Law - Exam 1 - Acts/Amendments
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98 terms
Terms | Definitions |
|---|---|
 this act prohibits food and drugs that were distributed through interstate commerce to be adulterated or misbranded | Pure Food and Drug Act of 1906 |
| T/F: the Pure Food and Drug Act of 1906 did not require manufacturers to list ingredients or directions for use | true |
| T/F: the Pure Food and Drug Act of 1906 did not regulate cosmetic products or medical devices | true |
| this act came about b/c of deaths caused by diethylene glycol (antifreeze) in elixir, it required that new drugs must be "safe" when used according to the label | Food, Drug, and Cosmetic Act of 1938 (FD&CA) |
| did the FD&CA require that labels must have adequate directions for use and warnings about habit forming drugs in the product? | yes |
| T/F: the FD&CA applies to cosmetics, food, drugs and medical devices | true |
| drugs prior to 1938 were ____ into the FD&CA of 1938 | grandfathered |
| T/F: the FD&CA required that new drugs must be safe AND effective | false (just safe) |
| are drugs that were grandfathered into the FD&CA listed in the Orange Book? | no |
| this act introduced pre-market approval process (NDA) | FD&CA (of 1938) |
| this is the first regulatory law | Pure Food and Drug Act of 1906 |
| this means something is impure, non-sterile, corrupted, or poisoned | adultered |
| NDA | new drug application |
| this act required manufacturer's labels to have adequate directions for use, warning labels for habit-forming drugs, and it applied to cosmetics and medical devices | FD&CA (of 1938) |
| do grandfathered drugs have NDAs? | no |
| are grandfathered drugs listed in Orange Book for therapeutic equivalencies? | no |
| drugs that were grandfathered into the FD&CA of 1938 follow the ___ ___ __ law | ex post facto |
| this act made a distinction between Rx Only drugs and OTC drugs | Durham-Humphrey Act (Amendment) of 1951 |
| this act stated that OTCs are safe to use w/o medical supervision but must be labeled with adequate directions for use | Durham-Humphrey Act (Amendment of 1951) |
| this act stated that Rx Only drugs dispensed by a pharmacist pursuant to a prescription from a licensed prescriber must be safe when under medical supervision | Durham-Humphrey Act (Amendment of 1951) |
| T/F: the Durham-Humphrey Act of 1951 said that Rx Only drugs are exempted from "adequate directions for use" requirement if properly labeled by the dispensing pharmacy or prescriber | true |
| T/F: under the Durham-Humphrey Act of 1951, manufacturer's external label of an Rx Only drug must include "federal legend" | true |
| OTC drugs are advertised and marketed by the ___ | FTC |
| Rx drugs are regulated by the ___ | FDA |
| T/F: under the Durham-Humphrey Act of 1951, for prescription drugs, a pharmacy label replaced adequate directions for use | true |
| this act established the concept of communicating prescriptions orally | Durham-Humphrey Act of 1951 |
| this act established the idea of prescription drug refills | Durham-Humphrey Act of 1951 |
| this act created 503b drugs | Durham-Humphrey Act of 1951 |
| label requirements (7) under the Durham-Humphrey Act of 1951 | name of the pharmacy address of the pharmacy rx number date of the rx (or its filling) name of prescriber name of patient directions for use |
| this act required drugs to be proven safe AND effective by the manufacturer, it came about b/c several women gave birth to babies with deformities after using thalidomide while pregnant | Kefauver-Harris Act (Amendment) of 1962 |
| you could call this act a "drug efficacy" amendment to FD&CA | Kefauver-Harris Act (Amendment) of 1962 |
| this act established a unique pre-enactment provision for drugs marketed between 1938 and 1962 | Kefauver-Harris Act (of 1962) |
| under the Kefauver-Harris Act, a pre-enactment provision stated that drugs marketed between 1938 and 1962 were subject to ___ ___ ___ implementation aka ____ | drug efficacy study, DESI |
| in order to avoid __ __ __, under the Kefauver-Harris Act, drugs put on the market before 1938 didn't have to prove safety or efficacy | ex post facto |
| the Kefauver_Harris Act shifted the burden of proof of safety and efficacy from the ___ to the ___ | manufacturer, government |
| this act established DESI class of drugs for those marketed between 1938 and 1962 | Kefauver-Harris Act |
| one of the early effects of the DESI study was the development of the ____ | ANDA |
| ANDA | abbreviated new drug application |
| this act gave authority to regulated advertising and marketing of Rx drugs to the FDA and OTC drugs to the FTC | Kefauver-Harris Act |
| the nation's consumer protection agency which works for the consumer to prevent fraud, deception, and unfair business practices in the marketplace | FTC |
| FTC | federal trade commission |
| T/F: FDA/FTC regulation of drugs creates a serious dichotomy between federal agencies over jurisdictional issues | true |
| this act made medical devices subject to pre-market approval process (had to get NDAs) | Medical Device Act (of 1976) |
| T/F: statutes ALWAYS take precedence over regulations | true |
| T/F: regulations ALWAYS take precedence over statutes | false (statutes always take precedence) |
| GMP | good manufacturing practices |
| cGMP | current good manufacturing practices |
| used for administering a drug to a patient | medical device |
| the Medical Device Act of 1976 made medical devices subject to the ____ and have similar record-keeping requirements as drugs | GMP |
| 2 other names for the Drug Price Competition and Patent Term Restoration Act of 1984: | DPC & PTR, Waxman-Hatch Act (or vice versa) |
| this act formalized a practice that the FDA used to approve generic drugs | Drug Price Competition and Patent Term Restoration Act (of 1984) |
| how many years does a patent holder have from the date the patent was granted to have an exclusive monopoly over that product so that no one else can market, sell, distribute, or administer that product? | 17 years |
| a ____ gives an exclusive monopoly to market a drug once it receives FDA approval for 17 years | patent |
| the innovator of a new drug has to get a __ as the first step in pre-market approval | NDA (new drug approval) |
| this act allowed generic drug manufacturers to submit data to get a generic drug approved without having to prove that it was safe and effective, they just have to apply for an ANDA to prove it is bioequivalent | Drug Price Competition and Patent Term Restoration Act (of 1984) |
| in what book does the FDA rate generic equivalencies of approved drugs with NDAs? | Orange Book |
| SNDA | supplemental new drug application (approval, whatevs) |
| ANDA | abbreviated new drug approval |
| 3 choices for the answer: NDA, ANDA, SNDA when there is a discovery that there are new uses for which the drug can be safe and effective as intended, that was not available when they initially applied for pre-market approval, this has to be applied for | SNDA |
| PHRMA | pharmaceutical research and manufacturing administration |
| this group represents brand name drug companies | PHRMA |
| while waiting for FDA approval of a drug, can the manufacturer sell the product? | no |
| T/F: the minute a patent runs out on a drug anyone else can make that product just by proving their drug is the same entity and bioequivalent | true |
| T/F: generic drug manufacturers have to prove safety and efficacy | false (just bioequivalency and it is the same entity) |
| PDMA | Prescription Drug Marketing Act (of 1987) |
| this act made allowing samples to be distributed by pharmacies illegal | Prescription Drug Marketing Act (of 1987) |
| this act prohibited the transfer of drugs between community pharmacies and hospital pharmacies | Prescription Drug Marketing Act (of 1987) |
| is there any exception to the rule in the Prescription Drug Marketing Act prohibiting the transfer of drugs between community and hospital pharmacies? | yes, there can be a bone fide emergency transfer of drugs (due to drug shortages, if a pharmacy has a real, honest need for drugs) |
| this act regulated coupons so that they would be used for intended purposes | Prescription Drug Marketing Act (of 1987) |
| this act banned re-importation of drugs in order to ensure the integrity of the drug supply in the US is safe and effective | Prescription Drug Marketing Act (of 1987) |
| pharmacies can only buy drugs from manufacturers that are registered and approved by the ___ | FDA |
| practice of pharmacy is governed by ___ (federal/state) law | state |
| T/F: the practice of pharmacy is governed by federal law | false (state law) |
| this act transformed the FDA from a public watchdog agency funded by taxpayer money that should be protecting the interests of the population USA to being funded by PHRMA | Prescription Drug User Fee Act (of 1992) |
| this act has a sunset provision | Prescription Drug User Fee Act (of 1992) |
| who funds FDA activities now? | PHRMA |
| FDAMA | Food and Drug Modernization Act (of 1997) |
| this act mandated that manufacturers of pediatric drugs do tesst on pediatric populations | Food and Drug Modernization Act (of 1997) |
| this act attempted to address the compounding of drugs by pharmacists | Food and Drug Modernization Act (of 1997) |
| this act gave some tax advantage to fast track drugs which treat life-threatening illnesses and gave them the ability to go around the normal pre-market approval process | Food and Drug Modernization Act (of 1997) |
| this act changed the "prescription legend" to "Rx-only" | Food and Drug Modernization Act (of 1997) |
| aka MMA | Medicare Modernization Act |
| this act created Medicare Part D which allows Medicare patients to get some government subsidies to pay for part of their drugs | Medicare Prescription Drug Improvement and Modernization Act (of 2003) |
| after a drug product has been introduced onto the market, health professionals may find new therapeutic indications for it that are not included in the drug's product insert, such indications are called: | off-label prescribing |
| T/F: prescribers may prescribe a drug for unofficial "off-label" indications and pharmacists, using their professional discretion, may dispense such prescriptions | true |
| T/F: the drug manufacturer may not advertise off-label uses nor allow its sales representatives to detail such unofficial uses | true |
| T/F: the drug manufacturer may distribute peer-reviewed research papers that describe the off-label use of drugs | true |
| the drug manufacturer is required to provide a __ ___ in prescription drug packages that must be approved by the FDA and is for informational use only | package insert |
| many potentially dangerous drugs must be dispensed with a __ __ __. | patient package insert |
| this is a document, written in lay language that is intended to educate the patient about the proper use and potential dangers of the drug | patient package insert |
| if a marketed drug product exhibits problems, the manufacturer is encouraged to issue a __ __ notice | drug recall |
| which drug recall class: the drug may cause serious, adverse health consequences including death | class I |
| which drug recall class: the drug may cause temporary or reversible effects but the probability of serious adverse effects is remote | class II |
| which drug recall class: the drug is unlikely to cause any adverse health consequences | class III |
| it is the ___ responsibility to send written recall notices to all wholesalers and pharmacies for recalls in the Class I and II categories | manufacturer |
| __ rated products are those that are determined to be bioequivalent to the innovator's drug product and are "therapeutically equivalent", this identification is in the Orange Book | A |
| __ rate products are those that are found NOT to be bioequivalent to the innovators drug product, this identification is in the Orange Book | B |
| products that are ___ rated may be substituted for one another while __ rated products cannot | A, B |
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