PTCB Regulatory Compliance Test
Questions and Answers
categories of accreditation standards a pharmacy must meet - ANS-Administration and
pharmacy organization/management
Pharmacy operations, including the physical environment
Patient care programs and services
Clinical case management and quality programs
FDA (Food and Drug Administration) - ANS-responsible for ensuring the safety,
efficacy, and security of food, drugs, biologic products,, monoclonal antibodies,
radioactive products, medical devices, and cosmetics.
MedWatch - ANS-the FDA's medical product safety and adverse event reporting
program established to promote public safety
DEA (Drug Enforcement Administration) - ANS-established to enforce the Controlled
Substances Act of 1970 (CSA) and bring those involved in the illegal growing,
manufacturing, or distribution of controlled substances to the criminal and civil justice
systems... also recommends and supports programs aimed at reducing the availability
of illicit controlled substances on the domestic and international markets
APhA (American Pharmacists Association) - ANS-Their goal is to facilitate pharmacists'
delivery of the highest quality patient-centered care, the more classic definition of
professionalism became recognized.
to address the purity of drugs imported into the U.S - ANS-Why did Congress pass the
Drug Importation Act of 1848?
The Drug Importation Act of 1848 - ANS-empowered the U.S. Customs Service to
prevent the importation of adulterated drugs from other countries
What led to the establishment of the U.S. Food and Drug Administration (FDA)? - ANS-
The Pure Food and Drug Act of 1906
What Administration did the Pure Food and Drug Act of 1906 help establish? - ANS-
U.S. Food and Drug Administration (FDA)
, What act prevented the manufacture, sale, and transportation of adulterated,
misbranded (i.e., drug that makes false or misleading claims), or harmful drugs or
foods? - ANS-The Pure Food and Drug Act of 1906
What was preceded by the sulfanilamide tragedy of 1937 - ANS-Food, Drug, and
Cosmetic Act of 1938
What preceded the Food, Drug, and Cosmetic Act of 1938 - ANS-the sulfanilamide
tragedy of 1937
Which Act required premarketing safety testing - ANS-Food, Drug, and Cosmetic Act of
1938
What law required that drugs be labeled with adequate directions for safe use? - ANS-
Food, Drug, and Cosmetic Act of 1938
What law prohibited false therapeutic claims for drugs and authorized manufacturing
factory inspections - ANS-Food, Drug, and Cosmetic Act of 1938
What law mandated pre-market approval of all new drugs, such that a manufacturer
would have to prove to FDA that a drug was safe before it could be marketed and sold -
ANS-Food, Drug, and Cosmetic Act of 1938
What law explicitly defined 2 specific categories for medications, legend (i.e., requiring a
prescription) and over-the-counter. - ANS-Durham-Humphrey Amendment of 1951
What law defined prescription drugs as those unsafe for self-medication that should be
used only under a physician's supervision - ANS-Durham-Humphrey Amendment of
1951
What event led to the passage of the Kefauver-Harris Amendments of 1962 - ANS-The
thalidomide tragedy
The Kefauver-Harris Amendments of 1962 gave FDA the following authority: - ANS-
Required manufacturers to prove effectiveness of drug products before they are
marketed
Required manufacturers to report any adverse effects that occur post-marketing
Required evidence of effectiveness be based on adequate, well-controlled clinical
studies conducted by qualified experts
Required study subjects to give informed consent
Gave FDA 180 days to approve a new drug application
Required FDA to conduct a retrospective evaluation of the effectiveness of drugs
approved for safety (but not for effectiveness) between 1938 and 1962
Allowed FDA to set good manufacturing practices
Mandated regular inspections of production facilities
Questions and Answers
categories of accreditation standards a pharmacy must meet - ANS-Administration and
pharmacy organization/management
Pharmacy operations, including the physical environment
Patient care programs and services
Clinical case management and quality programs
FDA (Food and Drug Administration) - ANS-responsible for ensuring the safety,
efficacy, and security of food, drugs, biologic products,, monoclonal antibodies,
radioactive products, medical devices, and cosmetics.
MedWatch - ANS-the FDA's medical product safety and adverse event reporting
program established to promote public safety
DEA (Drug Enforcement Administration) - ANS-established to enforce the Controlled
Substances Act of 1970 (CSA) and bring those involved in the illegal growing,
manufacturing, or distribution of controlled substances to the criminal and civil justice
systems... also recommends and supports programs aimed at reducing the availability
of illicit controlled substances on the domestic and international markets
APhA (American Pharmacists Association) - ANS-Their goal is to facilitate pharmacists'
delivery of the highest quality patient-centered care, the more classic definition of
professionalism became recognized.
to address the purity of drugs imported into the U.S - ANS-Why did Congress pass the
Drug Importation Act of 1848?
The Drug Importation Act of 1848 - ANS-empowered the U.S. Customs Service to
prevent the importation of adulterated drugs from other countries
What led to the establishment of the U.S. Food and Drug Administration (FDA)? - ANS-
The Pure Food and Drug Act of 1906
What Administration did the Pure Food and Drug Act of 1906 help establish? - ANS-
U.S. Food and Drug Administration (FDA)
, What act prevented the manufacture, sale, and transportation of adulterated,
misbranded (i.e., drug that makes false or misleading claims), or harmful drugs or
foods? - ANS-The Pure Food and Drug Act of 1906
What was preceded by the sulfanilamide tragedy of 1937 - ANS-Food, Drug, and
Cosmetic Act of 1938
What preceded the Food, Drug, and Cosmetic Act of 1938 - ANS-the sulfanilamide
tragedy of 1937
Which Act required premarketing safety testing - ANS-Food, Drug, and Cosmetic Act of
1938
What law required that drugs be labeled with adequate directions for safe use? - ANS-
Food, Drug, and Cosmetic Act of 1938
What law prohibited false therapeutic claims for drugs and authorized manufacturing
factory inspections - ANS-Food, Drug, and Cosmetic Act of 1938
What law mandated pre-market approval of all new drugs, such that a manufacturer
would have to prove to FDA that a drug was safe before it could be marketed and sold -
ANS-Food, Drug, and Cosmetic Act of 1938
What law explicitly defined 2 specific categories for medications, legend (i.e., requiring a
prescription) and over-the-counter. - ANS-Durham-Humphrey Amendment of 1951
What law defined prescription drugs as those unsafe for self-medication that should be
used only under a physician's supervision - ANS-Durham-Humphrey Amendment of
1951
What event led to the passage of the Kefauver-Harris Amendments of 1962 - ANS-The
thalidomide tragedy
The Kefauver-Harris Amendments of 1962 gave FDA the following authority: - ANS-
Required manufacturers to prove effectiveness of drug products before they are
marketed
Required manufacturers to report any adverse effects that occur post-marketing
Required evidence of effectiveness be based on adequate, well-controlled clinical
studies conducted by qualified experts
Required study subjects to give informed consent
Gave FDA 180 days to approve a new drug application
Required FDA to conduct a retrospective evaluation of the effectiveness of drugs
approved for safety (but not for effectiveness) between 1938 and 1962
Allowed FDA to set good manufacturing practices
Mandated regular inspections of production facilities
