MPJE Review ACTUAL QUESTIONS AND
CORRECT ANSWERS
FDA - Correct answers✔section under Dept. of Health and Human Services (HHS) -
est. 1906 with passage of Pure Food & Drug Act
Lead by Commissioner who's appointed by the President w/ Senate confirmation
Administrative Agency w/ auth to ensure safety, efficacy, security of food, drugs, devices, etc
+ Pharmaceuticals: approval/ oversight of rx and OTC drugs
+ Medical Devices: ensuring safety & effectiveness of devices
+ Food: monitoring food products
+ Tobacco: policies to reduce tobacco-related harm
+ Cosmetics & DS: oversee labeling & safety standards
Rulemaking Auth: FDA develops regs based on laws set forth in FDCA or other laws under
which it operates
DEA Overview - Correct answers✔agency under US Dept Justice est 1973 to combat drug
trafficking & abuse
Responsibilities
- enforces federal Controlled Substances Act (CSA) and regulations
- regulating CS (manufacture, distribution, dispensing)
,- maintaining drug schedules
- preventing misuse of legal meds and CS
- supports legitimate medical use of CS, prevents misuse or diversion, upholds pt safety
Organizational Structure:
- overseen by DEA Admin who is appointed by the President & confirmed by Senate
Boards of Pharmacy Overview - Correct answers✔regulate pharmacy practice to ensure PH,
safety, welfare
compositions, functions, requirements may differ across states
Key Responsibilities
- licensing
- inspections & investigations to ensure compliance
- practice standards & approving educational programs
- addressing complaints & disciplinary action
- Board Members: attend meetings & vote on regulatory decisions, review applications &
complaints, collaborate with state agencies on PH initiatives, develop policies
MA Board of Pharmacy Composition - Correct answers✔13 members - appointed by the
Governor based on qualifications & expertise
(1) Sterile Compounding RPh
(1) LT Care RPh
(1) Academia RPH
,(1) Hospital RPh
(2) Chain Pharmacy RPh
(2) Independent Pharmacy RPh
(1) Pharmacy Tech
(1) Nurse
(1) MD
(2) Public Members
- one with experience in QI & patient safety
- one with experience in HC delivery, admin, consumer advocacy
MA Board of Pharmacy Member Requirements - Correct answers✔TERM LIMITS: max 2
*consecutive* terms, each lasting 3 years
- can be reappointed after taking 1 term off
RESIDENCY: must live and practice in MA at time of appointment
EXPERIENCE: *PHARMACY MEMBERS* must have 7 consecutive years of experience in
practice of pharmacy
- N/A to non-pharmacy members
- pharmacy tech requires 7 years of experience as well
- in the regulations, experience req is only mentioned for hospital, compounding, and LTC RPhs
- RPHs cannot sit in non-RPH seats d/t conflict of interest
, MA BOP Authority - Correct answers✔resp. for oversight of retail pharmacies, non-resident
pharmacies, shipping into MA, drug wholesalers, hospital pharmacies (sterile compounding
ONLY), and outsourcing
Inspections & Investigation - can conduct w/o prior notice
- assess staff, activities, and records for compliance
- req. to provide requested documents to BOP during inspections/ investigations - non-resident
phcy cover costs related to inspection
Plan of Correction: must be submitted in writing for EACH violation cited in inspection within
*21 days*, unless BOP agrees to different timeframe
Includes:
- corrective action
- expected completion/ implementation dates
- individuals responsible for carrying out each action
- signature by MOR
- compliance timelines - asap
Unacceptable Plans: POCs that fail requirements will be returned
- must be revised and submitted within 7 days of notice
Corresponding Responsibility - Correct answers✔obligation under fed/ state law req RPh to
ensure rx are issued for legitimate medical purpose in accordance w laws and regs
MA CSA aligns with federal CSA and builds on it by adding more specific / stricter regs:
CORRECT ANSWERS
FDA - Correct answers✔section under Dept. of Health and Human Services (HHS) -
est. 1906 with passage of Pure Food & Drug Act
Lead by Commissioner who's appointed by the President w/ Senate confirmation
Administrative Agency w/ auth to ensure safety, efficacy, security of food, drugs, devices, etc
+ Pharmaceuticals: approval/ oversight of rx and OTC drugs
+ Medical Devices: ensuring safety & effectiveness of devices
+ Food: monitoring food products
+ Tobacco: policies to reduce tobacco-related harm
+ Cosmetics & DS: oversee labeling & safety standards
Rulemaking Auth: FDA develops regs based on laws set forth in FDCA or other laws under
which it operates
DEA Overview - Correct answers✔agency under US Dept Justice est 1973 to combat drug
trafficking & abuse
Responsibilities
- enforces federal Controlled Substances Act (CSA) and regulations
- regulating CS (manufacture, distribution, dispensing)
,- maintaining drug schedules
- preventing misuse of legal meds and CS
- supports legitimate medical use of CS, prevents misuse or diversion, upholds pt safety
Organizational Structure:
- overseen by DEA Admin who is appointed by the President & confirmed by Senate
Boards of Pharmacy Overview - Correct answers✔regulate pharmacy practice to ensure PH,
safety, welfare
compositions, functions, requirements may differ across states
Key Responsibilities
- licensing
- inspections & investigations to ensure compliance
- practice standards & approving educational programs
- addressing complaints & disciplinary action
- Board Members: attend meetings & vote on regulatory decisions, review applications &
complaints, collaborate with state agencies on PH initiatives, develop policies
MA Board of Pharmacy Composition - Correct answers✔13 members - appointed by the
Governor based on qualifications & expertise
(1) Sterile Compounding RPh
(1) LT Care RPh
(1) Academia RPH
,(1) Hospital RPh
(2) Chain Pharmacy RPh
(2) Independent Pharmacy RPh
(1) Pharmacy Tech
(1) Nurse
(1) MD
(2) Public Members
- one with experience in QI & patient safety
- one with experience in HC delivery, admin, consumer advocacy
MA Board of Pharmacy Member Requirements - Correct answers✔TERM LIMITS: max 2
*consecutive* terms, each lasting 3 years
- can be reappointed after taking 1 term off
RESIDENCY: must live and practice in MA at time of appointment
EXPERIENCE: *PHARMACY MEMBERS* must have 7 consecutive years of experience in
practice of pharmacy
- N/A to non-pharmacy members
- pharmacy tech requires 7 years of experience as well
- in the regulations, experience req is only mentioned for hospital, compounding, and LTC RPhs
- RPHs cannot sit in non-RPH seats d/t conflict of interest
, MA BOP Authority - Correct answers✔resp. for oversight of retail pharmacies, non-resident
pharmacies, shipping into MA, drug wholesalers, hospital pharmacies (sterile compounding
ONLY), and outsourcing
Inspections & Investigation - can conduct w/o prior notice
- assess staff, activities, and records for compliance
- req. to provide requested documents to BOP during inspections/ investigations - non-resident
phcy cover costs related to inspection
Plan of Correction: must be submitted in writing for EACH violation cited in inspection within
*21 days*, unless BOP agrees to different timeframe
Includes:
- corrective action
- expected completion/ implementation dates
- individuals responsible for carrying out each action
- signature by MOR
- compliance timelines - asap
Unacceptable Plans: POCs that fail requirements will be returned
- must be revised and submitted within 7 days of notice
Corresponding Responsibility - Correct answers✔obligation under fed/ state law req RPh to
ensure rx are issued for legitimate medical purpose in accordance w laws and regs
MA CSA aligns with federal CSA and builds on it by adding more specific / stricter regs:
