PHARMACY LAWS

1906 Pure Food and Drug Act Enacted to stop sale of inaccurately labeled drugs

All manufacturers required to put truthful info on labels

Required all food and drug meet standard of purity and strength

Gov’t pre-approval required

1914 Harrison Narcotic Act

o Restricted to opium usageo Eventually extended to non-

narcotics: i,.e. cocaineo Limited opium transporto Available only with Rx, harder to

get

1938 Food, Drug, and Cosmetic Act Provided legal status for

Food and Drug Administration (FDA)

Enacted because 1906 act didn’t include cosmetics, not worded strong enough

Required package inserts

All controlled substances labeled with warning

Required new drugs be safe before marketing

1951 Durham-Humphrey Amendment Require label “Caution: Federal Law prohibits

dispensing without a prescription” an all controlled substances

Doctor order and supervision required; Dr. must authorize refills

Established difference btwn legend and OTC medications

1962 Kefauver-Harris Amendments

Set label requirements for mftr and dispenser to pts

Required drug mftr to provide proof of safety and efficacy before marketing

FDA placed in charge of advertising

Stopped US selling of Thalidomide (until recent years)

1962 Kefauver-Harris Amendments

Thalidomide Tragedy

1970 Comprehensive Drug Abuse Prevention Control Act or Controlled Substance Act

Drug Enforcement Agency (DEA) created to enforce laws about controlled substances

Drug Schedule introduced

Based on potential for abuse

1970 Poison Prevention Packaging Act

Required child-proof packaging on ALL controlled substances and on most Rx drugs

Occupational and Safety Act of 1970

Ensures safe and healthful workplace environment by reducing hazards

Gave rise to OSHA-Occupational Safety and Health Administration

All pharmacies should:Post phone number to poison controlHave Material Safety DataSheets (MSDS)

for “hazardous materials in the pharmacy” Should have reference guide for toxicities

1983 Orphan Drug Act

Allowed drug companies to provide meds to persons /c rare diseases /s going through the long requirement of testing

1987 Prescription Drug Marketing Act

Controlled use of drugs in animals by requiring veterinarians to write Rx

1990 Anabolic Steroid Control Act

Increased regs dealing with abuse problems and misuse by athletes

1990 Omnibus Budget Reconciliation Act (OBRA

90) Required pharmacists to counsel Medicaid

and Medicare patients getting new RxBoard of Pharmacy can fine pharmacies

AND pharmacists

Health Insurance Portability and Accountability Act of 1996

(HIPAA) Provided broad and stringent regulation

to protect patient safety

1997 FDA Modernization Act

Simplified the labeling requirements: “Rx only” symbol statement replaced the “Caution: Federal Law…” statement

Changed to legend requirement to “Rx only” phased in by Feb. 2003

FDA

Main fxn: enforce guidelines for manufacturers to ensure safety and effectiveness

MedWatch program allows consumers and HCP to report discrepancies and adverse rxn with meds

DEA

Created under Dept of JusticeTo prevent illegal distribution and

misuse of drugs Issues licenses to pharmacies,

practitioners, and manufacturers of controlled substances

The Joint Commission (TJC)

Mission to improve quality of care provided to general public

OSHA

Mission: to prevent work-related injuries, illnesses, and death by issuing and enforcing standards for workplace safety and health