Texas MPJE 2023-2024 Exam. Real Exam
Questions and Correct, Verified
Answers. Graded A+
2 types of remote pharmacy services using telepharmacy systems - ANSremote
healthcare sites and remote dispensing sites
a provider pharmacy cant supervise more than two remote sites
perpetual inventory of all CDS is required!! annual inventory done when provider
pharmacy is doing theirs
application to TSBP is required
2-letter coding system in FDA orange book - ANSNo bioequivalence issues:
- AA: conventional dosage forms
- AN: solution and powder for aerosolization
- AO: injectable oil solution
- AP: injectable aqueous solution
- AT: topical
Products w actual or potential bioequivalence problems, but adequate scientific
evidence has established bioequivalence - AB
AB1 and AB2 would not be bioequivalent to each other
4 types of remote pharmacy practices - ANS-emergency medication kits at nursing
homes
-automated pharmacy systems for routine dispensing at healthcare facilities
-telepharmacy systems for remote sites
-automated dispensing and delivery systems outside of a pharmacy
Records or all drugs sent/returned should be kept separate from the provider
pharmacy's other records and other remote site's records
5% (503A pharmacy) - ANSlimits interstate distribution of compounded drugs to 5%
unless located in a state that has entered into a memorandum of understanding with
FDA (texas does not have)
5% rule (CDS) - ANSPharmacies can distribute up to 5% of annual controlled substance
doses dispensed without registering with DEA as a distributor
503A Facility or Pharmacy - ANSCompounds pursuant to an individual RX order
Follows USP 797 (not GMP)- regulated by states
- anticipatory compounding
- NOT registered with FDA as outsourcing facility
,503B Facility or Pharmacy - ANSOutsourcing facility for compounded medications,
follows GMPs
A# are drug products the FDA considers to be _______ equivalent and _______
equivalent - ANSpharmaceutical and therapeutically
Additional labeling requirements for prescriptions at a telepharmacy - ANSProviding
pharmacy name, address, number
Additional labeling requirements of compounded prescriptions - ANSThat is has been
compounded, active ingredients
Additional labeling requirements of sterile prescriptions - ANSBeyond use date, active
ingredient
Additional required material for compounding pharmacy - ANSClass-A balance or
analytical balance with weights
balance must be registered with TSBP and shall be inspected by the board for accuracy
Additional requirement for prescriptions from an APRN or PA - ANSSupervising
physician name, address, phone number, identifying number
Additional requirement for verbal/electronic prescriptions with dispensing directive that
brand is necessary for Medicaid patients - ANSMust mail/fax written prescription within
30 days
Adulteration - ANSActual contents of product is below standard or is unsafe.
Adulteration - ANScontains filthy, putrid, or decomposed substance, prepared or held in
unsanitary conditions, manufacturing methods dont conform to GMP, container is
composed of poisonous substance, has unsafe color additive, different strength, mixed
or packed with substance that reduces strength and quality
expired drug
counting on tray that has residue
inadequate temperature control
Adultered and misbranded - ANSExpired drug with false exp date
Strength different
Not tamper evident packaging
advertising of drug compounding - ANSmay advertise that it offers the service including
that it compounds specific products but cant make any therapeutic claims
advertising of drug prices - ANS"reminder advertising"
exempt from FDA regulations if the following is met:
- only purpose is to provide price
,-contains brand, generic, strength, dosage form, price charged for a specific quantity
-may include other services (delivery available)
-price should include all charges including delivery (must be separated from drug price)
After administering vaccine on protocol - ANSNotify protocol physician within 24 hours
Notify PCP within 14 days
Age limit for vaccines - ANSUnder Age 14: services provided with physician referral
7 and up: can give *flu* vaccine WITHOUT physician-pt relationship
Age to buy Pseudophed - ANS16 years old
Alcohol and Tobacco Tax Trade Bureau (TTB) - ANSIssues permits for tax free alcohol
for pharmacies that use 95% ethanol for compounding (for a
scientific/medicinal/mechanical purpose)
cannot be resold or used in any beverage
ATF enforces the regulations
alcohol warning - ANSInternal analgesics & antipyretics including: ASA, APAP, IBU,
naproxen, ketoprofen, etc. are req' to warn consumers to consult Dr before taking these
drugs if they consume 3 or more alcoholic beverages per day
Allowable physician dispensing - ANS72 hour supply of dangerous drug, rural areas,
veterinarians
Allowed PHI disclosures - ANSProviding treatment, receiving payment, health care
operations, government functions including FAERs, AWARxE. Marketing purposes must
have singed authorization from patient
Allowed retakes of MPJE or NAPLEX - ANS4 each (5 attempts total)
Amount of time supplier has to send remaining CII order - ANS60 days
Amount of time TSBP must give license holder to comply with complaint - ANSno fewer
than 10 days (unless the public is in imminent danger)
animal drugs - ANSFDA regulates if it is rx or otc
rx can only be dispensed by a licensed vet and must have legend that federal law
restricts this drug to use by order of a vet
vets can prescribed human drugs too off-label
any iron in a solid dosage form OTC warning - ANS"accidental overdose of iron
containing products is the leading cause of fatal poisoning in children under 6. keep out
of reach of children. call MD or poison control center immediately in case of accidental
overdose"
, APAP OTC warning - ANSmust have acetaminophen prominently displayed
must warn about liver toxicity
must warn not to use with other products that have APAP and to consult before taking
with warfarin
are accelerated refills okay to give for a dangerous drug - ANSyes up to 90 days if the
number of refills allow up to that
can't be a controlled substance
MD must be notified
patient is at least 18 years old
not a psychotropic drug
are refills allowed on radioactive prescriptions? - ANSno
As of June 2019, preceptors do not have to publicly display licenses - ANS--
automatic revocation of license - ANSregistered sex offender
use of threat or force
offense committed while in the course of providing services to a patient
B# are drug products the FDA considers to ____ be _______ equivalent and _______
equivalent - ANSNOT, pharmaceutical, therapeutically
BUD of things made in a segregated compounding area - ANS12 hours (room temp or
fridge)
C-I list - ANSHIGH potential for abuse and SEVERE potential for dependence.
Opiate derivatives (heroin, dihydromorphine), marijuana, LSD, peyote, mescaline,
methaqualone
C-II list - ANSHIGH potential for abuse which may lead to SEVERE dependence.
Narcotics, cocaine, stimulants, amobarbital, secobarbital, pentobarbital
C-III list - ANSLOWER potential for abuse than CII and may lead to MODERATE or
LOW physical dependence or HIGH psychological dependence.
Anabolic steroids, ketamine, C-II barbituate suppositories, buprenorphone, codeine up
to 90mg/dose, opium combo up to 25mg/dose
C-IV list - ANSBZDs, carisoprodol, modafinil, phentermine, phenobarbital, tramadol
Questions and Correct, Verified
Answers. Graded A+
2 types of remote pharmacy services using telepharmacy systems - ANSremote
healthcare sites and remote dispensing sites
a provider pharmacy cant supervise more than two remote sites
perpetual inventory of all CDS is required!! annual inventory done when provider
pharmacy is doing theirs
application to TSBP is required
2-letter coding system in FDA orange book - ANSNo bioequivalence issues:
- AA: conventional dosage forms
- AN: solution and powder for aerosolization
- AO: injectable oil solution
- AP: injectable aqueous solution
- AT: topical
Products w actual or potential bioequivalence problems, but adequate scientific
evidence has established bioequivalence - AB
AB1 and AB2 would not be bioequivalent to each other
4 types of remote pharmacy practices - ANS-emergency medication kits at nursing
homes
-automated pharmacy systems for routine dispensing at healthcare facilities
-telepharmacy systems for remote sites
-automated dispensing and delivery systems outside of a pharmacy
Records or all drugs sent/returned should be kept separate from the provider
pharmacy's other records and other remote site's records
5% (503A pharmacy) - ANSlimits interstate distribution of compounded drugs to 5%
unless located in a state that has entered into a memorandum of understanding with
FDA (texas does not have)
5% rule (CDS) - ANSPharmacies can distribute up to 5% of annual controlled substance
doses dispensed without registering with DEA as a distributor
503A Facility or Pharmacy - ANSCompounds pursuant to an individual RX order
Follows USP 797 (not GMP)- regulated by states
- anticipatory compounding
- NOT registered with FDA as outsourcing facility
,503B Facility or Pharmacy - ANSOutsourcing facility for compounded medications,
follows GMPs
A# are drug products the FDA considers to be _______ equivalent and _______
equivalent - ANSpharmaceutical and therapeutically
Additional labeling requirements for prescriptions at a telepharmacy - ANSProviding
pharmacy name, address, number
Additional labeling requirements of compounded prescriptions - ANSThat is has been
compounded, active ingredients
Additional labeling requirements of sterile prescriptions - ANSBeyond use date, active
ingredient
Additional required material for compounding pharmacy - ANSClass-A balance or
analytical balance with weights
balance must be registered with TSBP and shall be inspected by the board for accuracy
Additional requirement for prescriptions from an APRN or PA - ANSSupervising
physician name, address, phone number, identifying number
Additional requirement for verbal/electronic prescriptions with dispensing directive that
brand is necessary for Medicaid patients - ANSMust mail/fax written prescription within
30 days
Adulteration - ANSActual contents of product is below standard or is unsafe.
Adulteration - ANScontains filthy, putrid, or decomposed substance, prepared or held in
unsanitary conditions, manufacturing methods dont conform to GMP, container is
composed of poisonous substance, has unsafe color additive, different strength, mixed
or packed with substance that reduces strength and quality
expired drug
counting on tray that has residue
inadequate temperature control
Adultered and misbranded - ANSExpired drug with false exp date
Strength different
Not tamper evident packaging
advertising of drug compounding - ANSmay advertise that it offers the service including
that it compounds specific products but cant make any therapeutic claims
advertising of drug prices - ANS"reminder advertising"
exempt from FDA regulations if the following is met:
- only purpose is to provide price
,-contains brand, generic, strength, dosage form, price charged for a specific quantity
-may include other services (delivery available)
-price should include all charges including delivery (must be separated from drug price)
After administering vaccine on protocol - ANSNotify protocol physician within 24 hours
Notify PCP within 14 days
Age limit for vaccines - ANSUnder Age 14: services provided with physician referral
7 and up: can give *flu* vaccine WITHOUT physician-pt relationship
Age to buy Pseudophed - ANS16 years old
Alcohol and Tobacco Tax Trade Bureau (TTB) - ANSIssues permits for tax free alcohol
for pharmacies that use 95% ethanol for compounding (for a
scientific/medicinal/mechanical purpose)
cannot be resold or used in any beverage
ATF enforces the regulations
alcohol warning - ANSInternal analgesics & antipyretics including: ASA, APAP, IBU,
naproxen, ketoprofen, etc. are req' to warn consumers to consult Dr before taking these
drugs if they consume 3 or more alcoholic beverages per day
Allowable physician dispensing - ANS72 hour supply of dangerous drug, rural areas,
veterinarians
Allowed PHI disclosures - ANSProviding treatment, receiving payment, health care
operations, government functions including FAERs, AWARxE. Marketing purposes must
have singed authorization from patient
Allowed retakes of MPJE or NAPLEX - ANS4 each (5 attempts total)
Amount of time supplier has to send remaining CII order - ANS60 days
Amount of time TSBP must give license holder to comply with complaint - ANSno fewer
than 10 days (unless the public is in imminent danger)
animal drugs - ANSFDA regulates if it is rx or otc
rx can only be dispensed by a licensed vet and must have legend that federal law
restricts this drug to use by order of a vet
vets can prescribed human drugs too off-label
any iron in a solid dosage form OTC warning - ANS"accidental overdose of iron
containing products is the leading cause of fatal poisoning in children under 6. keep out
of reach of children. call MD or poison control center immediately in case of accidental
overdose"
, APAP OTC warning - ANSmust have acetaminophen prominently displayed
must warn about liver toxicity
must warn not to use with other products that have APAP and to consult before taking
with warfarin
are accelerated refills okay to give for a dangerous drug - ANSyes up to 90 days if the
number of refills allow up to that
can't be a controlled substance
MD must be notified
patient is at least 18 years old
not a psychotropic drug
are refills allowed on radioactive prescriptions? - ANSno
As of June 2019, preceptors do not have to publicly display licenses - ANS--
automatic revocation of license - ANSregistered sex offender
use of threat or force
offense committed while in the course of providing services to a patient
B# are drug products the FDA considers to ____ be _______ equivalent and _______
equivalent - ANSNOT, pharmaceutical, therapeutically
BUD of things made in a segregated compounding area - ANS12 hours (room temp or
fridge)
C-I list - ANSHIGH potential for abuse and SEVERE potential for dependence.
Opiate derivatives (heroin, dihydromorphine), marijuana, LSD, peyote, mescaline,
methaqualone
C-II list - ANSHIGH potential for abuse which may lead to SEVERE dependence.
Narcotics, cocaine, stimulants, amobarbital, secobarbital, pentobarbital
C-III list - ANSLOWER potential for abuse than CII and may lead to MODERATE or
LOW physical dependence or HIGH psychological dependence.
Anabolic steroids, ketamine, C-II barbituate suppositories, buprenorphone, codeine up
to 90mg/dose, opium combo up to 25mg/dose
C-IV list - ANSBZDs, carisoprodol, modafinil, phentermine, phenobarbital, tramadol
