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
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
