Pharmacy Laws

May 21 STEPFUL

☆ 1906 PURE FOOD AND DRUG ACT

• First federal inspection of meat products

• Prohibited inferior foods and poisonous patent medicines

☆ 1912 SHERLY AMENDMENT

• Prohibited false therapeutic claims to protect consumers

1938 FOOD, DRUG, AND COSMETIC ACT

• Ensured that medications were labeled

• Founded FDA

☆ 1951 DURHAM-HUMPHREY AMENDMENT

• Required labeling for prescription drugs to distinguish from OTC drugs

• Requires prescription drugs to bear the legend, “"Caution: Federal law prohibits dispensing without a prescription"

• subsequent amendments replaced it with the legend, “Rx”

1962 KEFAVUER-HARRIS AMENDMENT

• Ensures the safety and effectiveness of all new medication on the market

1972 POISON PREVENTION PACKAGING ACT

Ensured that medication is stored in child protected packaging

1972 DRUG LISTING ACT

Medicines are more easily identifiable with National Drug Code

1983 ORPHAN DRUG ACT

Incentivizes development of drugs for rare conditions

1984 HATCH-WAXMAN ACT

Facilitated approval process for generic drugs to aid with access to medication

1987 PRESCRIPTION DRUG MARKETING ACT

Helps to prevent the sale of compromised, expired, or counterfeit drugs in the market

The Combat Methamphetamine Epidemic Act of 2005

Regulates over-the-counter sales of key ingredients to create methamphetamine, therefore restricting access to these substances

☆ OBRA 1990 - Omnibus Budget Reconciliation Act

Mandates pharmacist counseling for Medicaid recipients