Federal Pharmacology Laws in Nursing

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?

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?

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 was established during what year?

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 was established during what year?

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.

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.