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Questions and Answers
First law to regulate drugs was the _________, which prohibited
the sale of misbranded and adulterated drugs but did not address drug
effectiveness and safety. It established official requirements for labeling of drug products and established the forerunner of US FDA.
First law to regulate drugs was the _________, which prohibited the sale of misbranded and adulterated drugs but did not address drug effectiveness and safety. It established official requirements for labeling of drug products and established the forerunner of US FDA.
What year was the Pure Food and Drug Act established?
What year was the Pure Food and Drug Act established?
It distinguished between drugs that could be sold with or without prescription by a licensed health care provider.
It distinguished between drugs that could be sold with or without prescription by a licensed health care provider.
What year was Durham-Humphrey Amendment established?
What year was Durham-Humphrey Amendment established?
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The Harrison Narcotics Tax Act required prescriptions for drugs that
exceeded set narcotic limits. It also mandated increased record keeping
by physicians and pharmacists.
The Harrison Narcotics Tax Act required prescriptions for drugs that exceeded set narcotic limits. It also mandated increased record keeping by physicians and pharmacists.
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The Harrison Narcotics Tax Act was established during what year?
The Harrison Narcotics Tax Act was established during what year?
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The Sherley Amendment prohibited false therapeutic claims on drug
labels. It came about as a result of Mrs. Winslow’s Soothing Syrup, a
product advertised to treat teething and colic, which contained
_____ and led to the death of many infants. Under the Sherley
Amendment, the government had to prove intent to defraud before a
drug could be removed from the market.
The Sherley Amendment prohibited false therapeutic claims on drug labels. It came about as a result of Mrs. Winslow’s Soothing Syrup, a product advertised to treat teething and colic, which contained _____ and led to the death of many infants. Under the Sherley Amendment, the government had to prove intent to defraud before a drug could be removed from the market.
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The Sherley Amendment was established during what year?
The Sherley Amendment was established during what year?
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The Kefauver-Harris Amendment resulted from the widely publicized tragedy caused by Mrs. Winslow’s Soothing Syrup, a product advertised to treat teething and colic, which contained morphine and that led to the death of many infants.
The Kefauver-Harris Amendment resulted from the widely publicized tragedy caused by Mrs. Winslow’s Soothing Syrup, a product advertised to treat teething and colic, which contained morphine and that led to the death of many infants.
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It was designed to promote the development and manufacture of drugs used in the treatment of rare diseases (orphan drugs). The act’s three primary incentives are (1) federal funding of grants and contracts to perform clinical trials of orphan products; (2) a 50% tax credit for costs of clinical testing; and (3) exclusive rights to
market the drug for 7 years from the marketing approval date.
It was designed to promote the development and manufacture of drugs used in the treatment of rare diseases (orphan drugs). The act’s three primary incentives are (1) federal funding of grants and contracts to perform clinical trials of orphan products; (2) a 50% tax credit for costs of clinical testing; and (3) exclusive rights to market the drug for 7 years from the marketing approval date.
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Study Notes
Drug Regulation Milestones
- The Pure Food and Drug Act was the first law regulating drugs, prohibiting sales of misbranded and adulterated drugs; it did not address effectiveness or safety.
- Established official labeling requirements for drug products and laid the groundwork for the U.S. Food and Drug Administration (FDA).
- Enacted in 1906, it differentiated between prescription and non-prescription drugs.
Key Amendments and Acts
- The Durham-Humphrey Amendment distinguished between prescription-required and over-the-counter drugs, instituted in 1951.
- The Harrison Narcotics Tax Act required prescriptions for narcotics exceeding specified limits, enforced detailed record-keeping by medical professionals; established in 1914.
Sherley Amendment
- The Sherley Amendment prohibited false therapeutic claims on medications, stemming from issues with Mrs. Winslow’s Soothing Syrup, which contained harmful ingredients and resulted in infant fatalities.
- Under this amendment, proving intent to defraud was necessary to remove a drug from the market; enacted in 1912.
Kefauver-Harris Amendment
- The Kefauver-Harris Amendment emerged from the fallout of Mrs. Winslow’s Soothing Syrup tragedy, targeting more stringent drug safety and efficacy standards.
- Aimed at promoting orphan drug development for rare diseases through three incentives:
- Federal funding for clinical trials of orphan drugs.
- A 50% tax credit on clinical testing costs.
- Exclusive marketing rights for 7 years post-approval.
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Description
Learn about the first law to regulate drugs, its provisions, and its impact on the development of the US FDA. Test your knowledge on this significant event in pharmacy history.
