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)
(Continued)
◻ 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 Food, Drug & Cosmetic Act
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 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.
