Laws and Classifications

Pure food and drug act

prohibits interstate commerce of misbranded(poor labeling) or adulterated(fails to meet standards) drugs and foods

Federal food, drug and cosmetic act

requires drug manufactures to receive approval from FDA

Controlled substances act

regulates and classifies controlled substances

schedule 1

drugs that have a high potential for abuse and dependency with no accepted medical use

schedule 2

high potential for abuse and dependency but have a medically acceptable use.

schedule 3

moderate to low physical dependence but high psychological dependence

schedule 4

low abuse potential but can lead to addiction if combined with other drugs

schedule 5

low potential for abuse but may contain limited quantities of narcotics

DEA

implements CSA, and assigns letter followed by seven numbers, letters indicate type of practitioner and perscriber

one year

how long perscriptions for non controlled substances last

form 41

DEA form that’s used for reporting destruction of CS

form 104

DEA form that’s used for reporting pharmacy closure or surrender of permit

form 106

DEA form that’s used for reporting loss or theft of CS

form 222

DEA form that’s used for ordering C-1 and 2 CS

form 222a

DEA form that’s used for ordering more of form 222

form 224

DEA form that’s used for applying for a DEA registration number

form 224a

DEA form that’s used for DEA registration renewal every 3 years

Poison prevention packaging act

requires OTC drugs to be packaged in child-resistant containers

Federal anti-tampering act

mandates that OTC drugs must have tamper evident seal

perscription drug marketing act

prohibits selling and purchasing of drug samples

OBRA

established drug utilization review, patient counseling standards and patient record maintnence

Drug utilization review

pharmacists evaluate and review prescription it can be prospective and retrospective

patient counseling standards

an offer to counsel must be made to every patient

patient record maintnence

patient records must be maintained by all pharmacy staff

Dietary supplement health and education act

dietary supplements are considered food and do not need to be approved as drug by FDA

food and drug administration modernization act

eliminates certain labeling requirements

drug addiction treatment act

allows qualified prescribers to prescribe schedule 3,4,5 CS for opoid use disrder

combat methamphetamine epidemic act

regulates sale of OTC containing ephedrine(3.6 daily,7.5/9 every 30 days)

durham-humphrey act

prohibits dispensing of legend drugs without prescription(caution label, verbal rx, verbal refills)

kefauver-harris amendment

requires that both prescription and OTC drugs be effective and safe under FDA supervision(clinical trials)

orphan drug act

offers federal incentives to produce drugs previously unavailable in the US that affect fewer than 200,000 persons

drug listing act

established NDCs

NDC number

9 digit code created by FDA that identifies drug

Drug supply chain security act

requires NDC for prescription/OTC drugs