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pharmacy tech chap1

when was pure food and drug enacted? enacted in 1906
When was the Food, drug, and cosmetic act created and What does it require? created under FDCA 1938, which required that all new drug applications be filed with the FDA
what does the FDCA 1938 define? the adulteration and misbranding of drugs and food products
When was Durham-Humphrey Act established? was established in 1951.
Durham-Humphrey act seperated drugs into two categories:.. legend and nonlegend (over the counter [OTC])
Legend drugs requires a prescription
OTC drug does not require the supervision of a physician
what does Durham-Humphrey Act allow? verbal prescriptions over the telephone. refills to be called in from a physician's office
When was Kefauver-Harris Amendment established? in 1962
what year was Comprehensive drug abuse prevention and control act established? 1970
What does the pure food and drug act do? prohibit the interstate transportation or sale of adulterated and misbranded food or drugs
What is Durham-Humphrey Act about? An amendment to FDCA 1938 requiring all products to have adequate directions for use unless they contain the federal legend "Caution: Federal law prohibits dispensing without a prescription".
How was the Drug Enforcement Agency (DEA) created? It was created and placed under the supervision of the department of Justice. Controlled substances are placed in one of five schedules (classifications or categories) based on a potential for abuse and accepted medical use in the US
How many schedules are controlled substances placed in? 5
What is schedule I about? No accepted medical use in the US and possesses an extremely high potential for abuse
What is schedule II about? Has a medical use but has a high abuse potential with severe psychological or physical dependency
Schedule III? Has accepted medical use, and the abuse potential is less than with Schedule I and II drugs
Schedule Iv? abuse potential is less, but administration may lead to limited physical or psychological dependence
Schedule V? Abuse potential is less. Schedule includes exempt narcotics.
What is drug enforcement agency registration about? every facility that dispenses controlled substances must be registered with the DEA
how can the pharmacy registers with the DEA? by submitting a DEA form 224
How often must the pharmacy renew the drug enforcement agency registration? every 3 years
What form should be used to order schedule II drugs? a DEA Form 222 (a triplicate order form).
How long is a DEA Form 222 valid for? 60 days
how many items can be ordered in a DEA Form 222? 10 different items per form.
The inoice or packing slip, in addition to the completed DEA Form 222, must be retained in a secure location of the pharmacy for a minimum of 4 years. T/F? False. it must be retained in a secure location of the pharmacy for a minimum of 2 years.
How to order Drugs in Schedules III to V? Drugs in schedules III to V may be ordered by any method (written, faxed, verbal).
How long should a DEA record be maintained for? minimum of 2 years. It must be kept seperately from other invoices, and kept readily retrievable.
What should a pharmacy do with defective forms? must be kept for a minimum of 2 years and be readily retrievable
What should be done for a biennial inventory? an exact count for Schedule II and an estimated count for Schedule III to V drugs must be performed every 2 years. Records must be kept for a minimum of 2 years
What does a perpetual inventory do? it will show the actual number of units of a drug at a particular moment in time.
Return of controlled substances? can only be returned between DEA registrants
How to return schedule II drugs? Using The DEA form 222
Can controlled subsatnces be returned from long term care facilities? no. Because these facilities do not have a DEA number
Destruction of outdated or damaged controlled substances A DEA form 41 must be submitted to the DEA, indicating the name, strength, quantities of controlled substances, date & method & witnesses present for the destruction
What does form DEA 41 do and how many can a retail pharmacy submit each year? a retail pharmacy uses this form when there is a destruction of outdated or damaged controlled substances. It may submit one DEA form 41 each year.
How many DEA Form 41 can a hospital submit each year? Hospital may have "blanket authorization" which is direct authority to act without having to gain approval for each action. For example:
What form must a pharmacy complete if there is theft of controlled substances? DEA Forms 106
Exempt narcotic is a term used to generally describe those Over-the-Counter (OTC) medications, that contain low-level dosages of narcotic and narcotic-type drugs.
When was the federal National All Schedules Prescription Electronic Reporting Act introduced? in 2005
What is the federal national All Schedules Prescription Electronic Reporting Act about? the Act established an electronic system for practitioner monitoring of the dispensing of controlled substances in Schedules II, III, and IV
When was the poison prevention packaging act established? 1970
What is the poison prevention packaging act about? it was enacted to reduce accidental poisoning in children.
When was the occupational safety and health act (OSHA) established? 1970
What does OSHA require? the use of material Safety Data Sheets (MSDSs), which are to be provided by the seller of a particular product to the purchaser.
When was drug listing act established? 1972
What is a drug listing act about? Each drug is assigned a specific 11-digit number to identify it. This number is known as an NDC (National Drug Code) number
How does an NDC (national Drug Code) number work? 1st five digits identify the manufacturer, next four digits identify the drug product, and the final two digits represent the package size and packaging
When was orphan drug act established? 1983
What is orphan drug act about? for treatment of diseases or conditions of which there are fewer than 200,000 cases in the world. these product manufacturers receive tax incentives and exclusive licensing of products
What does Kefauver-Harris Amendment do? it required all medications in the US to be pure, safe, and effective (p.10)
When was drug price competition and patent term restoration act established? 1984
What is the drug price competition and patent term restoration act about? It encourages the creation of both generic and new medications.
When was the prescription drug marketing act established? 1987
What is the prescription drug marketing act about? It prohibits the reimportation of a drug into the US by anyone except the manufacturer. Prohibit the sale or distribution of samples to anyone other than those licensed to prescribe them
Which act requires the label:"Caution: Federal law restricts this drug to use by or on an order of a licensed veterinarian" to appear on all medications to be administered to animals? The prescription drug marketing act (p. 19)
Define medicare? /ˈmediˌke(ə)r/ A federal system of health insurance for people over 65 years of age and for certain younger people with disabilities
Define medicaid? /ˈmediˌkād/ A federal system of health insurance for those requiring financial assistance
Define regimen? /ˈrejəmən/ A prescribed course of medical treatment
Define antipsychotic drugs? æntɪsaɪˈkɒtɪk Used to treat psychotic disorders
What does anabolic steroid do? /ˌænəbɑlɪk ˈsteˌrɔɪd/ increase protein synthesis within cells, which results in the buildup of cellular tissue (anabolism), especially in muscles. growth of the vocal cords, testicles, and body hair
When was the omnibus budget reconciliation act occurred? 1987 and 1990
When was the FDA Safe medical devices act established? 1990
When was the Americans with disabilities act (ADA) established? 1990
What is the ADA about? prevents discrimination against potential employees who may possess a disability
What does EPA stand for? Environmental Protection Agency (p.20)
What is FDA modernization act about? The federal drug legend:"Federal law prohibits the dispensing of this medication without a prescription" is now represented by the abbreviation "RX" on the container under this act
What does DSHEA stand for? Dietary supplement Health and Education Act
When was the DSHEA established? 1994
What does HIPAA stand for? Health insurance Portability and Accountability Act.
When was the HIPAA established? 1996
What is the HIPAA about? It ensures that patient confidentiality be maintained. It sets boundaries on the use and the disclosure of protected health information
When was the Isotretinoin safety and risk management act established? 2004
define isotretinoin Isotretinoin (Accutane) is a very powerful medication used to treat acne. It might cause birth defects, induce abortions, produce adverse psychiatric effects, including depression, psychosis, suicidal ideation, suicide attempts, and suicide.
What is MPDIMA? Medicare Drug, Improvement, And Modernization Act
When was the MPDIMA established? 2003
When was combat methamphetamine epidemic Act established? 2005
What is combat methamphetamine epidemic Act about It is a federal law that placed ephedrine, pseudoephedrin, and phenylpropanolamine in the Controlled Substances Act category "scheduled listed chemical products. Products containing those medication are subject to sales restrictions...(P.22)
What is USP <797>? It is designed to cut down on infections transmitted to patients through pharmaceutical products n to better protect staff working in pharmacies in the course of their exposure to pharmaceuticals. (p.22)
What does ATF stand for? Bureau of alcohol, tobacco, and firearms
What does CMS stand for? centers for medicare and medicaid services
What does DEA stand for? Drug Enforcement agency
What does EPA stand for? Environmental Protection Agency
What does FDA stand for? Food and drug administration
What does TJC stand for? The joint commission (p. 23)
What does TJC do? It addresses quality of patient care and patient safety, establishes standards and accredits health care providers.
What does NABP stand for? National association of the boards of pharmacy (p.23)
What does BOP stand for? state boards of pharmacy (p. 23)
What does USP stand for? United states pharmacopeia
What does NABP do? composed of all State Boards of Pharmacy. Has no regulatory authority but meets to discuss current trends and issues in pharmacy that affect the practice of pharmacy
What is USP? it is an official public standards-setting authority for all prescription and OTC medicines and other health care products manufactured or sold in the US
What is therapeutic equivalence? 2 drugs are therapeutically equivalent if they contain the same active ingredients and have the same strength or concentration, some dosage form, route of administration, clinical effect n safety profile
what is therapeutic interchange? it is a substitution of one medication for another medication that is not generically equivalent but would provide the same therapeutic effct
Epidemiology p.25 is defined as a medical science that deals with the incidence, distribution, and control of a disease in a population. Khoa nghiên cứu bệnh dịch, dịch tễ học
Nomenclature /ˈnōmənˌklāCHər/ danh pháp, hệ ký hiệu
Antibiotic thuốc kháng sinh
Nomenclature danh pháp, ký hiệu
Prefix tiền tố
suffix hậu tố
sulfonamides hợp chất dùng để giết các vi khuẩn
Created by: jenniferdnguyen1



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