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mayhalls class

Pure Food & Drug Act 1906

Prohibited interstate transportation, sale of adulterated or misbranded food and drugs

Food, Drug, & Cosmetic Act (FDC) 1938

Created FDA and required manufacturers to file NDA AND NEW DRUGS BE SAFE BEFORE MARKETING.

Durham-Humphrey Amendment 1951

Bear legend, "Caution: Fed. law prohibits disp. w/o script", distinguished between legend/OTC drugs, limited refills.

Kefauver-Harris Amendment 1962

Requires that drugs not only be safe for humans but effective

1914 HARRISON TAX ACT

ESTABLISHES THAT MANUFACTURERS, PHARMACISTS, IMPORTERS, AND PHYSICIANS PRESCRIBING NORCOTICS ARE LICENSED & TAXED

Poison Prevention Packaging Act 1970

Mandated child-resistant containers (some exceptions)

CONTROLED SUBSTANCE ACT 1970 (CSA)

THE DEA WAS ESTABLISHED AS A DIVISION OF THE JUSTICE DEPT. AND CLASSIFIES 5 LEVELS OF DRUGS THAT HAVE POTENTIAL FOR ABUSE.

Orphan Drug Act 1983

Encourages development of new drugs to treat rare diseases by providing tax incentives, and fast review

Drug Price Competition & Patent-Term Restoration Act 1984(HATCH-WAXMAN)

Encouraged quicker introduction of both generic & new drugs and extension of patent terms.

THE THALIDOMIDE LESSON

IN 1962 A NEW SLEEPING PILL WITH THIS DRUG, WAS FOUND TO CAUSE SERVERE BIRTH DEFECTS WHEN USED BY PREGNANT WOMEN. FROM THEN ON DRUGS NEEDED TO BE SAFE AND EFFECTIVE BEFORE MARKETED.

Omnibus Budget Restoration Act 1990

Requires offer of counsel to medicare patients regarding there medications

EXEMPT NARCOTICS

MEDICATIONS THAT CONTAIN HABIT FORMING INGREDIENTS, BUT CAN BE SOLD BY A PHARMACIST WITHOUT A PRESCRIPTION TO PERSON 18 OR OLDER WITH 48 HOUR DOSAGE LIMITS WITH RECORDS MAINTAINED IN A BOUND BOOK

Health Insurance Portability & Accountability Act 1996

Established safeguards to protect patient confidentiality, to keep insur. when moving to new job

Food, Drug administration Act 2004

Rx Only instead of legend phrase

DUAL MARKETING STATUS

PLAN B EMERGENCY CONTRACEPTIVES HAVE THIS MEANING; 17 YEARS OLD AND YOUNGER NEED A PRESCRIPTION BUT 18 AND OVER IT IS OVER THE COUNTER (OTC)

Combat Methamphetamine Epidemic Act of 2005

Reclassifies and restricts access to products containing pseudoephedrine

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