March CE Quiz

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:

1780 1824 1848 1906 A. B. C. D. Rofecoxib Thalidomide Sulfanilamide Quardracycline

2. Federal authority to regulate medications comes from a provision in the U.S. Constitution known as:

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:

Health and Safety Authority Law Enforcement Authority Public Health Power Police Power

4. Regulation of pharmaceutical principally occurs at the _____ level of government whereas regulation of pharmacists and pharmacies primarily occurs at the _____ level of government. 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

9. What was unique and of particular interest to pharmacists about the sponsors of the DurhamHumphrey Amendments of 1951?

Federal/State State/Federal State/County Federal/County A. B. C. D. Both were physicians Both were pharmacists Both later held a higher national elected office Both were from the same state

5. Initially, enforcement of federal laws related to assuring drug quality was assigned to the:

Department of the Interior Department of Health and Human Services Department of Health and Family Services Department of Agriculture 10. Several pieces of legislation during the past twenty -five years had the goal of speeding up FDA processes for:

A.

B.

C.

D. Review and approval of medications for serious or life-threatening diseases Review and approval of medications for veterinary patients Review and approval of oral dosage forms of formerly injectable-only medications Review and approval of medications to treat disorder unique to children