Laws PTCE Flashcards
PURE FOOD AND DRUG ACT OF 1906
Prohibited the interstate sale and transmission of harmful or mislabeled drugs.
FOOD, DRUG AND COSMETIC ACT (FDCA) OF 1938
- Required manufactures to file a new drug application.
- Required manufactures to prove new drugs were safe to use.
- Created the food and Drug Administration
- Defined harmful drugs
- Defined mislabeled drugs
- Authorized the FDA to carry out inspections
KEFAVER-HARRIS AMENDMENT OF 1962
- Required that drugs must be effective
- Required manufacture to file an Investigational New Drug Application before beginning human trials
COMPREHENSIVE DRUG ABUSE PREVENTION AND CONTROL ACT OF 1970
- Classified drugs based on their potential for abuse
- created the Drug Enforcement Administration. (DEA)
POISON PREVENTION ACT OF 1970
-Required child resistant containers (with some exceptions)
DRUG LISTING ACT OF 1972
- FDA can keep a list of drugs
- Drugs must have a National Drug Code number (NDC)
ORPHAN DRUG ACT OF 1983
-Encouraged companies to create orphan drugs
PRESCRIPTION DRUG MARKETING ACT OF 1987
-Specified which agents could legally sell drugs
OMNIBUS BUDGET RECONCILIATION ACT OF (OBRA) 1990
- States required pharmacies to use the Drug Use Review or they would lose Medicaid
- Required pharmacies to offer to counsel patients
FDA MODERNIZATION ACT
-Changed labels from “legend” to “Rx only”
DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT (DSHEA) OF 1994
- Defined Dietary supplement
- Authorized the Food and Drug Administration to remove an unsafe dietary supplement from the market.
HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF (HIPPA) 1996
- Set up rules to protect patient privacy
- HIPPA violations are reported to the U.S. Department of Health and Human Services (centers for Medicare and Medicaid), The office of Inspector General (OIG), and/or the provider.
OCCUPATIONAL HEALTH AND SAFETY ADMINISTRATION (OSHA)
-Regulates workplace safety.
