4 Written Questions

1. regulates over the counter sales of ephedrine, pseudophedrine, and phenylpropanolamine products (cough medicine)
2. intended to stimulate development of drugs for rare diseases affecting 200,000 or fewer
3. "Prescription Drug Amendment"
   Required Rx to bear the legend "Caution: Federal law prohibits dispensing without a prescription"
   Later: "Rx only"
4. promped by the Sulfanilamide disaster of 1937
   Established the FDA
   Regulated who could prescribe legend drugs

4 Multiple Choice Questions

1. "Hatch-Waxman Act"
   est modern system of generic drugs
   manuf of generic drugs can seek FDA approval for generic versions of drugs whose patent protection is set to expire
   1. Pure Food and Drug Act 1906
   2. Drug Price Competition and Patent Term Restoration Act 1984
   3. Comprehensive Drug Abuse Prevention and Control Act 1970
   4. Food, Drug, and Cosmetic Act 1938
2. "Controlled Substances Act of 1970"
   Established DEA
   Established five "classes" or schedules for controlled substances (6 in MA)
   1. Pure Food and Drug Act 1906
   2. Food, Drug, and Cosmetic Act 1938
   3. Comprehensive Drug Abuse Prevention and Control Act 1970
   4. Drug Listing Act 1972
3. Ensure patient confidentiality and privacy
   Give patients the right to review medical records
   Est requirement of patient consent for transfer of medical records
   Defines protected health info (PHI) - info that may identify a patient, info created or received by the pharmacy, info related to the patients health; mental or physical; past, present, or future
   1. Health Insurance Portability and Accountability Act 1996 (HIPAA)
   2. Combat Methamphetamine Epidemic Act 2005 (CMEA)
   3. Pure Food and Drug Act 1906
   4. Comprehensive Drug Abuse Prevention and Control Act 1970
4. Increased necessity of pharm techs
   Focused on federal funding for Medicare and Medicaid
   Mandated that pharmacists perform drug utilizaton reviews (DUR) and offer counseling to patients
   1. Omnibus Budget Reconciliation Act 1990 (OBRA '90)
   2. Drug Listing Act 1972
   3. Food, Drug, and Cosmetic Act 1938
   4. Combat Methamphetamine Epidemic Act 2005 (CMEA)

3 True/False Questions

1. Drug Listing Act 1972 → intended to stimulate development of drugs for rare diseases affecting 200,000 or fewer

   True        False

2. Kefauver-Harris Amendment 1962 → "Prescription Drug Amendment"
   Required Rx to bear the legend "Caution: Federal law prohibits dispensing without a prescription"
   Later: "Rx only"

   True        False

3. Pure Food and Drug Act 1906 → intended to stimulate development of drugs for rare diseases affecting 200,000 or fewer

   True        False