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TCE Pharmacy Law

Pharmacy Federal Law

Year & Act/AmendmentDescription
1906 Federal Food & Drug Act Enacted to stop the sale of inaccurately labled drugs. Manufactures were required to put truthful information on the label before selling.
1914 Harrison Narcotic Act Enacted because of the excessive number of Opium accdicts in the U.S. Individuals could no longer obtain Opium without a prescription
1938 Food, Drug & Cosmetic Act Enacted because the earlier federal Food and Drug Act of 1906 was not strict enough and did not include cosmetics. Act requires controlled substances to be labled " Warning: May Be Habit Forming"
1951 Durham- Humphery Amendent Introduced legend drugs (prescription only) and OTC (non- prescription). Act requires the labeling "CAUTION: Federal Law Prohibits Dispensing Without a Prescription"
1962 Kefauver- Harris Amendment Enacted to ensure the safety and effectiveness of all new drugs on the market. GMP (Good Manufacturing Practices) was put into place.
1967 Fair Packaging and Labeling Act Label must show contents and measurements, all must be in metric and U.S. units.
1970 Comprehensive Drug Abuse Prevention & Control Act The DEA was formed to enforce laws. Scheduled of Controlled Substances was introduced for controlls 1-5.
1970 The Posion Prevention Packaging Act Requires manufactures and Pharmacies to place all medications with childproof caps.
1972 Drug Listing Act Provides the FDA with a list of all drugs. The Act amends the Food Drug & Cosmetic Act & prevents unfair deceptive packaging & labeling
1983 Orphan Drug Act Allowed drug companies to bypass the lengthy time requirements to treat rare diseases
1987 Prescription Drug And Marketing Act Enacted to control the use of drugs in Animals. Vets must give a prescription.
1990 Omnibus Budget Reconciliation Act (OBRA '90) Pharmacist mus offer counsel
Created by: felicity



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