Term
| Current laws trace back to two pieces of legislation from the early |
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Definition
|
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Term
| Racist fears about deviant behavior, including drug misuse, played a role in the |
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Definition
| development of drug regulation |
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Term
| Laws were developed to regulate |
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Definition
|
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Term
| Fraud in patent medicines that were sold directly to the public included what two things |
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Definition
False therapeutic claims
Habit-forming drug content |
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Term
| Opium was associated with which ethnic group |
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Definition
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Term
| U.S. was involved in international |
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Definition
|
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Term
| Opium smoking brought to U.S. by |
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Definition
|
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Term
| Laws passed against the _______, _______, and ____ of opium |
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Definition
| importation, manufacture, use |
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Term
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Definition
| Banned only the smoking of opium |
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Term
| Cocaine was viewed as a cause of increasing |
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Definition
|
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Term
| Did cocaine have racist connections |
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Definition
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Term
| 1906 Pure Food and Drug Act |
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Definition
| Required accurate labeling and listing of ingredients |
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Term
| 1906 Pure Food and Drug Act was later ammended to require |
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Definition
| safety testing and testing for effectiveness |
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Term
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Definition
| A law that required those who “produce, import, manufacture, compound, deal in, dispense, or give away” certain drugs to register and pay a special tax |
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Term
| Harrison Act of 1914 was later expanded to include |
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Definition
| other federal controlled-substance regulations |
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Term
| What resulted from the Harrison Act of 1914 |
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Definition
| Showing your id and signing for medications |
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Term
| The Harrison Act of 1914 imposed a system of |
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Definition
| taxes on opium an coca products and record keeping |
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Term
| The Pure Food and Drugs Act (1906)was passed by the |
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Definition
| U.S. Department of Agriculture |
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Term
| The goal of The Pure Food and Drug Act of 1906 |
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Definition
| drugs are pure and honestly labeled |
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Term
| Harrison Act (1914) was passed by |
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Definition
|
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Term
| The goal of the Harrison Act (1914) |
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Definition
| taxation of drugs to restrict commerce in opioids and cocaine to authorized physicians, pharmacists, and legitimate manufacturers |
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Term
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Definition
| The FDA is responsible for regulating, testing, evaluating, approving and recalling all food, prescriptions, OTC drugs, illicit drugs, medical devices, vaccines, animal feed and drugs, cosmetics, and radiation-emitting products. |
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Term
| Three parts of the Regulation of Pharmaceuticals |
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Definition
| purity, safety, and effectiveness |
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Term
|
Definition
The contents of the product must be accurately labelled
FDA encourages cooperation and compliance |
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Term
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Definition
Originally-no legal requirements that medications should be safe
1938 Food, Drug, and Cosmetic Act required pre-marketing testing for toxicity
Companies required to submit a New Drug Application (NDA) to the FDA
-FDA became a gatekeeper and expanded greatly
Directions must be included
-Adequate instructions for consumer OR
-Drugs can only be used only with physician prescription |
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Term
| Amendments of effectiveness |
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Definition
| 1962 Kefauver-Harris Amendments |
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Term
| Three parts of the 1962 Kefauver-Harris Amendments |
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Definition
Pre-approval required before human testing
Advertising for prescription drugs must include info about adverse reactions
Every new drug must be demonstrated to be effective for the illnesses mentioned on label |
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Term
| Three parts of marketing a new drug |
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Definition
Preclinical research and development
Clinical research and development
Permission to market |
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Term
| Three phases of clinical research and development |
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Definition
Phase one-low doses, 20-80 healthy volunteers
Phase two-few hundred patients who could benefit
Phase three-typically 1,000-5,000 patients |
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Term
| Marketing a new drug may require ____ years and costs __ billion |
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Definition
|
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Term
| Only __ new drugs approved by FDA in 2008 |
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Definition
|
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Term
|
Definition
| tax and other financial incentives |
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Term
| Prescription Drug Marketing Act 1997 |
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Definition
|
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Term
|
Definition
| guidelines for post marketing reporting, distribution of information on off label uses |
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Term
| Dietary Substances are regulated more like ____ than drugs |
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Definition
|
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Term
| Two requirements of marketing supplements |
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Definition
Labels must be accurate
Products can’t make unsubstantiated direct claims |
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Term
| Two abilities of marketing supplements |
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Definition
Products can make general health claims
Products can be marketed without first proving safety |
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Term
| Controlled substances have _____ enforcement and ______ penalties |
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Definition
|
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Term
|
Definition
|
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Term
| Two things that regulate controlled substances |
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Definition
Bureau of Narcotics (Treasury Department)
Drug Abuse Control Act Amendments of 1965 |
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Term
| Marijuana Tax Act of 1937 |
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Definition
Anyone attempting to sell marijuana had to pay the transfer tax.
Tax stamp would only be issued to those who were already in possession of the marijuana.
Possession of marijuana without having paid the transfer tax was illegal according to the draft.
Law was written in such a way as to make it impossible to follow. |
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Term
| Comprehensive Drug Abuse Prevention and Control Act of 1970 ______ or _____ all previous laws |
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Definition
|
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Term
| Drugs controlled by the Comprehensive Drug Abuse Prevention and Control Act of 1970 are under |
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Definition
|
|
Term
| Under the Comprehensive Drug Abuse Prevention and Control Act of 1970 _____ and ______ funding increased |
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Definition
|
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Term
| Goal of Comprehensive Drug Abuse Prevention and Control Act of 1970 |
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Definition
| Direct control of drugs, not control through taxation |
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Term
| Under the Comprehensive Drug Abuse Prevention and Control Act of 1970, enforcement was separated from _______ and ______ decisions |
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Definition
|
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Term
|
Definition
| Possession and selling penalties |
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Term
| What was established under the Comprehensive Drug Abuse Prevention and Control Act of 1970 |
|
Definition
| Office of National Drug Control Policy |
|
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Term
| Difference in _______ from state to state |
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Definition
|
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Term
|
Definition
|
|
Term
| Significant growth in number of Americans in |
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Definition
|
|
Term
| Four people who can get drug tested |
|
Definition
Military and federal employees
Transportation workers
Employees at private companies
Public schools employees |
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Term
| Different test = different |
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Definition
|
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Term
|
Definition
|
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Term
|
Definition
|
|
Term
| Costs of impact of drug enforcement |
|
Definition
Cost of prison population
Crimes committed to purchase drugs
Corruption in law enforcement
Conflicting international policy goals
Loss of individual freedom |
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Term
| About __-__ percent of illegal drug supply is seized each year |
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Definition
|
|
Term
| When supplies are restricted, ______ go up |
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Definition
|
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Term
| Higher ____ and increased difficulty in obtaining drugs may deter some would-be users |
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Definition
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