Law Study Guide PDF

Law Study online at https://quizlet.com/_ekoqvg 1. Branches of Gov- legislative, judicial, executive ernment 2. legislative make laws 3. judicial interpret laws 4. executive enforce law 5. administrative make laws, interpret, enforce laws 6. types of laws in constitution, statutory law, administrati...

Law Study online at https://quizlet.com/_ekoqvg 1. Branches of Gov- legislative, judicial, executive ernment 2. legislative make laws 3. judicial interpret laws 4. executive enforce law 5. administrative make laws, interpret, enforce laws 6. types of laws in constitution, statutory law, administrative law, common US law 7. US constitution law -supreme law of US -any federal or state law that conflicts is invalid -27 total amendments -first: freedom of sepech 8. statutory law a law made my legislatures (elected body of persons; Congresss) 9. descriptive statutory laws are ___, not perscriptive -intentionally vague 10. statutes organized in the following hierarchial order 1. federal statutes 2. state constitutions 3. state legislation 4. ordinances 11. regulations interpret and define statutes created by congress 12. common law -law made by courts -when two or more parties cannot settle a dispute or controversy among themselves, they are likely to ask the court to settle -duty of court is to apply the power law to the facts before it and resolve the matter through judicial opinions which are enforceable by law 1 / 29 Law Study online at https://quizlet.com/_ekoqvg -necessary when courts are needed to help interpret the meaning of statutes 13. stare decisis Let the decision stand; decisions are based on precedents from previous cases -applies only to lower courts w/in the jurisdiction; courts will often carefully consider opinions from other jurisdictions -establishes continuity of decisions -expedite judicial decision making 14. criminal law defines the limitation of the relationship b/w an individual and society ex. murder 15. civil law pertains to the relationship among individuals in society -ex. money issues 16. administrative law assures adherence to regulations -ex. losing licenses 17. statute of limita- a law stating the amount of time someone has to initiate tions a lawsuit 18. infraction fine or imprisionment 5 days to 1 year imprisonment, community service, probation 20. felony >1 year to life imprisonment 21. power of attorney the grant of authority of another to act on your behalf 22. MORE state law or regulation can be ___ strict than federal law or regulations (this would not be a conflict), but it cannot be less strict (this would be a conflict) 23. stricter always follow the ___ law 2 / 29 Law Study online at https://quizlet.com/_ekoqvg 24. product federal law focuses on the ___ in pharmacy 25. practice state law focuses on the ___ in pharmacy 26. FDCA (Food, Drug, and Cosmetic Act) 1938 -provides for the comprehensive regulation of all drugs introduced into interstate commerce -protects consumers from adulterated or misbranded foods, drugs, cosmetics, devices -no new drug may be marketed and sold unless it has been proven safe and effective for its intended use and approved by FDA 27. state pharamacy who regulates pharmacy practice? laws 28. FDA administers the FDCA -component of the department of health and human services (DHHS) 29. adulteration what happens when you drop a drug on the floor 30. all drugs the FDCA provides for the comprehenive regulation of ___ introduced into interstate commerce -it also protects consumers from adulterated or misbranded foods, drugs, cosmetics, or devices 31. state pharmacy laws who regulates pharmacy practice? 32. Department of Health and Human Services what is the FDA a component of? 33. FDCA the FDA administers the 34. Wiley-Heyburn Act Pure Food and Drug Act of 1906 -the primary forefunner of today's Food, Drug, and Cosmetic Act 35. 3 / 29 Law Study online at https://quizlet.com/_ekoqvg Adulteratin and Misbranding the Pure Food and Drug Act of 1906 prohibited ___ and ___ of food and drugs in interstate commerce 36. sulfanilamide tragedy the Food, Drug, and Cosmetic Act of 1938 was prompted by the ___ -this act, with amendments, is the nucleus of today's FDCA 37. SAFE with the FDCA of 1938, no new drug coule be marketed until proven ___ for use (establishd the drug approval process) 38. safety the FDCA addressed ___ only; says nothing about efficacy 39. Durham-Humphrey The amendment established two classes of drugs: Amendment of 1. prescription 1951 2. over the counter the amendment allowed for: 1. oral prescriptions 2. refills of prescription drugs -before package of this, drug manufacturers determined whether their products were prescription or OTC drugs 40. establishing cri- the durham-humphrey amendment resolved this situation teria by ___ for the classification of prescription drugs. All other drugs were considered nonprescription. 41. Categorizing prescription drugs -drugs unsafe for use except under the supervision of a practitioner because of the toxicity, the method of use, or collateral measures necessary to use the drug AND -drugs subject to the new drug application approval process 42. DH Amendment required that prescription drugs be dispensed: 1951 1. upon the written prescription of a practitioner licensed by law to administer such drugs 2. upon the practitioner's oral prescription, to be promptly reduced to writing and filled by the pharmacist 3. by refilling a written or oral presentation if the refill 4 / 29 Law Study online at https://quizlet.com/_ekoqvg was authorized by the prescriber either on the original prescription or orally, and then reduced to writing and filed by the pharmacist 4. by administration (dispensing) directly by the practitioner 43. thalidomide dis- The kefauver-harris amendment of 1962 was prompted aster by ___ 44. Safe and Effective this kefauver-harris amendment strengthened the new drug approval process by requiring that drugs be proven not only ___, but ___ -the efficacy requirement was made retroactive to all drugs marketed between 1938 and 1962 45. Orphan Drug Act pharmacetucial manufacturers urged congress to recogof 1983 nize that the NDA process was too expensive to develop drugs for diseases that affect relatively few people -congress passed this to provide tax and exclusive licensing incentives for manufacturers to develop drugs for the treatment of "rare diseases or conditions" 46. rare disease or conditions fewer than 200,000 americans 47. Waxman-Hatch Amendment (1984) Drug price competition and patent term restoration act -streamlined the generic approval process by requiring an Abbreviated New Drug Application (ANDA) instead of a New Drug Application (NDA), thus increasing access of generic drugs by the public 48. innovator manu- the drug price competition and patent term restoration act facturers of 1984 is for ___ -established patent-term extensions or market exclusivity for 2-5 years, depending on when the regulatory review of the drug began and how much time it required 49. patent term extensions available only if the patent has not expired 5 / 29 Law Study online at https://quizlet.com/_ekoqvg 50. markety exclusivity works independently of a drug's patent status. In general, for new chemical entities aproved under an NDA, the ___ provision prevents a generic drug application from being submitted for 5 years from the date of approval of the drug 51. PDMA (prescrip- enacted to minimize drug diversion tion drug market- the most significant amendments included: ing act) of 1987 -banning reimportation -banning the sale of drug samples 52. PDUFA (Prescription Drug User Fee Act 1992) requires manufacturers to pay fees for review of NDAs basically an application fee Fees provide the FDA with resources to hire more reviewers an hopefully speed up NDA reviews 53. DSHEA (Di-legally created a category of dietary supplements etary Supple-mandates the FDA regulate dietary supplements more ment Health and as special foods than as drugs Education Act of 1994) 54. FDAMA (food and drug administation modernization act of 1997) provisions include: 1. pharmacy compounding 2. expediting study and approval of fast track drugs 3. elimination of certain labeling requirements 4. dissemination of off-label treatment information 5. encouragement of pediatric studies 55. pharmacy compounding FDAMA clarified that the compounding of pharmaceutical products was approriately regulated by the states and exempted pharmacies from requirements for compliance with NDAs when compounding drugs for an identified individual patients 56. expediting study FDAMA established requirements for deignation of a drug and approval of as a "fast track" product to facilitatie the development fast tract drugs and expedite the review of drugs that treat a serious or life-threatening condition and demonstrate the potential to addresss unmet medical needs for such a condition 6 / 29 Law Study online at https://quizlet.com/_ekoqvg 57. Rx only the FDAMA amended that "caution: federal law prohibits dispensing without a prescription" on the label of prescription products changed to "___" 58. dissemination of FDAMA provided incentives for manufacturers to conduct off-label treatresearch on new uses of drugs and to file supplemenment infomation tal NDAs for these uses by allowing manufacturers to disseminate limited information on unapproved uses of drugs while in the review process 59. encouragement FDAMA encouraged drug manufacturers to preform peof pediatric diatric studies by providing them with an additional 6 studies months of marketic exclusivity of the drug 60. FDAAA (Food the law provides the FDA w/ significantly enahnced reand Drug Admin- sponsibilities and authority to regulate drug safety istration Amendments Act 2007) 61. Food An article used for food or drink in humans or animals, chewing gum, and substances used as components of food or drink 62. cosmetic article intended to be rubbed, poured, sprinkled, sprayed on, introduced into or otherwise applied to the human body for the purpose of cleansing, beautifying, promoting attractiveness, or altering the appearance. any component of the above articles is considered to be this as well 63. diagnosis, cure, drugs are articles intended for use in the ___ of disease mitigation, treat- in man or other animals ment, or prevention 64. New Drug a drug "not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use" -hasn't gone through drug approval process 65. 7 / 29 Law Study online at https://quizlet.com/_ekoqvg drug approval process 1. submit investigational new drug application 2. conduct clinincal trials 3. submit new drug application 66. IND applications name of drug, drug composition, methods of manufacture must include and quality control, information from preclinical investigations regarding pharmcology, pharmacokinetics, and toxicology, information about the experience and qualitifcations of the clinical investigators, complete outline of proposed clinical trails 67. purpose of IND Protect the safety of humans who will participate in the clinical trials, ensure that the clinical trails are designed properly so as to prevent problems during hte NDA review 68. 30 days if the FDA does not reject the IND within ___ of submission, human clinical testing may begin 69. Phase 1 clinical subject: small number of healthy individuals trials purpose: determine effectiveness of the drug and to obtain information about adequate dosage, relative safety, and AE conducted by sponsoring company 70. Phase 2 clinical subjects: 100+ patients who actually have the disease the trials drug is intended to treat purpose: determine the effectiveness of the drug and to obtain information about adequate dosage, safety, and adverse effects conducted by: sponsoring company 71. phase 3 clinical trials subjects: hundreds or thousands of pts; often occur in actual clinical settings such as hospitals/doctors' offices purpose: to obtain data concerning the drug's effectiveness as compared to a control group that receives placebo. Most are double blinded. conducted by: independent investigators at remote and varied clinical sites 72. 8 / 29 Law Study online at https://quizlet.com/_ekoqvg informed consent all three phases of clinical trials, the FDCA requires the investigators to secure the ___ of the patient for administration of an experimental drug. This requires that potential participants know the risks, possible benefits, and alternative courses of tx 73. postmarketing surveillance under the provision of this, the manufacturer must submit to the FDA 1. reports of serious AE 2. new information relating to the drug's safety and efficacy 3. information about current clinical studies 4. the quantiy of drugs distributed 5. information about labeling and advertising 74. long term ___ ae may not be discovered before approval 75. phase 4 studies 1. obtain dataa regarding the drug's safety and effectiveness 2. determine new uses for, or abuses of, the drug 76. FDAAA granted the agency authority to require phase 4 testing for any prescription drug 77. widespread accesss FDAMA modified the FDCA to state that an investigational new drug may be provided for ___ outside controlled clinical trials to treat patients with serious or immediately life-threatening disease for which no comparable or satisfactory therapy is available. 78. FDA IND Treatment Approval all of the folowwing apply: 1. used for a serious or immediately life-threatening disease or condition 2. no comparable or satisfactory alternative therapy available 3. drug under investigation for the disease or condition 4. sponsor is actively pursuing marketing approval of the drug 5. in case of serious diseases, there is sufficient evidence of safety and effectivenss for its use 9 / 29 Law Study online at https://quizlet.com/_ekoqvg 6. in the case of immediately life-threatening diseases, there is a reasonable bias to conclude that the drug may be effective and would not expose patients to unreasonable and significant risk 79. right to try allows eligible patients to have access to investigational drugs pt has 1. been diagnosed with a life-threatening disease or condition, exhausted approved treatment options and unable to participate in a clinical trial 2. eligable drug is one that phase one has been completed and not FDA apporved for any other use -in May 2018, congressed passes a federal ___ law as an amendment to the FDCA -creates alt pathway to investigational drugs by removing the FDA from the process, allowing the patient to go straight to the manufacturer 80. 21st century cares act designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently 81. Emergency Use mechanism to facilitate the availability and use of medAuthorization ical countermeasures, including vaccines, during public (EUA) health emergencies -est. 2004 -does not constitute approval of the drug in the full statutory meaning of the term, but instead authorizes FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency 82. EUA submission include all safety data accumulated from phase 1 and 2 studies conducted w/ the vaccine, with an expectation that phase 3 data will include a median follow-up of at least 2 months (meaning that at least half the vaccine recipients in phase 3 clinical trials have at least 2 months of follow up) after the completion of the full vaccination regimen 10 / 29 Law Study online at https://quizlet.com/_ekoqvg 83. ANDA need to demonstrate bioequivalence and acceptable manufacturing methods and controls 84. type 1 chemical new molecular entity 85. type 6 chemical new therapeutic indication for a drug already approved 86. Type P indicates that the drug represents a major therapeutic gain because there are no other effective drugs available for treating a particular illness of b/c it has significant advantages compared to currently marketed drugs -priority review 87. type S standard review -indicates that the drug is similar to other drugs on the marke 88. NDC system required for Rx and OTC drugs -11 digit code 89. NOT the NDC number does ___ have to appear on individual dosage units nor is there any federal law requiring that NDC numbers appear on prescription labels 90. manufacturer code first 5 numbers of NDC -manufacturer, packager, distributer 91. product code next 4 numbers on NDC -strength, dose form, formulation 92. package code last numbers on NDC package size and types 93. imprint the FDA requires manufactureres to ___ solid dosage forms, whether they are Rx or non-Rx products -must permit the ID of both the manufacturer and the specific drug product 94. set of regulations that establishes minimum requirements for the methods, facilities, or controls used in the manufac11 / 29 Law Study online at https://quizlet.com/_ekoqvg Good Manufac- ture, processing, packaging, or holding of a drug product turing Practices -ensures that the drug is safe and meets quality/purity (GMP) requirements 95. 2 years manufacturers must be registered w/ the FDA and are normally inspected by the FDA for compliance with CGMP once every ___ 96. adultering refers to the composition of a drug 97. misbranding refers to the labeling of a product - is the labeling false or misleading? *if a drug is dispensed to a patient without adequate directions for use *if a prescription is refilled without an authorization from the prescriber *if drug is dispensed without the required patient package insert (PPI) or medication guide *if poison prevention act of 1970 pertaining to child resistant containers is violated 98. medwatch This is the FDA reporting service for adverse effects that occur from use of approved drugs. -report serious AE -potential and actual product use errors -product quality problems 99. REMS FDAAA granted the FDA another safety tool called ___, whereby the FDA can require a sponsor to establish special procedures directed at patient safety -require the manufacturer to submit periodic postmarket assessments of whether the drug's risks are being adequately managed -can require distribution of medguides, distribution of PPI, distribution of a communication plan aimed at health professionals 100. Thalomid REMS -indication: newly diagnosed multiple myeloma, leprosy, etc. -safety issues: severe birth defects/VTE 12 / 29 Law Study online at https://quizlet.com/_ekoqvg -program requirements: prescribers and pharmacies must be registered, mandatory birth control 101. iPLEDGE program for isotretinoin -indication: acne -safety issuess: severe birth defects/depression/suicidal ideation/violence -program requirements: mandatory birth control, pregnancy tests 102. class I product recall there is a reasonable probability that the product will cause serious, adverse health consequences or death 103. class II product recall the product may cause temporary or medically reversible adverse health consequences, but the probability of serious health adverse effects is remote 104. class III product the product is not likely to cause adverse health conserecall quences (mislabeling) 105. label refers to the written, printed, or graphic matter appearing on the immediate commercial container of a drug product 106. labeling the information printed on the label and outside the package of a drug product. It refers to all labels and other written, printed, or graphic matter either on the product, its container, wrapper, or accompanying the product -package insert, PPI, medguide 107. sheet printed at not considered labeling. Not mandated or reviewed by pharmacy FDA 108. package insert must be approved by the FDA before distribution 109. boxed warnings when the use of a drug may lead to death or serious injury, the FDA may require the warning of the special problem in the package insert to be placed w/in a prominently displayed box 110. off-label 13 / 29 Law Study online at https://quizlet.com/_ekoqvg Any time that a drug is prescribed for an indication that is not FDA-approved and thus not listed in the drug's labeling, that use is considered ___ 111. potentially dangerous many ___ drugs must be dispensed with a PPI 112. patient package this is a documnet, provided by the manufacturer and writinsert ten in lay language that is intended to educate the patient about the proper use and potential dangers inherent in the use of hte product accompanying it 113. PPI requirements -must be provided to the patient by anyone dispensing the drug. -must include one for each package that it intends will be distributed to the patient, and in turn, pharmacists must include one with each container dispensed, regardless of whether it is initially dispensed for a refill 114. misbranding failure to give a PPI to the patient is ___ 115. PPI in considered to have been given if given to the patient acute/long-term -before the first admin care facilities -every 30 days after 116. serious and sig- in 1998, the FDA mandated the Medication Guide pronificant concern gram for drugs posing a ___ 117. MedGuides required for a product if the FDA determines that one or more of the following circumstances exist -labeling could help prevent serious AE -serious risks relative to benefits that patient should be aware to decide whether to use/continue the med -patient adherence to directions is critical to the drug's effectiveness 118. labeling PPIs and MedGuides are federally mandated (for certain drugs) and are considered ___ -require FDA approval before dissemination 14 / 29 Law Study online at https://quizlet.com/_ekoqvg 119. consumer med- written information provided by the pharmacy for all drugs ication informa- -does not replace the PPI or MedGuide, it is not federally tion (CMI) mandated and does not require FDA approval before distribution 120. Mufacturer con- -name and address of the manufacturer, packager, distainer label retributer quirements -established name of the drug -net quantitiy of the package -weight of each active ingredient contained in each dosage unit -Rx Only -Route of admin if not an oral dosage unit -special storage instructions, if approriate -manufacturer's control or lot number -expiration date established by the manufacturer 121. brand name does not need to be on the medication label 122. Unit Dose pack- -established name of the drug aging labeling re- -quantity of the active ingredient in each dosage unit quirements -expiration date -lot or control number -name of manufacturer, packer, distributer -any statements required by compendia if an official drug, or for unofficial drugs in any pertinent statement regarding special characteristics 123. bar codes the FDA does not require hospitals to use ___ 124. NDC the FDA ony requires the bar code to include the drug's ___ 125. MedPaks contain several solid dosage oral dosage forms with directions that specifically indicate the day and time that the contents are to be taken -usual info for unit dose packages is required, plus a serial number for the patient ___ in addition to the Rx serial numbers for each drug product 15 / 29 Law Study online at https://quizlet.com/_ekoqvg 126. Consumer Prod- the poison prevention packaging act (PPPA) was adminuct Safety Com- istered by the ___ mission (CPSC) 127. PPPA regulations -requires the use of child-resistant containers for nearly all prescription drugs, nonprescription drugs, and hazardous household products 128. CPSC established testing protocols for child-resistant packaging. Test panels used to assess such packaging consists of 1. children under 5 2. adults 50-70 129. 20% a package will fail the child-resistant test if more than ___ of the children test panel can open the package in 10 minutes 130. ONE manufacturers may market ___ size of an OTC product for the elderly or handicapped in non-compliant packaging -must contain the statment: this package not for households with young children, or Package not child-resistant 131. not prescription drugs not intended for oral administration are ___ required to be dispensed with child-resistant packaging 132. generic established name of the drug 133. Except pharmacists must normally dispense oral prescription drugs in child-resistant packaging, ___ when the physician or patient requests noncompliant packaging -requests may be oral, but should ALWAYS be documented by the pharmacist 134. tamper-evident packaging FDA regulations written for the federal anti-tampering act requires that certain OTC drugs, cosmetics, and devices be manufactured in ___ 135. Tempering 16 / 29 Law Study online at https://quizlet.com/_ekoqvg the improper interference with the product for the purpose of making objectionable or unauthorized changes 136. tamper evident Having an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. -regulations do not require tamper-proof packaging b/c technology does not exist to eliminate the risk of tampering completely 137. Federal -variety of packaging methods may be used, as long as Anti-Tampering they meet requirements Act Regulations -labeling statement to alert the consumer to the tamper-evident features placed in a location where it still can be read if the package has been tampered -for two-peice hard gelatin capsules, 2 tamper-evident features must be used, unless the capsules are selaed then only 1 feature is required -allo ther products only require 1 tamper evident-feature 138. Expiration Dating dating required on manufacturer's containers 139. Beyond Use Dat- dating of drug products that are dispensed by pharmaing cists 140. may not pharmacists ___ continue to dispense a drug product once its expiration date has passed. Most states require the pharamcist to remove any expired products from the working stock to an isolated area until the product cna either be destroyed or returned to the manufacturer 141. shorter the current guideline provided in the USP/NF is for re-packaged drug products to have the ___ of two potential dates: -6 months maximum -25% of the remaining time b/w the date of repackaging and the manufacturer's expiration date (divide remaining by 4, and add that time to the repackaging date) 17 / 29 Law Study online at https://quizlet.com/_ekoqvg 142. maximum of one there is no federal law concerning this type of beyond year use date. Instead, some states have established their own guidelines, usually a ___ 143. not longer, one year multiple unit containers dispensed by pharmacists have a BUD ___ than the manufacturer's expiration date, or ___ from the date dispensed, whichever is less 144. Med Pak the expiration of the ___ should not exceed 60 days from the date from when it was prepared, or earlier if the manufacturer's expiration date of any drug in the package is actually earlier 145. characteristics of non-prescription drugs -Their benefits outweigh their risks -The potential for misuse and abuse is low -Consumers can use them for self-diagnosed conditions -They can be adequately labeled -Health practitioners are not needed for the safe and effective use of the product 146. General labeling requirements for nonprescription drugs -Name of the product -Name and address of the manufacturer, packer, or distributer -Net contents of the package -Established name of all active ingredients and certain inactive ingredients -Name of any habit-forming drug present -Cautions and warnings needed to protect the consumer -Adequate directions for use If any of the above information is missing, the nonprescription product is considered MISBRANDED 147. Drug Facts in standard order -active ingredients -purpose -uses -warnings -directions -other information -inactive ingredients 18 / 29 Law Study online at https://quizlet.com/_ekoqvg 148. pharmacist may refill nonprescription drugs w/o PA unless -The dose requested is greater than the recommended dose on the label of the commercial OTC product -The prescriber has limited the number of refills on the original prescription -The drug is a Schedule V controlled substance where the number of refills must be designated by the prescriber -The individual state has set a time period limit for refills 149. 15 business days Dietary Supplement and Nonprescription Drug Consumer Act: -companies have to include contact information on their labels for consumers to reporting adverse events -the companies must also notify the FDA of any serious adverse event reports within ___ 150. nonprescription label requirements for ___ for pregnancy and nursing drugs mothers: -"if pregnant or breast-feeding, as a health professional before use" 151. aspirin products label requirements for ___ for pregnancy and nursing mothers -"it is especially important not to use this product during the last three months of pregnancy unless specifically directed to do so by a doctor" 152. dietary supplement a product that is intended for ingestion, is intended to supplement the diet, and contains any one or more of the following: -vitamin -mineral -herb or other botanical -amino acid -dietary substance for use by humans to supplement the diet by increasing the total dietary intake 153. DSHEA (Di-legally created a category and definition of dietary supetary Suppleplements ment Health and -prohibited the FDA from regulating dietary supplements 19 / 29 Law Study online at https://quizlet.com/_ekoqvg Education Act of as drugs 1994) -mandated that the FDA regulate dietary supplements more as a special class of foods than as drugs -The FDA cannot require pre-market approval of dietary supplements as they do for drugs. -Dietary supplements may be marketed without their efficacy or safety proven. -The FDA would have to challenge products after they had been introduced onto the market if evidence surfaced that they are ineffective for the advertised or labeled use or are unsafe 154. disease claims not allowed on dietary supplements labeling per DSHEA -claims that explicitly or implicitly say that a product can be used to prevent, treat, cure, mitigate, or diagnose disease -these types of claims would subject the product to the drug requirement under FDCA 155. structure/function claims are allowed on dietary supplements labeling per DSHEA 156. structure/function when ___ is on label: -The following statement must appear: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." -The manufacturer must have substantiation that such a statement is truthful and not misleading. -The manufacturer must notify the FDA within 30 days of the marketing of the dietary supplement with such a statement. 157. Medical Device Act of 1976 amending the FDCA to establish a comprehensive system of device regulation that includes: -device classification -pre-market testing -standards of performance 158. Class I medical device requires the least amount of regulation b/c they post the least potential harm to consumers 20 / 29 Law Study online at https://quizlet.com/_ekoqvg -general controls are adequate to ensure safety and effectiveness -ex. Needles, scissors, exam gloves, stethoscopes, toothbrushes 159. Class II medical general controls are not adequate to ensure safety and device effectiveness -products must meeet specific performance standards established by the FDA -ex. insulin syringes, infusion pumps, thermometers, diagnostic reagents, electric heating pads 160. Class III medical require pre-market approval b/c they are life-supporting device or life-sustaining or they prevent a potential risk of illness or injury -ex. pacemakers, contact lenses, replacement heart valves 161. approval process for devices -510(k) premarket notification -premarket approval -de novo pathway 162. claims are made the overriding factor in determining a product's status as drug or cosmetic may not be its ingredients, but what ___ for the product, especially on the label 163. cosmetics do not require premarketing approval from the FDA 164. Generic Substitution Law every state has enacted one; expanding the scope of pharmacy practice to allow pharmacists to sub a generically equivalent drug for the prescribed drug -apply only when a brnad name drug is prescribed -if the rx is written generically, the selection is not subject to the drug product selection law. In this situation, the pharmacist may dispense any product in the generic drug class using their professional judgement 165. misbranding labeling a substituted generic drug with a brand name drug would be considered what? 21 / 29 Law Study online at https://quizlet.com/_ekoqvg 166. bioequivalent Pharmacists are responsible for ensuring that a substituted generic drug product is ___ to the prescribed brand product. 167. pharmaceutical equivalents Products that contain the same active ingredients and are identical in strength and are of the same dosage form 168. bioequivalence display comparable bioavailability (rate and extent of absorbption) at the site of action under similar conditions 169. therapeutic equivalence bioequivalence as termed in the Orange Book 170. the orange boook lists approved drug products that are pharmaceutical equivalents and rates them for therapeutic equivalence 171. A rating therapeutically equivalent 172. AA, AN, AO, AP, AT drugs with no known or suspected bioequivalence problems 173. AB actual or potential bioequivalence problems that have been resolved with adequate in vivo and/or in vitro evidence supporting bioequivalence 174. B rating not therapeutically equivalent -drug products that hte FDA at this time, considers NOT to be therapeutically equivalent to other pharmaceutically equivalent products -may never have developed with the intention of making it bioequivalent to an innovator drug 175. OBRA (Omnibus requires prospective and retrospective DUR programs for Budget Recon- Medicaid patients ciliation Act) 176. prospective DUR pharmacists are required to screen prescriptions for poprogram tential drug therapy problems b/c of: -therapeutic duplication -drug/disease CI 22 / 29 Law Study online at https://quizlet.com/_ekoqvg -DDI -incorrect drug doseage -incorrection duration of therapy -allergy interactions -clinical abuse/misuse 177. offer to counsel OBRA 90 directs that in order to participate in the Medicaid program, states must enact requirements that pharmacists "___" Medicaid beneficiaries receiving Rx drugs 178. ALL although OBRA 90 only mandated the DUR, patient counseling, and patient medication record requirements for medicaid pts, most states have mandated these requirements for ___ patients 179. state law dictates who has the authority to prescribe and who may dispense drugs 180. self-prescribing is acceptable for some practitioners in some states, but some states have prohibited controlled substances 181. pharmacist may -the Rx is suspected to be forged or fictitious refuse to fill -the pharmacist will be violating a law if he/she fills it -drug is not in stock -pharmacist believes the drug will be harmful to the pt 182. forged written using the name and info of a legitimate prescriber 183. fictitious written creating information based on a nonexistent prescriber 184. the pharmacy once a Rx has been filled and dispensed, the prescription is legally owned by who? 185. copy if the prescriber or patient requests the actual prescription, the pharmacist should refuse but offer a ___ 186. 10 years MMA requires keeping medicare prescriptions for ___ 187. 6 years HIPAA requires keeping prescriptions for ___ 23 / 29 Law Study online at https://quizlet.com/_ekoqvg 188. 5 years FDA can request prescriptions back to ___ 189. 6 years MS requires keeping prescriptions for ___ 190. 2 years controlled substance act requires keeping prescriptions for ___ 191. FDCA requires that every prescription bottle must be labeled with the ___ -name of patient -Rx (serial number) -date when prescription is either written or dispensed -directions fur use -name of prescriber -name and address of pharmacy -any special precautionary statements that may be approriate 192. not required on expiration date, lot number of drug, name of drug, manuprescription bot- facturer, strength, telephone number of pharmacy tle 193. pharmacy compounding -medication is not commercially available -made for individual patients -cannot be sold in bulk for resale -cannot advertise specific drugs 194. State boards of pharmacy regulate pharmacy compounding 195. pharmaceutical manufacturing medication is commercially available -made in mass production -can be sold in bulk for resale -can advertise specific drugs (DTCA) 196. FDA regulates pharamceutical manufacturing 197. the drug quality law that amended the FDCA to grant the FDA more and security act authority to regulate and monitor the manufacturing of compounded drugs -created 503A and 503B 24 / 29 Law Study online at https://quizlet.com/_ekoqvg 198. 503A facilities referred to by the FDA as a traditional compounding pharmacy that compounds in accordance to patient specific prescriptions and is required by the state boards of pharmacy to comply with USP nd guidelines 199. 503B facilities referred to by the FDA as an outsourcing facility that may product large batches with or without prescriptions to be sold to healthcare facilities as office use only or shipping out of state and is regulated by the FDA 200. validates every process in a 503B facility has to be ___ 201. nonsterile USP 795 202. sterile USP 797 203. hazardous USP 800 204. USP (United States Pharmacopeia) -non-profit that sets standards for all drugs and compounding -does not do law enforcement 205. FDA, state boards of pharmacy enforce USP standards 206. simple compop- ex. amoxicillin suspension unding -adding water and mixing -according the mannufacturer recommendations for BUD and stability data 207. moderate compounding ex. mixing two creams -stability isn't known or studied -BUD is uncertain due to lack of data 208. complex compounding ex. creating special transdermal dosage form -involves special training, equipment, facilities, procedures -probably won't see in community pharmacy 25 / 29 Law Study online at https://quizlet.com/_ekoqvg 209. USP 795 Requirements -staff competency, training -potable water -designated area -cleanliness -plumbing -disposal containers -lighting -heating/cooling -formula records -recalls -pt complaints -designated expert -BOP rules/regulations -storage -documentation 210. 6 months 795 BUD for nonaqueous compounds - ___ or earliest expiration date of any ingredient 211. 14 days 795 BUD for water containing oral compounds (refrigerated) - ___ or earliest expiration date of any ingredient 212. 30 days 795 BUD for water-containing topical and semisolid compounds - ___ or earliest expiration date of any ingredient 213. beyond use dates assigned dates or timeframes after which a compounded sterile preparation (CSP) should not be used. -determined based on potential for microbial contamination, chemical degradation, or loss of potency -not expiration dates 214. CSP category factors that determine: -primarily based on environment/conditions of where compounded -level of garbing -environmental testing and monitoring -frequency of application of a sporicidal -based on BUD assignment 26 / 29 Law Study online at https://quizlet.com/_ekoqvg 215. CSP Category 1 low risk level -revised: 24 hours refrigerated 217. CSP category 3 high risk level -revised: 24 h at room temp; 3 days refrigerated, 45 days frozen -old: BUDs may be older but can vary based on the specific conditions and requirements of hte CSP -sterility and endotoxin testing requirement 218. 797 regulations (personnel and training) -written testing -routine review/training -policies for testing/training -media fill tests 219. 8 ante area is ISO class ___ 220. 7 cleanroom is ISO class ___ 221. 5 work area (hood) is ISO Class ___ 222. positive pressure air flows out -for non-hazardous 223. laminar flow hood air blows towards you, clean if shut off, generally left on 224. chemo hood (hazardous) vertical air flow 225. Buffer area should not have sink/drain 27 / 29 Law Study online at https://quizlet.com/_ekoqvg 226. 797 requirements need a spelled out quality assurance program -cleaning process spelled out in policies and procedures 227. back to front when cleaning in 797, go from ___, do not touch HEPA filter 228. Personal Protec- goal is to protect healthcare workers from exposure to tive Equipment hazardous drugs (PPE) -2 pairs of gloves for chemo -chemo gowns for injectable chemo -cannot resuse gowns 229. safety data sheets (SDS) communicates the hazards of dangerous drugs and chemicals to anyone who compounds, stores, transports, or cleans these items -administered by OSHA 230. OSHA (Occupa- administers SDS tional Safety and Health Administration) 231. 30 years SDS document must be kept on file for ___ 232. BPCI Act (Biologics Price Competition and Innovation Act of 2009) -allows for approval of biosimilars -subtitle of the affordable care act -FDA determines therpeutic equivalence -12 years marketing exclusivity to the reference product -first interchangeable biological product receives up to one year of exclusiviety over subsequent follow-on biologics 233. biosimilar a biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components, and has no clinically meaninful differences in terms of safety, purity, and potency (safety and effectiveness) from the reference product 234. reference product 28 / 29 Law Study online at https://quizlet.com/_ekoqvg a biological product approved by the FDA under the Public Health Service Act based on a full complement of product-specific data, including nonclinical and clinical data 235. generic biologic is not approriate terminology b/c it implies an exact copy of the originator's product, which currently is impossible b/c of limitations in technology 236. interchangeable a biosimilar product that meets additional requirements product outlined by the Biologics Price Competition and Innovation Act. As part of fulfilling these additional requirements, info is needed ot show that this is expected to produce the same clinical result as the reference product in any given patient 237. substituted an interchangeable product may be ___ for the reference product by the pharmacist without the involvement of hte prescriber 238. Zarxio biosimilar for neupogen 239. purple book book with biological products and bio similar interchangeables 29 / 29