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 usage
o Eventually extended to nonnarcotics: i,.e. cocaine
o Limited opium transport
o 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

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
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
abuse
on potential for
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 control
 Have 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 Rx
 Board 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 Justice
 To 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