PT 101 DATES AND LAWS
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16 terms
Terms | Definitions |
|---|---|
 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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