North Carolina MPJE 2024 Edition. All
Questions and Correct Answers. Graded
A+
150 RX/Day Rule - ANSIf a mistake occurs and a Board hearing results and the
pharmacy filled more than 150 RX/Day/Pharmacist, then the pharmacy will suffer the
same penalty as given to the pharmacist
Typically used as an aggravating factor during a hearing, difficult to enforce
1938 Food, Drug, and Cosmetic Act - ANSFollowing sulfonilamide tragedy, required
companies to prove safety to the FDA
1951 Durham-Humphrey Amendment - ANSDistinguished RX from OTC, label must
read RX only
1961 Kefauver Harris - ANSRequired to prove drug safe and effective if introduced after
1962
Absence of Pharmacist - ANSWhen the health care facility pharmacy is not open 24
hours:
-Policies and procedures for provision of drugs and pharmaceutical care after hours is
required
-On call pharmacist coverage is required during all absences
-Ancillary drug cabinets are permitted
Who may enter pharmacy after hours:
-Only if the drug is needed and not in ancillary cabinet
-Nurse authorized by the pharmacist manager
Pharmacist must maintain a list of restricted medications:
-Removal of these medications can occur only after consultation with the on-call
pharmacist
-Consultation is to verify the appropriateness and accuracy of the medication ordered
and the medication removed
-Consideration given to the therapeutics of the medication, look alike, sound alike drugs,
etc.
Pharmacists must review medications removed from the pharmacy within 24 hours to
verify the accuracy and appropriateness of the order and the medication removed. Only
drugs in unit of use packaging should be removed
Records of drugs removed from ancillary drug cabinets shall be maintained for 3 years
and reviewed by the pharmacist-manager quarterly
,Only drugs in unit-of-use packaging shall be removed from ancillary drug cabinets,
prelabeled with name, strength, lot number, and expiration
Supportive personnel may be present in pharmacy after hours
-Must be approved by pharmacist-manager
-May perform clerical, repackaging and distributive functions
-Pharmacists or verifying technician must check any drugs handled prior to leaving the
pharmacy
Controlled substances may be stocked in ancillary cabinets, may not be removed from
the pharmacy in absence of a pharmacist
Written order required for all drugs removed
Adulteration - ANSDrugs that contain filthy putrid, and decomposed substances or
drugs held in unsanitary conditions
Not manufactured under GMP, represented as one strength but contains another, etc.
Ancillary Drug Cabinet Inventories - ANSRoutinely prescribed medications may be
stocked in limited quantities for use when not reasonably available from the pharmacy in
sufficient time to prevent patient discomfort or harm
Stock lists must be developed, approved, and maintained
Medications stocked must be secured in a locked cabinet
Access is limited to authorized personnel only
Only pre-packaged doses are stocked and in limited amounts
Records of withdrawal are maintained
Automated dispensing devices not in a facility with a pharmacy - ANSMust have a
limited service permit
Board of Pharmacy members - ANSConsists of 6 members
5 licensed pharmacists residing in NC, each from 5 geographic areas
Elected by all pharmacists, not just those in area
Voted on by all pharmacists with paid active or inactive license who resides in the state
1 public member (not a pharmacist) appointed by governor
When elected, go onto Board for 1 year internship, then serve their 5 year term
Meets monthly to conduct hearings and other work of the Board
Board hires an executive director (Jay Campbell)
Acts as prosecuting attorney- MUST investigate violations, may file complaint and
prosecute offender at Board hearing
BOP Disciplinary Authority - ANSIssues letters of:
Warning
Caution
Reprimand
Suspends, restricts, revokes, or refuses to grant or renew license
, Can require remedial education
Calculation of overpayment (Audit) - ANSCalculation does not include a dispensing fee
unless:
-The RX was not dispensed
-The RX was not approved by the prescriber
-The RX dispensed was a medication error
-The overpayment was due to an extra dispensing fee
-There is insufficient documentation
-Fraud
Can an NP prescribe refills for a CIII or CIV substances - ANSYes, may prescribe up to
5 refills but continue to be limited to a 30 day supply
Can electronically receive CII drugs - ANSDEA has certain approved vendors to send
through
Can I give prescription records to investigators from the Medical and Dental Boards? -
ANSYes, if they prescribed something for a mutual patient
Can patients get prescriptions from physician's offices free through patient assistance
programs sponsored by manufacturers? - ANSProvision of patient specific drugs for
such programs must comply with statute and rules dealing with out of state pharmacies-
this would require an out of state pharmacy permit
Central fill pharmacies - ANSMust be contracturally related
Must share common computer system with each sharing access
Label must identify pharmacy who filled RX and pharmacy who received it to provide to
the patient
Must indicate which one patient is to call with questions
Child-resistant packaging - ANSAt least 85% of children must be unable to open within
the first 5 minutes or at least 80% unable to open after demonstration/use of teeth
instruction
May dispense without a child-resistant feature if patient requests (usually written waiver)
or prescriber requests for an individual patient
Reuse plastic of safety containers is prohibited, may reuse non-safety containers or
glass vials
Clinical Pharmacist Practitioner - ANSMust obtain 35 hours of CE each year
Must wear a nametag spelling out "Clinical Pharmacist Practitioner"
Any pharmacist may become a CPP
May prescribe controlled substances
DEA will issue a DEA number starting with the letter M
Questions and Correct Answers. Graded
A+
150 RX/Day Rule - ANSIf a mistake occurs and a Board hearing results and the
pharmacy filled more than 150 RX/Day/Pharmacist, then the pharmacy will suffer the
same penalty as given to the pharmacist
Typically used as an aggravating factor during a hearing, difficult to enforce
1938 Food, Drug, and Cosmetic Act - ANSFollowing sulfonilamide tragedy, required
companies to prove safety to the FDA
1951 Durham-Humphrey Amendment - ANSDistinguished RX from OTC, label must
read RX only
1961 Kefauver Harris - ANSRequired to prove drug safe and effective if introduced after
1962
Absence of Pharmacist - ANSWhen the health care facility pharmacy is not open 24
hours:
-Policies and procedures for provision of drugs and pharmaceutical care after hours is
required
-On call pharmacist coverage is required during all absences
-Ancillary drug cabinets are permitted
Who may enter pharmacy after hours:
-Only if the drug is needed and not in ancillary cabinet
-Nurse authorized by the pharmacist manager
Pharmacist must maintain a list of restricted medications:
-Removal of these medications can occur only after consultation with the on-call
pharmacist
-Consultation is to verify the appropriateness and accuracy of the medication ordered
and the medication removed
-Consideration given to the therapeutics of the medication, look alike, sound alike drugs,
etc.
Pharmacists must review medications removed from the pharmacy within 24 hours to
verify the accuracy and appropriateness of the order and the medication removed. Only
drugs in unit of use packaging should be removed
Records of drugs removed from ancillary drug cabinets shall be maintained for 3 years
and reviewed by the pharmacist-manager quarterly
,Only drugs in unit-of-use packaging shall be removed from ancillary drug cabinets,
prelabeled with name, strength, lot number, and expiration
Supportive personnel may be present in pharmacy after hours
-Must be approved by pharmacist-manager
-May perform clerical, repackaging and distributive functions
-Pharmacists or verifying technician must check any drugs handled prior to leaving the
pharmacy
Controlled substances may be stocked in ancillary cabinets, may not be removed from
the pharmacy in absence of a pharmacist
Written order required for all drugs removed
Adulteration - ANSDrugs that contain filthy putrid, and decomposed substances or
drugs held in unsanitary conditions
Not manufactured under GMP, represented as one strength but contains another, etc.
Ancillary Drug Cabinet Inventories - ANSRoutinely prescribed medications may be
stocked in limited quantities for use when not reasonably available from the pharmacy in
sufficient time to prevent patient discomfort or harm
Stock lists must be developed, approved, and maintained
Medications stocked must be secured in a locked cabinet
Access is limited to authorized personnel only
Only pre-packaged doses are stocked and in limited amounts
Records of withdrawal are maintained
Automated dispensing devices not in a facility with a pharmacy - ANSMust have a
limited service permit
Board of Pharmacy members - ANSConsists of 6 members
5 licensed pharmacists residing in NC, each from 5 geographic areas
Elected by all pharmacists, not just those in area
Voted on by all pharmacists with paid active or inactive license who resides in the state
1 public member (not a pharmacist) appointed by governor
When elected, go onto Board for 1 year internship, then serve their 5 year term
Meets monthly to conduct hearings and other work of the Board
Board hires an executive director (Jay Campbell)
Acts as prosecuting attorney- MUST investigate violations, may file complaint and
prosecute offender at Board hearing
BOP Disciplinary Authority - ANSIssues letters of:
Warning
Caution
Reprimand
Suspends, restricts, revokes, or refuses to grant or renew license
, Can require remedial education
Calculation of overpayment (Audit) - ANSCalculation does not include a dispensing fee
unless:
-The RX was not dispensed
-The RX was not approved by the prescriber
-The RX dispensed was a medication error
-The overpayment was due to an extra dispensing fee
-There is insufficient documentation
-Fraud
Can an NP prescribe refills for a CIII or CIV substances - ANSYes, may prescribe up to
5 refills but continue to be limited to a 30 day supply
Can electronically receive CII drugs - ANSDEA has certain approved vendors to send
through
Can I give prescription records to investigators from the Medical and Dental Boards? -
ANSYes, if they prescribed something for a mutual patient
Can patients get prescriptions from physician's offices free through patient assistance
programs sponsored by manufacturers? - ANSProvision of patient specific drugs for
such programs must comply with statute and rules dealing with out of state pharmacies-
this would require an out of state pharmacy permit
Central fill pharmacies - ANSMust be contracturally related
Must share common computer system with each sharing access
Label must identify pharmacy who filled RX and pharmacy who received it to provide to
the patient
Must indicate which one patient is to call with questions
Child-resistant packaging - ANSAt least 85% of children must be unable to open within
the first 5 minutes or at least 80% unable to open after demonstration/use of teeth
instruction
May dispense without a child-resistant feature if patient requests (usually written waiver)
or prescriber requests for an individual patient
Reuse plastic of safety containers is prohibited, may reuse non-safety containers or
glass vials
Clinical Pharmacist Practitioner - ANSMust obtain 35 hours of CE each year
Must wear a nametag spelling out "Clinical Pharmacist Practitioner"
Any pharmacist may become a CPP
May prescribe controlled substances
DEA will issue a DEA number starting with the letter M
