Federal Law

importance of law

• guides to day to day practice

• RPh must follow laws and practice sound professional judgement

Negligence

• civil or personal wrong: hurting another party

• deviates from the standard of care

• unintentional: not planned

four elements of negligence

• duty to care

• breach of duty

• injury/actual damage

• causation/proximate cause

administrative law

• greater level of expertise

• promulgate rules and regulation

• rule that are passed by legislature to pass the law

Pure food and drug act

• wiley act

• offered protection to consumers

• reuired labing and ingredients meet USP/ NF standards for strength, quality, and purity

• adulteration and misbranding

• list the presence and amount of dangerous ingredients

food drug and cosmetic act

• requiree all new drugs proven safe

• requied adequate direction

• required habit forming warnings

• applied to drugs cosmetics and DEVICES

• Came about because of a tragedy occurred with sulfanilamide

durham humphery amendent

• established two classes of drugs

• authorized oral prescriptions and refills

kefauver- harris

• required proof of drug safety and efficacy

• estblished good manufacturing practices

• estalished responsibility advertisment

• required informed concent from research supjects and adverse event reporting

thalidomide, was not helpful with pregnancy and vomiting

comprehensive drug abuse prevention control act

• created 5 schedules of controlled substances

• estblished record keeping and inventory requirements

• established significant penalties for violation

Poison prevention packaging act

• failure to comply is misbranding

• must be packaged in child resistant containers

• OTCs must be sold in child resistant packaging

Drug listing act

• required all involved in manufacuring, precription, propagation, compounding or processing a drig to register with teh FDA

• require NDC number

Medical device amendment

• required deviced be classified based on function

• required pre-market approval

• manufacturing in accordance with GMP standards

• established performance standards

• outlined recordkeeping and reported requirement s

Federal Anti-Tampering

• enacted due to 1982 tylenol poisoning death

• created federal criminal jurisdiction over tampering of consumer products

• required tamper-resistant features for OTCs

orphan drug act

• affect 200000 americans

• provided tax and exclusive licensing incentives to manufacturers

Drug price competition and patent term

• waxman-hatch amendement

• strealined the generic drug approval process

• extends patent terms in some circumstances

• go through a abrevated process

Prescription drug marketing act

• controlled distribution of precription drugs and samples

• required states to licence wolesalers

• banned reimportation of drugs

• prohibited resale of prescription drug purchased by hospitals or other healthcare facilities

  • counterfeit Ovulen-21

nutrition labeling and education act

• mandated nutrition labeling on food products

• authorized health claimes on products labels so long as claims were in compliance with FDA regulations

medicaid patient only

omnibus reconciliation

• outlined expectation for pharmacists

• primary goal to save the federal government money by improving therapeutic outcomes

dietary supplement health and education act

• dietary supplement manufacturers were not satisfied with the Nutrition Labeling and Education Act of 199

• felt it gave the FDA too much authority and restricted promotion of dietary supplements

• supplements can promote health but not claim to cure

Health insurance portability and accountability

• privacy rule component

• imposed 5 key provision for pharmacists

• what is protected and what we can share this information wtih

food and drug modernization act

• creat a fast track approval process

• established a data bank of into on clincial trialsfor investigation and expand the manufacturers right to disseminate unlabeled use information

medicare modernization

• four part medicare

• formal medication therapy management programs

combat methamphetamine epidemic

• regulated retail OTC drug of ephedrine, psudoephendrine, and phenlypropanolamine products

• established sales limts and record keeping requirements

• regulated product placement in the pharmacy

• established minimun age requiremnt for purchasers

• required self- certification for sellers

FDA amendment

established risk, evaluation, and mitigation systems

• intended to ensure use of drug provides greater benefits than risk

all three progams have to be enrolled

biologics price competition and innovation

• living organisms

• approved without full pre clinical and clinical data but must have the same MOA, route of administration, dosage form, and strength

• purple book

patient protection and affordable care act

• required all individuals to have health insurance

• stopped agreements between manufacturers that would limit or deplay competition by generics

drug quality and security act

• enhanced FDA oversight of pharmacies engaged in large scale compounding and shipping of sterile products

• created track and trace for all entities in the chain of distribution

• 305B facility is inspected regularly by FDA

pregnancy, lactation labeling

pregnancy

lactation

females and males of reproductive potentia

comprehensive addiction and recovery

• permits partial fills at the request of the patient for 30 days