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Questions and Answers
What is the significance of following established codes of ethics in healthcare companies?
What is the significance of following established codes of ethics in healthcare companies?
Which major statutory law addressed the problems of dangerous ingredients, false marketing claims, and inaccurate labeling in pharmacy?
Which major statutory law addressed the problems of dangerous ingredients, false marketing claims, and inaccurate labeling in pharmacy?
What was the primary goal of the Pure Food and Drug Act of 1906?
What was the primary goal of the Pure Food and Drug Act of 1906?
Why did the US Congress start relying on the USP for standardization of drug ingredients in 1820?
Why did the US Congress start relying on the USP for standardization of drug ingredients in 1820?
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Why was the Pure Food and Drug Act of 1906 necessary?
Why was the Pure Food and Drug Act of 1906 necessary?
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How did the Pure Food and Drug Act of 1906 impact the sale and transport of food and drugs?
How did the Pure Food and Drug Act of 1906 impact the sale and transport of food and drugs?
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What is the main focus of Section 2.3 of the text?
What is the main focus of Section 2.3 of the text?
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What is the primary responsibility of the Drug Enforcement Administration (DEA) as mentioned in Section 2.4?
What is the primary responsibility of the Drug Enforcement Administration (DEA) as mentioned in Section 2.4?
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In which section of the text is the application of the legal term 'standard of care' discussed?
In which section of the text is the application of the legal term 'standard of care' discussed?
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What is a key difference between criminal and civil law as they apply to pharmacy professionals?
What is a key difference between criminal and civil law as they apply to pharmacy professionals?
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What do state boards of pharmacy primarily oversee, as mentioned in Section 2.4?
What do state boards of pharmacy primarily oversee, as mentioned in Section 2.4?
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In Section 2.1 of the text, what is the main objective when outlining an overview of governmental pharmacy oversight?
In Section 2.1 of the text, what is the main objective when outlining an overview of governmental pharmacy oversight?
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What role do legal mechanisms play in pharmacy practice?
What role do legal mechanisms play in pharmacy practice?
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What consequences may result from violations of pharmacy laws and standards?
What consequences may result from violations of pharmacy laws and standards?
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Why is it important for pharmacy technicians to understand the legal context of their practice?
Why is it important for pharmacy technicians to understand the legal context of their practice?
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What is the purpose of professional organizations establishing standards in pharmacy practice?
What is the purpose of professional organizations establishing standards in pharmacy practice?
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What was the state of drug manufacture in the United States during the 19th century?
What was the state of drug manufacture in the United States during the 19th century?
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Which statement is true regarding pharmacy laws and regulations?
Which statement is true regarding pharmacy laws and regulations?
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Study Notes
Pharmacy Oversight
- In the US, governmental pharmacy oversight involves laws, regulations, and standards at federal, state, and local levels to ensure safe and effective care.
- Professional organizations, such as the US Pharmacopeial Convention, also establish standards for pharmacy practice.
Laws, Regulations, and Standards
- Laws are enacted by government bodies to address public health concerns.
- Regulations are rules set by government agencies to enforce laws.
- Standards are guidelines established by professional organizations to ensure quality and safety in pharmacy practice.
- Professional ethics are moral principles that guide a pharmacist's or pharmacy technician's behavior.
History of US Statutory Pharmacy Law
- In the 19th century, drug manufacturing in the US was unregulated, and medicines did not have to be proven safe or effective to be marketed.
- The Pure Food and Drug Act of 1906 prohibited the sale or interstate transportation of adulterated or misbranded food and drugs.
Role of Government Agencies and Professional Organizations
- The Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and US Pharmacopeial Convention are key government agencies and professional organizations that create standards and enforce laws and regulations in pharmacy practice.
State Boards of Pharmacy and Federal Laws
- State boards of pharmacy oversee pharmacy practice at the state level, while federal laws and regulations govern pharmacy practice at the national level.
- The strictest rule applies when state and federal laws differ.
Legal Terms and Liability
- Standard of care refers to the level of care a pharmacist or pharmacy technician is expected to provide.
- Criminal law and civil law differ in their application to the pharmacy profession, with varying levels of liability for pharmacists and pharmacy technicians.
- Negligence, malpractice, and the law of agency and contracts can lead to legal actions against pharmacy technicians.
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Description
Test your knowledge on governmental pharmacy oversight in the US, including laws, regulations, standards, and professional ethics. Explore the impact of drug injuries on protective legislation and federal drug laws in the 20th century. Understand the roles of government regulatory agencies and professional organizations.