pharmacy law Flashcards
1906 Pure Food & Drug Act
- 1st federal law regulating drugs
- enacted to stop the sale of inaccurately labeled drugs
1914 Harrison Narcotic Act
- enacted bc of the excessive # of opium addicts in US
- people could no longer obtain opium w/o a prescription
1938 Food, Drug, & Cosmetic Act
- enacted bc the 1906 Pure Food & Drug Act was not worded strictly enough & didn’t 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)
- defined the exact labeling for products & defined misbranding & 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) & non-prescription (over-the-counter or OTC medications)
- required legend drugs be labeled “Caution: Federal law prohibits dispensing w/o a prescription”
- must be prescription by licensed practitioner
1962 Kefauver-Harris Amendment
- enacted in an attempt to ensure the safety & effectiveness of all new drugs on the market (both legend & OTC)
- burden put on manufacturing companies to have good manufacturing practices (GMP), FDA inspections, drug testing & approval required
- prevented the sale of thalidomide in the US bc children were born w/ birth defects after use in pregnancy
1970 Comprehensive Drug Abuse Prevention & Control Act
- Drug Enforcement Agency (DEA) was formed to enforce the laws concerning narcotics & their distribution
- created controlled substance I-V
- closed system allowing distribution of controlled substances to only those registered w/ DEA
- established strict record keeping guidelines
1970 Poison Prevention Packaging Act (PPPA)
- enacted to reduce accidental poisoning in children
- requires most OTC & legend drugs be packaged in child-resistant containers, 80% under 5yrs can’t open & 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 & Health Act of 1970 (OSHA)
- ensures a safe & healthful workplace for all employees
- requires a reporting system for job-related injuries & illness
- attempts to reduce hazards in the workplace & conduct audits to ensure compliance w/ the Act
- established universal precautions
- addresses air contaminants, flammable & combustible liquids, eyes & skin protection, & hazard communication standards
- OSHA requires use of Safety Data Sheet (SDS) 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 # divided into 3 segments (labeler, product code, package code)
Orphan Drug Act of 1983
- allowed drug companies to bypass the lengthy time requirements of testing a new drug & the cost that accompanied them to provide a medication to people who had rare disease(s) (disease that affected 1 in every 200,00 people)
- also covers disease that affect >200,000 if it could be proved that the cost of developing & testing the drug couldn’t be recovered by the eventual sales
1987 Prescription Drug Marketing Act
- maintain legal supply channel from mfg. to distributors & 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
Resource Conservation & Recovery Act (RCRA)
- general guidelines for the waste management program envisioned by Congress
- hazardous waste: 2 categories (listed or characteristic wastes)
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- deals w/ 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
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 & Modernization Act
- medicare is a government-managed insurance program that provides assistance to people older than 65
- younger than 65 w/ disabilities & individuals w/ end-stage renal failure
- provides drug discount card to beneficiaries w/ low incomes who require pharmacy company assistance for obtaining medications
Isotretinoin Safety & Risk Management Act of 2004
-regulates use of Acutane
2004 Anabolic Steroid Control Act
- placed anabolic steroids on Schedule III
- harsher penalties for the abuse of anabolic steroids & their misuse by athletes
- amended in 2004 (stricter)
2005 Combat Meth Act
- bill addresses all area of manufacturing, law enforcement, & sale of ephedrine & pseudoephedrine, which is used as an ingredient in the preparation of methamphetamine
- strict guidelines: only a licensed pharmacist technician may dispense, sell, or distribute this drug
Biologics Price Competition & Innovation (BPCI) Act of 2009
- created an abbreviated pathway for approval of biological products demonstrated to be biosimilar to or interchangeable w/ an FDA-licensed reference biological product-lowers cost & provides patient access to crucial biological therapies that they need
- permits the FDA to approve a biosimilar product w/ a designation that is interchangeable w/ the FDA-licensed reference biologic
Drug Supply Chain Security Act (DSCSA)
-outlines critical steps to build a electronic, interoperable system to identify & trace certain prescription drugs as they are distributed in the US
2010 Patient Protection & Affordable Care Act
- makes preventative care more accessible & affordable for many Americans
- requires insurance companies to cover all applicants w/ new minimum standards, including individuals w/ preexisting conditions
- components of the ACA involve pharmacy professionals
2013 Drug Quality & Security Act
- gives FDA greater oversight of bulk pharmaceutical compounding & enhances the agency’s ability to track drugs through the distribution process
- comprises 2 separate acts (Compounding Quality Act & Drug Supply Chain Security Act)
