Maryland MPJE Questions and Answers
Already Passed
Pure Food and Drug Act of 1906 (Wiley Act) ✔✔Prevents adulteration and misbranding
Drugs met standard of strength/quality/purity according to USP/NF
Food, Drug, and Cosmetic Act of 1938 ✔✔Required manufacturer to prove drug safety prior to
marketing it
Also defined/regulated: adulteration, misbranding, interstate commerce
Durham Humphrey Amendment of 1951 ✔✔Divided medications into OTC and prescription
(legend) drugs
Kefauver-Harris Amendment of 1962 ✔✔Manufacturer's must prove that a drug is both safe and
effective
Poison Prevention and Packaging Act of 1970 ✔✔Required child-resistant (C-R) packaging for
drugs and dangerous household substances
,Exempt for C-R packaging: SL nitroglycerin
Must record request for non C-R packaging on prescription or patient's profile
Prescription Drug Marketing Act of 1987 ✔✔Laws prohibiting reimportation of drugs
Patients can not buy drugs in other countries and bring to US unless:
1. It is for a 90 day supply or less and for that specific patient (not resold)
2. Effective treatment not available in the US, the condition is serious, and drug has no
unreasonable risk
Omnibus Budget Reconciliation Act of 1990 ✔✔Required counseling and patient profiles for all
Medicaid patients
Dietary Supplement Health And Education Act of 1994 ✔✔Defined dietary supplements as food
products
MD Board of Pharmacy Members ✔✔Total of 12 members:
, 10 pharmacists (must have 5 years of practice) representing:
Chain
Independent
Acute care
At large
Long term care
Home infusion
2 consumers, appointed by the governor
MD Board of Pharmacy Term Length and Removal ✔✔4 years, may serve 2 consecutive terms
Member may be removed if they miss 2 consecutive meetings without being excused (and for
incompetence, misconduct)
MD Pharmacist Licensure Requirements ✔✔1. Good moral character
2. At least 18 y/o
Already Passed
Pure Food and Drug Act of 1906 (Wiley Act) ✔✔Prevents adulteration and misbranding
Drugs met standard of strength/quality/purity according to USP/NF
Food, Drug, and Cosmetic Act of 1938 ✔✔Required manufacturer to prove drug safety prior to
marketing it
Also defined/regulated: adulteration, misbranding, interstate commerce
Durham Humphrey Amendment of 1951 ✔✔Divided medications into OTC and prescription
(legend) drugs
Kefauver-Harris Amendment of 1962 ✔✔Manufacturer's must prove that a drug is both safe and
effective
Poison Prevention and Packaging Act of 1970 ✔✔Required child-resistant (C-R) packaging for
drugs and dangerous household substances
,Exempt for C-R packaging: SL nitroglycerin
Must record request for non C-R packaging on prescription or patient's profile
Prescription Drug Marketing Act of 1987 ✔✔Laws prohibiting reimportation of drugs
Patients can not buy drugs in other countries and bring to US unless:
1. It is for a 90 day supply or less and for that specific patient (not resold)
2. Effective treatment not available in the US, the condition is serious, and drug has no
unreasonable risk
Omnibus Budget Reconciliation Act of 1990 ✔✔Required counseling and patient profiles for all
Medicaid patients
Dietary Supplement Health And Education Act of 1994 ✔✔Defined dietary supplements as food
products
MD Board of Pharmacy Members ✔✔Total of 12 members:
, 10 pharmacists (must have 5 years of practice) representing:
Chain
Independent
Acute care
At large
Long term care
Home infusion
2 consumers, appointed by the governor
MD Board of Pharmacy Term Length and Removal ✔✔4 years, may serve 2 consecutive terms
Member may be removed if they miss 2 consecutive meetings without being excused (and for
incompetence, misconduct)
MD Pharmacist Licensure Requirements ✔✔1. Good moral character
2. At least 18 y/o
