Chapter 3: Pharmacy Laws, Regulations, Ethics

Chapter 3 - Drug Regulations, Recall, DEA forms And Schedules

Food and Drug Act

Prohibits commerce of adulterated or misbranded food, drinks, and drugs. Government preapproval is required.

Harrison Narcotics Act

Establishes that prescribers prescribing narcotics be licensed and required to pay a tax

Food, Drug, and Insecticide Administration

Law enforcement agency is formed, renamed as the Food and Drug Administration

Food, Drug, and Cosmetic (FDC) Act

Requires that any new drug, before it can be marketed, must be proven safe when used according to the directions on the label. The act also establishes FDA and the legal framework for its operation.

Alberty Food Products VS. US

Court of appeals ruled that the purpose for which a drug is to be used must be included on its label.

Durham-Humphrey Amendment

Established 2 classes of drugs: Legend drugs and OTC drugs. Legend drugs are those that need prescriptions. Legend drugs are required to include the legend on their label “Caution: Federal law prohibits dispensing without a prescription.”

Kefauver-Harris Amendment

Required that all new drugs marketed in the US must first be shown to be safe and effective.

Social Security Act

Established medicare program

Fair Packaging and labeling Act

Requires all consumer products in interstate commerce be honestly and informatively labeled

Poison Prevention Act

Requires childproof packaging on all controlled and most prescription drugs dispensed by pharmacies. Non childproof containers may only be used if prescriber or patient requests them.

Controlled Substances Act (CSA)

Classifies the five levels of controlled substances that have potential for abuse and therefore restricts their distribution. Establishes the DEA as part of the justice department

Medical Device Amendment

Requires pre market approval for safety and effectiveness of life sustaining and life supporting medical devices

Orphan Drug Act

Provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases

Prescription Drug Marketing Act

Restricts distribution of prescription drugs to legitimate commercial channels; requires drug wholesalers to be licensed by the states

Health Insurance Portability and Accountability Act

Encourages providers to use electronic transactions and allows a minimum amount of patient health information to be transferred among providers, without patient consent, for purposed of treatment, payment or administrative operations. The act makes health-care providers responsible for maintaining privacy and security of patient information

Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman)

Allows for both extension of drug patent terms and quicker introduction of lower cost generic drugs

Omnibus Budget Reconciliation Act (OBRA)

Act requires pharmacists to offer counseling to medicase patients regarding medications

Anabolic Steroid Control Act

Passed to address the abuse of steroids by athletes, especially youngsters and teenagers.

Medicare Modernization Act

Established optional Medicare part D to provide coverage for prescription drugs and medication therapy management (MTM)

Combat Methamphetamine Epidemic Act

Establishes strict controls on OTC sales of pseudoephedrine, ephedrine, and phenylpropanolamine

FDA Amendments Act

Establishes risk evaluation and mitigation strategy (REMS) requirements for manufacturers of drugs and biologicals

Health Information Technology for Economic and Clinical Health (HITECH) Act

Promotes expanded health information technology and improves privacy and security provisions of HIPAA

Patient Protection and Affordable Care Act

Obamacare; signed into law with overall goals of improving patient care, quality, and outcomes while also reducing cost

FDA Safety and Innovation Act

Establishes user fees to enhance access to medication and medical devices and made provisions for addressing drug product shortages in the United States

Drug quality and Security

Expands the authority of the Food and Drug Administration for compounded drugs

Class I recall

strong likelihood product will cause serious adverse effectsC

Class II recall

product may cause temporary but reversible adverse effects or little likelihood of serious adverse effects

Class III recall

not likely to cause adverse effects

Schedule I

high abuse potential, no accepted medical use

Schedule II

High abuse potential, accepted medical use

Schedule III

less abuse potential than I and II, accepted medical use

Schedule IV

less abuse potential than I, II, or III, accepted medical useS

Schedule V

less abuse potential than other 4, accepted medical use

DEA 222 form

ordering C-I and C-II substances

DEA form - 41

Registrants inventory of drugs surrendered

DEA form - 106

report of theft or loss of controlled substances

DEA form - 224

application for new registration