Pharmacy Law Flashcards
1906 Pure Food and Drug Act
Stopped the sale of mislabeled drugs
1914 Harrison Narcotic Act
People can no longer purchase opium without a perscription
1938 Food, Drug, and Cosmetic Act
Required adequate directions for use
All narcotics are to be labeled with “Warning: may be habit-forming”
Defined exact labeling for products
Misbranding and adulteration now is illegal
1951 Durham-Humphrey Amendment
Makes the distinction between prescription drugs and over-the-counter medications
Requires legend drugs to be labeled: “Caution, Federal law prohibits dispensing without a prescription”
Certain drugs must be prescribed by licensed practitioner
1962 Kefauver-Harris Amendment
Burden of good manufacturing practices on manufacturing companies
Prevents the sale of thalidomide
1970 Comprehensive Drug Abuse Prevention and Control Act
DEA is formed for enforcing narcotic laws and their distribution
Creates the control substance categories
Establish strict recordkeeping guidelines
1970 Poison Prevention Packaging Act (PPPA)
Requires most OTC and legend drugs have a child-resistant container
Occupational Safety and Health Act of 1970 (OSHA)
Ensures a safe workplace for workers
Attempts to reduce hazards in the workplace
Requires for there to be a report system for job-related injuries and illnesses
Requires the use of Safety Data Sheets (SDS)
1972 Drug Listing Act: National Drug Code
Every drug now has a unique 10 digit code that is divided into 3 segments
Orphan Drug Act of 1983
Allows companies to bypass the time requirements of testing a new drug to provide medication to those with rare diseases
1987 Prescription Drug Marketing Act
Prohibits the sale or distribution of samples to anyone other than those who can prescribe them
Controls the use of drugs for animals
Required the label: “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 reimbursements on Medicaid and Medicare for medication
All prescribed medication will be evaluated for appropriateness
Pharmacists must counsel all patients who receive new medications
Patients must be given all information about their medication
Resource Conservation and Recovery Act (RCRA)
Guidelines for waste management
Health Insurance Portability and Accountability Act of 1996 (HIPPA)
Patient’s right to privacy
Technicians must uphold confidentiality
2000 Drug Addiction Treatment Act (DATA 2000)
Allows physicians to prescribe controlled substances to those with an opioid addiction for detoxify treatments
2003 Medicare Prescription and Modernization Act
A program started to help people who are either
older than 65 or those who are younger with disabilities
Provides drug discounts
Isotretinoin Safety and Risk Management Act of 2004
Regulates the use of Accutane
Registration and education for physicians, pharmacists and patients
Female patients must take pregnancy test before prescription filled
2004 Anabolic Steroid Control Act
Placed anabolic steroids on CIII
Harsher penalties for those who abused/misused steroids, especially athletes
2005 Combat Meth Act
Focuses on ephedrine, which is used to make meth
Strict guidelines on how much technicians and pharmacists can dispense, sell or distribute it
Biologics Price Competition and Innovation (BPCI) Act of 2009
Lowers cost and provides patients with needed biological therapies
Permits the FDA approve biosimilar products
Drug Supply Chain Security Act (DSCSA)
Gives an outline for an electronic interoperable system to identity and trace the distribution of certain drugs within the U.S.
2010 Patient and Affordable Care Act
Makes preventative care easier and more affordable for Americans
Requires insurance companies to cover all applicants with new minimum standards
2013 Drug Quality and Security Act
Gives FDA better oversight over pharmaceuticals and it’s ability to track drugs through the distribution process
Creates new class of manufacturing that are an “outsourcing facility”
Requried the FDA to create and implement a national tracking system
