Law 2

What does the Food Drug and Cosmetic Act (FDCA) regulate?

It regulates the safety and efficacy of food, drugs, and cosmetics.

What is the primary purpose of the FDCA?

To ensure the safety and efficacy of food, drugs, and cosmetics.

What are the conditions that cause a drug to be deemed adulterated?

If it is mixed with cheaper alternatives, contains undesirable substances, or is degraded.

What are the conditions that cause a drug to be deemed misbranded?

If it has incomplete information, unclear warnings, or misleading claims.

What is required for manufacturers and distributors under FDCA?

They must register with the FDA.

What illegal acts are pharmacists prohibited from under the Durham-Humphrey Amendments?

Pharmacists cannot dispense prescription medications without a valid prescription.

What is the minimum number of years prescriptions must be kept?

At least 2 years.

What are Good Manufacturing Practices (GMPs)?

Regulations ensuring products are consistently produced and controlled according to quality standards.

What is a drug according to the FDA?

A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

What are the three official compendia in the USA?

The United States Pharmacopeia (USP), The National Formulary (NF), and Homeopathic Pharmacopoeia of the United States (HPUS).

What distinguishes OTC drugs from dietary supplements?

OTC drugs are classified as drugs and can claim to treat or prevent disease, while dietary supplements cannot.

What is the primary regulatory body for OTC drugs?

The FDA (Center for Drug Evaluation and Research).

What is the legal status of dietary supplements?

They are not classified as drugs and can only make structure/function claims.

What does the term 'adulterated' mean in drug regulation?

It refers to drugs that are impure or mixed with substandard substances.

What does 'misbranded' mean in the context of drugs?

It refers to drugs that have misleading labels or incomplete information.

What is the role of Pharmacy Benefit Managers (PBMs)?

They manage pharmacy benefits for health insurance entities.

What is the definition of a manufacturer under FDCA?

Any entity that engages in the manufacture, preparation, or processing of a drug.

What is the definition of a wholesale distributor?

Any entity engaged in the wholesale distribution of a drug to someone other than a consumer.

What is the significance of the Durham-Humphrey Amendment?

It established the distinction between prescription and over-the-counter medications.

Can an OTC drug be prescribed by a healthcare provider?

Yes, an OTC can be prescribed if deemed necessary by a provider.

What is the FDA's role in dietary supplement regulation?

The FDA oversees labeling and marketing but does not approve dietary supplements before they are marketed.

What are the labeling requirements for prescription drugs?

They must include professional labeling and medication guides for consumers.

What is the difference between prescription and OTC ibuprofen?

Prescription ibuprofen can be higher doses than OTC versions.

What is the FDA's approach to drug recalls?

Recalls are classified based on the potential risk to health, with Class I being the most serious.

What is the significance of the DSHEA of 1994?

It established regulations for dietary supplements and their marketing.

What are the implications of a drug being classified as 'adulterated'?

It may be deemed unsafe for consumption and subject to regulatory action.

What is the importance of the USP-NF?

It sets legally recognized standards for drug quality, strength, and purity.

Which companies dominate the U.S. pharmaceutical wholesale distribution industry?

McKesson Corporation, Cardinal Health, and Cencora (formerly AmerisourceBergen)

What is a Third-Party Logistics Provider (3PL)?

An entity that provides or coordinates warehousing or logistics services without taking ownership of the product.

What must a Third-Party Logistics Provider do according to the FDA?

Register with the FDA.

What is the definition of 'Label' in pharmaceutical terms?

Display of written, printed, or graphic matter upon the immediate container of any article.

What does 'Labeling' include?

All labels and other written, printed, or graphic matter accompanying an article while held for sale.

What is 'On-Label Use' of a drug?

Using a drug for the purpose specified in the product labeling after FDA approval.

What is 'Off-Label Use' of a drug?

Using a drug for a purpose outside the product labeling.

What constitutes an 'Unapproved Use' of a drug?

Using a drug that has not been approved for any use.

What is a medication order in an inpatient facility?

An order for actions to be given to a patient within a hospital or institution.

What is the duration of a medication order in an inpatient facility?

Usually has no end time unless the patient is transferred or discharged.

What is a prescription for outpatient use?

A specific medication order for an individual patient written by a licensed practitioner.

What is the maximum duration for an outpatient prescription?

No more than 1 year.

What is the Pure Food and Drug Act of 1906?

The first major federal legislation prohibiting the sale of adulterated or misbranded food and drugs.

What did the Food, Drug, and Cosmetic Act of 1938 require?

New drugs must be proven safe prior to marketing.

What major event prompted the passage of the FDCA of 1938?

The Elixir Sulfanilamide incident, which resulted in over 100 deaths.

What does the Durham-Humphrey Amendment of 1951 address?

It distinguishes between prescription and over-the-counter drugs.

What is the purpose of the Controlled Substances Act (CSA) of 1970?

To regulate the manufacture and distribution of narcotics and other drugs that can be abused.

What does the Drug Quality and Security Act (DQSA) of 2013 establish?

It enhances the FDA's ability to protect consumers from unsafe drugs and ensures the integrity of the drug supply chain.

What is the significance of the Orphan Drug Act of 1983?

It provides incentives for the development of drugs for rare diseases.

What is the FDA Safety and Innovation Act (FDASIA) of 2012?

It aims to enhance the FDA's ability to ensure the safety and efficacy of drugs.

What does the Prescription Drug User Fee Act (PDUFA) of 1992 allow?

It allows the FDA to collect fees from drug manufacturers to expedite the drug approval process.

What is the role of the Food and Drug Administration (FDA)?

To regulate the safety and efficacy of drugs, food, and medical devices.

What does the term 'adulterated' refer to in the context of the Pure Food and Drug Act?

Products that are impure or mixed with undesirable substances.

What is meant by 'misbranded' in pharmaceutical terms?

Products that have false or misleading labeling.

What is the purpose of the Food Additives Amendment of 1958?

To ensure that food additives are safe for consumption.

What does the Best Pharmaceuticals for Children Act (BPCA) of 2002 encourage?

Research into the safety and efficacy of drugs for pediatric use.

What is the significance of the Patient Protection and Affordable Care Act (ACA) of 2010?

It aims to improve access to healthcare and reduce costs.

What are the three major firms dominating the U.S. pharmaceutical wholesale distribution industry?

McKesson Corporation, Cardinal Health, and Cencora (formerly AmerisourceBergen)

What does the term 'label' refer to in pharmaceutical context?

The display of written, printed, or graphic matter upon the immediate container of any article.

What is included in the term 'labeling'?

All labels and other written, printed, or graphic matter upon any article or its containers, or accompanying such article.

What defines an 'unapproved use' of a drug/device?

Using a drug/device that has NOT been approved for any use by the FDA.

What major event led to the passing of the Food, Drug, and Cosmetic Act (FDCA) of 1938?

The Elixir Sulfanilamide incident, which resulted in over 100 deaths.

What does the FDCA require for new drugs?

New drugs must be proven safe prior to marketing.

What is the role of the FDA under the FDCA?

To approve the marketing of drugs in the U.S. and ensure their safety.

What is the significance of the Medical Device Amendments of 1976?

It established a regulatory framework for medical devices.

What does the Orphan Drug Act of 1983 encourage?

The development of drugs for rare diseases.

What is the focus of the Drug Quality and Security Act (DQSA) of 2013?

To enhance the safety and security of the drug supply chain.

What does the FDA Safety and Innovation Act (FDASIA) of 2012 aim to improve?

The efficiency of the FDA's drug approval process and enhance the safety of drugs.

What does the Food Additives Amendment of 1958 require?

Food additives must be proven safe before being used in food products.

What must Third-Party Logistics Providers do according to the FDA?

They are required to register with the FDA.

What is the definition of a 'Label' in pharmacy?

The display of written, printed, or graphic matter upon the immediate container of any article.

What is a medication order in an inpatient setting?

An order for actions to be given to a patient within a care unit of a facility, usually without a specified end time unless the patient is transferred or discharged.

What is the difference between a medication order and a prescription?

A medication order is for inpatient care and does not have an end time, while a prescription is for outpatient care and has a definite end time.

What is the Food, Drug, and Cosmetic Act (FDCA) of 1938?

The most important pharmacy legislation that required new drugs to be proven safe prior to marketing.

What major event led to the passage of the FDCA?

The Elixir Sulfanilamide incident, which resulted in over 100 deaths in 1937.

What does the Pure Food and Drug Act of 1906 prohibit?

The sale of adulterated or misbranded foods, drugs, and liquors in interstate commerce.

What is the significance of the Pure Food and Drug Act?

It created the foundation for the FDA by requiring accurate labeling of active ingredients and banning harmful additives.

What is the role of the FDA according to the FDCA?

To approve the marketing of drugs and ensure their safety.

What is the definition of 'adulterated' in the context of the Pure Food and Drug Act?

Products that are impure, altered, or mixed with cheaper alternatives or undesirable substances.

What does 'misbranded' mean in the context of pharmacy legislation?

Products that have incomplete information, unclear warnings, or misleading claims.

What is the purpose of the Drug Quality and Security Act of 2013?

To enhance the FDA's ability to regulate compounding and ensure the quality of drugs.

What is the significance of the Controlled Substances Act (CSA) of 1970?

It regulates the manufacture and distribution of narcotics and other drugs that have the potential for abuse.

What does the Orphan Drug Act of 1983 provide?

Incentives for the development of drugs for rare diseases affecting fewer than 200,000 people.

What is the purpose of the Prescription Drug User Fee Act of 1992?

To allow the FDA to collect fees from drug manufacturers to expedite the review process for new drugs.

What is the Patient Protection and Affordable Care Act (ACA) of 2010?

A comprehensive healthcare reform law aimed at increasing healthcare access and affordability.

What is the significance of the FDA Safety and Innovation Act (FDASIA) of 2012?

It aims to enhance the FDA's ability to ensure the safety of drugs and devices and to promote innovation.

What is the purpose of the Food and Drug Administration Modernization Act (FDAMA) of 1997?

To streamline the drug approval process and improve the regulation of food and drugs.

What year was the Food, Drug, and Cosmetic Act (FDCA) enacted?

1938

What must be proven before a new drug can be introduced into interstate commerce?

Safety through an FDA-approved application (NDA).

What significant amendment was made to the FDCA in 1962?

The requirement for new drugs to be proven safe and effective for their claimed use.

What are the two classes of drugs established by the Durham-Humphrey Amendment of 1951?

Prescription drugs and over-the-counter (OTC) drugs.

What does the term 'adulteration' refer to under the FDCA?

Drugs that contain filthy, putrid, or decomposed substances or have been prepared under unsanitary conditions.

What is misbranding according to the FDCA?

Labeling that is false or misleading, or failing to include required information on the label.

What is required on the label of prescription drugs?

The name and address of the manufacturer, brand/generic name, net quantity, and specific storage instructions.

What must OTC drug labels include?

A principal display panel, identity statement, net quantity, cautions, and adequate directions for use.

What is the significance of the 'Rx only' statement on prescription drugs?

It indicates that the drug can only be dispensed with a valid prescription.

What constitutes a violation of the FDCA?

Engaging in interstate commerce with unapproved drugs or failing to meet GMPs.

What is the Poison Prevention Packaging Act (PPPA) of 1970?

A law requiring drugs to be packaged in child-resistant containers.

What does it mean if a drug is considered adulterated?

It does not meet the quality or purity standards set by the official compendium.

What is required for a drug to be considered safe and effective?

It must undergo clinical investigation and demonstrate safety and effectiveness for its intended use.

What is the role of the FDA regarding drug advertising?

The FDA has jurisdiction over prescription drug advertising to ensure it is not misleading.

What are some examples of forbidden activities under the FDCA?

Adulteration, misbranding, and violating FDCA requirements during interstate commerce.

What information is required on the label of OTC drugs?

Active ingredients, purpose, uses, warnings, directions, and inactive ingredients.