Exam (elaborations)
Kansas MPJE Exam Edition. All Questions and Correct, Verified Answers. Graded A+
- Course
- Institution
Kansas MPJE Exam Edition. All Questions and Correct, Verified Answers. Graded A+
[Show more]
Seller
Follow
wilfredmburuUS
Content preview
Kansas MPJE Exam 2023-2024 Edition.All Questions and Correct, Verified
Answers. Graded A+
"Adequate directions for use" - ANSLabeling requirements for OTC Drugs
"Adequate information for use" - ANSLabeling requirements for Rx Drugs
> Aka the Prescription Drug Amendment
> Established 2 classes of drugs, prescription and OTC
> Labels of prescription drugs need not contain "adequate directions for use" so long as
they contained the legend, "Caution: Federal law prohibits dispensing without a
prescription."
> Authorizes oral prescriptions and refills of prescription drugs - ANSDurham-Humphrey
Amendment of 1951
> Aka Waxman-Hatch Amendment
> ANDA process initiated
> Patent extensions, in certain cases to innovator drugs
> Intent: make generic drugs more readily available to the public and, at the same time,
provide incentives for manufacturers to develop new drugs - ANSDrug Price
Competition and Patent Term Restoration Act of 1984
> Authorized the FDA to ban individuals or firms from participating in the drug approval
process if convicted of related felonies
> Also imposes severe civil penalties for any false statements, bribes, failures to
disclose material facts, and other related offenses - ANSThe Generic Drug Enforcement
Act of 1992
> Blocks re-importation of exported US drugs
> Bans the sale, purchase, or trade of drug samples
> Prohibits hospitals and other health care entities from reselling their drug purchases to
other businesses (exceptions)
> Requires the state licensing of drug wholesalers - ANSPrescription Drug Marketing
Act of 1987
> Defined dietary supplements and permit manufacturers to make certain claims that
otherwise would have been illegal under the FDCA
> Forced the FDA to regulate dietary supplements more as foods than as drugs -
ANSDietary Supplement Health and Education Act of 1994 (DSHEA)
> Expedited availability of safe and effective drugs and devices
> Changed "legend" to "Rx only"
,> Fast-track approval process for serious or life-threatening diseases
> Expands the rights of manufacturers to disseminate unlabeled use information
> Expands the FDA's authority of OTC drugs and establishes ingredient-labeling
requirements for inactive ingredients - ANSFood and Drug Administration Modernization
Act of 1997 (FDAMA)
> Mandates nutrition labeling on food products and authorizes health claims on product
labeling, as long as they are made in compliance with FDA regulations> - ANSNutrition
Labeling and Education Act of 1990
> No new drug, cosmetic, or device could be marketed until proven safe
> Labels must contain adequate directions for use and warnings about the habit-forming
properties of certain drugs. - ANSFood, Drug, and Cosmetic Act of 1938 (FDCA)
> Provided for more extensive regulation and administrative authority regarding the
safety and efficacy of medical devices by requiring:
- Classification of devices according to their function
- Premarket approval
- Establishment of performance standards
- Conformance with GMP regulations
- Adherence to record and reporting requirements - ANSMedical Device Amendments
of 1976 (MDA)
> Required that drugs be proved not only safe, but also effective
> Established Good Manufacturing Practices (GMP) requirements
> Required informed consent of research subjects and reporting of adverse drug
reactions
> Retroactive to all drugs marketed b/w 1938 and 1962 - ANSKefauver-Harris
Amendment of 1962
> Requires manufacturers to pay fees for applications and supplements when the FDA
must review clinical studies
> The fees provide the FDA with the resources to hire more reviewers to assess these
clinical studies and hopefully speed up the NDA reviews - ANSPrescription Drug User
Fee Act of 1992 (PDUFA)
>3.6g of base per purchaser per day
>9g per purchaser per 30 days
>7.5g per purchaser per 30 days if over mail order - ANSCombat Meth...Act of 2005 -
Sales Limits
>All the normal stuff, plus date it was delivered to the retail pharmacy and method of
how it was delivered - ANSCentral Fill - Filling Site : C-II Rx
>Allows the FDA broader use of the fees generated from PDUFA, while substantially
increasing the fees
,>Provides the FDA with significantly enhanced responsibilities and authority to regulate
drug safety, including to:
- Mandate labeling changes related to safety
- Require clinical trial data reporting and registries
- Require post-market (phase 4) clinical studies to assess risks
- Require companies to implement risk evaluation and mitigation strategies (REMS)
when necessary - ANSFood and Drug Administration Amendments Act of 2007
(FDAAA)
>At least 14 days prior
>Return unused 222 Forms - ANSDEA : Transferring Pharmacy Time Frame
>C-II : only for narcotic parentral pain, pt in LTCF, pt in a Medicare certified hospice
care - ANSFaxed orders for Controlled Substances
>C-III : Not > 1.8g per 100ml or 90mg per dosage unit with at least 1 other non narcotic
drug
>C-V : Not > 200mg or any salts per 100ml or 100g - ANSCodeine Scheduling
>Called MedWatch (drugs) & VAERS (vaccines)
>Mandatory for Industry
>Voluntary for Practitioners, Lay Public - ANSFDA Post Marketing Surveillance
>Can be endorsed to another supplier, but must send all drugs to that new supplier -
ANSDEA-222 Form - What if Supplier can't supply Drug?
>Class 1 : Serious adverse health/death
>Class 2 : temporary or reversible
>Class 3 : adverse health not likely - ANSClasses of Drug Recalls
>Community Pharmacy - buy with tax 190 proof alcohol from wholesalers for
compounding
>Hospital Pharmacy - buy tax free, compounding for inpatients only, not sold or
distributed off premises - ANSAlcohol Federal Regulations
>Copy 1 - Suppliers (brown)
>Copy 2 - DEA (green)
>Copy 3 - Purchaser (blue) - ANSDEA-222 Form - 3 Copies go to whom?
>Current copy of Kansas Pharmacy Practice Act, Kansas Uniform Controlled
substances Act, and regulations for both acts
>Drug Information Reference
>Reference in Toxicology, Pharmacology, and Drug Interactions
>Reference on drug equivalencies
>Medical Dictionary - ANSMinimum Requirements for a Pharmacy Library
, >Duty of PIC to setup and maintain
>Any reportable incident
>Kept for 5 years
>PIC must meet quarterly with Continuous Quality Improvement Program to go over
incidents and steps to correct and prevent - ANSIncident Reports
>Enforced by the Consumer Product Safety Commission
>Defines tamper resistant vs Child resistant
>Failure to abide by child resistant packaging is misbranding - ANSPoison Prevention
Packaging Act (1970)
>Exact count of C-II, hydrocodone, and any CS in a container over 1000 doses
>Estimated count of C-III thru C-V in containers less than 1000 - ANSCS Inventory
Exact vs Estimated Counts
>Federal Register - daily updates to laws
>CFR - Final year end copy of Federal Register - ANSFederal Register vs. Code of
Federal Regulations (CFR)
>For Medicaid Patients
>Prospective DUR
>Maintaining adequate medical records
>Counseling
>Lower cost back to state - ANSOmnibus Budget Reconciliation Act (1990)
>Form 224a
>Renewal every 3 years - ANSPharmacy DEA Renewal Form
>Form 225
>Pharmacy may stay a dispenser if they keep sales to other registrants under 5% of
their sales - ANSApplication as a Manufacturer
>Immediate use : intended for immediate use
>Low : Single transfer of sterile dosage forms. Manually measuring and mixing no more
than 3 manufactured products into IV
>Medium : TPN's or more than 3 injections
>High : Non-sterile bulk drug that will be terminally sterilized - ANSUSP <797> Sterile
Preparation Levels
>Importers must be DEA registered
>Must have a legitimate doctor/patient relationship
>VIPPS - Verified Pharmacy Practice Sites - ANSInternet Dispensing of CS
>Kept for 5 years (KS Law)
>Maintained Separate from Others
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 wilfredmburuUS. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $20.49. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
77254 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now
Recently viewed by you
Exam (elaborations) ·
NHA CBCS CERTIFICATION Exam | Questions & 100% Correct Answers (Verified) | Latest Update | GradeA+
