Laws PTCE Flashcards
(13 cards)
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.
