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PHCY 609 Exam 3 Latest Update
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PHCY 609 Exam 3 Latest Update ...
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PHCY 609 Exam 3 LatestUpdate
Name the articles of the constitution which created each of the 3 main branches of the
federal government - Answer Article 1 for legislative, Article 2 for executive, article 3 for
judicial
Purpose of administrative agencies? - Answer regulatory body to assist in carrying out
the laws made by the legislative branch
Are administrative agencies made up of experts or members of the public? - Answer
Both, generally
What is the role of the legislature with respect to administrative agencies? - Answer
broadly define its scope, oversee its actions, use power of the purse as leverage
What are some administrative agencies relevant to pharmacy? - Answer NCBOP, DEA,
FDA, CDC, DHHS
Agencies are "____ ____ ____," and the scope of agencies are defined through the "____
____" - Answer creatures of statute; enabling statute
'rule' and 'regulation' are interchangeable (for the purposes of this course) (T/F) -
Answer T
Are the rules/regulations made by agencies enforceable? How? - Answer Yes, through
civil penalties and through suspension or revocation of licensure
Why is it a good thing administrative agencies have an easier time changing policy? -
Answer more limited scope of power, more expertise on hand to make evidence-based
decisions
What is the process for an administrative agency to make a new policy? - Answer
Majority of agency leaders agree to make a new rule, then there's at least 90-120 days
for public comment, the comments are read to the agency board and the leaders decide
whether to accept the policy, reject the policy, or revise the policy and put it back out
for public comment
What is one "check" on the legislative power of administrative agencies specific to NC?
- Answer Rules review commission of NC
The "____ ____ ____" procedure means that any proposed rule must be published for
public comment before accepting it - Answer notice and comment
, Who enforces rules created by administrative agencies if someone breaks them? -
Answer administrative agencies
How does someone become a member of an administrative agency? - Answer generally,
one is appointed by the executive branch (although in NC the legislature is attempting to
strip this power from the executive)
What judicial authority can the legislature have over administrative agencies? - Answer
Can hold public hearings; can decide to limit or expand an agency's authority
How might the judicial branch of government impact administrative agencies? - Answer
can rule whether administrative agencies acted outside their scope of authority as
defined by the legislature
NCBOP vs Rules Review Committee - Answer NCBOP rules that pharmacists cannot be
required to work >12 hrs/day or work >6 hrs without a 30 min lunch break; Rules review
commission said this was outside NCBOP's scope of authority; NCBOP appealed the
case and won in the NC Supreme Court
KV Pharmaceutical Company vs US FDA - Answer hydroxyprogesterone acetate had
been compounded to treat preterm birth off-label for years; KV pharma comes along
and gets it FDA approved with organ drug benefit and charges $1500/dose; local
compounders violated patent law and kept making the drug for cheap; KV pharma
alleged FDA was inadequately enforcing patent law; courts sided with FDA and said the
agency has the right to decide what rules/regulations to enforce given their limited
time/resources
What are the two main lawmaking responsibilities of the FDA? - Answer Promulgation of
rules under FD&C act; issuance of guidance documents
What are the two main lawmaking responsibilities of the DEA? - Answer promulgation of
rules under CSA; occasionally release guidance documents
responsibilities of CMS? - Answer administering and enforcing federal Medicare
program and the federal component of the Medicaid program, impacting both payment
conditions and some pharmacy practice requirements
State boards of pharmacies are created a ____ body and housed in a ____ body - Answer
legislative, executive
What is the #1 mission of a state board of pharmacy - Answer protect public health and
safety
How many members of the NCBOP board are pharmacists? members of the public? -
Answer 5, 1
How is the public member on the board of NCBOP chosen? - Answer appointed by the
governor
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