1906 Federal Food and Drug Act

Was one of the first laws enacted to stop the sale of inaccurately labeled drugs. In 1970 the Food and Drug Act was rewritten to incorporate all the changes.

1914 Harrison Narcotic Act

Enacted because of the excessive number of opium addicts in the United States.

1938 Food, Drug, and Cosmetic Act

This law required drug companies to include package inserts and directions to the consumer regarding use and package inserts on drugs. This act also provided the legal status for the Food and Drug Administration (FDA)

1951 Durham-Humphrey Amendment

Required labeling "Caution: Federal law prohibits dispensing without a prescrition." It made the initial distinction between legend drugs (by prescription only) and over-the-counter medications (OTCs)

1962 Kefauver-Harris Amendments

In an attempt to ensure the safety and effectiveness of all new drugs on the market. The Food and Drug Administration (FDA) was placed in charge of how advertising was handled.

1970 Comprehensive Drug Abuse Prevention and Control Act

Drug Enforcement Agency (DEA) was formed to enforce the laws concerning controlled substances and their distribution. A schedule V drug requires less documentation tahn a schedule II drug.

Allowed drug companies to bypass the lengthy time requirements of testing a new drug and the costs that accompanied them to provide a medication to persons who had a rare disease. Diseases taht affected fewer than 200,000 persons were waived.

1987 Prescription Drug Marketing Act

This new act required the labeling "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

1990 Anabolic Steroids Control Act

Stiffen regulation on the abuse problems of anabolic steroids and their misuse by athletes.

1990 Omnibus Budget Reconciliation Act (Obra 90)

Deals specifically with practicing pharmacists. Also deals with the specifics of reimbursement for medications. A pharmacist must offer to counsel all patients who recieve new prescriptions.

Health Insurance Portability and Accountability Act of 1996

This bill deals with a patient's right to continuance of health insurance even when changing employers. Changes are related to implementing consent forms.

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Module 13

Laws and Acts

Question	Answer
1906 Federal Food and Drug Act	Was one of the first laws enacted to stop the sale of inaccurately labeled drugs. In 1970 the Food and Drug Act was rewritten to incorporate all the changes.
1914 Harrison Narcotic Act	Enacted because of the excessive number of opium addicts in the United States.
1938 Food, Drug, and Cosmetic Act	This law required drug companies to include package inserts and directions to the consumer regarding use and package inserts on drugs. This act also provided the legal status for the Food and Drug Administration (FDA)
1951 Durham-Humphrey Amendment	Required labeling "Caution: Federal law prohibits dispensing without a prescrition." It made the initial distinction between legend drugs (by prescription only) and over-the-counter medications (OTCs)
1962 Kefauver-Harris Amendments	In an attempt to ensure the safety and effectiveness of all new drugs on the market. The Food and Drug Administration (FDA) was placed in charge of how advertising was handled.
1970 Comprehensive Drug Abuse Prevention and Control Act	Drug Enforcement Agency (DEA) was formed to enforce the laws concerning controlled substances and their distribution. A schedule V drug requires less documentation tahn a schedule II drug.
1983 Orphan Drug Act	Allowed drug companies to bypass the lengthy time requirements of testing a new drug and the costs that accompanied them to provide a medication to persons who had a rare disease. Diseases taht affected fewer than 200,000 persons were waived.
1987 Prescription Drug Marketing Act	This new act required the labeling "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
1990 Anabolic Steroids Control Act	Stiffen regulation on the abuse problems of anabolic steroids and their misuse by athletes.
1990 Omnibus Budget Reconciliation Act (Obra 90)	Deals specifically with practicing pharmacists. Also deals with the specifics of reimbursement for medications. A pharmacist must offer to counsel all patients who recieve new prescriptions.
Health Insurance Portability and Accountability Act of 1996	This bill deals with a patient's right to continuance of health insurance even when changing employers. Changes are related to implementing consent forms.

Created by: samiect

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