Texas Drug Law – Flashcards
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Most pharmacy records are required to be kept for how many years?
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2 years
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What are the provisions for dispensing a CII without an official prescription by a hospital pharmacy?
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1. rx must be manually signed 2. must be dispensed before patient is discharged 3. pt must be "admitted to the hospital" 4. qty does not exceed 7 day supply 5. rx is filed in outpatient records
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In which class setting of pharmacy must a perpetual CII inventory be maintained?
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Class C institutional
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How often must the pharmacist in a hospital setting review floor stock records?
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every 30 days
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What must the PIC do if loses data during the discontinuation of a data processing system?
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Must notify the Board in writing any significant data within 10 days of discovery
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A hospital's drug distribution record of controlled substances including Nubain must include what information?
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1. patient's name and room # 2. Prescriber 3. name, strength, dosage form 4. quantity (if not retrievable electronically then also 1. prescriber's address & DEA
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How often must the hospital print out the drug distribution record for controlled substances if doesn't have electronic retention system?
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at least monthly / sorted by drug name
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When do most records have to be presented when requested by the board?
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within 72 hrs
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Class C, for 101 or more beds, when must the pharmacist perform a drug regimen review after drugs have been removed by designated practitioner after hours?
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within 72 hrs
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Class C, for 100 or less beds, when must a part-time pharmacist perform a drug regimen review after drugs have been removed by designated practitioner after hours?
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no later than 7 days
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Class C 100 beds or less, how often is the pharmacist required to available by telephone?
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24 hrs a day
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How many facilities can a PIC be in charge of a class C pharmacy with 100 or less beds?
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3 but not more than a total of 150 beds (no one facility may have more than 100 beds)
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If a Class C pharmacy with 100 or less beds employs a full-time pharmacist how often must the pharmacist perform drug regimen review when drugs are removed after hours by a designated practitioner?
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within 72 hours
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Where must the pharmacy be located in Ambulatory Surgical Centers ?
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located separate from patient areas
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What are the library requirements for Class A pharmacies?
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1. Tx Pharm Act 2. Tx Dangerous Drug Act 3. Tx Controlled Act 4. either USPD vol II or reference text with pt info 5. Drug Interactions 6. General Info Text like Facts and Comparisons
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What are the additional library requirements for Ambulatory Surgical Centers besides those required for Class A and C pharmacies?
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1. American Hospital Formulary Service or Facts and Comparisons 2. Handbook of Injectable Drugs
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Which policies and procedures are not required for Ambulatory Surgical Centers?
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1. stop orders and furloughs 2. inspections of nursing station 3. distribution of inpatient drugs 4. handling of med orders in absence of pharmacist
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Drugs for postoperative use by Ambulatory Surgical Centers may be dispensed in a quantity of 72 hr supply with the exception of what types of medication?
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topicals and ophthalmics
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The incomplete label for drugs for postoperative drugs in ACS by only be completed by who?
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doctor (not the nurse)
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How often must the pharmacist working for and Ambulatory Surgical center review records?
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at least every 7 days
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What library is required for Class C pharmacies?
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1. Same as class A 2. Handbook of Injectable Drugs 3. antidote info and poison control # 4. weight and measure conversion chart
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What are the library requirements for Class B?
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1. USP/NF 2. State Laws 3. Tx regs for Control of Radiation 4. ref for safe handling 5. 3 texts min dealing with nuclear medicine science 6. ref on sterile product preparation 7. code of federal regs (CFR)
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How many nuclear pharmacies may the PIC be in charge of?
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only one
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Nuclear pharmacists must meet standards set by which organizations?
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1. Bureau of Radiation Control 2. Texas Department of Health
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Certification to be a nuclear pharmacist requires how many hours of structure education by a preceptor? How many of these hours must be didactic?
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700 hrs , 200 hrs must be didactic
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500 hrs of experience to be certified as a nuclear pharmacist must involve what 5 types of activities?
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1. shipping, receiving-radiation surveys 2. use of equipment 3. preparing dosages 4. using controls to avoid mistakes 5. using measure to avoid contamination
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What is the ratio of pharmacists to technicians in Class B pharmacies?
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1:3 one must be registered and one must be engaged in compounding
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What are the licensing requirements for Class B pharmacies?
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Texas Dept of Health Radiation Control Number
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How many times can a prescription be refilled for a radioactive drug?
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zero
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What are the additional requirements for labeling the outer container?
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Radiation symbol and statement "Caution-Radioactive Material"
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How many Class D pharmacies may a PIC supervise?
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no limit
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What is the pharmacist to supportive personnel in a Class D setting?
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no ratio
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What documents need to be submitted to the board upon initial license application by the Class D pharmacy?
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policies and procedure manual including formulary
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How many temporary locations may a Class D pharmacy have?
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no more than 3 and must notify board of location at the time of application
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What drugs are not allowed to be on the formulary for Class D pharmacies?
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Nubain (Nalbuphine) , ED drugs, controlled medication
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The class D pharmacy may petition the board to add additional classes to the formulary if what percent of their patients are indigent?
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80% but still no controlled substances will be allowed
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How often must the pharmacist provide retrospective drug regimen reviews of a random sample of patients?
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every quarter
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What contents may supportive personnel add to the label of a prepackaged drug under orders of a practitioner in a clinic?
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patient's name, directions of use, date of provision, practitioner's name
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Which 3 people shall serve on the Pharmacy and Therapeutics committee for a clinical setting?
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PIC, Medical Director and a person responsible for the provision of drugs - shall meet annually
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If not a government funded clinic, how often must the pharmacist inspect the clinic?
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monthly
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An inspection report for a class E pharmacy application must not me older than how many years?
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2 years
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An inspection report for a class E pharmacy renewal must not me older than how many years?
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3 years
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What is a Class F pharmacy?
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Freestanding Emergency Medical Care Center
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What is the maximum amount of sodium allowed in an OTC product not to require a warning label due to diet restrictions?
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140mg
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What is the maximum amount of calcium allowed in an OTC product not to require a warning label due to diet restrictions?
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3.2 grams
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What is the max amount of magnesium before warned on label of OTC product due to diet restrictions?
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600mg
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What is the max amount of potassium before warned on label of OTC product due to diet restrictions?
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975 mg
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When are warning labels required for methyl salicylate?
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greater than 5%
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When are warning labels required for Ipecac?
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more than 30ml/box
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Makers of dietary supplements must give how much notification to the FDA before marketing?
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30 days
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Serious adverse reactions or deaths must be reported to the manufacturer and FDA on what form?
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MEDWATCH 3500A within 15 days
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Which DEA form to register as a dispenser (pharmacy, hospital, practitioner etc)
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224
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Which DEA form to register as MFR, distributor, researcher etc?
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225
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Which DEA form to register as narcotic treatment center?
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363
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How often must the DEA 224A registration be renewed?
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every 3 years
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How often must DEA 225A registration be renewed?
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every year
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How many days may new owner use previous owner's DEA#?
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45 days after purchase date
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Max dose of codeine to be considered schedule V? schedule III?
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200mg/100ml for CV and 1.8g/100ml or 90 mg unit for CIII
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Max dose morphine schedule III
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50mg/100ml
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Max dose opium schedule V? schedule III?
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50mg/100ml for CV and 500mg/100ml or 25 mg unit for CIII
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DEA for stolen or loss C2s?
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106
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DEA for destruction of C2s?
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41
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How often must inventory of controlled substances must be taken according to the TSBP? TCSA?
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every year TSBP and every two years TCSA
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When would a facility not need to register as a distributor?
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If the total quantity distributed in 12 months is less than 5% of total quantity dispensed
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How often must pharmacies and practitioners register with DPS?
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every year
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When must online pharmacies register with the US Attorney General before planing to sell online?
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within 30 days
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What are the limitations for prescribing controlled substances for PAs and APNs?
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90 day limit including refills
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What are the schedule V quantity limits for opium? for all other?
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8 oz or 48 dosage forms/ 4 oz or 24 dosage forms
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When must you report to DPS electronically?
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within 15 days of the last day of the month
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How long is the waiver from electronically reporting to DPS?
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1 year
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What are the pseudophed limits? FDA? Tx? by mail?
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FDA 3.6gm/day 9g/mo TX 6gm or 2 pks mail 7.5 gm/mo
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What percent of the time must PAs and APNs be supervised?
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10%
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Optometric Glucoma specialist have what prescribing limits for antibiotics, NSAIDS, Antihistamines or controlled analgesics?
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antibiotics - 10days NSAIDS - 7 days antihistamines and controlled analgesics - 3 days
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Emergency kits are limited to how many dose units of each drug?
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5 units
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When do emergency kits expire?
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six months or earliest expiring med in kit
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In a Home and Community Support Services setting (hospice), how long do nurses have to reduce physician order to writing and send to pharmacy?
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24 hours
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In HCSS setting (hospice) how long does the doctor have to send a signed rx to the pharmacy?
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20 days
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Within what time frame dose a pharmacist have to notify md after administering a vaccine (not including influenza)? youngest age of patient allowed?
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24 hours/ 14 years old
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What is the youngest age allowed to administer influenza vaccine?
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must be older than 7 years
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How long is an emergency pharmacist license active?
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6 months
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How can a pharmacist renew an expired license?
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pay fee 1.5 times if expired less than 90 days, pay 2 times if expired between 90 days and 1 year
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How much CE is granted for attending board meeting, task foce, ismp, gpp?
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0.2 CEU
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How many CEU's is getting CPR certified worth?
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0.1 CEU (1.2 CEU's for ACLS)
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How long are licenses for emergency remote pharmacies valid?
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6 months may renew for 6 more months (must produce license within 48 hrs)
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What steps must be taken to dispense a generic for a narrow therapeutic range medication? transplant medication?
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get patient's permission and notify doctor within 72 hrs /// patient's permission and notify doctor within 48 hrs
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What action must a doctor take to prohibit generic substitution for an ERX for Medicaid?
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verbally indicate not substitution and fax in rx within 30 days
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A "rural hospital" contains how many beds within what population?
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less than 75 beds and less than 50,000 people
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How often must pharmacist review medication records of nurses/doctors removing medication in a rural hospital setting?
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within 7 days
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who requires registration of emergency kits?
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DPS (not DEA)
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Within how many miles must a remote pharmacy be located in order to supply emergency kits to a facility?
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20 miles
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How many remote sites may one pharmacist supervise?
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up to 3
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Telepharmacy systems must be tested how often?
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every 6 months
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What are the requirements in order for a doctor to dispense medication in a rural area?
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population less than 5,000 within 15 miles of doctor's office (there can be no pharmacies)
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What is the ratio of pharmacists to techs if pharmacy dispenses less than 20 different drugs?
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1 : 5 four techs must me registered and each tech may only perform one duty at a time
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Can a tech with an expired certification still renew?
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yes, if pay 2 times regular fee and expired less than a year
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When will the board generally investigate a pharmacist or technician?
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if receive more than 3 complaints in 5 years
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After lawsuit closed, a follow-up report must be submitted to the board after how many days?
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105 days
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How many CE's must a a Drug Therapy Management pharmacist under the supervision of a doctor required to complete related to DTM?
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6 hours
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How much notice should a pharmacy give the board when moving locations?
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14 days
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When must the annual controlled substance inventory be completed in regards to scheduled date?
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within 4 days
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How long does a pharmacy have to comply with the boards recommendation before an official complaint is filed?
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10 days
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How many members are on the discipline committee?
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3
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Can the discipline committee suspend a license without a hearing?
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yes, but proceedings must be held within 14 days (if second hearing doesn't take place within 60 days of first, license with be reinstated)
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What exemption from having to register as a wholesaler (PDMA) does Texas Law allow?
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Hospitals and other health care entities may sell drugs to each other for emergency medical reasons or if there is a temporary shortage.
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When dose a "child resistant container" fail testing?
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when, after demonstration, more than 20% of the children can open in 10 minutes and/or 10% of adults can't open
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How long is the DPS registration for all registrants valid?
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one year
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Who may give consent to have drugs dispensed in a med-pak prepared by the pharmacist?
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Patient, agent of the patient or the prescriber
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What is required to be on the label of a med-pak?
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pt name, unique id #, drug name, str, drug description, qty, directions, cautionary labels, storage instructions, prescriber, date made, beyond use (1 yr), pharmacy info, rph id (not required if in computer)
