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Pharm Law
Pharmacy Federal Laws
| Question | Answer |
|---|---|
| Pure Food and Drug Act 1906 | Prevented the sale of inaccurately labeled drugs. Known as "Truth in Marketing". Amended in 1938 and again in 1970 on same topic |
| Harrison Narcotic Act 1914 | Opium based drugs by Rx only due to the increase in US addicts. |
| Food, Drug and Cosmetic Act 1938 | Misbranded and and adulterated drugs are illegal. This law made the laws of 1906 more stringent (strict). Requires package inserts available on all drugs and also to all consumers who ask for them. “Warning: May be habit forming “ became a requirement; |
| Durham-Humphrey Amendment 1951 | Required all drug companies to place the following caution on the containers: “Caution: Federal Law prohibits dispensing with out a prescription”. Separtated drugs into two categories: Legend or prescription drugs and Non-Legend or over the counter drugs |
| Kefauver-Harris Amendment 1962 | Requires Safety and efficacy to be established on all drugs to be marketed. Drug Companies must follow GMP’s or ”Good Manufacturing Practices.” This was a direct result of the Thalidomide scare, in which women who took this drug during their pregnancy, t |
| Poison Control Act 1970 | The Drug Enforcement Agency, DEA, was formed to suppress the sale of recreational drugs; high abuse and addiction potential. Further categorized drugs into 5 different schedules of descending order of abuse and addiction potential |
| Orphan Drug Act 1983 | Allows drug companies to avoid long and costly clinical trials and their requirements, in order to provide drugs to people of a rare disease of which less than. 200,000 are afflicted and/or research costs could not be recovered with future sales. |
| Anabolic Steroid Control Act 1990 | Made existing regulations for anabolic steroids more stringent due to the abuse potential by athletes |
| OBRA Omnibus Budget Reconciliation ACT 1990 | US Congress enacts this law to mandate that pharmacists must offer counseling of a NEW prescription drug at time of dispensing to the patient or patients agent, enforces auxiliary warnings, Required that patients in nursing homes must not be given drugs t |
| HIPAA Health Insurance Portability and Accountability Act 1996 | Allows a patient to continue healthcare coverage despite separation from a company and changing employers. Also assures privacy of personal information. |
| Pure Food and Drug Act | Regulates food production,"The Jungle," clamps down on misrepresentation, institutes content labeling, decline of "patent medicines," Beginning of government regulation |
| Sherly Amendment | Focus on effectiveness |
| Harrison Narcotics Act | Regulates Production, Importation, Distribution, and Use of Opiates. Department od treasury: Narcotics Division established |
| Narcotic Drug Import and Export Act (Jones -Miller Act) | Intended to eliminate use of narcotics except for legitimate medicinal use. Establishes: Federal Narcotics Control Board (Still Treasury Department) |
| Heroin Act | Makes it illegal to manufacture heroin |
| Focus shift to curing addiction (Linder Case 1925) | Federal Hospitals in Lexington and Fort Worth for Narcotic Addiction |
| Issue of Corruption in Narcotics Board | Bureau of Narcotics (Harry Anslinger) |
| Marijuana Tax Act | Applies controls over marijuana similar to narcotics |
| Food, Drug and Cosmetic Act | FDA given control over drug safety, Drugs redefined:effect body even in absence of disease, Establishes class of drugs available by Prescription (Company determines status) |
| Opium Poppy Control Act | Prohibits growing poppy w/o license |
| Durham-Humphrey Amendment | Established more specific guidelines for prescription drugs: habit forming, safety, and evaluation of new drugs |
| Boggs Amendment to the Harrison Narcotic Act | Mandatory sentences for narcotic violations |
| Narcotics Control Act | Intends to impose even more severe penalties for narcotics violations |
| Drug Abuse Control Amendments (DACA) | Strict controls over amphetamines, barbiturates, LSD, etc. (Bureau of Narcotics and dangerous Drugs) |
| Narcotic Addict Rehabilitation Act (NARA) | Allows treatment as an alternative to jail |
| DACA Amendments | Provides that sentence may be suspended and record expunged if no further violations within 1 year |
| Comprehensive Drug Abuse and Control Act | Replaces and updates all previous laws concerning narcotics and other dangerous drugs. Emphasis on law enforcement. |
| Drug Abuse Office and Treatment Act | Establishes federally funded programs for prevention and treatment |
| Methadone Control Act | Regulates methadone licensing |
| Heroin Trafficking Act | Increases penalties for distribution |
| Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) | Consolidates NIMH, NIDA, and NIAAA under umbrella organization |
| Drug Enforcement Administration (DEA) | Remodels Bureau of Narcotics and Dangerous Drugs into DEA |
| Drug Abuse Treatment and Control Amendments | Extends 1972 act |
| Alcohol and Drug Abuse Education Amendments | Sets up education programs within Department of Education |
| Drug Abuse Prevention, Treatment, and Rehabilitation Amendments | Extends prevention education and treatment programs |
| Drug Offenders Act | Sets up special programs for offenders and organizes treatment |
| Analogue (Designer Drug) Act | Makes use of substances with similar effects and structure to existing illicit drug illegal |
| Anti-Drug Abuse Act | Establishes oversight office: National Drug Control Policy |
| ADAMHA Reorganization | Transfers NIDA, NIMH, and NIAAA to NIH and incorporates ADAMHA's programs into the Substance Abuse and Mental Health Services Administration (SAMHSA) |
Created by:
KCHERISH
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