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PT 101 DATES AND LAWS
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
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