Enactment of which major federal drug regulations required that new drug products be proven both safe and effective before they could be approved for sale in the United States?
a. Federal Food, Drug, and Cosmetic Act (FD&C Act), 1938
b. Comprehensive Drug Abuse Prevention and Control Act (Controlled Substances Act), 1970
c. Durham-Humphrey Amendment to the FD&C Act, 1951
d. Kefauver-Harris Amendment to the FD&C Act, 1962
Question 2
A patient is on a cardiac medication and has been drinking alcohol every evening while watching television. On a visit to the clinic, the patient tells the nurse this information and asks if this is all right. What should be the nurse's response?
a. Limit your alcohol use to 8 ounces a day with a meal.
b. Alcohol and drugs may alter the drug's ability to work.
c. There is no alteration with alcohol and drugs if you eat.
d. The effects of alcohol and drugs only alter sometimes.
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