In the 19th century, the United States had no effective drug regulation, opium was widely used in medications, and many medicines made scientifically unsupported claims.
Drug injuries and deaths contributed to the emergence of laws, regulatory agencies, and professional organizations during the 20th century to protect consumers and regulate medicines.
Unregulated medicines → injuries and deaths → protective legislation
L-R-S-E: Laws, Regulations, Standards, Ethics
The Food, Drug, and Cosmetic Act of 1938 created the Federal Food and Drug Administration and required pharmaceutical manufacturers to obtain approval before releasing a new drug.
The Comprehensive Drug Abuse Prevention and Control Act of 1970, also called the Controlled Substances Act, classified drugs with abuse potential into five schedules with different levels of restriction.
The DEA can classify new drugs or change a drug’s schedule, and in 2014 it reclassified hydrocodone combination products from Schedule III to Schedule II.
The Poison Prevention Packaging Act of 1970 required most over-the-counter and prescription drugs to be packaged in child-resistant containers to prevent accidental childhood poisonings.
The Drug Price Competition and Patent Term Restoration Act of 1984, or Hatch-Waxman Act, streamlined approval of equally effective generic drugs and required manufacturers to prove bioequivalence to the brand-name product.
1938 approval → 1970 control and packaging → 1984 generics
The USP-NF is a key pharmacy resource that sets standards for pharmacy practice by pharmacists and pharmacy technicians.
USP-NF General Chapter <795> addresses nonsterile compounding standards.
USP-NF General Chapter <797> addresses sterile compounding standards.
USP General Chapter <800> addresses the handling of hazardous substances in compounding, including chemotherapy drugs.
<795> nonsterile, <797> sterile, <800> hazardous
Criminal law punishes offenses, whereas civil law addresses disputes and harm
Four Types of Oversight
| Type | Meaning | Primary function |
|---|---|---|
| Laws | Rules passed by legislative branches | Guide conduct |
| Regulations | Rules and procedures carrying out laws | Implement laws |
| Standards | Benchmarks for quality | Define desired performance |
| Professional ethics | Code of high professional standards | Guide professional conduct |
Test your knowledge on Pharmacy Law and Professional Standards with 21 multiple-choice questions with detailed corrections.
1. Which condition characterized drug use and medicine claims in the United States during the nineteenth century?
2. What development did drug-related injuries and deaths help produce during the twentieth century?
Memorize the key concepts of Pharmacy Law and Professional Standards with 29 interactive flashcards.
What was the status of drug regulation in 19th century United States?
There was no effective drug regulation.
Which substance was widely used in 19th century medications in the US?
Opium was widely used.
What type of claims did many 19th century medicines make?
They made scientifically unsupported claims.
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