front 1 Which law prohibited adulteration and misbranding and prevented false statements concerning drug's identity? | back 1 Pure Food and Drug Act (PFDA) |
front 2 Which law required that Manufacturers must demonstrate drug safety to FDA PRIOR to marketing and gave | back 2 Food, Drug and Cosmetics Act (FDCA) |
front 3 Which law established 2 classes of meds and is the drug law most commonly to be violated by pharmacists | back 3 Durham-Humphrey Amendment (DHA) |
front 4 Which law required that Manufacturers must show effectiveness and safety and established GMP requirements | back 4 Kefauver-Harris Act Amendment |
front 5 Which law Established sales restrictions and recordkeeping requirements for prescription drug samples | back 5 Prescription Drug Marketing Act (PDMA) |
front 6 What are covered entities that are protected under HIPPA | back 6 1. Health plans 2. Healthcare clearinghouses 3. Healthcare providers 4. Business associates of covered entities |
front 7 Aspects of the privacy rule that PHI may be disclosed: | back 7 1. To the individual 2. For treatment 3. For payment 4. Healthcare operations- workers compensation |
front 8 PHI can be disclosed if pt gives authorization in writing for: | back 8 1. Psychotherapy notes 2. Marketing 3. Fundraising 4. Employment determination 5. Pre-enrollment underwriting 6. Any other non-treatment payment, and healthcare operations purpose |
front 9 Safe Harbor Method 18 types of Identifiers | back 9 1. All geographic subdivisions smaller than a state
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front 10 What application will be done for approval of generic products after innovator patent expires? | back 10 ANDA Abbreviated New Drug Application |
front 11 Which application will be done for any changes in the info reviewed and approved by the FDA in the NDA or ANDA | back 11 Supplemental New Drug Application |
front 12 What are the requirements for a pt requesting an treatment IND | back 12 1. Pt must not be in the clinical trial 2. Imminent life-threatening stage of illness without cure and IND shows promise 3. Trial and failure or no commercially available effective drug approved |
front 13 Dietary supplements are "food products" | back 13 True |
front 14 Dietary supplements labeling: | back 14
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front 15 RX dogs can be made safe by including adequate directions for use and expert agree that adequate directions for self-medication can be provided? | back 15 FALSE |
front 16 Non-prescription drugs are recognized by experts as safe and effective? | back 16 TRUE |
front 17 FDA labeling requirements | back 17
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front 18 Class I recall | back 18 ADULTERATION: Reasonable probability of SERIOUS adverse health consequences/death |
front 19 Class II recall | back 19 Temporary or reversible adverse health consequence or probability of serious health consequences is low |
front 20 Class III recall | back 20 Not likely to cause serious adverse health consequences |
front 21 Estrogen products: | back 21 Must have package insert containing benefits and risks |
front 22 OCPs | back 22 Its must be fully informed of benefits and risks Must have package insert |
front 23 What warning must be be on OTC products with salicylates | back 23
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front 24 Safety closures are required for OTC salicylates? | back 24 False - RECOMMENDED |
front 25 What are the three categories for the Pregnancy and Lactation Labeling Rule | back 25 1. Pregnancy: Labor/deliver 2. Lactation: Nursing mothers 3. Females and Males of reproductive age |
front 26 What 4 classes are exempt from tamper evident packaging? | back 26 1. Dermatological 2. Dentrifice 3. Insulin 4. Lozenges |
front 27 Glass bottles can be replaced but MUST replace the cap? | back 27 True |
front 28 What products are exempt from poison prevention? | back 28
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front 29 What warning must be on OTC iron products? | back 29
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front 30 Which products must be in child-resistant packaging? | back 30 Iron |
front 31 What are the 4 powers of the IDFPR? | back 31 1. Rulemaking 2. Discipline 3. Licensing 4. Variances |
front 32 How many years of experience must the IL Chief Pharmacy Coordinator have? | back 32 5 years |
front 33 How many members make up the State board of pharmacy | back 33 11 members |
front 34 How many pharmacist are on the State board of pharmacy? | back 34 8 1 must be an inpatient pharmacist |
front 35 How many pharmacy techs are on the State board of pharmacy? | back 35 1 |
front 36 How many year terms are allowable for members of the State board? | back 36 5 yr terms |
front 37 How many terms can a member serve on the state board? | back 37 2 terms |
front 38 When do pharmacists licenses expire? | back 38 March 31st of EVEN NUMBERED YEARS |
front 39 How many years from passing a licensing exam do you have to apply for licensure? | back 39 ONE YEAR |
front 40 What examination must be passed to transfer a license? | back 40 Illinois multi-state jurisprudence exam |
front 41 How many CE hours are required to renew a pharmacy license? | back 41 30 hrs |
front 42 One hour each much be done for which CE's for pharmacists? | back 42 Sexual harassment Implicit bias |
front 43 A pharmacy license can be placed on inactive status? | back 43 False |
front 44 If license expired for 5 years of less, pharmacist shall have the license renewed upon payment of all lapsed renewal fees and proof of 30 hours of CE | back 44 True |
front 45 If license placed on inactive status for 5 years or less, pharmacist shall have the license restored upon payment of current renewal fee and proof of 30 hours of CE | back 45 True |
front 46
| back 46 30 hrs of CE 600 hrs of clinical practice Successful completion of Pharmacist Assessment for Remediation Evaluation (PARE) |
front 47 How many years do techs have to become a CPhT | back 47 2 |
front 48 When do technicians licenses expire? | back 48 Expires on March 31st of every year |
front 49 How many CE hours do techs need? | back 49 20 hrs |
front 50 Which three subjects must techs do CEs on? | back 50 1. Sexual harassment 2. Patient safety 3. Pharmacy law |
front 51 What are the 6 tasks that techs cannot due: | back 51
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front 52 Interns who drop out, don't pass exams, or fail licensure 3 times can become a registered certified pharmacy tech? | back 52 True |
front 53 Pharmacist in IL can prescribe and administer COVID-19 and flu vaccines to pts 7 and up? | back 53 True |
front 54 Pharmacy licensed under PPA shall not require a pharmacist, student pharmacist or pharmacy technician to work more than 12 continuous hours per day, inclusive of breaks | back 54 True |
front 55 What are the three exceptions to the 72 hour supply for dispensing from the ER? | back 55 1. Antimicrobials 2. Unit of use packages 3. Drugs dispenses via RAPSs |
front 56 Drug administration under the PPA is limited to what routes? | back 56 Oral Topical Injectable Inhalation |
front 57 Pharmacist care must be inclusive of dispensing of drugs/devices? | back 57 FALSE |
front 58 If out of date drugs are in stock a pharmacy license can be issues? | back 58 False |
front 59 How much stock does someone have to own to be considered an "owner" | back 59 5% |
front 60 Pharmacy licenses expire at the same frequency as pharmacist licenses? | back 60 True |
front 61 A PIC can be a PIC at more than 1 location? | back 61 True |
front 62 How many hrs must a PIC work at their home location? | back 62 8 |
front 63 2 conditions when you would need to file a new pharmacy application? | back 63 >10% of ownership changes >50% of board of directors changes |
front 64 IDFPR can refuse to issue or suspend a license of a pharmacist who fails to pay their taxes? | back 64 True |
front 65 When can a pharmacists license be revoked? | back 65 Conviction a second time of committing any felony |
front 66 A pharmacy's hours must be conspicuously displayed? | back 66 True: If they differ from front store |
front 67 What are the exceptions to the duty to dispense rule? | back 67 1. Clinical reason 2. Emergencies/guidelines affecting availability 3. Lack of specialized equipment 4. Potentially fraudulent prescriptions 5. OOS 6. Drug is not typically carried in similar practice settings |
front 68 Who do off-site institutional pharmacies serve? | back 68 Patients and residents |
front 69 Medications for future use in off-site institutional pharmacies must have reference code to identify source and lot #, BUD, and expiration date? | back 69 True |
front 70 What is unique about IV meds for future use in off-site institutional pharmacies? | back 70 Name, concentration, and volume of the base parenteral solution and date of admixture |
front 71 Medications for immediate use in in off-site institutional pharmacies must have BUD? | back 71 Only if BUD <60 days from dispensing date |
front 72 Meds to a specific pt via unit dose need BUD? | back 72 False |
front 73 Who can be serviced by on-site institutional pharmacies? | back 73 patients residents employees prescribers students |
front 74 Unique requirement for sterile solns in on-site institutional pharmacies? | back 74 Reference code to identify source and lot # |
front 75 Unique requirement for investigational new drugs? | back 75 “For investigational use only” |
front 76 Unique requirement for RX copies to pts? | back 76 “For Information Purposes Only” |
front 77 Where are non-resident pharmacies licensed? | back 77 In the state where the dispensing facility is located and from which drugs are dispensed |
front 78 Which type of pharmacy has to have a Toll free number with a pharmacist available 40 hours over at least 6 days per week | back 78 non-resident pharmacies |
front 79 Have many feet of space is required for nuclear pharmacies? | back 79 At least 300 ft2 |
front 80 What unique requirements are for nuclear RXs OUTER CONTAINER? | back 80 1. Amount of radioactive material 2. Requested calibration time and amount of radioactivity contained 3. Name or initials of nuclear pharmacist |
front 81 What unique requirements are for nuclear RXs INNER CONTAINER? | back 81 Name and address of pharmacy |
front 82 A pharmacist can dispense an emergency supply for acute medications? | back 82 False- chronic |
front 83 What 2 conditions must be met for generic substitution? | back 83 1. Physician does not prohibit 2. Selected product is cheaper than brand |
front 84 Prescription requirements in IL: | back 84
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front 85 active ingredients should be within how many % to be deem equivalent? | back 85 1% |
front 86 For anti-seizure meds DRs may check the box of write do not substitute? | back 86 True |
front 87 You are required to notify responsible person of generic change for anti-seizure drugs? | back 87 True |
front 88 Pts must be notified of generic change for which two categories? | back 88 Biologics ASDs |
front 89 Dispensed medications can be returned for return/exchange? | back 89 False |
front 90 When can drugs be returned? | back 90 For destruction only |
front 91 Remote prescription processing systems must share the same owner/written contract? | back 91 True |
front 92 Telepharmacies must counsel on all pick up even if a refill? | back 92 True |
front 93 Telepharmacisies can share licenses? | back 93 False - each on must have their own licenses |
front 94 CII drugs need to be locked securely in remote dispensing sites? | back 94 False |
front 95 How many remote sites can a pharmacist supervise that are simultaneously open | back 95 3 |
front 96 Technicians must be certified to work where? | back 96 Remote dispensing sites |
front 97 RAPSs can be used by physicians? | back 97 False |
front 98 Automated dispensing and storage systems Operate under the same license as pharmacy utilizing it | back 98 True |
front 99 Automated dispensing and storage systems can allow direct patient access? | back 99 False |
front 100 What are the exceptions for unit of use packages for Automated dispensing and storage systems? | back 100 1. Injectables in the original multi dose vials (insulin) 2. OTC products in their original multi dose container |
front 101 Which method is used in institutions int he absence of a pharmacist? | back 101
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front 102 Which method meets the immediate needs of the patient, not available from another source in sufficient time | back 102 Emergency kits (crash carts) |
front 103 How many hypodermic syringes and needles can be sold to an individual >/=18? | back 103 100 |