Lecture 9 - Introduction to the Controlled Substance Act (CSA)

Question 1

What is the Harrison Narcotics Act?

Answer 1

Required importers, manufacturers and distributors of cocaine and opiates (narcotics) to:
-Register with the US treasury (the first enforcement agency for controlled substances)
-Pay a special tax on these drugs
-Keep records of each transaction

Question 2

What happened as a result of the passing of the Harrison Narcotics Act?

Answer 2

-The Treasury viewed patient drug maintenance with narcotics as beyond the scope of practice, and many prescribers were jailed as a result
-The Narcotic Division of the Internal Revenue Bureau was responsible for enforcing this law, and shut down many narcotic clinics throughout the country, earning the nickname narcs
-As a result of this enforcement, physicians stopped prescribing narcotics, and many users went to the black market to seek these products

Question 3

What was the effect of prohibition on the use of marijuana?

Answer 3

People started using marijuana more when alcohol was outlawed

Question 4

What did The Marihuana Tax Act do?

Answer 4

-The federal government banned marijuana under this act by requiring a high-cost transfer tax stamp for every sale of marijuana
-These stamps were very rarely issued
-Following this act all states made marijuana illegal

Question 5

What did the controlled substance law in 1968 do?

Answer 5

FBN combined with the Bureau of Drug Abuse Control to form the Bureau of Narcotics and Dangerous Drugs, now under the department of justice. (Merged with customs and changed to the Drug Enforcement Agency (DEA) in 1973)

Question 6

What are the three titles of the Comprehensive Drug Abuse Prevention and Control Act?

Answer 6

-Title 1: Instituted programs for controlled substance use disorder
-Title 2: Established five separate schedules of controlled substances. Regulated the manufacture, distribution, and dispensation of controlled substances
-Title 3: Addressed the import and export of controlled substances

Question 7

What is the most important title from the Comprehensive Drug Abuse Prevention and Control Act?

Answer 7

Title 2 is more commonly referred to as the Controlled Substance Act (CSA) and is the basis of 98% of all federal legislation which impacts pharmacy practice related to controlled substances today

Question 8

What aspects of controlled substance does the CSA cover?

Answer 8

-Controlled substance schedules
-Registration with the DEA
-Inventory requirements
-Recordkeeping requirements
-Ordering requirements for controlled substances
-Prescription requirements
-Dispensing requirements
-Security requirements
-Transfer or disposal of controlled substances

Question 9

What is a controlled substance?

Answer 9

A controlled substance is a drug with dependence liability and/or abuse potential

Question 10

What is the primary function of the DEA?

Answer 10

Enforcing the Controlled Substances Act

Question 11

What are the factors determining scheduling of controlled substances?

Answer 11

-Its actual or relative potential for abuse
-Scientific evidence of its pharmacologic effects, if known
-The state of current knowledge regarding the drug or other substance
-Its history and current pattern of abuse
-The scope duration, and significance of abuse
-What, if any, risk there is to public health
-Its psychic or physiologic dependence liability
-Whether the substance is an immediate precursor of a substance already controlled under this subchapter

Question 12

What do these factors for determining controlled substance scheduling allow for?

Answer 12

-Scheduling a drug that was previously not scheduled
-Changing a drug from one schedule to another
-Removing a drug from the schedules entirely
-Keeping a drug in its current position (controlled/uncontrolled)

Question 13

Which schedule has no medical use?

Answer 13

C1

Question 14

Which schedules have a high abuse potential?

Answer 14

C1 and C2

Question 15

What is the psychological dependency of C1?

Answer 15

Not defined

Question 16

What is the physical dependency of C1?

Answer 16

Not defined

Question 17

What is the psychological dependency of C2?

Answer 17

Severe

Question 18

What is the physical dependency of C2?

Answer 18

Severe

Question 19

What is the psychological dependency of C3?

Answer 19

High

Question 20

What is the physical dependency of C3?

Answer 20

Moderate to low

Question 21

What is the psychological dependency of C4?

Answer 21

Limited compared to C3

Question 22

What is the physical dependency of C4?

Answer 22

Limited compared to C3

Question 23

What is the psychological dependency of C5?

Answer 23

Limited compared to C4

Question 24

What is the physical dependency of C5?

Answer 24

Limited compared to C4

Question 25

Should you follow federal or state scheduling?

Answer 25

Whichever is stricter

Question 26

Can OTC controlled substances be sold without a prescription?

Answer 26

Yes

Question 27

What rules must be followed in order to sell a controlled substance OTC?

Answer 27

-A pharmacist must decide to sell the medication, and only to someone 18 years or older -Sale is limited to 240 mL or 48 dosage unites of any controlled substance containing opium, or 120 mL or 24 dosage unites of any other controlled substance in a 48-hour period -A pharmacist must verify the patient and record information about the sale

Question 28

What information must be recorded when selling an OTC controlled substance?

Answer 28

-Review a valid form of ID (not required if pharmacist knows patient) and record information -Name of purchaser -Name and quantity of controlled substance purchased -Date of each purchase -Name or initials of pharmacist -All information must be recorded in a bound book (not electronically or on loose papers)

Question 29

Which three products does the CSA limit the sale of that are not controlled substances?

Answer 29

-Pseudoephedrine -Ephedrine -Phenylpropanolamine

Question 30

What are the sale limits on the three "listed chemicals"?

Answer 30

-Federal law limits to 3.6 grams/day and 9 grams in 30 days -Many states have additional and/or stricter limits on these products

Question 31

What is required to sell the three listed chemicals?

Answer 31

-Written or electronic sales record which contains name, address and signature of purchaser, date and time of sale, and name and amount of product purchased -Purchaser must present a valid form of identification which contains a photograph, is nonexpired, and issued by a state or federal government

Question 32

What is required on controlled substance labeling?

Answer 32

-A symbol prominently displayed on the label of the commercial container -The symbol should denote the schedule of the substance (C1, C2, C3, C4, C5) with the number residing within the C -The symbol must be large enough to easily identify the products schedule on a pharmacy warehouse or shelf