laws / books

durham-humphrey amendment (Rx vs. OTC)

• 1951

• amended the Federal Food, Drug, and Cosmetic Act to distinguish between Rx and OTC drugs

• a lot of prescription medications now used to be OTC

• this amendment formally defined which drugs needed a prescription (i.e. habit-forming, potentially harmful, or require practitioner oversight)

• prescription drugs must carry the legend: “caution: federal law prohibits dispensing without a prescription”

durham-humphrey amendment (operational)

• telephone prescriptions became legally acceptable

• refills authorized by prescriber

• reinforced role of pharmacists in verifying and dispensing medications appropriately

kefauver-harris amendment

• 1962

• strengthened the Federal Food, Drug, and Cosmetic Act by requiring that all drugs be proven safe and effective before public use

• due to thalidomide scandal that was supposed to treat motion sickness but caused severe birth defects

kefauver-harris amendment (protections)

• strengthened FDA oversight, and was a direct response to real-world harm

• required substantial evidence of safety and efficacy through well-controlled clinical trials

• mandated informed consent of patients participating in clinical studies

• required FDA approval before marketing new drug

• strengthened Good Manufacturing Practices (GMPs) and allowed factory inspections

• gave FDA more control over drug advertising and labeling

poison prevention packaging act

• 1970

• designed to reduce accidental poisoning in children by requiring child-resistant packaging for many medicines and household substances

• packaging has to be difficult for at least 80% of children under 5 y/o to open, while still allowing 90% of adults to open properly

• most prescription medications must be dispensed in child-resistant containers

• many OTC products are also required to use child-resistant packaging

• purpose: to prevent accidental ingestion and poisoning in children

poison prevention packaging act (exceptions

• medications like: sublingual nitroglycerin, birth control, potassium effervescent tablets, some corticosteroids

• institutional settings like hospitals or nursing homes may not require childproof packaging

• patients can request non-safety containers, but this requires a waiver to be kept on profile

red book

drug pricing data

orange book

approved drug products with therapeutic equivalent evaluations

yellow book

cdc health info for international travel

pink book

epidemiology and prevention of vaccine-preventative diseases

purple

innovator biological products (interchangeable)

pure food and drugs act of 1906

• prohibits interstate transportation or sale of adulterated (unsanitary or poisonous) or disbanded food or drugs

food, drug, cosmetic act of 1938

• FDCA created FDA

• required all new drug applications to be filed with FDA

• defined mislabeling and adulteration

comprehensive drugs abuse prevention and control act of 1970

• established controlled medications into 5 schedules

• created Drug Enforcement Agency (DEA)

united states pharmocopeia

• sets public quality standards for medicines, dietary supplements, and food ingredients

• goal is patient safety

prescription monitoring programs (federal national all scheduled prescription electronic reporting act in 2005)

• electronic system for practitioner monitoring of controlled medications 2-5

occupational safety and health act (osha)

• ensures safe and healthful workplace for all employees. job and safety standards

• requires material safety data sheets (msds) to be in use

drug listing act of 1972

• established NDC

orphan drug act of 1982

• passed to promote research and development of drugs that affect rare diseases

• financial and pharmaceutical incentives

drug price competition and patent term restoration act of 1984

• encouraged creation of both generic and new medications streamlining process for generic drug approval and by extending patent licenses

prescription drug marketing act of 1987

• prohibits re-importation of drug into US by anyone except manufacturer

• required labels on all meds for animals

omnibus budget reconciliation act of 1987

• revision to medicare and medicaid conditions of participation regarding long term care facilities and pharmacy

• required manufacturers to provide lowest prices for any pt or medicaid pt

• offer to counsel and DUR implementation or loss of funding

FDA safe medical devices act of 1990

• requires that all medical devices be tracked

• records maintained for durable medical equipment

american with disabilities act

• prevents discrimination against potential employees

resources conservation and recovery act

• formed by EPA

• in regards to disposal of hazardous waste

temperatures for storage

• freezer: -25c to -10c (13-14f)

• fridge: 2-8c (36-46f)

• cool: 8-15c (46-59f)

temperature for room

• controlled room: 20-25c (68-77f) allowable temporary excursions (15-30c) (59-86f)

• warm: 30-40c (86-104f)

• excessive heat: 40c (104f)

dietary supplement health and education act (DSHEA)

• prevent adulteration of herbal products and dietary supplements

• dietary supplements identifies all ingredients and quantities of ingredient in label

• meet quality, purity, and compositional specifications

anabolic steroid control act

• eliminate requirement to prove muscle growth

• increase number of anabolic steroids to 59 substances

any willing provider law

• any pharmacy can participate in prescription drug benefit plan as long as pharmacy agrees to terms and conditions

freedom of choice law

• allows member of prescription drug plan to select any pharmacy as long as pharmacy agrees to terms to conditions of plans

usp <795>

• non-sterile compounding

• preparing non-sterile medications (capsules, creams, ointments, oral liquids)

• prevents contamination, calculation errors, and improper ingredient quality

• requires master formulation records, compounding logs, and water-activity guidelines to set beyond-use dates

usp <797>

• sterile compounding

• preparing sterile preparations like injections, iv solutions, and eye drops

• prevents microbial contamination and pyrogen errors in high-risk delivery routes

• uses strict cleanroom environments, positive pressure airflow, specific garbing steps, and risk categories (1, 2, 3)

usp <800>

• hazardous drugs

• overlaps with 795 and 797

• protecting staff, patients, and the environment from hazardous drugs (chemo, dangerous hormones)

• stops occupational exposure during receipt, storage, mixing, disposal

• requires negative-pressure rooms, external ventilation, and specialized PPE for both sterile and non-sterile hazardous workflows