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PTCB HEALTHCARE REGULATORY AGENCIES ACTUAL EXAM 2025, 127 QUESTIONS WITH ACCURATE SOLUTIONS

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1. What is the primary purpose of the Orphan Drug Act of 1982? To regulate the pricing of pharmaceuticals To provide tax incentives and exclusive licensing for orphan medications To oversee the approval process for all new drugs To manage controlled substances in healthcare 2. The Poison Prevention Packaging Act of 1970 requires that packaging cannot be opened by 80% of ______ but can be opened by 90% of ______ adults; children children; elderly elderly; children children; adults 3. What significant legislation established the requirement for new drug applications to be submitted to the FDA? Omnibus Budget Reconciliation Act Food, Drugs, and Cosmetic Act of 1938

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PTCB HEALTHCARE REGULATORY AGENCIES
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PTCB HEALTHCARE REGULATORY AGENCIES

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PTCB HEALTHCARE REGULATORY AGENCIES ACTUAL EXAM 2025,
127 QUESTIONS WITH ACCURATE SOLUTIONS



1. What is the primary purpose of the Orphan Drug Act of

1982? To regulate the pricing of

pharmaceuticals

To provide tax incentives and exclusive licensing for
orphan medications
To oversee the approval process for all new

drugs To manage controlled substances in

healthcare

2. The Poison Prevention Packaging Act of 1970 requires that
packaging cannot be opened by 80% of ______ but can be opened by
90% of ______
adults; children

children;

elderly elderly;

children

children; adults

3. What significant legislation established the requirement for new
drug applications to be submitted to the FDA?

, Omnibus Budget Reconciliation Act
Food, Drugs, and Cosmetic Act of 1938
Anabolic Steroid Control

Act Americans with

Disabilities Act

4. Identify a feature of the Americans with Disabilities Act (ADA) of
1990.
It requires organizations to make "reasonable accommodation"
to a qualified person who is disabled.
It has created a specific set of guidelines regarding the type
of accommodations that companies should make to avoid
violating

, the ADA.
It does not prohibit companies from discriminating against
employees who have been with them for less than 3 months.
It requires employers to provide reasonable accommodation
even if employees do not ask for it.

5. If a state Medicaid agency fails to implement the drug utilization
review process as required by OBRA-90, what potential
consequence might it face?
Increased federal funding for healthcare services.
Loss of Medicaid funding for the state.
Mandatory audits by the FDA.
Legal action from pharmaceutical companies.

6. What does the Freedom of Choice law allow members of a
prescription drug plan to do?
Select any pharmacy that is part of the plan's network
Choose any pharmacy as long as it agrees to the plan's terms
Only use mail-order pharmacies for prescriptions
Obtain prescriptions from out-of-state pharmacies without
restrictions

7. Under a state law, health plans and PBMs must accept into their
networks any pharmacy willing to accept their terms and conditions.
This describes
A freedom of choice law

, An any willing provider
A network substitution

law A broad network

law

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Institution
PTCB HEALTHCARE REGULATORY AGENCIES
Course
PTCB HEALTHCARE REGULATORY AGENCIES

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