PHP307 - the legal system latest updated questions and answers 2025

reasons for increasing regulations on drugs

- prescription drug monitoring programs (PMP/PDMP)

- compounding

- hazardous medications

- technician responsibilities

- prescribing by pharmacist

reasons to decrease regulations on drugs

- more OTC products

- over the counter kits (think covid, HIV, and pregnancy)

- oral contraceptives

- increased number of prescribers (NP, PA, PharmD)

what does the US government being a tripartite system mean?

has three parts (legislative, judicial, and executive)

T/F - pharmacy is one of the most regulated professions

True

Where do US Congress (federal) laws apply?

in interstate commerce, the federal government ALWAYS wins over the states

where do state laws apply?

regulated on state level, what is allowed in one state may not be allowed in another state

how is the federal level run?

- laws by Congress or state legislative bodies

- regulation by federal and state agencies

- courts have the judicial law

who are laws interpreted by?

administrative agencies that are housed in the executive branch

examples of administrative agencies

DEA, NIH, FDA

why are administrative agencies created?

to oversee the laws

examples of agencies that impact us?

Board of Pharmacy, CDC, DOH, FDA, DEA, Office of the Inspector General, CMS, etc

what are the validity tests of a regulation?

1. within the scope of an agency's authority

2. based upon statutory authority

3. reasonable relationship to public health, safety, and welfare

what does regulations enacted via notice and comment rule-making mean? example?

whoever gets the regulation needs to be within the scope of that pharmacy; the Board of Pharmacy cannot regulate how pharmacists dress

where does the FDA publish to add a labeling requirement?

the Federal Register

what does the FDA have to publish in the Federal Register?

- the proposed regulations outlining the change

- a notice of intent to enact this regulation

FDA reasons for proposing the regulation

- a number would be included that would indicate where in the CFR it would be located if enacted

- the notice would invite public comment by a certain date

- at the end of the comment period the FDA would review the comments and draft final regulations

- the final regulations, agency's comments and effective date in the federal register

what code of federal regulations is the FDA?

Title 21

What happens when a rule gets broken? example?

they are enforced by law; not renewing intern license and continuing to practice

when are agency decisions subject to judicial review?

after exhausting all legal remedies at the legislative level

what does the board of pharmacy do?

regulates the practice of pharmacy in the states

what is the mission of the board of pharmacy?

to protect the public

T/F - the board of pharmacy is only made up of pharmacists

False, it is made up of pharmacists, consumers, etc

T/F - license revocation may serve as the basis for revocation in another state

True

T/F - you can sue your doctor for breaching confidentiality

False

what is stare decisis?

let the decision stand

what is judicial opinions?

enforceable as law, binding on lower courts in the same jurisdiction

what is summary judgement?

final ruling by the judge in favor of one party based on the evidence disclosed by discovery

what is the role of the pharmacist in summary judgement?

dispensing only

National Association of Boards of Pharmacy oversees what?

the standardized licensure exam process (NAPLEX, MPJE, CE monitor)

what medication heads the short list of prescription drugs other than opioids and benzodiazepines with substantial black market abuse potential?

gabapentin

Define accreditation

the action of process of officially recognizing someone or something as having a particular status or being qualified to perform a particular activity

T/F: you can sit for pharmacy boards if you don't graduate from an accredited pharmacy program

False, you must graduate from an accredited program to sit for boards

When federal and state law conflict, federal law will preempt state law under the ________ clause of the U.S. Constitution

Supremacy

T/F - conflicts generally exist when state law is less strict than federal law.

true

federal authority to regulate drugs generally arises from the _______ Clause

Interstate Commerce Clause

State authority to regulate generally derives from the _______ and under its inherent police powers.

10th amendment

State regulations must bear a reasonable relationship to the _________, ____________, and _____________ and must be in the ___________ of the agency as given by statutory authority.

public health, safety, welfare, and scope