NUR240 Chapter 2: Chapter 2
Chapter 2: Drug Approval and Regulation
o Drug regulations and standards
o Until the 19th century there were few standards or guidelines to protect the
public from drug misuse
o Formulary: list of drugs and drug recipes; consensus on standards for
drug quality
â–Ş First standard commonly used by pharmacists
o US Pharmacopoeia of 1820: first comprehensive publication of drug
standards
â–Ş Pharmacopoeia: medical reference summarizing standards of
drug purity, strength, and directions for synthesis
o American Pharmaceutical Organization (APha)
â–Ş National professional society of pharmacists, established 1852
â–Ş Maintained the national compendia of drug standards, the National
Formulary (NF)
â–Ş National Formulary competed with other compendia, US
Pharmacopeia
o USP-NF (1975): merger of US pharmacopoeia and national formulary
o Excipients: inactive ingredients
o Biologics Act of (1902): started to test and regulate serum and blood
product quality
o Pure Food and Drug Act of 1906 gave the government power to
control the labeling of medicines
o Sherley Amendment (1912): prohibited sale of drugs with printed false
therapeutic claims
o Food, Drug, and Cosmetic Act (1938): first law preventing sale of
drugs that had not been thoroughly tested before marketing
o Dietary Supplement Health and Education Act, 1994: controls
misleading industry claims
o FDA: 19088; government agency of health and human services
â–Ş Know what their purpose is
o Center for Drug Evaluation and Research (CDER)
â–Ş Branch of FDA
â–Ş Determines safety and efficacy of drugs
â–Ş Pharmaceutical laboratories must solicit approval from FDA before
marketing a drug
o The role of the food and drug administration
o Black box warnings: notifications within a prescription drug’s package
to call attention to an extreme adverse drug effect which a drug might have
▪ Gives warning for drugs with “special problems”
