Exam (elaborations)
Wisconsin MPJE 2024-25 (211 QUESTIONS WITH COMPLETE SOLUTIONS)
- Course
- Just Wisconsin
- Institution
- University Of Wisconsin-Madison
Wisconsin MPJE 2024-25 (211 QUESTIONS WITH COMPLETE SOLUTIONS)
[Show more]
Content preview
Wisconsin MPJE2024-25 (211
QUESTIONS
WITH COMPLETE
SOLUTIONS)
Pure Food and Drug Act - answer 1906 - Prohibited
drugs that were misbranded or adulterated, but
was difficult to enforce
Food Drug and Cosmetic Act - answer 1938 - Drugs
were required to be safe, defined drug and labeling
requirements. Established FDA. Passed in response
to sulfanilamide tragedy
Durham-Humphrey Amendment - answer 1951 -
Established OTC vs prescription drugs
,Kefauver-Harris Amendment - answer 1962 -
Passed in response to thalidomide tragedy.
Required drugs to be EFFECTIVE and safe.
Established GMPs and informed consent for
research subjects
Poison Prevention Packaging Act (& CR-packaging
exceptions) - answer 1970 - Established child-
resistant packaging
*a patient may request NCR-packaging for any/all
of Rxs
*prescribers can only request NCR on per-
prescription basis
Exceptions to child resistant packaging:
-nitroglycerin
-mnemonic packaging
-powders
-inhalers
-topicals
,Hatch-Waxman Act - answer 1984 - Streamlined
generic drug approval process and ANDA. Generics
must prove QUALITY and BIOEQUIVALENCE to
brand drugs
Prescription Drug Marketing Act - answer 1987 -
Prohibited sale of drug samples, re-imported drugs,
and resale of drugs by healthcare orgs. Required
state licensing of wholesalers
Omnibus Budget Reconciliation Act (OBRA) -
answer 1990 - Mandated for Medicaid patients:
prospective drug utilization review (DUR) and
patient counseling
Prescription Drug Use Fee Act - answer 1992 -
Allowed FDA to charge fees to manufacturers for
new drug approvals
Dietary Supplement Health and Education Act -
answer 1994 - Created "dietary supplements" -
regulated more like food than drugs. FDA
premarket approval not required but they may be
removed. Can make "structure/function" claims but
not "disease" claims
, FDA Modernization Act - answer 1997 - Created
fast-track approval processes, affirmed RPHs ability
to compound based on individual Rx (503A),
established Clinicalrials.gov
Combat Methamphetamine Epidemic Act - answer
2005 - Regulated methamphetamine precursors,
limited quantities to be sold, records of all sales,
sellers must self-certify with DEA
Drug Quality and Security Act - answer 2013 -
Created 503B to tighten sterile compounding
regulations, established track-and-trace processes
for all drugs, and electronic, interoperable system
to track drug products by 2023
Pharmacy Examining Board (PEB) - composition -
answer -7 WI residents: 5 pharmacist, 2 public
-Appointed by governor to a max of 2 consecutive
4-year terms
-Cannot be an officer of a private pharmacy org
-Located with DSPS
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller GUARANTEEDSUCCESS. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $12.99. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
73314 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now