Constitution
Defines governmental powers
Statues
Federal or state laws
Regulations/Rules
Enacted administratively based on statutes and have the effect of statutes (aka administrative law)
Criminal Law
Relationship between an individual and society
Civil Law
Pertains to relationships among individuals
Contract Law
Duties based on agreements
Tort Law
Duties based on law
Negligent Torts
Someone sustains damages as a result of someone else not meeting standards of care
Professional Negligence (Malpractice)
Occurs when a professional causes damages due to acting in a manner that does not meet professional standards
Non-feasance
Not doing something that should be done
Mis-feasance
Doing something that ought not be done
Duty of Care, Breach of Duty, (Substantial) Damages, Proximate Cause
The four elements of negligence
Pure Food and Drug Act of 1906 (Wiley-Heyburn Act)
Prohibited adulteration and misbranding of food and drugs
Pure Food and Drug Act of 1906 (Wiley-Heyburn Act)
Required that drugs comply with standards of strength and purity professed for them
Pure Food and Drug Act of 1906 (Wiley-Heyburn Act)
Gave "official" status to the USP and NF
Pure Food and Drug Act of 1906 (Wiley-Heyburn Act)
1912 Amendment clarified "misbranding" to prohibit false and fraudulent efficacy claims
Pure Food and Drug Act of 1906 (Wiley-Heyburn Act)
Administered by the FDA
Harrison Narcotic Act of 1914 (Harrison Tax Act)
Set standards for narcotic drug use
Harrison Narcotic Act of 1914 (Harrison Tax Act)
Controlled importation, manufacturing, production, and distribution of narcotics
Harrison Narcotic Act of 1914 (Harrison Tax Act)
Special taxation on narcotics
Federal Food, Drug, and Cosmetic Act of 1938 (FDCA)
Passed due to sulfanilamide tragedy in 1937
Federal Food, Drug, and Cosmetic Act of 1938 (FDCA)
Required pre-market testing of new drugs for safety
Federal Food, Drug, and Cosmetic Act of 1938 (FDCA)
Restricted the dispensing of certain drugs by pharmacist pursuant to prescription only
Federal Food, Drug, and Cosmetic Act of 1938 (FDCA)
Required labels to bear a warning about the habit-forming nature of certain drugs, other precautionary measures, and adequate directions for use
Federal Food, Drug, and Cosmetic Act of 1938 (FDCA)
Began the regulation of cosmetics and devices
Federal Food, Drug, and Cosmetic Act of 1938 (FDCA)
Introduced Strict Liability (liability without fault)
Durham-Humphrey Amendment (to the FDCA) of 1951
Classified drugs as OTC or "Legend" drugs. Manufacturer's container label must contain "Rx Only
Durham-Humphrey Amendment (to the FDCA) of 1951
Established the general rules regarding labeling of prescription drugs
Durham-Humphrey Amendment (to the FDCA) of 1951
Established restrictions on dispensing prescription drugs
Kefauver-Harris Amendment (to the FDCA) of 1961 (Drug Efficacy Amendments)
Passed due to problems with Thalidomide
Kefauver-Harris Amendment (to the FDCA) of 1961 (Drug Efficacy Amendments)
Included pre-market testing for efficacy as well as safety for drugs introduced after 1962
Kefauver-Harris Amendment (to the FDCA) of 1961 (Drug Efficacy Amendments)
Required retroactive review of safety and efficacy of drugs approved from 1938-1962
Kefauver-Harris Amendment (to the FDCA) of 1961 (Drug Efficacy Amendments)
Incorporated good manufacturing practices, regular factory inspections, and increased labeling and manufacturing requirements
Kefauver-Harris Amendment (to the FDCA) of 1961 (Drug Efficacy Amendments)
Must show balance between drug risk and benefits in labeling and advertising, gave mechanisms for reporting ADRs, and informed consent required from test subjects
Kefauver-Harris Amendment (to the FDCA) of 1961 (Drug Efficacy Amendments)
Investigational procedures for new drugs were established to substantiate safety and efficacy
Misbranding
To sell, dispense, or distribute a drug in violation of the FDCA
New Drug
Drug not generally recognized by experts as safe and effective for recommended use (new chemical, established drug with new dosage form or strength, packaged in a novel material such as plastic, or an established drug with new medical claims)
Approved Drug
A drug with a New Drug Application (NDA) or was in use before 1938
Orphan Drug Act - 1983
Provided measures to help drugs treating rare diseases come to the market
Drug Price Competition and Patent Term Restoration Act of 1984 (Waxman-Hatch Act)
Passed to make generic drugs more widely available; speeds up generic approval through the use of the ANDA
Drug Price Competition and Patent Term Restoration Act of 1984 (Waxman-Hatch Act)
Gave manufacturers of pioneer drugs a guaranteed five years of exclusive marketing even if the patent has expired on those drugs
Drug Price Competition and Patent Term Restoration Act of 1984 (Waxman-Hatch Act)
Mandated Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
Class I Recall
There is a reasonable possibility that the use of or exposure to a violative product will cause either serious adverse effects on health or death
Class II Recall
Use or exposure may cause temporary or medically reversible adverse effects on health or where the probability of serious adverse effects on health is remote
Class III Recall
Use or exposure is not likely to cause adverse health consequences
Labeling
All written material accompanying a product (including the container's label)
Federal Hazardous Substances Act (1927)
Defines "hazardous" substance and gives requirements for their labeling
Poison Prevention Packaging Act of 1970
Mandated that certain substances must be packaged in "child-resistant" containers
Sherman Antitrust Act & Clayton Antitrust Act (1914)
Prohibited price discrimination of selling same product, same grade, same quality, and same quantity. Allowed price differentials based on different purchasing methods
Robinson-Patman Act
Allowed price savings for large buyers based solely on differences in quantity.
Non-profit Institutions Act (1938 Amendment to Robinson-Patman)
Exempted purchases of supplies to churches, schools, hospitals, and other non-profit institutions for own-use
Abbott Laboratories et. al. v. Portland Retail Druggists Association
Own use" for hospitals was clarified by the U.S. Supreme Court
Jefferson County Pharmaceutical Association vs. Abbott Laboratories, et. al.
U.S. Supreme Court ruled that government hospitals are subject to the same "own use" restrictions as other non-profit institutions
DeModena v. Kaiser Foundation Health Plan (1984)
Non-profit HMOs were considered "charitable institutions" and can purchase at preferential prices
Prescription Drug Marketing Act of 1987 (amends the FDCA)
Covered drug diversion, reimportation of prescription drugs, pedigree, restrictions on drug samples, and standards for wholesalers
Omnibus Budget Reconciliation Act of 1990
Required states to set up DUR programs to oversee Medicaid prescriptions
Omnibus Budget Reconciliation Act of 1990
Required states to set up ProDUR including a patient profile/history and clinical review before dispensing
Omnibus Budget Reconciliation Act of 1990
Required states to set up RetroDUR to review drug therapy for Medicaid outpatients
FDA Modernization Act of 1997 (FDMA)
Allowed prescription drug user fees (pharmaceutical industry could pay for FDA to increase its employees and speed up drug approval process)
FDA Modernization Act of 1997 (FDMA)
Allowed manufacturers to provide peer-reviewed journal articles about off-label uses of a product of the company would conduct research regarding the safety and effectiveness of that product
FDA Modernization Act of 1997 (FDMA)
Allowed manufacturers to provide more economic data regarding their products than in the past
FDA Modernization Act of 1997 (FDMA)
Gave restrictions on compounding such as advertising, compounding ahead of time, sources of materials, and compounding products similar to commercial products
Dietary Supplement Health and Education Act of 1994 (DSHEA)
Amended the FDCA by requiring dietary supplements introduced after 1994 do not have to be proven safe; also gave label and some other requirements
Officer of Inspector General (OIG) Exclusion List
Prohibits from individuals on the LEIE list to participate in federally funded health care programs, even to the point of working for an organization that is not on the LEIE
CMS' Requirement for Medicare Part D Fraud, Waste, and Abuse Training
Required training when hired and once yearly for all pharmacy staff who handle Medicare Part D prescriptions
FDA Amendments Act of 2007
Gave 6-month exclusivity for pharmaceutics if pediatric research is conducted
FDA Amendments Act of 2007
Established Risk Evaluation and Mitigation Strategies (REMS) as part of post-marketing surveillance process
Federal Anti-Tampering Act (1982)
Required most OTC products to be in tamper-resistant containers after the Tylenol murders in the Chicago area