Enacted in 1906

prohibited interstate distribution of adulterated (less than pure) or miss branded food and drugs.

Enacted in 1938

manufacturer had to ensure the purity, safety, packaging, and strength of a medication.

requires medication be labeled with adequate directions for safe use.

1951 amendment

Added the label "Caution: Federal law prohibits dispensing this medication without a prescription."

Prohibited dispensing legend drugs without a prescription.

Enacted in 1963

all meds both RX and OTC be pure, effective, and safe

FDA supervised RX advertising 

manufacturing site inspections

Enacted in 1970

divided controlled substances into 5 classes or schedules

industry to keep records and maintain security measures for certain meds

Drugs have no accepted medical use in the US. 

high abuse potential

example: LSD, crack heroin

Drugs having an acceptable medical use and a high abuse potential

severe psychic or physical dependence 

example: cocaine, Ritalin

ordered using form DEA 222

Drugs having an accepted medical use

abuse potential less than 1 or 2

example: Vicodin, T3

Drugs having an accepted medical use

abuse potential less than those in 3

example: Ambien, Lorazepam

Drugs having an accepted medical use 

abuse potential less than those listed for 4

example: Lomotil, Robitussin AC

Enacted in 1970

standards for child-resistant packaging 

standard: cannot be opened by 80% of children younger than five, but can be opened by 90% of adults

Enacted in 1970

prevents workplace disease and injury

workplace is free from recognized hazards

example: radioactive or cytotoxic drugs

Enacted in 1972

assigns a unique and permanent drug code to each medication

called NDC National Drug Code

11 digits: 5 manuf, 4 product and strength, 2 container size

Enacted in 1960

use and disposal of hazardous material

"Hazardous Substance" containers

"sharps" boxes for sharp equip like needles

Enacted in 1983

financial incentive to develop and market medications not previously available in the US.

tax breaks, and 7 year monopoly on drug patent

Enacted in 1990

pharmacies filling Medicaid RX must obtain, record, and maintain basic patient information

pharmacists must provide counseling to patients and perform drug utilization reviews

pharmacist must fix any errors in report

Enacted in 1990

allows CSA to regulate anabolic steroids

anabolic steroids became a schedule III controlled substance

HIPPA

Health Insurance Portability and Accountability Act

Enacted in 1996

improve continuity and portability of health insurance

establish patient rights to their info

confidentiality of the protected health info

establish common set of rule for transmitting claims

Enacted in 1997

safe pharmacy compounding

regulation of medical devices

labels of every legend med to say "Rx Only"

focus was on speeding up the approval process of new meds

Enacted in 2005

ephedrine and pseudoephedrine must be kept behind the counter

limit of 3.6g per person at one time

limit of 7.5g per month

must have ID registered at the pharmacy

names entered into national database

State Board of Pharmacy

BOP

Each state has it's own

state specific pharmacy laws and regs

admin of licenses and cert of pharmacy personnel

administers board exams, oversight, and disipline of perfessionals

Drug Enforcement Agency

DEA

Enforcing controlled substance legislation

the pharmacy is regulated by many laws enforced by the DEA 

uses assets seized to help help combat other targets

Food and Drug Administration

FDA

Enforces safety and effectiveness

Uses a system called Medwatch to receive info about adverse events or product problems

Joint Commission on Acceditation of Heathcare Organizations

JCAHO

Body that accredits and certifies healthcare organizations in the US

works to improve safety and quality of healthcare

National Association of the Boards of Pharmacy

Develop uniform standards

reduce the likelihood of errors and public harm due to complexity of medications.