US Pharmaceutical Legislation History

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What is the mechanism of drug absorption characterized by the drug molecules passing through a membrane without actively participating in the process?

Active transport

First-pass effect

Facilitated diffusion

Passive diffusion (correct)

Which process involves the drug being moved across the membrane against a concentration gradient through the use of a carrier?

Active transport (correct)

Facilitated diffusion

Passive diffusion

First-pass effect

What is the term used to describe the intestinal and hepatic degradation or alteration of a drug taken orally, before it enters general circulation?

Active transport

Passive diffusion

First-pass effect (correct)

Facilitated diffusion

Which term describes the time it takes for a drug to begin acting after administration?

Onset of action Signup and view all the answers

Which USP General Chapter specifically addresses pharmaceutical compounding for nonsterile preparations?

USP General Chapter 795 Signup and view all the answers

What is a key characteristic of a 'goal drug' as described in the text?

Produces no side effects Signup and view all the answers

What is the main purpose of the Comprehensive Drug Abuse Prevention and Control Act of 1970 according to the text?

To consolidate various laws governing controlled substances Signup and view all the answers

What is a key goal of current Good Manufacturing Practice (cGMP) as described in the text?

To establish standards for drug packaging and labeling Signup and view all the answers

What is the primary role of the United States Pharmacopeia and National Formulary (USP/NF) according to the text?

No information is provided about the role of USP/NF in the given text Signup and view all the answers

Which of the following is a key characteristic of a Schedule I drug under the Comprehensive Drug Abuse Prevention and Control Act of 1970?

Has a high potential for abuse and no accepted medical use Signup and view all the answers

Which of the following physicochemical properties of a drug substance can affect its dissolution rate?

Solubility and particle size Signup and view all the answers

What is the relationship between particle size and the rate of drug dissolution?

The rate of dissolution is inversely proportional to the particle size. Signup and view all the answers

How does the crystalline state of a drug affect its dissolution rate?

Crystalline drugs tend to dissolve more slowly than amorphous forms. Signup and view all the answers

How does the fed state affect drug dissolution compared to the fasted state?

Drug dissolution is faster in the fed state. Signup and view all the answers

How does the pH in the gastrointestinal tract affect drug dissolution?

Drug dissolution is better in the more alkaline environment of the fed state. Signup and view all the answers

What defines a prodrug?

An inactive form of a drug that is transformed into an active form Signup and view all the answers

Which property increases membrane permeability of drug substances?

Low logP value Signup and view all the answers

What is the purpose of the Federal Food, Drug, and Cosmetic Act of 1938?

To prohibit the distribution of any new drug or drug product without prior FDA approval Signup and view all the answers

What differentiates amorphous solid forms from crystalline solid forms?

Amorphous forms lack long-range order in molecular units Signup and view all the answers

What characterizes solvates and hydrates in terms of crystal lattice inclusion?

Incorporation of water or solvent molecules into the lattice Signup and view all the answers

What is the purpose of the Durham-Humphrey Amendment of 1951?

To create a legal distinction between prescription and over-the-counter drugs Signup and view all the answers

How do polymorphic drugs affect drug formulation?

Exist in multiple crystalline structures with different properties Signup and view all the answers

What is the primary function of the United States Pharmacopeia (USP) and the National Formulary (NF)?

To provide standards for the strength, quality, and purity of drugs Signup and view all the answers

What is the primary purpose of current Good Manufacturing Practices (cGMP) regulations?

To establish guidelines for the manufacturing of drugs to ensure quality and safety Signup and view all the answers

Which federal law classifies drugs into different schedules based on their potential for abuse?

The Comprehensive Drug Abuse Prevention & Control Act of 1970 Signup and view all the answers

What is the onset of action?

The duration of time it takes for a drug's effects to become noticeable after administration Signup and view all the answers

Which factor is important in determining a drug's half-life?

The chemical and physical properties of the drug Signup and view all the answers

What is the primary purpose of the United States Pharmacopeia (USP) and the National Formulary (NF)?

To establish standards for drug purity and strength Signup and view all the answers

Which of the following is a requirement of the current Good Manufacturing Practices (cGMP) regulations?

Quality control measures must be implemented Signup and view all the answers

What is the purpose of the drug scheduling system?

To regulate the distribution and control of controlled substances Signup and view all the answers

What is the primary advantage of transdermal drug delivery compared to oral administration?

Improved bioavailability due to bypassing first-pass metabolism Signup and view all the answers

Which characteristic of a drug is MOST important for suitability in traditional transdermal delivery?

High lipophilicity Signup and view all the answers

What is the primary role of the backing membrane in a transdermal patch?

Provide structural support for the patch Signup and view all the answers

Which of the following is a key characteristic of a 'goal drug' under the Comprehensive Drug Abuse Prevention and Control Act of 1970?

Has a currently accepted medical use with no severe restrictions Signup and view all the answers

What is the primary purpose of current Good Manufacturing Practice (cGMP) according to the text?

To ensure the quality and safety of drug products Signup and view all the answers

Which USP General Chapter specifically addresses pharmaceutical compounding for nonsterile preparations?

Chapter <795> Signup and view all the answers

Which term describes the process where a drug is moved across a membrane against a concentration gradient using a carrier?

Active transport Signup and view all the answers

What is the term used to describe the intestinal and hepatic degradation or alteration of a drug taken orally, before it enters general circulation?

First-pass metabolism Signup and view all the answers

Which of the following is a key characteristic of a Schedule I drug under the Comprehensive Drug Abuse Prevention and Control Act of 1970?

Has a high potential for abuse and no accepted medical use Signup and view all the answers

What is the main purpose of the Comprehensive Drug Abuse Prevention and Control Act of 1970 according to the text?

To control the scheduling of controlled substances Signup and view all the answers

What is the main focus of Biopharmaceutics?

Drug absorption and distribution in the body Signup and view all the answers

Which process involves drugs moving from an area of higher concentration to an area of lower concentration without the use of energy?

Passive drug diffusion Signup and view all the answers

What does the acronym ADME stand for?

Absorption, Distribution, Metabolism, and Excretion Signup and view all the answers

What factor affects the rate of dissolution by altering the drug's form as either crystal or amorphous?

Salt concentration Signup and view all the answers

Which term refers to the process of how a drug is absorbed into the bloodstream, distributed to tissues, metabolized, and excreted from the body?

Pharmacokinetics Signup and view all the answers

What is the primary advantage of the oral route of drug administration compared to parenteral administration?

More economical and easier to administer Signup and view all the answers

What is the primary disadvantage of the rectal route of drug administration?

Absorption depends on the disease state and can be uncomfortable Signup and view all the answers

Which of the following is a key benefit of the parenteral route of drug administration?

Avoidance of first-pass metabolism Signup and view all the answers

What is the primary disadvantage of the parenteral route of drug administration?

Increased risk of infection Signup and view all the answers

What is the key factor that determines a drug's half-life?

The time it takes the body to break down and excrete the drug Signup and view all the answers

What type of rate reaction occurs when the loss of drug is directly proportional to the concentration remaining with respect to time?

First order Signup and view all the answers

Which aspect of stability ensures that there is no significant increase in toxicity of a drug product?

Toxicologic stability Signup and view all the answers

When a drug's loss is constant with respect to time and independent of the concentration of reactants, what order reaction is it?

Zero order Signup and view all the answers

Which type of agents may be added to protect a drug product from water and enhance its stability?

Antioxidants Signup and view all the answers

Why are shelf life estimates necessary for drug products?

To guide storage conditions and expiration dates Signup and view all the answers

Where does a drug exert its effect?

At the site of action Signup and view all the answers

What drives the absorption process through passive diffusion?

Drug concentration gradient across the membrane Signup and view all the answers

What factor primarily determines a drug's ultimate effectiveness?

How well it passes through natural body barriers Signup and view all the answers

Which process involves molecules passing through a membrane without active participation by the membrane itself?

Passive diffusion Signup and view all the answers

What is the primary difference between local and systemic use of drugs?

Local use involves absorption into the blood, while systemic use is site-specific. Signup and view all the answers

According to the passage, what is the responsibility of the pharmacist when it comes to dispensing products?

Dispense the oldest stock first and observe expiration dates Signup and view all the answers

What should the pharmacist do with products that are repackaged, diluted, or mixed with other products?

Properly treat/label them Signup and view all the answers

What should the pharmacist do when informing/educating patients about products?

Provide information about proper storage and use, including the disposition of outdated or excessively aged prescriptions Signup and view all the answers

Why is the choice of dosage form (drug delivery system) important according to the passage?

The wrong choice can cause failure of therapy Signup and view all the answers

What is a key responsibility of pharmacists according to the passage?

Pharmacists should be able to handle and administer the drug properly or advise the patient about it Signup and view all the answers

US Pharmaceutical Legislation History

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Questions and Answers

What is the mechanism of drug absorption characterized by the drug molecules passing through a membrane without actively participating in the process?

Which process involves the drug being moved across the membrane against a concentration gradient through the use of a carrier?

What is the term used to describe the intestinal and hepatic degradation or alteration of a drug taken orally, before it enters general circulation?

Which term describes the time it takes for a drug to begin acting after administration?

Which USP General Chapter specifically addresses pharmaceutical compounding for nonsterile preparations?

What is a key characteristic of a 'goal drug' as described in the text?

What is the main purpose of the Comprehensive Drug Abuse Prevention and Control Act of 1970 according to the text?

What is a key goal of current Good Manufacturing Practice (cGMP) as described in the text?

What is the primary role of the United States Pharmacopeia and National Formulary (USP/NF) according to the text?

Which of the following is a key characteristic of a Schedule I drug under the Comprehensive Drug Abuse Prevention and Control Act of 1970?

Which of the following physicochemical properties of a drug substance can affect its dissolution rate?

What is the relationship between particle size and the rate of drug dissolution?

How does the crystalline state of a drug affect its dissolution rate?

How does the fed state affect drug dissolution compared to the fasted state?

How does the pH in the gastrointestinal tract affect drug dissolution?

What defines a prodrug?

Which property increases membrane permeability of drug substances?

What is the purpose of the Federal Food, Drug, and Cosmetic Act of 1938?

What differentiates amorphous solid forms from crystalline solid forms?

What characterizes solvates and hydrates in terms of crystal lattice inclusion?

What is the purpose of the Durham-Humphrey Amendment of 1951?

How do polymorphic drugs affect drug formulation?

What is the primary function of the United States Pharmacopeia (USP) and the National Formulary (NF)?

What is the primary purpose of current Good Manufacturing Practices (cGMP) regulations?

Which federal law classifies drugs into different schedules based on their potential for abuse?

What is the onset of action?

Which factor is important in determining a drug's half-life?

What is the primary purpose of the United States Pharmacopeia (USP) and the National Formulary (NF)?

Which of the following is a requirement of the current Good Manufacturing Practices (cGMP) regulations?

What is the purpose of the drug scheduling system?

What is the primary advantage of transdermal drug delivery compared to oral administration?

Which characteristic of a drug is MOST important for suitability in traditional transdermal delivery?

What is the primary role of the backing membrane in a transdermal patch?

Which of the following is a key characteristic of a 'goal drug' under the Comprehensive Drug Abuse Prevention and Control Act of 1970?

What is the primary purpose of current Good Manufacturing Practice (cGMP) according to the text?

Which USP General Chapter specifically addresses pharmaceutical compounding for nonsterile preparations?

Which term describes the process where a drug is moved across a membrane against a concentration gradient using a carrier?

What is the term used to describe the intestinal and hepatic degradation or alteration of a drug taken orally, before it enters general circulation?

Which of the following is a key characteristic of a Schedule I drug under the Comprehensive Drug Abuse Prevention and Control Act of 1970?

What is the main purpose of the Comprehensive Drug Abuse Prevention and Control Act of 1970 according to the text?

What is the main focus of Biopharmaceutics?

Which process involves drugs moving from an area of higher concentration to an area of lower concentration without the use of energy?

What does the acronym ADME stand for?

What factor affects the rate of dissolution by altering the drug's form as either crystal or amorphous?

Which term refers to the process of how a drug is absorbed into the bloodstream, distributed to tissues, metabolized, and excreted from the body?

What is the primary advantage of the oral route of drug administration compared to parenteral administration?

What is the primary disadvantage of the rectal route of drug administration?

Which of the following is a key benefit of the parenteral route of drug administration?

What is the primary disadvantage of the parenteral route of drug administration?

What is the key factor that determines a drug's half-life?

What type of rate reaction occurs when the loss of drug is directly proportional to the concentration remaining with respect to time?

Which aspect of stability ensures that there is no significant increase in toxicity of a drug product?

When a drug's loss is constant with respect to time and independent of the concentration of reactants, what order reaction is it?

Which type of agents may be added to protect a drug product from water and enhance its stability?

Why are shelf life estimates necessary for drug products?

Where does a drug exert its effect?

What drives the absorption process through passive diffusion?

What factor primarily determines a drug's ultimate effectiveness?

Which process involves molecules passing through a membrane without active participation by the membrane itself?

What is the primary difference between local and systemic use of drugs?

According to the passage, what is the responsibility of the pharmacist when it comes to dispensing products?

What should the pharmacist do with products that are repackaged, diluted, or mixed with other products?

What should the pharmacist do when informing/educating patients about products?

Why is the choice of dosage form (drug delivery system) important according to the passage?

What is a key responsibility of pharmacists according to the passage?

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