| Question | Answer |
|---|---|
| Which agency holds the legal responsibility for deciding whether a drug may be distributed and sold? | FDA |
| The combination of two drugs can cause an effect that is greater than the sum of the individual effects of each: | Synergism |
| Suppositories are inserted: | Rectal administration |
Who can dispose of controlled substances in the US?
Distributors, dispensers, and manufacturers are all registered with DEA. The distributor, dispenser, or manufacturer can itself dispose of the controlled substances under the procedures outlined in 21 CFR 1307.21.
How does the FDA make decisions about drugs?
How a drug is broken down in the body, and how long it stays in the body. Which foods, drinks, or other drugs can be used at the same time or should be avoided. Clinical trial results allow the FDA to make decisions about whether or not a drug should be approved for marketing. Q: How long does the drug approval process take?
How does the Controlled Substances Act affect drug laws?
Each state has its own drug laws and regulations, but the Controlled Substances Act allows Feds to enforce federal drug laws in any jurisdiction regardless of the laws of any state. 1 President Richard Nixon sought greater federal control over drugs in the early 1970s.
Why are drug manufacturers no longer involved in the disposal process?
However, over the past decade, environmental concerns and regulatory changes have caused drug manufacturers and government agencies (including DEA and State authorities) to become increasingly reluctant to be involved in the disposal process. Thus, many disposal options are no longer available.
Which agency holds the legal responsibility for deciding whether a drug may be distributed or sold?
The Food and Drug Administration (FDA), a regulatory agency within the Department of Health and Human Services, regulates the safety and effectiveness of drugs sold in the United States.
Which agency has the responsibility of enforcing the Controlled Substances Act of 1970 quizlet?
Explanation: The Drug Enforcement Agency (DEA) is responsible for enforcing the control of drugs with abuse potential.
What is it called when drugs are injected through a syringe into a muscle vein or body cavity?
Administration by injection (parenteral administration) includes the following routes: Subcutaneous (under the skin) Intramuscular (in a muscle) Intravenous (in a vein)
What is morphine quizlet?
Morphine is. narcotic drug derived from opium analgesic, used to treat severe pain.
Which agency has the primary responsibility of enforcing the nation's drug laws?
The mission of the Drug Enforcement Administration (DEA) is to enforce the controlled substances laws and regulations of the United States and bring to the criminal and civil justice system of the United States, or any other competent jurisdiction, those organizations and principal members of organizations, involved in ...
Which agency is responsible for the enforcement of controlled substances quizlet?
The Drug Enforcement Administration (DEA) is responsible for enforcing the federal Controlled Substances Act (CSA).
Which of the following is a general rule for drug administration?
Ch 53 midtermQuestionAnswerWhich of the following is a general rule for drug administration?Calculate the dose and it double-checked if unsure of your answerWhich of the following is included when administration a drug according to the "rights" of drug administration?Read the drug label on the container three times74 more rows
Which of the following is included when administering a drug according to the rights?
One of the recommendations to reduce medication errors and harm is to use the “five rights”: the right patient, the right drug, the right dose, the right route, and the right time.
Which word describes how the drug is delivered through the body?
Pharmacokinetics focuses on how drugs move within the body once administered. The movement of drugs involves four processes which include absorption, distribution, metabolism, and excretion.
What is naloxone quizlet?
(Naloxone) Action. 1. Narcotic antagonist, used in the management and reversal of overdoses caused by narcotics and synthetic narcotic agents. 2. Compared to other narcotic antagonists which do not completely inhibit the analgesic properties of opiates, naloxone antagonizes all actions of morphine.
What is nitroglycerin quizlet?
Smooth muscle relaxant acting on vascular, bronchial, uterine and intestinal smooth muscle. Dilation of arterioles and veins in the periphery, reduces preload and afterload, decreases the. work load of the heart, and myocardial 02 demand. Indications.
Is Tylenol an Nsaid?
Acetaminophen (Tylenol) is known as a non-aspirin pain reliever. It is NOT an NSAID, which is described below. Acetaminophen relieves fever and headaches, and other common aches and pains.
What are the laws that regulate the use of drugs?
Guide to U.S. Drug Laws. Federal drug laws, including the Controlled Substances Act, regulate the possession, trafficking, and manufacturing of drugs. Even though states have their own laws on drugs, federal laws supersede state laws—including those regarding the medical/recreational use of marijuana. No federal laws regulate drug testing ...
Which act allows the federal government to enforce drug laws in any jurisdiction?
Each state has its own drug laws and regulations, but the Controlled Substances Act allows Feds to enforce federal drug laws in any jurisdiction regardless of the laws of any state. 1.
What are federal drug laws?
Federal drug laws exist to control the use, manufacturing, possession, and distribution of various drugs that are legal and illegal. 1. Federal agencies collaborate with both state and local law enforcement to ensure effective controls over substances that are deemed to be a danger to individuals and to society.
What did Nixon do to control drugs?
During his presidency, the Comprehensive Drug Abuse Prevention and Control Act of 1970 was passed. 1 One aspect of this law was the Controlled Substances Act (CSA), which allowed federal jurisdiction over specific plants, drugs, and chemical substances. It established a classification or scheduling system for drugs. 1
What are some examples of Schedule I drugs?
Schedule I drugs have a high potential for misuse, no accepted medical treatment in the United States, and a lack of safety even if they were to be supervised by a medical professional. Heroin, GHB, LSD, Quaaludes, and marijuana are examples of Schedule I drugs.
Why did the new mandatory minimum sentencing laws create a rise in prison populations?
The new mandatory minimum sentencing laws created a rise in prison populations due to drug charges. About half of the federal prison population is serving time for drug offenses. The vast majority of this group was involved in drug trafficking (96%), while only 0.8% were serving time for possession in 2013. 1.
How many arrests were made for drug charges in 2012?
Most drug offenses are handled at the state level. In 2012, the DEA made just over 30,000 arrests for drug charges, while state and local police made over 1.3 million arrests for drug offenses. 1.
What is a drug study called?
A drug being studied in a clinical trial is called an investigational drug . Clinical trials of drugs provide information about: Whether the drug has the effect it is supposed to have. How much of the drug to give to a patient and how often. What side effects are associated with the drug and how they can best be managed.
What is an IND drug?
A: Investigational New Drug (IND) -- Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. New Drug Application (NDA) -- When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's ...
What is a biologics license?
A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market ...
How many OTC drugs are there?
A: No. Because there are over 300,000 marketed OTC drug products, instead of individual drug products, FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs, for example analgesics or antacids.
What is an OTC monograph?
OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval.
What are the clinical trials of drugs?
Clinical trials of drugs provide information about: 1 Whether the drug has the effect it is supposed to have. 2 How much of the drug to give to a patient and how often. 3 What side effects are associated with the drug and how they can best be managed. 4 How a drug is broken down in the body, and how long it stays in the body. 5 Which foods, drinks, or other drugs can be used at the same time or should be avoided. 6 Clinical trial results allow the FDA to make decisions about whether or not a drug should be approved for marketing.
What is a BLA in medical?
Once approved, an applicant may manufacture and market the generic drug product. Biologic License Application (BLA) -- Biological products are approved for marketing under the provisions of the Public Health Service Act.
Question
Study of the interaction of drugs and subcellular entities such as enzymes and DNA is called:
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What is the DEA agency?
AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Interim final rule with request for comment. SUMMARY: DEA is amending its regulations to define the term "reverse distributor" and to establish a new category of registration for persons handling controlled substances. The amendments establish the regulatory standards ...
What amendments did the DEA propose?
Finally, DEA proposed amendments to a number of gender-specific sections to make them gender neutral.
Is DEA gender neutral?
Finally, DEA proposed amendments to a number of gender-specific sections to make them gender neutral. DEA originally based its decision to define the persons performing the reverse distribution function as disposers on the definition of "manufacturer.".
Is a disposal company a reverse distributor?
On the other hand, if a disposal company receives controlled substances from a DEA registrant and then dispose s of them later, the disposal company becomes part of the chain of responsible parties and must therefore be registered by DEA as a reverse distributor.
Does the DEA have flexibility?
However, the regulatory structure does provide some flexibility and, where possible, DEA has made adjustments to address some of the problems the industry has encountered, including use of a separate category of registration and application of the inventory requirements for dispensers and researchers.
Can a distributor dispose of controlled substances?
The distributor, dispenser, or manufacturer can itself dispose of the controlled substances under the procedures outlined in 21 CFR 1307.21. Under 21 CFR 1307.21, any person may request permission to dispose of controlled substances without the benefit of a DEA or State witness.
Is reverse distributors a separate category?
Since DEA has decided to create a completely separate category for reverse distributors, persons who fall under this category will be required to comply with the same security, reporting, and other requirements that apply to distributors rather than the requirements that apply to manufacturers.
Federal Drug Laws
Possession
- The charge of possession can be broken into 2 categories: simple possession and possession with the intent to distribute. 1. Simple possession occurs when a person is caught with a small amount of an illegal substance for personal use.5 Under federal law, simple possession is a misdemeanor that can carry a sentence of up to a year in jail and/or a fine of at least $1,000, whi…
Trafficking Or Distribution
- Drug trafficking and distribution laws set penalties for the transportation, sale, or smuggling of drugs. This term also applies to the illegal distribution of prescription drugs.7 Trafficking is a felony, and the penalties depend on the substance or substances, amount of drugs involved, where the drugs are distributed, where the arrest occurs, and if drugs were distributed to minors.7
Manufacturing
- Manufacturing refers to involvement of any step of producing an illicit drug, such as sales of chemicals used to make drugs or equipment used to produce drugs, or assisting in the production process.8 Growing marijuana is considered manufacturing, along with production of methamphetamine.8 A person caught with 1-49 marijuana plants can face up to 5 years in priso…
Marijuana Laws
- Federal laws consider marijuana to be a Schedule I drug, with penalties for the possession, distribution, growth, or sale of marijuana. However, various states have established laws and regulations for medicinal and even recreational use of marijuana.1 When it comes to marijuana, federal law enforcement agencies have traditionally targeted criminal networks instead of indivi…
State Drug Laws
- Each state has individual laws regarding drug offenses, and these laws can be very different.States each have their own statutory authorities, scheduling bodies, and controlled substance acts, though federal agencies can take over jurisdiction at any time.1,11 Most drug offenses are handled at the state level. In 2012, the DEA made just over 30,000 arrests for drug …
Workplace and Drug Testing Laws
- A number of federal requirements surround workplace drug testing. Private employers do not need a policy to ensure drug-free workplaces, with the exception of federal contractors and companies in safety or security-sensitive industries.15,16 There are 2 categories of federal laws regarding substance use in the workplace: those aimed at substance use in the workplace and t…