question
agencies are created by ____ (or, at the state level, in the _____), but housed in the ____
answer
created by congress (state level = state legislature), housed in the executive branch
question
the design of congress is to
answer
gridlock
question
agencies are created by (the body and the regulation)
answer
statutes, enacted by congress (federal) or legislature (state)
question
why do we need administrative agencies
answer
to act as experts in specialized fields; want people who understand the field to bring their expertise
question
_____ builds the framework, ____ put in all the details
answer
legislatures build the framework, agencies pull all the details
question
____ bodies are general bodies
answer
legislative
question
what defines an "expert" for an administrative agency
answer
people who have experience in that area or specific knowledge of the field
question
T/F: in order to be an expert in an administrative agency, regardless of the topic, you have to have some type of legal background
answer
false; experts are not necessarily legal experts
question
agencies are "creatures of ____"
answer
statute
question
administrative agencies owe its existence to _____, who establish ____
answer
existence to legislatures, who establish its scope of authority
question
what things do legislatures tell/establish for agencies (2)
answer
scope of authority
the steps you must do when you are exercising this authority
the steps you must do when you are exercising this authority
question
an agency's authority is defined and limited by ____ in the ____
answer
by legislature in the enabling statute
question
"an agency must exercise its authority following ______ prescribed by the ____"
answer
following the legislature's procedures prescribed by the legislature
question
who is responsible for "filling in the gaps" needed to implement a statutory scheme
answer
administrative agencies
question
T/F: the subject of the rule making does not have to be within the agency's statutory authority
answer
false; it must be within their authority
question
is it more difficult or easier to pass a law at the federal level (why)
answer
difficult, because it's designed to week out massive amounts of terrible ideas
question
what established the notice and comment procedure
answer
the federal Administrative Procedure Act
question
where is an agency's proposed rule posted for comment (federal and state)
answer
Federal = Federal Registrar
NC = NC registrar and agency's website
NC = NC registrar and agency's website
question
3 ways the notice and comment procedure can occur
answer
1) agencies may decide to publish proposed rules
2) They may be required to do so by legislative action
3) Petition by a member of the public
2) They may be required to do so by legislative action
3) Petition by a member of the public
question
who are usually the ones that comment on the proposed rule set forth by an agency
answer
people woh have a specific interest
question
what must an agency do if its proposed rule garners comments
answer
must address comments in a final decision to adopt, reject, or amend the proposed rule
question
in NC, once an agency adopts a rule, what occurs
answer
it goes through a second review by an oversight agency (NC = rules review commission)
question
In NC, if parties are unhappy with a rule adopted by the agency, what can they do
answer
suspend the agency's operation by filing enough objections to trigger state legislative review
question
T/F: an agency's rule making procedural compliance is not typically strictly enforced
answer
false; it is typically strictly enforced
question
____ makes the law (pharmacy)
____ enforced the law
____ has the power to interpret and define the law
____ enforced the law
____ has the power to interpret and define the law
answer
BOP, BOP, BOP
question
disadvantages of having judicial power within the BOP
answer
there is a lot of power within a single body, since the BOP also makes and enforces the law
very limited opportunity for anyone other than the charged party to be hear
very limited opportunity for anyone other than the charged party to be hear
question
In terms of the BOP, what type of lawmaking do they do
answer
Quasi-judicial lawmaking
question
who approves the members of administrative agencies in the executive branch
answer
Governor (state)
President (feral)
President (feral)
question
purpose of executive branch (in scope of this lecture)
answer
agency member appointments and agenda setting
question
purpose of legislative branch
answer
legislative changes, oversight, and funding
question
purpose of judicial branch
answer
court of review of an agency's exercise of authority
question
if the legislature thinks an administrative agency is not working the way they want, what can they do
answer
can destroy/take away the powers of the administrative agency (pass laws expanding their authority)
can take money away from the administrative agency (power of the purse)
can take money away from the administrative agency (power of the purse)
question
enforcement priority decision
answer
determine if a decision is one that should be enforced at all times
question
T/F: guidance documents have the force and effect of law
answer
false
question
FDA responsible for
answer
administering and enforcing the Food Drug and Cosmetic act (which drugs get to market, under what conditions, regulation of purity and quality of drugs, regulation of drug marketing)
question
commissioner of the FDA appointed by
answer
the preseident
question
DEA responsible for
answer
administering and enforcing the controlled substances act
question
FDA promulgation of rules under
answer
the Food drug and cosmetic act
question
DEA promulgation of rules under the
answer
CSA (controlled substances Act)
question
center of medicare and medicaid services (CMS) responsible for
answer
administering and enforcing federal medicare program and federal component of the medicare and medicaid programs
question
CMS impacts both ___ and ___
answer
payment conditions and some pharmacy practice requirements
question
lawmaking authority of the CMS
answer
promulgation of rules, issuance of guidance documents
question
T/F: CMS is the only federal agency that issues guidance documents
answer
False
FDA, DEA, and CMS all issue guidance documents on the federal level
FDA, DEA, and CMS all issue guidance documents on the federal level
question
federal agencies
answer
FDA
DEA
CMS
DEA
CMS
question
state agency
answer
BOPs
question
state boards of pharmacy are administrative agencies, created by a _____, but housed in a _____
answer
created by a legislative body, but housed in an executive body
question
BOP serves what one function
answer
protect the public health and safety
question
membership of BOP in other states v. NC
answer
other states: all board members appointed directly by the governor
NC: hybrid, 5 elected members and 1 public member appointed
NC: hybrid, 5 elected members and 1 public member appointed
question
who appoints the members of the NC BOP
answer
5 pharmacist members -- electect
one public member -- appointed by gov
one public member -- appointed by gov
question
requirement to be an elected member of NC BOP
answer
must be a licensed pharmacist in NC and a resident of the state when elected and throughout their term
question
terms for NC BOP elected memebrs
answer
no more than two consecutive 5 year terms
question
T/F: the governor is allowed to remove a board member of the BOP
answer
true; can do so for "good cause"
question
3 major subroles of the BOP
answer
licensing of pharmacists
Permitting of pharmacies
Discipline
Permitting of pharmacies
Discipline
question
what does permitting of pharmacies mean in terms of the BOP
answer
does a place where pharmacy services will be provided to the public have requisite physical facilities, equipment, etc. to properly and safely allow pharmacy care delivery?
question
which is easier to make laws: federal or administrative level
answer
administrative
question
FYI: the courts do not entertain cases to 2nd guess an agents authorities (say ok
answer
ok
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