Sources of Law in the United States
Laws in the United States come from various sources.
-United States constitution and various states constitutions,
-Laws (legislation) passed by Congress aand the various state legislatures,
-Regulations passed by federal and statee agencies such as the DEA, FDA, Ohio Board of Pharmacy, and finally
-Law developed through court decisions.<
Overlap of Laws
Some areas of life are exclusively controlled by state law. Registration of pharmacists, physicians, and nurses in each state.
Some areas are governed exclusively by Federal law - such as postal regulations, but other areas can overlap. Both the federal government and the state can pass laws and regulations dealing with the same area. An example of this would be controlled substances. They are regulated by both the Pharmacy Board of a state and by the Federal Drug Enforcement Administration.
Courts in the United States and in Ohio
Court System
Types of Liability
An individual can get in trouble in several different areas from committing just one act. A pharmacist can incur criminal, civil and administrative liability from on illegal act. An example would be selling a Schedule II drug without a prescription where the purchaser died from an overdose.
The pharmacist could be :
sued for damages for wrongful death (civil), prosecuted for trafficking (criminal), and the pharmacy board could revoke his or her license (administrative). See next slide
Types of Liability
B. Criminal
C. Administrative
Act by pharmacist
Such as selling Schedule II narcotic without prescription. Buyer dies. R.Ph. Can be sued for damages(A), prosecuted(B), & be called before pharmacy board for possible license action(C)
History of Federal Drug Regulation
1. Food and Drug Act of 1906
Prohibited Adulteration and Misbranding of Drugs
Misbranding was defined as "false and fraudulent".
2.The Federal Food, Drug and Cosmetic Act of 1938
Proof of false and fraudulent no longer required.
Court injunctions and factory inspections authorized
Premarket approval based on safety required
3. Durham-Humphrey Amendment of 1951
Established the status of prescriptions drugs
4. The Drug Amendments of 1962
Premarket approval for efficacy required
Broadened investigational new drug requirements
Record keeping requirements
Required GMP'S
Drug Efficacy Study Implementation (DESI) Review
OTC Drug Review
5. Orphan Drug Act of 1983
Created Status of Orphan Drugs
Provided Tax Credits and Market Exclusivity for Developing Orphan Drugs
6. The Drug Price Competition and Patent Restoration Act of 1984
Abbreviated new drug applications (ANDA)
Paper NDA'S
Patent extensions for portion of patent term lost while drug was in regulatory review
7. The Prescription Drug Marketing Act of 1987
Prohibits:
· Reimportation
· Sale or trade of samples. Physicians must request samples and drug reps must keep records of requests and distribution of samples.
Note in Ohio pharmacists are prohibited from even storing prescription drug samples.
· Hospitals from reselling Rx drugs.
· Wholesalers must be licensed with the states in which they do business
8.
Prescription Drug User Fee ActFDA Modernization Act of 1997