Chapt 6 Regulatory Standards in Pharmacy Practice

Question 1

A package insert is required to be given to all patients who are taking…

Answer 1

steroids, analgesics, and estrogenic drugs

Question 2

Which of the following is considered a controlled substance?

Answer 2

Demerol (CII), Morphine (CII), Valium (CIV)

Question 3

Regulations affecting pharmacy practice encompass…

Answer 3

Federal and state statutes, states rules and regulations, CSA regulations

Question 4

Which of the following is NOT an approved use of tax-free alcohol?

Answer 4

Beverage purposes.

Question 5

Which of the following is NOT a responsability of the Food, Drug, and Cosmetic ACT (FDCA)?

Answer 5

Collection of adverse drug reaction reports.

Question 6

Controlled substances are required by federal law to have appropiate safeguards with their use. Which of the following is NOT an issue?

Answer 6

Patient consent.

Question 7

Which of the following is NOT a reason to report adverse drug reactions to the FDA?

Answer 7

…

Question 8

A Class I recall does NOT include…

Answer 8

assigment of the drug recall classification by the FDA.

Question 9

The intent of the Occupational Safety and Health Administration (OSHA) is…

Answer 9

To monitor job-related injuries, to develop job safety and health standards, to ensure a safe and healthy workplace

Question 10

Pharmacy practice standards, guidelines, and statements…

Answer 10

define reasonable and prudent practices.

Question 11

Durham-Humphrey Amendment

Answer 11

Establishes prescription versus over-the-counter drugs.

Question 12

Orphan Drug Act

Answer 12

Creates incentives for manufactures to research and develop drugs to treat rare diseases and disorders.

Question 13

Controlled Substances Act

Answer 13

Regulates the manufacture, sale, and distribution of drugs that have a high abuse potential.

Question 14

Poison Prevention Packaging Act

Answer 14

Establishes requirements for child-resistant containers.

Question 15

Hazard Communication Standard

Answer 15

Establishes the rights of employees to know the dangers of substances used in the workplace.

Question 16

Health Insurance Portability and Accountability Act

Answer 16

Establishes guidelines to protect patient privacy.

Question 17

RULES and REGULATIONS…

Answer 17

are administrative enactments implemented by government agencies that meet the intent of statutory policies.

Question 18

The PURE FOOD AND DRUG ACT OF 1906…

Answer 18

… prohibits the adulteration and misbranding of foods in interstate commerce.

Question 19

The FOOD, DRUG, AND COSMETIC ACT OF 1938…

Answer 19

requires that all new drugs be proven safe and effective

Question 20

Schedule “ I “…

Answer 20

drugs have no approved medical use in the United States.

Question 21

The FDA requires distribution of…

Answer 21

.. PATIENT PACKAGE INSERTS (PPIs) to educate patients about the proper use of and potential hazards of drugs.

Question 22

Federal Statutes

Answer 22

Laws enacted by a legislative body that dictate the conduct of persons or organizations subject to the law.

Question 23

Rules and Regulations

Answer 23

Promulgated by government agencies at the local, state, and federal levels.

Question 24

Food and Drug Administration (FDA)

Answer 24

Promulgates rules, regulations, and standards; inspects drug and food facilities to ensure public safety regarding drug products.

Question 25

Drug Enforcement Administration (DEA)

Answer 25

A federal agency established to implement the rules and regulations to enforce the Controlled Substances Act (CSA) to combat controlled substance abuse.

Question 26

Quasi-Legal Standards

Answer 26

Recognized standards that are similar to laws.

Question 27

Federal vs State Drug Control Laws

Answer 27

Pharmacists are equally responsible for compliance with both federal and state law and respective regulations foverning their pharmacy practice. If the federal law or regulation is more STRINGENT than the comparable state law or regulation, or vice versa, the more stringent law or regulation must be followed.

Question 28

State Board of Pharmacy

Answer 28

Body established to ensure that the public is well served professionally by pharmacists.

Question 29

Other responsabilities of the State Board of Pharmacy

Answer 29

Licensing and registering pharmacies. Delaing with complaints of professional misconduct. Carrying out disciplinary proceedings. Developing regulations relating to filling and refilling prescriptions. Substituting generic and therapeutic drugs. Labeling. Performing inspections. Defining pisons and mandating records to be maintained upon retail sale.

Question 30

FDCA Regulations

Answer 30

``` Pure Food and Drug Act of 1906. Food, Drug, and Cosmetic Act of 1938. Durham-Humphrey Amendment of 1951. Kefauver-Harris Amendment of 1962. Medical Device Amendment of 1976. Orphan Drug Act of 1983. Food and Drug Administration Modernization Act of 1997. ```

Question 31

Federal Food, Drug, and Cosmetic Act (FDCA)

Answer 31

Federal law through which the Food and Drug Administration promulgates its rules and regulations.

Question 32

Food, Drug, and Cosmetic Act of 1938

Answer 32

The federal statute through which the FDA promulgates its rules and regulations.

Question 33

Kefauver-Harris Amendment

Answer 33

An amendmento to the Federal Food and Cosmetic Act that required all new drugs marketed in the United States to be shown to be not only safe, but also efective.