Pure Food and Drug Act of 1906 (Wiley Act) - correct answer Prevents adulteration and misbranding
Drugs met standard of strength/quality/purity according to USP/NF
Food, Drug, and Cosmetic Act of 1938 - correct answer Required manufacturer to prove drug safety prior to marketing it
Also defi...
Pure Food and Drug Act of 1906 (Wiley Act) - correct answer✔✔ Prevents adulteration and misbranding
Drugs met standard of strength/quality/purity according to USP/NF
Food, Drug, and Cosmetic Act of 1938 - correct answer✔✔ Required manufacturer to prove drug safety
prior to marketing it
Also defined/regulated: adulteration, misbranding, interstate commerce
Durham Humphrey Amendment of 1951 - correct answer✔✔ Divided medications into OTC and
prescription (legend) drugs
Kefauver-Harris Amendment of 1962 - correct answer✔✔ Manufacturer's must prove that a drug is both
safe and effective
Poison Prevention and Packaging Act of 1970 - correct answer✔✔ 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 - correct answer✔✔ 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 - correct answer✔✔ Required counseling and patient
profiles for all Medicaid patients
Dietary Supplement Health And Education Act of 1994 - correct answer✔✔ Defined dietary supplements
as food products
MD Board of Pharmacy Members - correct answer✔✔ 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 - correct answer✔✔ 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 - correct answer✔✔ 1. Good moral character
2. At least 18 y/o
3. Graduate of ACPE pharmacy
school
4. Completed professional
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