
 alprazolam (Xanax®)
 carisoprodol (Soma®)
 clonazepam (Klonopin®)
 clorazepate (Tranxene®)
 diazepam (Valium®)
 lorazepam (Ativan®)
 midazolam (Versed®)
 temazepam (Restoril®)
 triazolam (Halcion®).

15. Classification: Schedule V Drugs
 Drug or other substance has a low potential for abuse
relative to schedule IV substances
 Drug or substance has currently accepted medical use
 Abuse of drug or substance may lead to limited physical
dependence or psychological dependence relative to
schedule IV drugs
 Includes primarily preparations containing limited quantities
of certain narcotics

16. Classification: Schedule V Drugs
Examples
 cough preparations containing not more than 200
milligrams of codeine per 100 milliliters or per 100 grams
(Robitussin AC®, Phenergan with Codeine®), and
ezogabine.

17. Controlled Drug
Prescription
• Date of issue;
• Patient's name and address;
• Practitioner's name, address, and
DEA registration number;
• Drug name;
• Drug strength;
• Dosage form;
• Quantity prescribed;
• Directions for use;
• Number of refills (if any) authorized;
and
• Manual signature of prescriber.

18. Prescribing: Schedule I
 No prescriptions allowed
 They are also subject to production quotas which
the DEA imposes
 It is illegal (a class 1 felony) even to conduct
otherwise legitimate scientific research of any
kind of schedule I substance

19. Prescribing: Schedule II
 Must have a written (can also be
faxed) prescription from a practitioner
 There is no refilling of prescription
but can write max. of 3 prescription
when refill is required

20. Prescribing: Schedule III
 Requires a written or oral prescription
 Can not be filled or refilled more than
6 months after date
 Max. number of refills is 5 in 6 month
period

21. Prescribing: Schedule IV
 Similar to schedule III
 May be refilled up to 5 times within a
six-month period

22. Prescribing: Schedule V
 Must be distributed or dispensed for
medical purpose only
 Requires a written, oral or faxed
prescription from a practitioner
 Can be refilled as instructed by
practitioner

23. Procurement of Controlled Drugs
 Must have a DEA license
 Must use special DEA order form (for
schedule I and II)
 Must be shipped to address on
licence and once received become the
responsibility of the licence holder
 Shipments must be insured against
theft and damage

24. CD Order Form
Example
Form contains detailed
information about drug, supplier
and receiver
Schedule I and II drugs must be
ordered separately from
schedule III, IV and V drugs

25. Storing of Controlled Drugs
 Must be stored in a double locked, secured
container
 Box must be secured to an immovable
object
 Licence holder should have possession of
storage box keys
 There should be no label on the outside

26. Dispensing and Inventory Control of
Controlled Drugs
 A log book is maintained for each drug
 Log book includes
 Authorized users signature log
 Unopened container log
 Opened container log
 One log book should be maintained for all
drugs

27. Authorized User
Signature Log
• Records all users accessing
the CD storage cabinet

28. Unopened
Container Log
• Each drug must have its own
log
• Reordered in numerical order
according to date acquired
• Containers moved from
unopened to opened log
must be recorded

29. Opened Container
Log
• Continuous from unopened
container log
• Objects moved from
unopened to opened
container in sequential order
• Must have same record
number in both log books

30. Biennial CD
Inventory Form
• Used to track all drugs
• Kept for a 2 year period
• Must be updated frequently

31. Disposing of Controlled Drugs
 All expired or unused controlled substances must be turned over to a
Reverse Distributor licensed by the DEA.
 If you have expired controlled substances, mark them accordingly
and store them in the controlled substances cabinet until they can be
relinquished to the reverse distributor.
 You will get a receipt for your controlled substances. Record this in
your drug logs (opened or unopened container).
 Keep the receipt in a notebook with your order packing slips/invoices
for at least 2 years

32. Questions?

33. Thank you!