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