Maryland MPJE / Key Questions with 100% Correct
Answers.
Terms in this set (55)
Pure Food and Drug Act of Prevents adulteration and misbranding Drugs met
1906 (Wiley Act) standard of strength/quality/purity according to
USP/NF
Food, Drug, and Cosmetic Required manufacturer to prove drug safety prior to marketing it
Act of 1938
Also defined/regulated: adulteration, misbranding, interstate
commerce
Durham Humphrey Divided medications into OTC and prescription
Amendment of 1951 (legend) drugs
Kefauver-Harris Manufacturer's must prove that a drug is both safe and
Amendment of 1962 effective
Required child-resistant (C-R) packaging for drugs and
dangerous household substances
Poison Prevention and
Exempt for C-R packaging: SL nitroglycerin
Packaging Act of 1970
Must record request for non C-R packaging on prescription or
patient's profile
, Prescription Drug Laws prohibiting reimportation of drugs
Marketing Act of 1987
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 specificpatient
(not resold)
2. Effective treatment not available in the US, thecondition is
serious, and drug has no unreasonable risk
Omnibus Budget Required counseling and patient profiles for all
Reconciliation Act of 1990 Medicaid patients
Dietary Supplement Health Defined dietary supplements as food products
And Education Act of 1994
MD Board of Pharmacy Total of 12 members:
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
4 years, may serve 2 consecutive terms
MD Board of Pharmacy
Member may be removed if they miss 2 consecutive
Term Length and Removal
meetings without being excused (and for incompetence,
misconduct)
Answers.
Terms in this set (55)
Pure Food and Drug Act of Prevents adulteration and misbranding Drugs met
1906 (Wiley Act) standard of strength/quality/purity according to
USP/NF
Food, Drug, and Cosmetic Required manufacturer to prove drug safety prior to marketing it
Act of 1938
Also defined/regulated: adulteration, misbranding, interstate
commerce
Durham Humphrey Divided medications into OTC and prescription
Amendment of 1951 (legend) drugs
Kefauver-Harris Manufacturer's must prove that a drug is both safe and
Amendment of 1962 effective
Required child-resistant (C-R) packaging for drugs and
dangerous household substances
Poison Prevention and
Exempt for C-R packaging: SL nitroglycerin
Packaging Act of 1970
Must record request for non C-R packaging on prescription or
patient's profile
, Prescription Drug Laws prohibiting reimportation of drugs
Marketing Act of 1987
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 specificpatient
(not resold)
2. Effective treatment not available in the US, thecondition is
serious, and drug has no unreasonable risk
Omnibus Budget Required counseling and patient profiles for all
Reconciliation Act of 1990 Medicaid patients
Dietary Supplement Health Defined dietary supplements as food products
And Education Act of 1994
MD Board of Pharmacy Total of 12 members:
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
4 years, may serve 2 consecutive terms
MD Board of Pharmacy
Member may be removed if they miss 2 consecutive
Term Length and Removal
meetings without being excused (and for incompetence,
misconduct)