Pharm. Laws Flashcards
(23 cards)
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
-Defined the exact labeling for products and defined
misbranding and adulteration as being illegal
-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”
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
1962 Kefauver-Harris Amendment
- FDA inspections
- Drug testing and approval required
-Enacted in an attempt to ensure the safety and
effectiveness of all new drugs on the market (both
legend and OTC)
-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
-A 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
-Exceptions to child-resistant containers
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 the 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)
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
1990 Omnibus Budget Reconciliation Act (OBRA 90)
-Set limitations on Medicare & Medicaid reimbursement for medications
619
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.
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.
+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 and 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 the use of Accutane because it Can cause severe birth defects & adverse psychiatric effects
(depression/suicide)
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
- Daily sales limit of 3.6 grams / 9 g per 30 days
- Placement out of direct customer access
- Customer identification/recordkeeping
-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
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
-the Compounding Quality Act
-the Drug Supply Chain Security Act
1906 Pure Food and Drug Act
-1st federal law regulating drugs
-Enacted to stop the sale of
inaccurately labeled drugs
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
+EHR incentives and e-prescribing
+MTM
+ACO
+The Home Demonstration Project(medication management
and Medicare Part D
