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Flashcards in Pharmacy Law and Regulations Deck (50)
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1

The law requiring pharmacist to perform a prospective drug review, provide patients counseling, and maintain patient records is the_____.
A. Resource Conservation and Recovery Act
B. Medicare Prescription Drug, Improvement, and Modernization Act of 2003
C. Health Insurance Portability and Accountability Act of 1996
D. Omnibus Budget Reconciliation Act of 1990

D. Omnibus Budget Reconciliation Act of 1990

2

Pharmacy employees who handle a hazardous chemical should refer to which of the following resources to find information about the hazards of the product and advised safety precautions?
A. Safety Data Sheet (SDS)
B. United States Pharmacopeia
C. Orange Book
D. The Merick Manual

A. Safety Data Sheet (SDS)

3

After the discovery of a theft of controlled substances, the pharmacy must notify the local DEA office in writing within ____ day(s).
A. one
B. three
C. seven
D. fourteen

A. one

4

Which of the following is true regarding mailing controlled substances via the U.S postal service?
A. Schedule II controlled substances cannot be mailed
B. Schedule III-V controlled substances cannot be mailed
C. Only schedule V controlled substances are permitted to be mailed
D. All controlled substances are permitted to be mailed

D. All controlled substances are permitted to be mailed

5

The 3RD segment of an NDC number identifies which of the following?
A. Drug manufacturer (labeler)
B. Package size and type (package code)
C. Strength, dosage forms, and formulation (product code)
D. Expiration date

B. Package size and type (package code)

6

ALL BUT WHICH of the following are examples of Schedule V controlled substances
A. Tylenol with codeine
B. Robitussin AC
C. Phenergan with codeine
D. Lomotil

A. Tylenol with codeine

7

A prescription for a schedule II controlled substance may be faxed to a pharmacy in ALL BUT WHICH of the following scenarios?
A. The patient is in hospice care
B. The patient is a resident of a long-term care facility
C. The prescription is for a Schedule II controlled substance to be compounded for direct patient administration via parenteral, IV, intramuscular, subcutaneous, or intraspinal infusion
D. The patient is being discharged from a hospital

D. The patient is being discharged from a hospital

8

How often must a pharmacy complete an inventory of controlled substances according to federal law?
A. Every year
B. Every 2 years
C. Every 3 years
D. Every 4 years

B. Every 2 years

9

Which chapter of the U.S Pharmacopeia provides guidance for the compounding of non-sterile formulations for human or animal administration?
A. USP <795>
B. USP <797>
C. USP <1160>
D. USP <1176>

A. USP <795>

10

A drug recall in which the use or exposure of a violative substance is NOT LIKELY to cause adverse health consequences would be in which of the following recall classes?
A. Class I recall
B. Class II recall
C. Class III recall
D. None of the above

C. Class III recall

11

Which of the following organizations develops the standards regarding the identity, strength, quality, and purity of medications and dietary supplements?
A. FDA
B. TJC
C. USP
D. DEA

C. USP

12

An oral order for a Schedule II controlled substance is permitted______.
A. if the patient is a resident of a long-term care facility
B. In an emergnecy situation
C. If the patient is terminally ill
D. If a prescription is being filled

B. In an emergency situation

13

Which organization evaluates and accredits health care organizations and programs in the U.S?
A. FDA
B. OSHA
C. TJC
D. CMS

C. TJC

14

Medications that have NO CURRENTLY ACCEPTED medical use and a high potential for abuse are in which of the following drug schedules?
A. Schedule I
B. Schedule II
C. Schedule III
D. Schedule V

A. Schedule I

15

Which of the following laws requiring that new drugs must be proven safe and have FDA approval granted prior to marketing?
A. Food, Drug, and Cosmetic Act of 1938
B. Pure Foods and Drug Act of 1906
C. Durham-Humphrey Amendment of 1951
D. Controlled Substances Act

A. Food, Drug, and Cosmetic Act of 1938

16

Which of the following should be the last digit of Dr. Brent Cole’s DEA number if it begins with BC372514_?
A. 2
B. 5
C. 8
D. 9

C. 8

17

In which of the following scenarios is partially filling a Schedule II controlled substance permitted?
A. Schedule II controlled substances can never be partially filled
B. The pharmacy is out of stock of the particular medications
C. There are no restrictions on partially filling Schedule II controlled substances
D. None of the above

B. The pharmacy is out of stock of the particular medications

18

The 2ND segment of an NDC number identifies which of the following?
A. Drug manufacturer (labeler)
B. Package size and type (package code)
C. Strength, dosage forms, and formulation (product code)
D. Expiration date

C. Strength, Dosage form, and Formuation (product code)

19

Accodring to federal law, a prescription for a Schedule II controlled substances must be filled within how many days or months after being signed by the prescriber?
A. 14 days
B. 30 days
C. 6 months
D. None of the above

D. None of the above

20

Which of the following reference books is required to be in every pharmacy?
A. U.S Pharmacopeia
B. American Drug Index
C. Facts and Comparisons
D. Orange Book

A. U.S Pharmacopeia

21

Chemotherapeutic agents should be prepared in which of the following types of environments?
A. Compounding Aseptic Isolater
B. Recirculating Compounding Aseptic Isolater
C. Class II Biological Safety Cabinet (Vertical Laminar Flow Hood)
D. Buffer Area

C. Class II Biological Safety Cabinet (Vertical Laminar Flow Hood)

22

Which of the following laws seperated drugs into prescription and OTC categories?
A. Durham-Humphrey Amendment of 1951
B. Kefauver-Harris Amendment of 1962
C. Food, Drug, And Cosmetic Act of 1938
D. Pure Food and Drug Act of 1906

A. Durham-Humphrey Amendment of 1951

23

Which of the following medications are exempt from requirements of the Poison Prevention Packaging Act of 1970?
A. Penicillin
B. Sublingual Nitroglyceran Tablets
C. Prednisolone
D. Methotrexate

B. Sublingual Nitroglycerin Tablets

24

The 1ST segment of an NDC number identifies which of the following?
A. Drug manufacturer (labeler)
B. Package size and type (package code)
C. Strength, dosage forms, and formulation (product code)
D. Expiration date

A. Drug manufacturer (labeler)

25

If a patient requests that medication can be dispensed in a “non-child resistant” container, the pharmacy should do which of the following?
A. Document the information in the patient’s record
B. Receive authorization from the prescriber
C. Refuse to dispense the medication
D. No further action is necessary

A. Document the information in the patient’s record

26

Which of the following laws classified controlled substances into one of five categories based on their abuse potential and accepted medical use?
A. Narcotic Drug Act of 1914
B. Orphan Drug Act of 1983
C. Food, Drug, and Cosmetic Act of 1938
D. Comprehensive Drug Abuse Prevention and Control Act of 1970

D. Comprehensive Drug Abuse Prevention and Control Act of 1970

27

Which of the following laws established the provision that all patient medical records and other personal health information must be kept private?
A. Medicare Prescription Drug , Improvement and Modernization Act of 2003
B. Health Insurance Portability and Accountability Act of 1996
C. Omnibus Budget and Reconciliation Act of 1990
D. Kefauver-Harris Amendment of 1962

B. Health Insuracne Portability and Accountability Act of 1996

28

The Combat Methamphetamine Epidemic Act of 2005 regulates the sale of OTC products containing ALL BUT WHICH of the following?
A. Phentermine
B. Pseudoephedrine
C. Ephedrine
D. Phenylpropanolamine

A. Phentermine

29

Which of the following regulations are included in the Occupational Saftey and Health Act of 1970?
A. Set standards to ensure that employers are providing safe and healty workplace
B. Requires that chemical manufacturers provide to the purchaser Safety Data Sheets for hazardous chemicals
C. Gives employees the right to file a complaint with OSHA regarding safety and health conditions in their workplace
D. All of the above

D. All of the above

30

iPledge is a Risk Evaluation and Mitigation Stragety (REMS) program that pertains to which of the following medications?
A. Thalidomide
B. Isotertinoin
C. Clozapine
D. Lithium

B. Isotertinoin