Pharmacy Laws Flashcards
1906 Pure Food and Drug Act
1st federal law regulating drugs
Enacted to stop the sale of
inaccurately labeled drugs
1914 Harrison Narcotic Act
Enacted because of the excessive number of opium
addicts in the United States
People could no longer obtain opium without a prescription
1938 Food, Drug, and Cosmetic Act
Enacted because the 1906 Pure Food and Drug Act
was not worded strictly enough and did not include
cosmetics
Basis for pharmacy law today
New Drug Application required by FDA
All narcotics were required to be labeled “Warning: May
be habit-forming”
Required adequate directions for use (package inserts)
1938 Food, Drug, and Cosmetic Act
Defined the exact labeling for products and defined
misbranding and adulteration as being illegal
Adulteration
Unsanitary, unsafe (including preparation & storage)
Misbranding
False or misleading
Poorly labeled
Lacking warning labels if addictive
1951 Durham-Humphrey
Amendment
Made the initial distinction between legend drugs
(by prescription only) and non-prescription
(over-the-counter or OTC medications)
Required legend drugs be labeled “Caution: Federal
law prohibits dispensing without a prescription”
Must be prescription by a licensed practitioner
Physicians, veterinarians, dentists, physician assistants, nurse
practitioners
1962 Kefauver-Harris Amendment
Enacted in an attempt to ensure the safety and
effectiveness of all new drugs on the market (both
legend and OTC)
Burden put on manufacturing companies
to have good manufacturing practices (GMP)
FDA inspections
Drug testing and approval required
Prevented the sale of thalidomide in the United States
because children were born with birth defects after
use in pregnancy
1970 Comprehensive Drug Abuse
Prevention and Control Act
The Drug Enforcement Agency (DEA) was formed
to enforce the laws concerning narcotics and their
distribution
Created controlled substance schedule
I-V
Closed system allowing distribution of
controlled substances to only those
registered with DEA
Established strict recordkeeping guidelines
1970 Poison Prevention Packaging Act (PPPA)
Enacted to reduce accidental poisoning in children
Requires most OTC and legend drugs be packaged
in child-resistant containers
80% under 5yrs cannot open and 90% adults should be able to
open
Exceptions to child-resistant containers
Upon specific request of physician or written consent of
patient (elderly)
Institutionalized patients
Certain emergency medications (sublingual nitroglycerine
tablets)
Occupational Safety and Health
Act of 1970 (OSHA)
Ensures a safe and healthful workplace for all employees.
Requires a reporting system for job-related injuries and illness.
Attempts to reduce hazards in the workplace and conduct audits to ensure
compliance with the Act.
Established universal precautions.
Addresses air contaminants, flammable and combustible liquids, eye and
skin protection, and hazard communication standards.
OSHA requires use of Safety Data Sheets (SDSs), which are to be
provided by the seller of a particular product to the purchaser.
1972 Drug Listing Act: National
Drug Code
Implemented under the authority of the FDA
Every drug has a unique 10-digit number divided
into three segments
Orphan Drug Act of 1983
Allowed drug companies to bypass the lengthy time
requirements of testing a new drug and the cost that
accompanied them to provide a medication to
persons who had rare disease(s) (disease that
affected 1 in every 200,000 people)
Also covers diseases that affect >200,000 if it could
be proved that the cost of developing and testing the
drug could not be recovered by the eventual sales.
1987 Prescription Drug Marketing
Act
Maintain legal supply channel from mfg. to
distributors and wholesalers.
Prohibits sale or distribution of samples to anyone
other than who can prescribe them.
Controlled the use of drugs in animals
Required the labeling “Caution: Federal law restricts
this drug to use by or in order of a licensed
veterinarian”
1990 Omnibus Budget Reconciliation Act (OBRA 90)
Set limitations on Medicare & Medicaid
reimbursement for medications
All medication prescribed would be reviewed for
appropriateness
States that a pharmacist must counsel (at the time
of purchase) all patients who receive new
prescriptions
All patients must be given information on the drug
that they are taking, its name, when to take it, how
long to take it, and any side effects or possible
interactions
Act created need for pharmacy technicians
Resource Conservation and Recovery Act (RCRA)
General guidelines for the waste management
program envisioned by Congress.
Hazardous waste – waste with properties that
make it dangerous or potentially harmful to human
health or the environment.
Hazardous wastes fall into 2 categories:
Listed wastes, which appear on one of the four hazardous wastes list
established by Environmental Protection Agency (EPA) regulations: F-
list, P- list, K- list, and U- list.
Characteristic wastes, which exhibit one or more of four characteristics
defined by ignitability, corrosivity, reactivity, and toxicity.
Health Insurance Portability and
Accountability Act of 1996 (HIPAA)
Deals with patient’s right to continuance of health
insurance even when changing employers
Confidentiality: technician has direct knowledge of
patient’s medical information on a daily basis, so
patients sign a consent form to grant access to this
information. Includes:
Any information created or received by the pharmacy
Any information relating to patients health, (mental, physical, past,
present or future)
Information that may identify a patient
2000 Drug Addiction Treatment Act
DATA 2000
Permits physicians to prescribe controlled substances
(pre-approved by the DEA) in schedules C-III, C-IV,
C-V to individuals suffering from opioid addiction
for the purpose of maintenance or detoxification
treatments.
2003 Medicare Prescription and
Modernization Act
Medicare is a government-managed insurance
program that provides assistance to people older than
age 65
Younger than 65 with disabilities and individuals
with end-stage renal failure
Provides drug discount card to beneficiaries with low
incomes who require pharmacy company assistance
for obtaining medications
Isotretinoin Safety and Risk Management
Act of 2004
Regulates use of Accutane
Powerful medication used to treat acne
Can cause severe birth defects & adverse psychiatric effects
(depression/suicide)
Mandatory registration and education for physicians,
pharmacist, patients
No internet, mail order, phone prescriptions
Female patient required monthly pregnancy test before
prescription refilled
2004 Anabolic Steroid Control
Act
Placed anabolic steroids on Schedule III
Harsher penalties for the abuse of anabolic steroids
and their misuse by athletes
Amended in 2004 (stricter)
2005 Combat Meth Act
Bill addresses all areas of manufacturing, law
enforcement, and sale of ephedrine and
pseudoephedrine, which is used as an ingredient in
the preparation of methamphetamine
Strict guidelines: only a licensed pharmacist or
technician may dispense, sell, or distribute this drug
Daily sales limit of 3.6 grams / 9 g per 30 days
Placement out of direct customer access
Customer identification/recordkeeping
Biologics Price Competition and
Innovation (BPCI) Act of 2009
Created an abbreviated pathway for approval of
biological products demonstrated to be biosimilar
to or interchangeable with an FDA-licensed
reference biological product.
Lowers cost and provides patient access to crucial
biological therapies that they need.
Permits the FDA to approve a biosimilar product
with a designation that is interchangeable with the
FDA-licensed reference biologic.
Drug Supply Chain Security Act
DSCSA
Outlines critical steps to build an electronic,
interoperable system to identify and trace certain
prescription drugs as they are distributed in the
United States.
2010 Patient Protection and
Affordable Care Act
Makes preventive care more accessible and affordable for
many Americans
Requires insurance companies to cover all applicants with
new minimum standards, including individuals with
preexisting conditions
Components of the ACA involve pharmacy professionals,
such as:
EHR incentives and e-prescribing
MTM
ACO
The Home Demonstration Project(medication management
and Medicare Part D
2013 Drug Quality and Security Act
Gives FDA greater oversight of bulk pharmaceutical
compounding and enhances the agency’s ability to track
drugs through the distribution process
Comprises two separate acts
the Compounding Quality Act
creates a new class of compounding manufacturers that voluntarily register with the FDA as an “outsourcing facility”
the Drug Supply Chain Security Act
requires the FDA to create and implement a national tracking system
to be used by manufacturers
