Laws and Regulations

Pure food and drug act of 1906

• Prohibits interstate commerce, the misbranded and adulterated drugs and foods 

• The effect is giving them the responsibility to approve drugs and ensure purity standards by enforcing the rules against adulteration and misbranding.

Food, Drug, and Cosmetic Act of 1938 FDCA

It effectively created the Food and Drug Administration, the FDA.

• Class 1: for risk of serious adverse health consequences or death 

• Class 2 for risk of temporarily or medically reversible adverse health consequences 

• Class 3 for products unlikely to have adverse health Consquences.

(Prohibits Adulteration and Misbranding)

Health Insurance Portability and Accountability Act of 1996, HIPAA. 

• Defined Protected Health Infromation

• Pharmacies were required to insiture policies to protect patient’s PHI

• Severe civil and criminal penalties were put into place to protect PHI

1951 Durham-Humphrey Amendment

• Seperated medications into OTC and Legend medications

1962 Kefauver-Harris Amendment

• Standardized labeling requirements

• Required package inserts on legend medications

• Mandated good manufacturing processes

1970 Controlled Subdstances Act (CSA)

• Regulated use and Distribution of medications that could lead to abuse

• Created the DEA (Drug Enforcement Administration

• Set up Drug Schedules

1970 Poison Prevention Act

Adds child safety caps on medication bottles

1972 Drug Listing Act

• Made a list and assighed NDC numbers to them

• First 5 are the manufacturer

• Next four are the product code

• Last two are the package size code

1983 Orphan Drug Act

• Enables manufacturers to cread medications for use in rae disease

• Research grants

1984 Waxman-Hatch Act

• Enabled brand market exculsivity for a period of time

• Allowed Generics to enter the marketplace after that period

1990 OBRA

Pharmacist counsel

1997 FDA Modernization Act

• Sped up approval of new meds

• Modified sterps in the approval process

• Added Rx only to certain meds

2003 Medicare Prescription Drug Modernization Act

• Established Medicare part D

2005 Combat Methamphetamine Epidemic Act

• Psuedoephedrine must be Behind the counter

• Required record keeping of all sales

• 3.6g a day

• 9.0g a month