Pharmacy Law

accessory

any individual who helps a person to violate the law either directly or indirectly

administrative law

regulations set forth by governmental agencies, such as the International Revenue Service(IRS) and the Social Security Administration(SSA); also called regulatory law

adulterated

Tampering with or contaminating a product or substance.

Bioethics

A discipline dealing with the ethical and moral implications of biological research and applications.

Civil Law

Rules and regulations that govern the relationship between individuals within a society

crime

a violation of the law

criminal

An individual who violates the law.

Criminal Law

A law that defines crimes against the public order

Felony

A serious crime that carries a penalty of at least one year of imprisonment

Food and Drug Administration (FDA)

The agency within the U.S. Department of Health and Human Services that is responsible for assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the national food supply, cosmetics, and radioactive products

malpractice

professional misconduct or demonstration of an unreasonable lack of skill with the result of injury, loss, or damage to the patient

medical ethics

The discipline in which merits, risks, and social concerns are evaluated concerning the practice of medicine.

misbranding

Fraudulent labeling or marking.

misdemeanor

A crime less serious than a felony

National Drug Code (NDC)

A unique and permanent product code assigned to each new drug as it becomes available in the marketplace; it identifies the manufacturer or distributor, the drug formulation, and the size and type of its packaging.

National Formulary (NF)

a database of officially recognized drug names

negligence

failure to take proper care in doing something

orphan drug

A drug that is developed for small populations of people in need of the drug.

Regulatory Law

Regulations set forth by governmental agencies. It is also called administrative law.

Standard Code Sets

Under HIPAA, "codes used to encode data elements, tables of terms, medical concepts, diagnostic codes, or medical procedure." A code set includes the codes and descriptors of the codes.

standards

Established by authority, custom, or general consent as a model or example; something set up and established by authority as a rule for the measure of quantity, weight, extent, value, or quality.

statutes

rules and regulations resulting from decisions by legislatures

tort

A civil wrong committed against a person or property

Beneficence

actions designed to benefit patients and pharmacy customers

Fidelity

Promises are kept so that patients needs are fulfilled correctly and on time.

Veracity

truthfulness

Justice

fairness

Autonomy

self-reliance

Assumption of Risk

This refers to a patient who does not follow medical advice, and, therefore, becomes responsible for any problems that occur as a result of his or her decision.

Defendant

The person or group against whom charges are brought in a court action.

Deposition

An oral testimony taken by a court reporter at a location outside the courtroom, subject to the same requirements for truth as court testimony

Interrogatory

A written set of questions that must be answered under oath as if in a court, within a specific period

Jurisdiction

The power, right, and authority given to a court to hear a case and to make a judgment.

Litigant

A party to a lawsuit.

Litigation

A lawsuit or a contest in court.

Plaintiff

The person who files a lawsuit initiating a civil legal action. In criminal actions, the prosecution (government) is the plaintiff acting on behalf of the people

Statute of limitations

The law that limits the period during which a person can sue. The period varies from one to three years.

Subpoena

A court order that requires an individual to appear as a witness in court or to make himself or herself available to be deposed.

Contract law

Law that refers to agreements between individuals and entities that are binding

Pure Food and Drug Act of 1906

This law forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines and gave the government broad powers to ensure the safety and efficacy of drugs in order to abolish the "patent" drug trade. It paved the way for the eventual creation of the Food and Drug Administration (FDA) still in existence as the FDA.

The Harrison Narcotics Act of 1914

Intended to stop the recreational use of opium.

Food, Drug, and Cosmetic Act of 1938

Requires new drugs must be proven safe before marketing

The Durham-Humphrey Amendment of 1951

• Created a distinction between "OTC" and "Legend Drugs".

• The emphasis on this act was to insure safety thru qualified medical supervision.

Kefauver-Harris Amendment of 1962

requires all medications in US to be pure safe and effective

Comprehensive Drug Abuse Prevention and Control Act of 1970

Directs the manufacture, distribution, and dispensing of controlled substances that have potential for addiction and abuse.

Schedule I

high potential for abuse, no accepted medical use

Schedule II

high potential for abuse, but are currently accepted for medical use. Abuse of drugs may result in psychological or physical dependence.

Schedule III

moderate to low potential for abuse and are accepted for medical use. Contain limited quantities of certain narcotic and non-narcotic drugs

Schedule IV

low potential abuse, long-acting barbiturates

Schedule V

lowest abuse potential, generally used for antitussive and antidiarrheal purposes

Poison Prevention Packaging Act of 1970

Requires use of child-resistant containers for prescription and nonprescription drugs

Occupational Safety and Health Administration (OSHA)

Ensure workplace safety and a healthy environment within the workplace

Drug Listing Act of 1972

each new drug is assigned a unique and permanent product code, known as a National Drug Code (NDC)

Medical Device Amendments of 1976

Required manufacturers to register and list their products, follow good manufacturing practices, and report device failures

Orphan Drug Act of 1983

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

Drug Price Competition and Patent Term Restoration Act of 1984

Largely consumer-oriented and designed to lower drug prices by providing a mechanism to increase competition in the drug industry

Prescription Drug Marketing Act of 1987

Deals with safety and competition issues raised by secondary markets for drugs

Anabolic Steroids Control Act of 1990

placed anabolic steroids under the regulatory provisions of the CSA

Omnibus Budget Reconciliation Act of 1990

Requires pharmacists to offer to discuss information about new and refill prescription with Medicaid recipients

Dietary Supplement Health and Education Act of 1994

Clarify regulatory framework applicable to nutritional supplements and to create specific labeling requirements

The Drug Addiction Treatment Act of 2000

allows physicians to prescribe DEA-approved controlled substances from Schedules III, IV, or V to people who are addicted to opioids, as part of maintenance or detoxification treatments

Medicare Prescription Drug, Improvement, and Modernization Act of 2003

Provide senior citizens and disable individuals with a prescription drug benefit, established Medicare part D

Combat Methamphetamine Epidemic Act of 2005

designed to stop illegal use of drugs such as methamphetamine, crack cocaine, and others

Accutane iPledge Program of 2006

Program was designed to mandate distribution in the United States for the drug known as isotretinoin which can cause birth defects in expectant mothers

Ryan Haight Online Pharmacy Consumer Protection Act of 2008

Prohibit the delivery, distribution, or dispensing of a controlled substance that is a prescription drug over the internet without a valid prescription

Patient Protection and Affordable Care Act of 2010

Increase quality and affordability of health insurance, lower the uninsured rate, and reduce costs of healthcare for individuals and the government

Synthetic Drug Abuse Prevention Act of 2012

Banned compounds commonly found in synthetic marijuana sold as "K2" or "Spice," synthetic bath salts, and hallucinogens by placing them under Schedule 1 of the Controlled Substance Act.

Drug Quality and Security Act of 2013

Allows pharmacists to provide traditional compounding services to individual patients, and create track-and-trace requirements for drug products that will take effect over the next 10 years

Food and Drug Administration (FDA)

a federal agency responsible for regulating food and drug products sold to the public

Centers for Disease Control and Prevention (CDC)

provides facilities and services for investigation, identification, prevention, and control of disease

Drug Enforcement Administration(DEA)

oversees controlled substances

brand name

a word, symbol, or device assigned to a product by its manufacturer, registered or not registered, as a trademark of its entity