FEDERAL LAWS

Question 1

Pharmacy laws can be made by which government(s)?

Answer 1

Local, state, and federal governments.

Question 2

The first legislation to require purity of the product was the:

Answer 2

Federal Food and Drug Act, 1906.

Question 3

The legislation which created a “legend” class of drugs was the:

Answer 3

Durham-Humphrey Amendment.

Question 4

The legislation which was the first to require drug products be effective, as well as safe, was the:

Answer 4

Kefauver-Harris Amendment.

Question 5

Which legislation used “tax stamps” as a manner to control the use of narcotics?

Answer 5

Harrison Narcotic Act.

Question 6

Did the Federal Food, Drug and Cosmetic Act replace or amend the Federal Food and Drug Act? In what year?

Answer 6

Replaced in 1938.

Question 7

True or False

An Amendment replaces the original Act, it does not add to it.

Answer 7

False.

An Amendment does not replace the original Act, it only updates it.

Question 8

Which Act was the first to demand purity of product, the Federal Food, Drug, and Cosmetic Act or the Federal Food and Drug Act ? In what year?

Answer 8

Federal Food and Drug Act in 1906.

Question 9

Which Act was the first to demand safety for purpose, the Federal Food and Drug Act or the Federal Food, Drug, and Cosmetic Act? In what year?

Answer 9

Federal Food, Drug, and Cosmetic Act in 1938.

Question 10

Which Amendment created the class known as legend drugs, the Kefauver-Harris Amendment or the Durham-Humphrey Amendment? In what year?

Answer 10

Durham-Humphrey Amendment in 1951.

Question 11

Which Amendment required proof of effectiveness and regulated drug advertising, the Durham-Humphrey Amendment or the Kefauver-Harris Amendment? In what year?

Answer 11

Kefauver-Harris Amendment in 1962.

Question 12

Which of the following is not an exception to the requirement for locking caps on prescriptions dispensed from the pharmacy?

a) When a patient asks for a non-safety lid
b) When a prescriber asks for a non-safety lid
c) When a pharmacist asks for a non-safety lid
d) When the drug dispensed is an exempted drug

Answer 12

c) When a pharmacist asks for a non-safety lid

This isn’t one of the three exceptions

Question 13

Manufacturers of certain medical devices were also required to get pre-market approval from the FDA according to which Amendment? In what year?

Answer 13

Medical Device Amendment, 1976.

Question 14

Did the Medical Device Amendment affect prescription drugs?

Answer 14

No.

Question 15

Describe the Prescription Drug Marketing Act’s (PDMA) intent. What year was this law passed?

Answer 15

Ensure drugs available for purchase by consumers were safe and effective, and to avoid reimportation of U.S. drugs from other countries.

Question 16

Which Act amended the FFDCA to establish standards for dietary supplements? In what year?

Answer 16

Dietary Supplement Health and Education Act (DSHEA).

1994.

Question 17

Which Act changed the marking on a prescription stock bottle to the Rx symbol we see today?

a) The Harrison Narcotic Act (1916)
b) FDA Modernization Act (1997)
c) Medicare Prescription Drug, Improvement, and Modernization Act (2003)
d) Omnibus Budget Reconciliation Act (1990)

Answer 17

b) FDA Modernization Act in 1997.

Question 18

What does DSCSA stand for and what is it’s main objective?

Answer 18

Drug Supply Chain Security Act (2013).

Electronically identify and trace prescription drugs traveling across the country.

Question 19

What was the purpose of the Harrison Narcotic Act? In what year was it legislated?

Answer 19

Tax stamp narcotics to prevent illegal narcotic trafficking.
1916.

Question 20

True or False

If a narcotic was found without tax stamps, it is not subject to seizure.

Answer 20

False.

Any products found without tax stamps were sold illegally without taxation, therefore subject to seizure.

Question 21

Which Amendment expanded the Harrison Act to include barbiturates and stimulants, and also levied the taxation of narcotics?

Answer 21

Drug Abuse Control Amendment (DACA, 1968).

Question 22

In ____, the ________ ___ and the ____ _____ _______ __________ were combined under the jurisdiction of the newly formed Bureau of Narcotics and Dangerous Drugs.

Answer 22

1968
Harrison Narcotic Act
Drug Abuse Control Amendment

Question 23

The Bureau of Narcotics and Dangerous Drugs was renamed in 1972. What is the name now?

Answer 23

The Drug Enforcement Administration (DEA).

Question 24

What was the last major change made in the controlled drug legislation and in what year did this change take place?

Answer 24

Controlled Substances Act (CSA), in 1970.

Question 25

True or False | The concept of the DEA number originated with the CSA.

Answer 25

True.

Question 26

True or False | The CSA did not repeal and replace Harrison and DACA.

Answer 26

False. It did, relying on regulation of interstate trade for its power.

Question 27

What was the purpose of the Anabolic Steroid Control Act? What schedule were they placed in and what year?

Answer 27

To recognize the danger of misusing anabolic steroids, listing them as Schedule III controlled substances. 1990.

Question 28

How did the Combat Methamphetamine Epidemic Act (CMEA, 2005) contribute to prevention of controlled substances?

Answer 28

Created a new list of regulated compounds known as Scheduled Listed Chemical Products (SLCP).

Question 29

Per the requirements of the CMEA regarding SLCP's, retail sellers must maintain a log of each sale that includes what?

Answer 29

Purchaser's name, address, and signature. Product and quantity sold. Purchase date and time.

Question 30

True or False | SLCP's must be stored behind the pharmacy counter or in a locked cabinet.

Answer 30

True.

Question 31

How long must a log book be maintained according to the requirements of the CMEA?

Answer 31

Two years from the date of the last sale.

Question 32

Which of the following is true per the requirements of the CMEA? a) All employees involved in the sale of SLCP's must have specialized training. b) Retail sellers are not obligated to verify the identity of the purchaser c) Limits the amount of SLCP's per purchase per month d) Both a and c e) Both b and c

Answer 32

d) both a and c. Retail sellers must verify the identity of the purchaser.

Question 33

What does OBRA stand for and state it's objective.

Answer 33

Omnibus Budget Reconciliation Act (1990). | Save taxpayers money by efficiently funding scripts using taxpayer dollars.

Question 34

State the meaning of HIPAA and it's relation to pharmacy.

Answer 34

Health Insurance Portability and Accountability Act. | Patient privacy.

Question 35

Which of the following was a result of the Medicare Modernization Act, MMA (2003)? a) Introduced an entitlement for prescription drugs for Medicare Recipients b) Created the Medicare Advantage health care plans c) Introduced tamper-resistant prescription blanks d) Created Health Savings Accounts e) only b, c, and d f) only a, b, and d

Answer 35

f) only a, b, and d

Question 36

The first attempts at controlling narcotics came from the illegal distribution of _______.

Answer 36

Opium.

Question 37

Name the Act passed in 1983 that facilitated the development of drugs for rare diseases.

Answer 37

Orphan Drug Act.

Question 38

Which of the following is not considered a rare disease? a) Diabetes b) Huntington's c) Myoclonus d) ALS

Answer 38

a) Diabetes

Question 39

Which DEA form must be used whenever a Schedule I or II drug is bough, sold or transferred between pharmacies or qualified distributors?

Answer 39

Form 222

Question 40

Establish which of the following statements are true or false of DEA FORM 222. If false, explain. a) Forms are only available through the DEA. b) Errors are not acceptable on the form. c) In case of an error, the form must be voided, kept on file, and a new form must be used. d) This form is not necessary for Schedule II-IV drugs.

Answer 40

a) True b) True c) True d) False, this form is not necessary for Schedule III-V drugs