HLSC 130 Ch 3
The Treasury department
the harrison act of 1914
Rank the following regulations int he US in the order in which they were implemented, beginning with the first to be implemented
1 Regulation of pharmaceutical manufacturing and sales 2 regulation of opioids and cocaine, 3 prohibition of alcohol
Department of Agriculture
1906 Pure food and drugs act
True or False the hHarrison act criminalized individual use or possession of certain habit forming drugs
False - only taxed
One of the major concerns of the US Senate in the late 1950s was that some of the most widely sold over the counter medicines were probably " ", and there was no law against this
Ineffective
According to the 1906 Pure food and drugs act, " " Covered "Any statement, design or device regarding a drug, or the ingredients or substances contained therein, which shall be false or misleading in any particular way
Misbranding
" " is a narcotic and the primary active chemical in opium from which heroin is derived
Morphine
The broadest impact on drug use in the US during the late 19th century and early 20th century came from the widespread legal distribution of " ", which were dispensed by traveling peddlers and were readily available at local stores for self medication
Patent medicines
As FDA officials investigated more and more cases, they determined that many violations of the 1906 Pure Food and Drugs Act were unintentional and caused primarily by poor manufacturing techniques and an absence of
Quality control measures
In the early 1900s, Dr. Hamilton Wright, the father of American narcotics laws, decided the US could gain favored trading status with China by leading international efforts to
Reduce opium importation
What is otherwise known as "An Act to provide for the registration of, with collectors of internal revenue, and to impose a special tax upon all persons who produce, import, manufacture, compound, deal in, dispense, or give away opium or coca leaves, their salts, derivatives, or preparations, and for other purposes?
The Harrison Act of 1914
When 107 people in the US died in 1937 from taking Elixir Sulfanilamide containing diethylene glycol that causes kidney poisoning, why was the federal government unable to intervene on the grounds that the mixture was toxic?
There was no legal requirement that medicine be safe
What do an 1875 SF ordinance, an 1882 NY law, and an 1890 federal act in the US all have in common?
They all regulated the manufacture and use of opium
How were physicians, dentists, and veterinary surgeons affected by the Harrison Act of 1914
They had to register to be potential lawful distributors of opioids and cocaine
One of the precursors to the Pure Food and Drugs Act was the 1906 publication of " ", which exposed the horribly unsanitary conditions in the meat packing industry and shocked congress and America
Upton Sinclair's the jungle
When does a pharmaceutical company, desiring to introduce a new drug, supply to the FDA a "Notice of Claimed Investigational Exemption for a New Drug" (IND)?
When it is ready to study the effects of a compound on humans
Phase three of clinical investigation
administers the drug to larger numbers of individuals, 1000-5000, with the disease or symptom for which the drug is intended
The largely unsubstantiated fear that " " was important in building support for federal drug control laws among Southern senators and congressmen in the US despite their opposition to increasing federalism
cocaine use was responsible for an increase in violent crimes
What were provisions added by the 1962 Kefauver-Harris amendments to federal law?
companies need to seek approval before conducting clinical trials on humans advertisements for prescription drugs need to summarize adverse reactions to the drug
Phase two of clinical investigation
human studies involves patients who have the condition the candidate drug is designed to treat
The 1850's in the united states saw the introduction of " ", which was a potent delivery system for morphine that led to increasing medical recognition of the negative aspects of 'morphinism'
hypodermic syringes
The 1906 Pure Food and Drugs Act Prohibited
interstate commerce in adulterated or misbranded food and drugs
During the period after the civil war in the US, concerns about drunkenness, crime, drug misuse, and other forms of deviant behavior came to be associated with
minority racial groups
According to the 1938 Food, Drug and Cosmetic Act, A company had to submit " ", " ", " " , (NDA) to the FDA that included "full reports of investigations which have been made to show whether or not a drug is safe for use" which had to be approved before the drug could be marketed
new drug application
people enforcing the harrison act changed in 1919 and they believed that the cure for narcotic dependence was to
prevent users from having access
The Orphan Drug Act passed by Congress in 1993 offered tax incentives and exclusive sales rights for a guaranteed seven years for any company developing a drug for
rare disorders afflicting no more than 200,000 people
Why were morphine and heroin popular among lower class opium users when states and municipalities int he US began to outlaw opium dens?
readily available and inexpensive
identify reasons why the new drug application provision under the 1938 food drug and cosmetic act was important
reduced the likelihood of companies run by untrained people introducing new drugs increased power and responsibility of the FDA as well as its size
According to the comprehensive Drug Abuse Prevention and Control act of 1970, physicians are not allowed to prescribe " " drugs and they are not found in pharmacies
schedule 1 - high addictive
According to the Harrison act of 1914, physicians
were still free to prescribe heroin, cocaine, or any other available drug
According to the 1906 pure food and drugs act, the packaging of drugs had to indicate
what proportion of habit forming drugs they included
Phase one of Clinical Investigation
encompasses studies with relatively low doses of the drug on a limited number of healthy peopl
In the early 1800s, the most reliable and effective medicine of medical doctors, used for a variety of conditions but most notable as a pain reliever was " "
opium