Maryland MPJE
Pure Food and Drug Act of 1906 (Wiley Act) - answerPrevents adulteration and
misbranding
Drugs met standard of strength/quality/purity according to USP/NF
Food, Drug, and Cosmetic Act of 1938 - answerRequired manufacturer to prove drug
safety prior to marketing it
Also defined/regulated: adulteration, misbranding, interstate commerce
Durham Humphrey Amendment of 1951 - answerDivided medications into OTC and
prescription (legend) drugs
Kefauver-Harris Amendment of 1962 - answerManufacturer's must prove that a drug is
both safe and effective
Poison Prevention and Packaging Act of 1970 - answerRequired 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 - answerLaws 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 - answerRequired counseling and patient
profiles for all Medicaid patients
, Dietary Supplement Health And Education Act of 1994 - answerDefined dietary
supplements as food products
MD Board of Pharmacy Members - answerTotal 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 - answer4 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 - answer1. Good moral character
2. At least 18 y/o
3. Graduate of ACPE pharmacy
school
4. Completed professional
experience program
-1000 hours in ACPE school or
-1560 hours of work training
under direct supervision of
pharmacist (typically for
foreign grad)
5. Pass NAPLEX
6. Pass MPJE
MD Pharmacist License Renewal Time and Requirements - answerBiennial (every 2
years), renewal due by last day of birth month
30 hours of CE (must keep documentation of completing CEs for 4 years after date of
renewal)
-2 hours must be live
-1 hour must be in med errors
-4 hours related to vaccines if vaccine certified
-can earn 2 hours from attending BOP meeting, max of 4 hours per renewal
Pure Food and Drug Act of 1906 (Wiley Act) - answerPrevents adulteration and
misbranding
Drugs met standard of strength/quality/purity according to USP/NF
Food, Drug, and Cosmetic Act of 1938 - answerRequired manufacturer to prove drug
safety prior to marketing it
Also defined/regulated: adulteration, misbranding, interstate commerce
Durham Humphrey Amendment of 1951 - answerDivided medications into OTC and
prescription (legend) drugs
Kefauver-Harris Amendment of 1962 - answerManufacturer's must prove that a drug is
both safe and effective
Poison Prevention and Packaging Act of 1970 - answerRequired 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 - answerLaws 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 - answerRequired counseling and patient
profiles for all Medicaid patients
, Dietary Supplement Health And Education Act of 1994 - answerDefined dietary
supplements as food products
MD Board of Pharmacy Members - answerTotal 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 - answer4 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 - answer1. Good moral character
2. At least 18 y/o
3. Graduate of ACPE pharmacy
school
4. Completed professional
experience program
-1000 hours in ACPE school or
-1560 hours of work training
under direct supervision of
pharmacist (typically for
foreign grad)
5. Pass NAPLEX
6. Pass MPJE
MD Pharmacist License Renewal Time and Requirements - answerBiennial (every 2
years), renewal due by last day of birth month
30 hours of CE (must keep documentation of completing CEs for 4 years after date of
renewal)
-2 hours must be live
-1 hour must be in med errors
-4 hours related to vaccines if vaccine certified
-can earn 2 hours from attending BOP meeting, max of 4 hours per renewal
