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Current good manufacturing practice (CGMP or cGMP) is a set of regulations that establish the minimum requirements for manufacturing drug products for administration to humans or animals. These regulations assure proper design, monitoring, and control of manufacturing processes and facilities. These regulations apply to _ manufacturers, but not pharmacies, unless the pharmacy engages in manufacturing. Adulteration vs Misbranding? A - messing w/ the actual drug M - messing with the what...

Board of Pharmacy consists of how many members? 7 (6 pharmacists) No more than ___ members of the BOP can be of the same political party 4 How many members of the BOP must be a consumer, IN resident, no affiliations with pharmacy 1 True or False: One member of the BOP has to be a hospital pharmacist true Who are the BOP members appointed by? Governor BOP term of office 4 years What are the qualifications for being on BOP? Licensed in IN, good stan...

Pure Food and Drug Act Prevent adulturation and misbranding Food, Drug, and Cosmetic Act No marketing until safe Directions Warning Prescription Drug Marketing Act No re-importation Storage Modernization Act Fast track Waxman 5 year marketing exclusivity Kefauver Prove safe and effective cGMP (Due to thalidomide) Durham-Humphrey OTC C2 Amytal, Pentobarbtial C3 Anabolic steroids Burp endorphins Dronabinol Fiorinal Ketamine ...

What titles can Indiana code information be found? 16, 25, 35, 856 Aldulteration Something wrong with the preparation, strength, or purity of a product. What organization focuses on preventing Aldulteration? FDA Misbranding Something wrong with the outside of the product or something wrong with the words associated with the product. How often does a manufacturer go through an inspection process with the FDA? At least once every 2 years. If a manufacturing ...

where to find federal laws United States Code where to find federal regulations Code of Federal Regulations (CFR) where to find Indiana Code Indiana Code Indiana Administrative Code (AIC) adulteration making unpure poorer in quality -dropping tablets on the floor -not meeting cGMP -container made of poisonous substance -strength doesnt match -has been mixed to reduce strength -unsafe dye added misbranding the label is false or misleading -doesnt have name...

inventory records must be kept for how long 2 years phycian who writes the drug order, prescription, or protocol is liscended in and activitely practicing in a medical office in Indiana and IS OR IS NOT EMPLOYED BY THE PHARMACY? NOT EMPLOYED Within how many days should pharmacist tell the doc who write the Rx for immunization and the patients PCP that they recieved the immunization? 14 LSD Schedule I Heroin Schedule I Marijuana Schedule I Difenoxin...

If an institutional pharmacy is closed and unattended by a pharmacist, how can a nurse obtain a needed medication while the pharmacy is closed? (All that apply) A. Remove from emergency kit B. Remove from floor stock of floor mechanical devices C. Ask authorized supervisory nurse to remove from pharmacy following proper procedures D. Ask a pharmacist to come in and get the medication for them. E. There is no way to get a medication while a pharmacist is not on duty A, B, C, D T/F th...

Test information - 120 questions - answer all questions; penalized for each left blank - 75 is the score (not a %) needed to pass Adulteration - issues with the product itself - does not "actually" have to have something wrong with it; we assume product has been adultered if it has gone through a situation in which is may have been --products can be misbranded AND adultered; not mutually exclusive-- Misbranding - issues with the words associated with the product - p...

Adulteration Something wrong with the preparation, strength, or purity of a product - making the product less pure Expired products - adulteration or misbranding? Adulteration Contaminated drug packaging - adulteration or misbranding? Adulteration Not meeting current good manufacturing practices (cGMP) - adulteration or misbranding? Adulteration Using an unsafe coloring agent - adulteration or misbranding? Adulteration Not meeting USP standards - adulterat...

Ernest Burgess Developed Concentric Circle Theory with Robert E. Park in 1925. Wrote the 'The City' together. Patrick Geddes Author of Cities in Evolution, Scottish botanist and biologist, considered father of regional planning. Innovating planning theorist, introduced concept of 'region.' Believed social processes and spatial form are related. Designed and Jerusalem expansion and Tel Aviv around Garden City movement. Alfred Bettman Cincinnati lawyer. Drafted a bill 1915 tha...

Where to find federal laws and regulations United States Code (USC) The Code of Federal Regulations (CFR) Majority can be found in Title 21 of both Where to find Indiana laws and regulations (Rules in Indiana) The Indiana Code (IC) Indiana Administrative Code (IAC) Pure Food and Drug Act of 1906 Prevented the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors Food, Drug, and Cosmetic Act (F...

sale is defined as... manufacturing/ processing/ handling/ transporting/ packing exposure, offer, proffer holding, storing, possession dispensing, delivering, giving, applying, administering big 4 prescribers physicians (MD, DO) podiatrist (DPM) Dentist (DDS/DDM) Veterinarians (DVM) indiana mid-level practitioners APN (NP, certified nurse midwives, clinical nurse specialists) PA optometrists filling an Rx for a big 4 prescriber not in Indiana can honor, as long ...

how many members does the board of pharmacy consist of? 7 true or false? no more than 4 members of the board of pharmacy can be from the same political party? true what is true of one member of the board of pharmacy? one member must be a consumer, be Indiana resident and not be affiliated with pharmacy true or false? One member of the board of pharmacy must be a practicing hospital pharmacist True who appoints the board of pharmacy members? the Governor wh...

Law a written law enacted by the legislature (congress or local municipalities, governor, president) ELECTED OFFICIALS) T/F LAWS GO THROUGH A PUBLIC COMMENT AND REVISION PROCESS FALSE Where are federal laws found? United States Code (USC) Where are Indiana laws found? Indiana Code (IC) What is a Regulation/Rule? having the force of a law issued by an administrative agency- FDA, DEA, BOP (NON ELECTED ) Where are federal regulations published? Code of Feder...

BOP consists of ______ members 7 No more than _______ members of the BOP can be from the same political party 4 One member of the BOP must be..... IN resident with no affiliation with pharmacy One member of the BOP must be a practicing ________ pharmacist. Others must be from varied practice settings hospital Who appoints members of the BOP? governor T/F: The BOP may contain a COP professor or full-time staff member False How long is term of office...

Texas Health and Life Insurance Exam 2023 with 100% correct answers

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The Universal Life Policy is called an unbundled Life Policy because the policyholder can see the expense charges, the interest earned, and the Cost of insurance The investment gains from a Universal Life Policy usually go toward the cash value What is the MINIMUM benefit period that must be offered by a Long-Term Care policy? 12 months What type of life insurance gives the greatest amount of coverage for a limited period of time? Term life An Evidence of Coverage...

T owns an Accident & Health policy and notifies her insurance company that she has chosen a less hazardous occupation. Under the Change of Occupation provision, which of the following actions may her insurance company take? Increase her policy's coverage amount When an insurer issues a policy that refuses to cover certain risks, this is referred to as a(n) Exclusion An agent who tells claimants that their rights may be impaired if they fail to complete a release form within a gi...

What is the purpose of the buyer's guide? A.To Allow the consumer to compare the costs of different policies B. To provide the name and address of the agent. C. to list all policy riders. D. To provide information about the policy. A.To Allow the consumer to compare the costs of different policies Which of the following best describes the concept that the insured pays a small amount of premium for a large amount of risk on the part of the insurance company? AAdhesion BSubrogation ...