March 2021—Evolution of the Federal Legal Framework for Regulation of Medications 1. The first federal statute designed to address drug quality was adopted by Congress during:
6. The 1938 legislation was prompted by a tragic incident involving:
A. B. C. D.
A. B. C. D.
1780 1824 1848 1906
2. Federal authority to regulate medications comes from a provision in the U.S. Constitution known as: A. B. C. D.
Due Process Clause Commerce Clause Health and Safety Clause Business Clause
3. Authority of state-level agencies to regulate people, places and activities related to distribution of medications is rooted in a legal concept known as: A. B. C. D.
Health and Safety Authority Law Enforcement Authority Public Health Power Police Power
Rofecoxib Thalidomide Sulfanilamide Quardracycline
7. The requirement that safety be established before approval for marketing was a result of legislation enacted in: A. B. C. D.
1880 1906 1938 1963
8. The requirement that efficacy be established before approval for marketing was a result of legislation enacted in: A. B. C. D.
1880 1906 1938 1963
4. Regulation of pharmaceutical principally occurs at the _____ level of government whereas regulation of pharmacists and pharmacies primarily occurs at the _____ level of government.
9. What was unique and of particular interest to pharmacists about the sponsors of the DurhamHumphrey Amendments of 1951?
A. B. C. D.
A. B. C. D.
Federal/State State/Federal State/County Federal/County
5. Initially, enforcement of federal laws related to assuring drug quality was assigned to the: A. B. C. D.
Department of the Interior Department of Health and Human Services Department of Health and Family Services Department of Agriculture
|26| Kentucky Pharmacists Association | March/April 2021
Both were physicians Both were pharmacists Both later held a higher national elected office Both were from the same state
10. Several pieces of legislation during the past twenty -five years had the goal of speeding up FDA processes for: A. Review and approval of medications for serious or life-threatening diseases B. Review and approval of medications for veterinary patients C. Review and approval of oral dosage forms of formerly injectable-only medications D. Review and approval of medications to treat disorder unique to children
