STUVIA
NC MPJE Review
prohibited the adulteration and misbranding of foods and drugs - ✔✔Pure Food and
Drug Act of 1906
No new drug can be marketed/sold unless it is proven to be SAFE (ie does not require
the drug to be effective) - ✔✔Food, Drug, and Cosmetic Act of 1938
Created a distinction between "OTC" and "Rx" drugs
Also authorized oral prescriptions and refills of prescription drugs, and introduced label
requirements for pharmacies - ✔✔Durham-Humphrey Amendment of 1951
Drugs must be proven SAFE and EFFECTIVE; transferred drug advertising from FTC
to FDA, established Good Manufacturing Practices, and required informed consent of
research participants and reporting of ADRs - ✔✔Kefauver-Harris Amendment of
1962
%
Controlled Substances Act - ✔✔Federal Comprehensive Drug Abuse Prevention and
Control Act of 1970
Medical devices are classified in 1 of 3 categories according to their function:
1 - least regulation required (ie toothbrushes, scissors, gloves)
2 - general controls for safety, must meet specific performance standards (ie
thermometers, tampons, insulin syringes)
3 - require premarket approval; life-supporting or life-sustaining (pacemakers,
replacement heart valves) - ✔✔Medical Device Amendments of 1976
Provides tax and licensing incentives for manufacturers who develop drugs for rare
diseases or conditions - ✔✔Orphan Drug Act of 1983
Bans sale, trade, or purchase of drug samples - ✔✔Prescription Drug Marketing Act
(PDMA) of 1987
,STUVIA
Required pharmacists to perform prospective drug utilization reviews (DUR), patient
counseling and maintainance of accurate patient profiles - ✔✔The Omnibus Budget
Reconciliation Act of 1990
Created "dietary supplement" category which are treated more as foods than drugs -
✔✔Dietary Supplement Health & Education Act (DSHEA) of 1994
Regulated the privacy and security of health information
- Improved efficiency and effectiveness of the health care system
- Improved the continuity of health insurance coverage
Prohibits discrimination in health coverage - ✔✔Health Insurance Portability and
Accountability Act of 1996 (HIPAA)
FDA may mandate labeling changes related to safety
- Require clinical trial data reporting and registries
%
Require post-market clinical studies to assess risk (Phase 4 studies) - ✔✔Food &
Drug Administration Amendments Act (FDAAA) of 2007
Regulated pharmacy compounding and tracking of medications throughout the
distribution system
Came as a result of New England compounding tragedy - ✔✔Drug Quality and Safety
Act of 2013
Controlled substance prescriptions for Medicare Advantage and Part D will be required
to be transmitted electronically beginning January 1, 2021
- Allows additional mid-level practitioners to prescribe buprenorphine for opioid
addiction - ✔✔Substance Use-Disorder Prevention that Promotes Opioid Recovery
and Treatment for Patients and Communities Act
6 members: 5 are elected and are licensed NC pharmacists, 1 member is appointed by
the governor and CANNOT be a healthcare provider
,STUVIA
Can serve 2 complete. consecutive 5-year terms - ✔✔NC Board of Pharmacy
members
Acts as secretary and treasurer, must be a pharmacist. Can conduct investigations -
✔✔Executive Director of the NCBOP
can prevent a person from practicing or a pharmacy from operating - ✔✔NCBOP is an
administrative agency which has injunctive authority. Define injunctive authority.
If any of the following occurs:
· Made false representations or withheld material information in connection with
securing a license or permit
· Been found guilty of or plead guilty or nolo contendere to any felony in connection
with the practice of pharmacy or distribution of drugs
· Indulged in the use of drugs to an extent that renders the pharmacist unfit to practice
pharmacy
%
· Made false representations in connection with the practice of pharmacy that endanger
or are likely to endanger the health or safety of the public, or that defraud any person
· Violating the APhA Code of Ethics
· Developed a physical or mental disability that renders the pharmacist unfit to practice
pharmacy with reasonable skill, competence, and safety to the public
· Failed to comply with the laws governing the practice of pharmacy and the distribution
of drugs
· Failed to comply with any provision of this Article or rules adopted by the B -
✔✔What constitutes disciplinary action per the NCBOP?
Letter of reprimand
Suspension (active, stayed, or summary)
Restriction of practice
Revocation of license
Refusal to grant or renew license
Requirements made to licensees to successfully complete remedial education -
✔✔Types of Disciplinary Action
, STUVIA
Applicants must complete BOP application and submit criminal record report, degree
from approved SOP, must pass MPJE and NAPLEX within 2 years from date of first
passing score (max 5 attempts for each) - ✔✔Requirements for pharmacist licensing
by examination
(ie getting a license if already licensed in another state)
Take and pass MPJE, complete NABP license transfer application, complete NCBOP
form and submit CRC
If >2 years but <5 years of not practicing pharmacy --> obtain 15h CE per year not
active, additional 500 intern hours under NC RPh
If >5 years not practicing pharmacy --> 1500 intern hours + pass NAPLEX and NC
MPJE - ✔✔Requirements for pharmacist licensing by reciprocity
%
Must pass Foreign Pharmacy Graduate Equivalency Examination (FPGEE), complete
1500 intern hours, pass written and spoken English language exams, pass
NAPLEX/MPJE - ✔✔Requirements for pharmacist licensing for foreign graduates
15h of board certified CE every year
- 5 hours must be "live" or "contact"
- May acquire CE through precepting (160h = 5 CE hours)
- Must keep records of CE for 3 years - ✔✔Continuing Education (CE) Requirements
Must be renewed annually, expires December 31st each year
60-day grace period after deadline (unlawful to practice if after 60 days) - ✔✔License
Renewal
Must be present for 1/2 the hours the pharmacy is open or 32h per week, whichever is
less
NC MPJE Review
prohibited the adulteration and misbranding of foods and drugs - ✔✔Pure Food and
Drug Act of 1906
No new drug can be marketed/sold unless it is proven to be SAFE (ie does not require
the drug to be effective) - ✔✔Food, Drug, and Cosmetic Act of 1938
Created a distinction between "OTC" and "Rx" drugs
Also authorized oral prescriptions and refills of prescription drugs, and introduced label
requirements for pharmacies - ✔✔Durham-Humphrey Amendment of 1951
Drugs must be proven SAFE and EFFECTIVE; transferred drug advertising from FTC
to FDA, established Good Manufacturing Practices, and required informed consent of
research participants and reporting of ADRs - ✔✔Kefauver-Harris Amendment of
1962
%
Controlled Substances Act - ✔✔Federal Comprehensive Drug Abuse Prevention and
Control Act of 1970
Medical devices are classified in 1 of 3 categories according to their function:
1 - least regulation required (ie toothbrushes, scissors, gloves)
2 - general controls for safety, must meet specific performance standards (ie
thermometers, tampons, insulin syringes)
3 - require premarket approval; life-supporting or life-sustaining (pacemakers,
replacement heart valves) - ✔✔Medical Device Amendments of 1976
Provides tax and licensing incentives for manufacturers who develop drugs for rare
diseases or conditions - ✔✔Orphan Drug Act of 1983
Bans sale, trade, or purchase of drug samples - ✔✔Prescription Drug Marketing Act
(PDMA) of 1987
,STUVIA
Required pharmacists to perform prospective drug utilization reviews (DUR), patient
counseling and maintainance of accurate patient profiles - ✔✔The Omnibus Budget
Reconciliation Act of 1990
Created "dietary supplement" category which are treated more as foods than drugs -
✔✔Dietary Supplement Health & Education Act (DSHEA) of 1994
Regulated the privacy and security of health information
- Improved efficiency and effectiveness of the health care system
- Improved the continuity of health insurance coverage
Prohibits discrimination in health coverage - ✔✔Health Insurance Portability and
Accountability Act of 1996 (HIPAA)
FDA may mandate labeling changes related to safety
- Require clinical trial data reporting and registries
%
Require post-market clinical studies to assess risk (Phase 4 studies) - ✔✔Food &
Drug Administration Amendments Act (FDAAA) of 2007
Regulated pharmacy compounding and tracking of medications throughout the
distribution system
Came as a result of New England compounding tragedy - ✔✔Drug Quality and Safety
Act of 2013
Controlled substance prescriptions for Medicare Advantage and Part D will be required
to be transmitted electronically beginning January 1, 2021
- Allows additional mid-level practitioners to prescribe buprenorphine for opioid
addiction - ✔✔Substance Use-Disorder Prevention that Promotes Opioid Recovery
and Treatment for Patients and Communities Act
6 members: 5 are elected and are licensed NC pharmacists, 1 member is appointed by
the governor and CANNOT be a healthcare provider
,STUVIA
Can serve 2 complete. consecutive 5-year terms - ✔✔NC Board of Pharmacy
members
Acts as secretary and treasurer, must be a pharmacist. Can conduct investigations -
✔✔Executive Director of the NCBOP
can prevent a person from practicing or a pharmacy from operating - ✔✔NCBOP is an
administrative agency which has injunctive authority. Define injunctive authority.
If any of the following occurs:
· Made false representations or withheld material information in connection with
securing a license or permit
· Been found guilty of or plead guilty or nolo contendere to any felony in connection
with the practice of pharmacy or distribution of drugs
· Indulged in the use of drugs to an extent that renders the pharmacist unfit to practice
pharmacy
%
· Made false representations in connection with the practice of pharmacy that endanger
or are likely to endanger the health or safety of the public, or that defraud any person
· Violating the APhA Code of Ethics
· Developed a physical or mental disability that renders the pharmacist unfit to practice
pharmacy with reasonable skill, competence, and safety to the public
· Failed to comply with the laws governing the practice of pharmacy and the distribution
of drugs
· Failed to comply with any provision of this Article or rules adopted by the B -
✔✔What constitutes disciplinary action per the NCBOP?
Letter of reprimand
Suspension (active, stayed, or summary)
Restriction of practice
Revocation of license
Refusal to grant or renew license
Requirements made to licensees to successfully complete remedial education -
✔✔Types of Disciplinary Action
, STUVIA
Applicants must complete BOP application and submit criminal record report, degree
from approved SOP, must pass MPJE and NAPLEX within 2 years from date of first
passing score (max 5 attempts for each) - ✔✔Requirements for pharmacist licensing
by examination
(ie getting a license if already licensed in another state)
Take and pass MPJE, complete NABP license transfer application, complete NCBOP
form and submit CRC
If >2 years but <5 years of not practicing pharmacy --> obtain 15h CE per year not
active, additional 500 intern hours under NC RPh
If >5 years not practicing pharmacy --> 1500 intern hours + pass NAPLEX and NC
MPJE - ✔✔Requirements for pharmacist licensing by reciprocity
%
Must pass Foreign Pharmacy Graduate Equivalency Examination (FPGEE), complete
1500 intern hours, pass written and spoken English language exams, pass
NAPLEX/MPJE - ✔✔Requirements for pharmacist licensing for foreign graduates
15h of board certified CE every year
- 5 hours must be "live" or "contact"
- May acquire CE through precepting (160h = 5 CE hours)
- Must keep records of CE for 3 years - ✔✔Continuing Education (CE) Requirements
Must be renewed annually, expires December 31st each year
60-day grace period after deadline (unlawful to practice if after 60 days) - ✔✔License
Renewal
Must be present for 1/2 the hours the pharmacy is open or 32h per week, whichever is
less
