1. Jessica Tagerman, PharmD, RPh
Pharmacy Law Review
Jessica Tagerman, PharmD, RPh

2. Pure Food and Drug Act of 1906

3. Pure Food and Drug Act of 1906
Prohibits INTERSTATE TRANSPORTATION of adulterated and misbranded food or drugs.
Pure Food and Drug Act of 1906

4. Food, Drug, and Cosmetic Act of 1938

5. Food, Drug, and Cosmetic Act of 1938
Clearly defines ADULTERATION and MISBRANDING of drugs and food products Adulteration: filthy, putrid, dirty Misbranding: false or misleading in any way
Food, Drug, and Cosmetic Act of 1938

6. Durham-Humphrey Act of 1951

7. Durham-Humphrey Act of 1951
Separated drugs into two categories: legend and non-legend drugs “Caution: Federal law prohibits dispensing without a prescription”
Durham-Humphrey Act of 1951

8. Kefauver-Harris Amendment of 1962

9. Kefauver-Harris Amendment of 1962
Requires all drugs to be pure, safe, and effective
Kefauver-Harris Amendment of 1962
Ke-fauver= fever.
If your kid has a fever, and you give them medication, you want that medication to be pure, safe, and effective

10. Comprehensive Drug Abuse Prevention and Control Act of 1970

11. Comprehensive Drug Abuse Prevention and Control Act of 1970
Prevents Drug Abuse! Established drug schedules, procedures for ordering and receipt of medications that have high potential for abuse, DEA numbers, prescription management, etc.
Comprehensive Drug Abuse Prevention and Control Act of 1970

12. Poison Prevention Packaging Act of 1970

13. Poison Prevention Packaging Act of 1970
Most OTC and legend drugs must be packaged in child-resistant containers
Poison Prevention Packaging Act of 1970

14. Occupational Safety and Health Act of 1970

15. Occupational Safety and Health Act of 1970
Established OSHA (Occupational Safety and Health Administration) Ensures a safe and healthful workplace for all the employees
Occupational Safety and Health Act of 1970

16. Drug Listing Act of 1972

17. xxxxx-xxxx-xx Drug Listing Act of 1972 Established NDC Numbers
Manufacturer
Product name and strength
Package Size

18. Orphan Drug Act of 1983

19. Provides tax incentives and exclusive licensing of products for manufacturers to develop and market orphan medications Orphan drug = medications for treatment of diseases or conditions of which there are fewer than 200,000 cases in the world
Orphan Drug Act of 1983

20. Hatch-Waxman Act of 1984

21. Encouraged the creation of both generic and new medications by streamlining the process for generic drug approval
Hatch-Waxman Act of 1984
Wax museum- “a copy of the real person”. Generic drugs are “a copy of the real medication”

22. Anabolic Steroid Control Act of 1990

23. Anabolic Steroid Control Act of 1990
Harsher penalties for the abuse of anabolic steroids and their misuse by athletes
Anabolic Steroid Control Act of 1990

24. Omnibus Budget Reconciliation Act of 1990

25. Omnibus Budget Reconciliation Act of 1990
Requires states to establish drug use review programs (DUR programs)
Omnibus Budget Reconciliation Act of 1990

26. Health Insurance Portability and Accountability Act of 1996

27. Health Insurance Portability and Accountability Act of 1996
HIPAA!
Health Insurance Portability and Accountability Act of 1996