pharm laws

The Pure Food and Drug Act of 1906

Prohibited interstate distribution or sale of adulterated and misbranded food and drugs.

The Food, Drug, and Cosmetic Act of 1938

Under this act, manufacturers must be concerned with the purity, strength,

effectiveness, safety, and packaging of drugs. Foods and cosmetics are also

regulated. By this act, the FDA has the power to approve or deny new drug

applications and even to conduct inspections to ensure compliance. approves the investigational use of drugs on humans and ensures that all

approved drugs are safe and eff ective.

The Durham–Humphrey Amendment of 1951

Prohibits

dispensing of legend drugs without a prescription. Nonlegend, OTC drugs

were not restricted for sale and use under medical supervision. Creates a distinction between the two.

The Kefauver–Harris Amendment of 1962

Requires that drug products, both

prescription and nonprescription, must be eff ective and safe. Prescription

drug advertising was placed under supervision of the FDA and qualifi ca-

tions of drug investigators were subjected to review.

Th e Comprehensive Drug Abuse Prevention and

Control Act of 1970

also called the Controlled Substances Act (CSA), directs the man-

ufacture, distribution, and dispensing of controlled substances that have the potential for addiction and abuse. Th is law replaced most previous narcotic

and drug abuse control laws. Creates schedules

Th e Poison Prevention Packaging Act of 1970

create standards for child-resistant packaging. Th is act

requires that most OTC and legend drugs be packaged in child-resistant con-

tainers.

Th e Occupational Safety and Health Act of 1970

mission is to ensure workplace safety and a healthy environment within the

workplace. violations include the following: no eyewash facilities

available, no labeling or improper labeling of hazardous chemicals, no docu-

mentation of initial employee training,

Th e Drug Listing Act of 1972

each new drug is assigned a unique and permanent product

code, known as a National Drug Code (NDC), that identifi es the manufacturer or distributor, the drug formulation, and the size and type of its packaging (####-####-####) = (manufacturer-drug-packaging)

Th e Orphan Drug Act of 1983

off ers federal fi nancial incentives to commercial and nonprofi t organizations to develop and market drugs previously

unavailable in the United States. Orphan drug act effects less than 200,000 people in the country. The Orphan Drug Act off ers tax breaks and a seven-year monopoly on

drug sales

Th e Omnibus Budget Reconciliation Act of 1990

requires pharmacists to off er to discuss information about new and refi ll prescriptions with

Medicare and Medicaid recipients (patients). Dicuss all info about drugs, ex administration, dosage, interactions, etc