Overview of Pharmacy Laws and Medication Safety

Historical Context

• The safety of medications is ensured through various pharmacy laws.

Key Legislation

Pure Food and Drug Act (1906)

• Initiated regulation of drug safety and labeling in the U.S.
• First federal inspection of meat products.
• Prohibited adulterated foods and poisonous patent medicines.

Shirley Amendment (1912)

• Targeted false therapeutic claims on drug labels.

Food, Drug, and Cosmetic Act (1938)

• Ensured medications were accurately labeled.
• Created the FDA to oversee drug market safety.

Prescription and Drug Regulation

Durham-Humphrey Amendment (1951)

• Established rules for prescription and over-the-counter drugs.
• Mandated caution labels.
• Allowed verbal prescription refills.

Kefauver-Harris Amendment (1962)

• Also known as the Drug Efficacy Amendment.
• Ensured rigorous testing for drug safety and effectiveness.

Safety Measures

Poison Prevention Packaging Act (1972)

• Mandated child-resistant packaging for medications.

Drug Listing Act (1972)

• Required all commercial drugs to have a National Drug Code (NDC).

Addressing Rare Diseases

Orphan Drug Act (1983)

• Incentivized the development of treatments for rare diseases.
• Aimed to ensure no patients are overlooked.

Accessibility and Distribution

Hatch-Waxman Act (1984)

• Promoted accessibility to medications.
• Facilitated approval process for generic drugs.

Prescription Drug Marketing Act (1987)

• Safeguarded the integrity of prescription drugs.
• Regulated distribution to prevent misuse and ensure necessary access.

Conclusion

• From early regulations to modern safeguards, these laws have shaped pharmacy practices.
• Ensured efficacy, safety, and accessibility of medications for public health.