Pharmacy Law

5 Written Questions

1. prohibit the interstate transportation or sale of adulterated and misbranded food and drugs
2. quick market drugs, provides incentives to promote research, approval, and marketing of drugs needed for the treatment of disease
3. national drug code
   manufacturer, drug strength & dosage, package size
4. requires child-proof packaging on all controlled and most prescription drugs;can sign waiver for non-child proof
5. restricts distribution of pres. drugs to legitimate commercial channels and drug wholesales to be state licensed

5 Multiple Choice Questions

1. sets daily and monthly limits on OTC sale of pseudoephedrine and ephedrine-3.6g/day, 7.5 g/mth
   1. 1938-Food Drug and Cosmetic Act
   2. 2005-CMEA Combat Methamphetamine Epidemic Act
   3. 1990-Anabolic Steroid Control Act
   4. 1906-Pure Food and Drug Act
2. pharmacists must offer counseling to medicaid patients
   1. 1990-OBRA
   2. 1983 Orphan Drug Act
   3. 1906-Pure Food and Drug Act
   4. 1972- Drug Listing Act
3. passed to address abuse of steroids by athletes, teenagers
   1. 1970-Controlled Substances Act
   2. 1990-Anabolic Steroid Control Act
   3. 1938-Food Drug and Cosmetic Act
   4. 1972- Drug Listing Act
4. classified five level of drugs w/ potential for abuse, restricts distribution. enforced by DEA
   1. 1983 Orphan Drug Act
   2. 1970-Controlled Substances Act
   3. 1938-Food Drug and Cosmetic Act
   4. 1972- Drug Listing Act
5. requires new drugs to show proof of safety and effectiveness before marketing
   1. 1983 Orphan Drug Act
   2. 1962-Kefauver-Harris Amendment
   3. 1951-Durham-Humphrey Amendment
   4. 1972- Drug Listing Act

4 True/False Questions

1. 1951-Durham-Humphrey Amendment → requires new drugs to show proof of safety and effectiveness before marketing

   True        False

2. 1984-Drug price competition and patent term restoration act (hatch-waxman) → brand/generic; allowed for extension of drug patent terms and quicker intro of low-cost generic

   True        False

3. 1996-HIPPA Health Insurance Portability and Accountability Act → privacy practices used to govern the transfer of patient health information communicated electronically, by paper, or orally

   True        False

4. 1938-Food Drug and Cosmetic Act → requires new drugs to be shown safe before marketing, Phase I

   True        False