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Drugs included in the USP-NF have met high standards for therapeutic use, patient safety, quality, purity, strength, packaging safety, and dosage form. Drugs that meet these standards have the initials “USP” following their official name, denoting globalrecognition of high quality. The International Pharmacopeia, first published in 1951 by the World Health Organization (WHO), provides a basis for standards in strength and composition of drugs for use throughout the world. The book is published in English, Spanish, and French. H2: U.S. Federal Legislation ELO: List the major pieces of legislation throughout U.S. history that help shape drug standards today. Federal legislation attempts to protect the public from drugs that are impure, toxic, ineffective, or not tested before public sale. The primary purpose of the legislation is to ensure safety. America’sfirst law to regulate drugs was the Food and Drug Act of 1906, which prohibited the sale of misbranded and adulterated drugs but did not address drug effectiveness and safety. H3: 1912: The Sherley Amendment This act 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 morphine 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 themarket. H3: 1914: The Harrison Narcotic Act This act required prescriptions for drugs that exceeded set narcotic limits. It also mandated increased record keeping by physicians and pharmacists. H3: 1938: The Federal Food, Drug, and Cosmetic Act The Federal Food, Drug, and Cosmetic Act of 1938 empowered the FDA to ensure a drug was safe prior to marketing. It is the FDA’s responsibility to ensure that all drugs are tested for harmful effects; it also required that drugs be labeled with accurate information and have detailed literature in the drug packaging that explains adverse effects. The FDA can prevent themarketing of any drug it judges to be incompletely tested or dangerous. Only drugs considered safe by the FDA are approved for marketing. H3: 1951: Durham-Humphrey Amendment The Durham-Humphrey Amendment distinguished between drugs that could be sold with or without prescription by a licensed health care provider. H3: 1962: Kefauver-Harris Amendment to the 1938 Act The Kefauver-Harris Amendment resulted from the widely publicized thalidomide tragedy of the 1950s in which European patients who took the sedative-hypnotic thalidomide during the first trimester of pregnancy gave birth to infants with extreme limb deformities. The Kefauver-Harris amendment tightened controls on drug safety, especially experimental drugs, and required that adverse reactions and contraindications must be labeled and included in the literature. The amendment also included provisions for the evaluation of testing methods used by manufacturers, the process for withdrawal of approved drugs when safety and effectiveness were in doubt, and the establishment of effectiveness of new drugs before marketing. H3: 1965: Drug Abuse Control Amendments Enacted in 1965, the Drug Abuse Control Amendments attempted to control the abuse of depressants, stimulants, and hallucinogens. H3: 1970: The Comprehensive Drug Abuse Prevention and Control Act Commented [SL24]: This main (H1) heading has been reworded to account for the addition of an additional second-level (H2) head. A TLO has been created and aligned with the H1. (p. 6) Commented [SL25]: An ELO has been created and aligned with this H2. (p. 6) Commented [SL26]: An ELO has been created and aligned with this H2. (p. 6) Commented [SL27]: Third-level (H3) headings do not require learning objectives. (p. 8) 9 In 1970, Congress passed the Comprehensive Drug Abuse Prevention and Control Act. This act, designed to remedy the escalating problem of drug abuse, included several provisions: • promotion of drug education and research into the prevention and treatment of drug dependence; • strengthening of enforcement authority; • establishment of treatment and rehabilitation facilities; and • designation of
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