5680 Law Exam 1
(60).webp "5680 Law Exam 1 - Quiz")
history, fda approval, labeling, federal and state prescription considerations
Questions and Answers
- 1.
Which entity is responsible for laws, imposes penalties for violation, "what must be"
Explanation
The government is responsible for creating and enforcing laws, as well as imposing penalties for violations. It is the governing body that sets the rules and regulations that must be followed by individuals and organizations within a society. The government ensures that these laws are upheld and punishes those who do not comply with them.Rate this question:
- 2.
Which entity is responsible for ethics, self regulation, "what ought to be"
Explanation
Professions are responsible for ethics, self-regulation, and determining what is morally right or wrong in their respective fields. They establish codes of conduct and standards to ensure that their members adhere to ethical principles and maintain professional integrity. Professions play a crucial role in guiding practitioners on how they should behave, make decisions, and interact with clients or the public. They are accountable for upholding the values and ideals of their profession, and promoting the well-being and trust of society.Rate this question:
- 3.
The DEA and board of pharmacy fall under which branch of government
Explanation
The DEA (Drug Enforcement Administration) and the board of pharmacy are regulatory bodies that oversee the distribution and control of drugs. They enforce laws and regulations related to pharmaceuticals and controlled substances. The legislative branch of government is responsible for creating and passing laws. Therefore, it makes sense for the DEA and board of pharmacy to fall under the legislative branch as they operate based on the laws and regulations set by this branch.Rate this question:
- 4.
Under which type of law are fines, incarceration, capitol punishment enforced
Explanation
Fines, incarceration, and capital punishment are enforced under criminal law. Criminal law deals with offenses committed against the public and society as a whole, and it aims to maintain social order and protect individuals by punishing those who violate the law. This type of law focuses on the punishment and rehabilitation of offenders through various means, including fines, imprisonment, and in extreme cases, capital punishment.Rate this question:
- 5.
Under which type of law are damages, financial awards, possible jail time enforced
Explanation
Under civil law, damages and financial awards are enforced through legal actions in order to compensate for harm or loss suffered by one party due to the actions or negligence of another party. In some cases, civil law may also involve the possibility of imposing jail time as a form of punishment for certain offenses. Unlike criminal law, civil law focuses on resolving disputes between individuals or entities rather than prosecuting criminal behavior.Rate this question:
- 6.
Under which type of law can license be suspended, but no incarceration
Explanation
Under administrative law, a license can be suspended without the need for incarceration. Administrative law deals with the rules and regulations set by government agencies to govern various industries and professions. These agencies have the authority to suspend licenses if individuals fail to comply with the required standards or regulations. This form of punishment aims to protect the public and maintain the integrity of the profession or industry, without resorting to imprisonment.Rate this question:
- 7.
Which piece of legislation established FDA, definitions for adulterated and misbranded products
- 8.
Which piece of legislation requires new drug to be proven safe when used according to labeled directions, developed warnings for habit forming drugs, included cosmetics and medical devices, basis for GA dangerous drug act
- 9.
Piece of legislation written by pharmacists establishing two classes of drugs: legend "dangerous" drugs with the wording: "caution: federal law prohibits dispensing w/o a prescription", and non-prescription drugs, required directions, allowed oral prescriptions, regulated prescription refills
- 10.
Which events helped persuade the passing of the food drug cosmetic act of 1938
- 11.
Which event persuaded the passing of the kefauver-harris amendment of 1962
- 12.
Piece of legislation requiring efficacy in new drugs, granted regulation of prescription drug advertising to FDA, required informed consent, reporting of adr, creation of good manufacturing practices, standardized new drug application process
- 13.
Piece of legislation providing tax and licensing incentives to manufacturers to develop drugs that treat rare diseases, less than 200K ppl
- 14.
Piece of legislation facilitating generic drugs to market by creating ANDA (abbrev NDA) to prove bioequiv and 180 day exclusivity; gave innovator companies additional 5yr of exclusive marketing after approval, aka drug price competition and patent term restoration act
- 15.
Piece of legislation establishing controls for distribution and record keeping of drug samples, regulation of wholesalers, banned re-importation of prescription drugs produced in US, allows starter packs, coupons, vouchers; retail pharmacies may not possess any prescription drug samples obtained from any source
- 16.
Legislation establishing prospective DUR, patient counseling, standard of practice, offer to counsel made by pharmacist
- 17.
Legislation creating fast track NDA, allowed state regulation of compounding, shortened legend to RX only, creation of supplemental NDA for new uses of existing drugs, encouraged pediatric studies by granting innovator company extra 6mo of marketing exclusivity
- 18.
Legislation establishing Medicare part D prescription drug coverage, allows center for medicaid and medicare services (CMS) to supervise, includes prescription drug plan and medication therapy management, encompasses four programs
- 19.
Which drug classes are required in a medicare part d formulary
- 20.
Which resources are listed in federal regulations as accepted standards; contain monographs of recognized drugs
- 21.
Application required before testing in humans, drug must show safety and efficacy, FDA has 30 days to approve or deny
Explanation
An IND (Investigational New Drug) application is required before testing a drug in humans. The drug must demonstrate both safety and efficacy in preclinical studies before the application can be submitted to the FDA. Once the IND is submitted, the FDA has 30 days to review and either approve or deny the application. This process ensures that potential new drugs are thoroughly evaluated for their safety and effectiveness before being tested in human subjects.Rate this question:
- 22.
When is NDA submitted to FDA? what must be included?
- 23.
Who is contacted for fast track drug review? under what conditions will this be granted?
- 24.
Application for drug already on market, usually submitted by innovator company, for changes in formulation, new dosage form/strength, packaging/labeling change, new indication, extension of sole proprietorship
Explanation
An SNDA (Supplemental New Drug Application) is an application submitted by the innovator company of a drug that is already on the market. It is typically filed to request changes in the drug's formulation, dosage form or strength, packaging or labeling, new indications for use, or an extension of the sole proprietorship. This application allows the innovator company to make necessary modifications or improvements to the drug while ensuring its safety and efficacy.Rate this question:
- 25.
Application for generics, must show bioequiv; able to skip IND and clinical trials
Explanation
An ANDA (abbreviated new drug application) is a type of application for generics that allows the applicant to skip the lengthy and expensive process of conducting IND (Investigational New Drug) studies and clinical trials. Instead, the applicant must demonstrate bioequivalence, which means that the generic drug is equivalent to the brand-name drug in terms of dosage form, strength, route of administration, quality, performance characteristics, and intended use. This streamlined process allows for faster approval and market entry of generic drugs, promoting competition and affordability in the pharmaceutical industry.Rate this question:
- 26.
Therapeutic classification of NDA for drug of major therapeutic gain, new class, no previous effective tx; given priority review
Explanation
The given answer "type p" is the correct answer because it accurately describes the therapeutic classification of the NDA (New Drug Application) for a drug that belongs to a new class and has no previous effective treatment. This drug is considered to have a major therapeutic gain and has been given priority review. The classification "type p" likely refers to a specific category or class within the therapeutic classification system.Rate this question:
- 27.
Therapeutic classification for NDA of drug similar to other available agent; given standard review
- 28.
Organization determining generic drug names; must be simple, informative, non-proprietary
Explanation
The US Adopted Names Council (USAN) is responsible for determining generic drug names. These names must be simple, informative, and non-proprietary. The USAN ensures that generic drug names are easy to understand and provide relevant information about the drug. By adopting these names, the council helps to standardize the naming process and promote clarity in the pharmaceutical industry.Rate this question:
- 29.
Term for ingredient or integrity problem; failure to conform to standards for purity, quality, strength, approp assays, not stored according to USP
Explanation
Adulterated is the appropriate term for an ingredient or integrity problem, indicating a failure to meet standards for purity, quality, strength, appropriate assays, or proper storage according to the USP. It suggests that the substance has been contaminated or mixed with impurities, rendering it unfit for use or consumption.Rate this question:
- 30.
Term for labeling that is incomplete or misleading
Explanation
Misbranded is the term used to describe labeling that is incomplete or misleading. This means that the labeling of a product does not provide all the necessary information or may provide false or misleading information to consumers. It is important for products to have accurate and complete labeling to ensure that consumers are well-informed about the product and its potential risks or benefits.Rate this question:
- 31.
What are labeling requirements for manufacturer containers (stock bottles)
- 32.
What are requirements for OTC labels
- 33.
Which ingredients require special warning labels for allergies
- 34.
Which products require special warning labels for amount dispensed
- 35.
What is the expiration date for unit dose repackaging
- 36.
FDA program for monitoring and reporting of adverse drug events, mail, phone, fax, internet form
Explanation
MedWatch is the correct answer because it is a program established by the FDA for monitoring and reporting adverse drug events. It allows individuals to report any negative effects or reactions they experience from medications through various channels such as mail, phone, fax, or internet forms. MedWatch plays a crucial role in collecting and analyzing data on adverse drug events, helping to ensure the safety and effectiveness of medications in the market.Rate this question:
- 37.
Program/act for reporting of device problems
Explanation
The Safe Medical Device Act (SMDA) is a program or act that focuses on the reporting of device problems in the medical field. It is an important legislation that ensures the safety and effectiveness of medical devices by requiring manufacturers, distributors, and importers to report any adverse events, malfunctions, or defects associated with their products. The SMDA aims to protect patients and healthcare providers by promoting transparency and accountability in the medical device industry.Rate this question:
- 38.
Special FDA/CDC program to report vaccine problems
Explanation
VAERS stands for Vaccine Adverse Event Reporting System, a special program by the FDA and CDC to report any problems or adverse events related to vaccines. It serves as a national system for monitoring the safety of vaccines and collecting data on any side effects or complications that may occur after vaccination. Through VAERS, healthcare professionals and the public can report any adverse events they suspect may be related to vaccines, helping to ensure the ongoing safety and effectiveness of vaccines.Rate this question:
- 39.
Most serious type of drug recall, serious effects, death, requires recall of stock and notification of patients
Explanation
Class I is the most serious type of drug recall. It is categorized as such because it involves drugs with serious effects, including the potential for death. When a drug is classified as Class I, it requires a recall of the stock from the market and notification of patients who may have been prescribed or used the drug. This classification is reserved for situations where the drug poses a significant risk to the health and safety of patients.Rate this question:
- 40.
Type of recall due to temporary or reversible adverse effects, remote probability of harm, recall from stocks
Explanation
Class II recalls are issued for products that may cause temporary or reversible adverse effects on health, or have a remote probability of causing serious harm. These recalls are typically initiated when there is a need to remove the product from stocks and prevent further distribution or use. Therefore, the given answer of "class II" aligns with the description provided.Rate this question:
- 41.
Type of recall that may be requested by FDA,
Explanation
Voluntary recall refers to a type of recall that is initiated by the manufacturer or distributor of a product without any legal obligation or requirement from the FDA. It is a proactive measure taken by the company to remove or correct a product that may pose a risk to public health or safety. This type of recall is not mandated by the FDA, but rather done voluntarily by the company to ensure consumer protection.Rate this question:
- 42.
Expiration date for non-aqueous solutions compounded with solid drugs
- 43.
Which compounds are exempt from compounding standards
Explanation
Radiopharmaceuticals are exempt from compounding standards because they are specialized pharmaceuticals that contain radioactive substances. These substances are used for diagnostic or therapeutic purposes, such as in nuclear medicine. Due to the unique nature of radiopharmaceuticals and the potential risks associated with handling radioactive materials, they are subject to separate regulations and guidelines specific to their production, storage, and administration. Therefore, they are exempt from the general compounding standards that apply to other pharmaceutical compounds.Rate this question:
- 44.
Term defined in food drug cosmetic act as articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man and other animals; recognized in USP/NF or homeopathic pharmacopoeia of US (HPUS)
Explanation
The term "drug" is defined in the Food Drug Cosmetic Act as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans and animals. Additionally, for a substance to be considered a drug, it must be recognized in the United States Pharmacopeia/National Formulary (USP/NF) or the Homeopathic Pharmacopoeia of the United States (HPUS). Therefore, the correct answer is "drug."Rate this question:
- 45.
Term defined in food drug cosmetic act as article used for food or drink for man or other animals, chewing gum, and articles used for components of any such article ingredients
Explanation
The term "food" is defined in the Food Drug Cosmetic Act as an article that is used for food or drink for humans or animals, including chewing gum, as well as articles used as ingredients or components of any such article. Therefore, the correct answer is "food" because it encompasses all the items mentioned in the definition provided.Rate this question:
- 46.
Term defined in food drug cosmetic act as product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following: vitamin, mineral, herb or other botanical, amino acid, substance used to supplement the diet by increasing total dietary intake, concentrate, metabolite, constituent, extract, combo of any ingredient described above
Explanation
A dietary supplement is a product, other than tobacco, that is intended to supplement the diet. It can contain one or more of the following: vitamins, minerals, herbs or other botanicals, amino acids, substances used to increase total dietary intake, concentrates, metabolites, constituents, extracts, or a combination of any of these ingredients. This definition is based on the Food Drug Cosmetic Act.Rate this question:
- 47.
Term described by food drug cosmetic act as articles to be rubbed, poured, sprinkled, or sprayed on, introduced to, or otherwise applied to human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering appearance, and articles for use as component of any such articles; except soap
Explanation
The term described by the Food Drug Cosmetic Act as articles to be rubbed, poured, sprinkled, or sprayed on, introduced to, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering appearance, and articles for use as a component of any such articles, except soap, is referred to as a cosmetic.Rate this question:
- 48.
Under GA law, who can prescribe?
- 49.
What are requirements for a CII prescription
- 50.
In what conditions may a CII prescription order fax be used as original hardcopy
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Jun 24, 2024Quiz Edited by
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Feb 14, 2012Quiz Created by
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