PTCB Exam 2022Federal Requirements with
complete solutions
The State Board of Pharmacy
establish state specific pharmacy laws and regulations
The FDA
The agency that is responsible for determining if a food or drug is safe and effective enough to be sold
to the public.
The DEA
The agency that enforces the federal Controlled Substance Act (CSA) and classified drugs as controlled
substances.
OSHA
The agency in the Department of Labor to maintain a safe and healthy work environment
Federal Trade Commission (FTC)
a federal agency established in 1914 to investigate and stop unfair business practices (advertising)
Vitamins and herbal supplements are classified as
Food substances
Poison Prevention Packaging Act of 1970 (PPPA)
• Designed to reduce the risk of children ingesting dangerous substances.
• Required locking caps on most prescriptions
Omnibus Budget Reconciliation Act of 1990 (OBRA '90)
requires pharmacist to perform DURs and offer counsel to Medicaid patients
(Try to remember the phrase "Oh... Bruh!" Like something is wrong and you need to call your friend to
answer or fix something)
HIPPA
-Health Insurance Portability and Accountability Act of 1996
-protects the privacy and security of patient medical records and information
Federal Food, Drug, and Cosmetic Act (FFDCA)
a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration
(FDA) to oversee the safety of food, drugs, and cosmetics.
Schedule I Controlled Substances
A HIGH ABUSE POTENTIAL AND "NO ACCEPTED MEDICAL USE"
Schedule II Controlled Substances
High abuse potential leading to:
complete solutions
The State Board of Pharmacy
establish state specific pharmacy laws and regulations
The FDA
The agency that is responsible for determining if a food or drug is safe and effective enough to be sold
to the public.
The DEA
The agency that enforces the federal Controlled Substance Act (CSA) and classified drugs as controlled
substances.
OSHA
The agency in the Department of Labor to maintain a safe and healthy work environment
Federal Trade Commission (FTC)
a federal agency established in 1914 to investigate and stop unfair business practices (advertising)
Vitamins and herbal supplements are classified as
Food substances
Poison Prevention Packaging Act of 1970 (PPPA)
• Designed to reduce the risk of children ingesting dangerous substances.
• Required locking caps on most prescriptions
Omnibus Budget Reconciliation Act of 1990 (OBRA '90)
requires pharmacist to perform DURs and offer counsel to Medicaid patients
(Try to remember the phrase "Oh... Bruh!" Like something is wrong and you need to call your friend to
answer or fix something)
HIPPA
-Health Insurance Portability and Accountability Act of 1996
-protects the privacy and security of patient medical records and information
Federal Food, Drug, and Cosmetic Act (FFDCA)
a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration
(FDA) to oversee the safety of food, drugs, and cosmetics.
Schedule I Controlled Substances
A HIGH ABUSE POTENTIAL AND "NO ACCEPTED MEDICAL USE"
Schedule II Controlled Substances
High abuse potential leading to:
