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207 Cards in this Set
- Front
- Back
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Sherman Antitrust Act |
monopoly anti trust = business |
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Federal Food drug cosmetic act |
Adulteration/Misbrand Label |
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PHSA (public health service act) |
biologics |
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Durham Humprey |
Rx vs OTC |
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Kefauver-Harris kief |
Efficacy Phase 1, 2, 3 |
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Packaging (who can request non-child resistant?) |
Patient: non-safety for ALL Physician: individual Rx |
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Hatch-Waxman |
aNDA generic |
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Orange book lists ___ |
brand = generic
AB rated drugs can be substituted |
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Prescription drug marketing act |
prohibits drug samples no counterfeiting no importing |
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OBRA |
Counsel |
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FDA modernization act |
fast track drugs allows compounding |
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Methadone dose for addiction only? max patient limit? |
40 mg tabs/disk for addiction only 30 patients max |
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Pseudoephedrine max per day? max per 30 days? max mail order? |
3.6 grams/day 9 grams/30 days mail: 7.5 grams/30 days |
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FDA Amendment Act REMS |
Safety risk evaluation and medication strategies |
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Ryan Haight Act |
if in person medical evaluation = true then can have internet controlled substance |
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Plan B age? |
> 17 y/o |
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Drug recall 1,2,3? |
1. Serious 2. medically reversible health consequences 3. no health consequences |
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Thalidomide ____ program |
steps |
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C2 allow refills? allow transfers? |
no no |
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C2 multiple Rx acceptable? |
yes. - written different blank - date |
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c2 max day limit? |
90 day |
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C2 must get written Rx within ___ days?
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must get written rx within 7 days |
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C2 partial ___ days? |
3 days (72 hours) |
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LTCF partial fill prescription valid for ___ days |
60
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DEA form 41 |
dispose controlled substance |
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C3 - C5 max refills? |
5 |
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C3 - C5 Rx is good for ___ months? |
6 months |
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C3 - C5 number of transfers? (different chain) |
1 transfer permitted |
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Who can transfer C3 - C5? |
Pharmacist or intern |
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How to file prescriptions (3 methods) |
1. C2, C3 - C5, non C 2. C2, C3 - C5 (with stamp) + non C 3. C2 + C3 - C5 + non C |
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Control stamp C_? size? location? |
C3 - C5 1 inch lower right corner |
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DEA form 106 |
theft |
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Can midlevel practitioners prescribe C? |
no |
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can receptionist phone in C? |
yes |
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DEA copies 1? 2? 3? |
1. supplier 2. DEA 3. keep |
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> __ % control must register as distributor? |
5% |
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Fax C3 - C5 to retail? |
yes but need hard copy |
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Expiration of C2? |
1 year |
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Expiration C3 - C5? |
6 months C2 is 1 year |
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Store prescriptions for ___ years? |
2 |
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DEA form 224 |
224 = new application 224a = renewal application 224b = affidavit (confirm) 224c = modification for online pharmacy |
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DEA form 224a |
224 = new application 224a = renewal application 224b = affidavit (confirm) 224c = modification for online pharmacy |
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DEA form 224b |
224 = new application 224a = renewal application 224b = affidavit (confirm) 224c = modification for online pharmacy |
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DEA 224c |
224 = new application 224a = renewal application 224b = affidavit (confirm) 224c = modification for online pharmacy |
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DEA 363 |
narcotic treatment programs |
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Rule of 3 |
Schedule 3 Codeine < 1.8 g/100 ml Hydrocodone 300 mg/100 ml |
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Rule of 5 |
Schedule 5 codeine 200 mg/100ml < 100 mg opium/100 ml < 2.5 mg dephenoxlate |
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dose of Codeine to be schedule 3 |
90 mg or 1.8 g/100 ml |
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dose of hydrocodone to be schedule 3 |
15 mg or 300 mg/100 ml |
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New RETAIL manager must notify state within ___ days |
10 |
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Class 1 Institution aka ___ |
nursing home |
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Class 2 Institution aka ___ |
hospital |
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Modified Class 2 A aka ___ formulary limited to ___ drugs AHHH! |
Methadone clinic dialysis center 15 drugs |
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Modified class 2 B aka ___ |
surgical center |
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Renew permit every ___ |
2 years |
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can non-pharmacist own permit? |
yes |
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check expiration dates every __ |
4 months ( 3 times/year) |
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When change to generic must ___ |
inform substitution inform price change give patient right to refuse |
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pharmacy must be open minimum ___ hours ___ days |
40 hours a week
5 days a week |
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NDC required on drug label? |
no |
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get Controlled inventory every ___ |
2 years (6 months buffer) |
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NSU College of Pharmacy MPJE Review - version 2.429 Mail order prescriptions exempt if covered by insurance |
delete |
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Immunize must have protocol with Dr? |
yes |
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who can counsel? |
Pharmacist or intern (under supervision) offer verbally and in writing |
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require ___ hrs CE every ___ year(s) |
30 hrs 2 years |
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____ hours CE must be ___ (topic) |
2 hours Med Errors |
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____ hours of CE must be live |
10 |
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define: prescriber care plan |
allows ordering specific drugs, lab tests etc |
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define: drug therapy management |
any act in compliance with Prescriber Care Plan |
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OTC max dose of codeine Opium? |
Codeine 120 mg q48h Opium 240 mg q48h |
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OTC max dose of opium codeine? |
Codeine 120 mg q48h Opium 240 mg q48h |
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what is DAMP? |
Drug/Alcohol/Mental/Physical (bad) |
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Consultant pharmacist require license? hours required? |
yes 40 hours under supervision within 3 months |
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intern:pharmacist? |
1:1 |
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Can intern give copies? transfers? |
yes |
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tech:pharmacist ratio? |
3:1 |
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C3 - C5 control expires in ___? |
6 months |
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can interns request a transfer of control substances? |
no |
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Can pt return a dispensed drug? Alternative? |
no give credit or refund |
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C2 expiration date? |
1year |
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FL rule on multiple drugs per 1 prescription blank |
each blank must only have drugs from the SAME CLASS (C2-5) |
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how many day supply for Oral prescriptions for C3. |
30 days |
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how to know if control script has been checked? |
pharmacist initials and date script |
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Counterfeit resistant prescriptions are required for ___? |
C 2-4 (if photocopied, has "void" under) |
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Who can authorize controls: Podiatrist? Midlevel practitioners? Vet? |
yes no yes |
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keep prescription for ____ |
2 years from last dispensing |
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check controlled substance inventory every ___ |
2 years |
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inventory records kept for ___ |
2 years |
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immunization records kept for ___ |
5 years |
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keep prescription drug distributions for ____ |
4 years |
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keep record of sales for ____ |
5 years |
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board of pharmacy has ____ members, appointed by ____ (person) |
9 members (7 rx + 2 non-rx)
the governor |
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can intern receive verbal? |
yes under supervision |
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can intern receive copy? |
yes under supervision |
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can pharmacy advertise drugs? |
yes EXCEPT controls |
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one pharmacy manager can manage ____ store(s)? |
1 May grant exception based on location and workload |
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can pharmacist order lab tests? |
if Pharma or consultant pharmacist then yes |
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if pharmacist order drug for patient, what is max day supply? |
34 days |
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if pharmacist orders drug for patient, what group can NOT be ordered for? hint: F |
pregnant or nursing mother |
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pt profile for pharmacy should be kept for ___ (Pharmacist dispenses drug for this pt) |
4 years |
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can intern order drugs for patients? |
no |
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max time for prescription? |
1 year |
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max mg of sodium fluoride? |
264 mg |
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define: Quality Related Event |
inappropriate dispensing or administration |
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review quality related event every ___ |
3 months |
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max pharmacist / tech ratio? |
3:1 non sterile compounding |
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can techs transfer a script? |
no
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can techs counsel? |
no |
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define: negative drug formulary List some drugs |
Therapeutic INequivalance (no sub) - conjugated estrogen - digiTOXIN - chlorpromazine - theophylline CR - Pancrelipase |
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Must a pharmacist inform patient of any substitution? |
yes. also tell $ ask to refuse |
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Pharmacy may possess sample drugs when: 1 2 |
institutional prescriber requests |
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keep compounded records for ___ |
4 years |
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USP Section 797 is ___ |
sterile products |
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how long should patient records be kept for? |
4 years |
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can pharmacy interns counsel? |
yes under direct supervision |
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Define: drug therapy management |
any act in compliance with orders in a Prescriber Care Plan |
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Before refusing a script, pharmacist must 1. communicate with ___ 2. communicate with ___ 3. if can't communicate, then ___ |
1. patient 2. prescriber 3. don't fill |
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if prescriber is involved with diversion of controlled substance, then report to ____ |
department of health |
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can E-scribe C2? |
yes |
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30 hours CE 1 hr must be _ _ _ |
HIV, TB |
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Board of pharmacy rotates every ___ (time) |
4 years |
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change pharmacy to another state. must tell new location within ___ |
30 days |
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Regular hours for pharmacy ___ days ___ hours |
6 days per week 40 hours per week |
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if change internet pharmacy, must disclose location principal corporate officer and pharmacist within ___ (time) |
30 days
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DEparmartment manager must notify department within ___ days of employment |
10 days |
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drug distribution records kept for ___ |
4 years |
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"Medically necessary" means |
write as brand name |
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What is the orange book? |
Therapeutic equivalence |
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Is it considered a transfer if filled in different state with same database? |
no same database = no such thing as transfer |
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Can Rx give emergency supply of C2? |
no |
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Dr can dispense ___ day supply of C2 for surgical procedure |
14 days |
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can interns immunize? |
yes under supervision |
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Control script must include 1, 2, 3 |
1. pt name and Address 2. dr name and address 3. date |
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Can fax C2 if 1,2,3 |
1. hospice 2. LTCF 3. IV |
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max day supply of C3-5 for ORAL rx? |
30 days
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___ hours training for epinephrine autoinjection
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3 hours
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1 yr inactive licence = ___ hrs CE makeup |
15 hr |
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can Rx order IV? |
no |
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can receive C2 fax? |
yes BUT need original copy |
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can receive C3-5 fax? |
yes BUT need Original copy |
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Prescription Drug Marketing Act prohibits sales of ___ |
drug samples
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FDA modernization act |
fast track life saving drugs |
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Age limit for pseudophed? |
yes 18 y/o |
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FDA Amendments Act established ___ program |
REMS |
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Print out computerized record past ___ days within ___ hrs |
60 days 72 hours |
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pseudophed may be exempt from digital document if < ___ g/month |
72 grams applies to pharmacy only (not physicians office) |
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change in leasing owner requires a new permit? |
no |
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prescription drugs must be examined every ___ months |
12 |
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consultant pharmacist can precept ___ people |
2 |
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Automated pharmacy system must be stocked by ___ |
pharmacist |
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influzena ___ hrs CE |
20 |
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Rx prescribe oral analgesics for ___ days |
6 |
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Rx prescribe Phenazopyridine for ___ days |
2 days pee pee |
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can a practitioner dispense? |
no |
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T/F all controls must be written down, then entered into computer
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T |
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partial supply of 222 must be filled within ___ days |
60 |
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CFR |
Code of Federal Regulations daily updates |
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> ___ mg/100 ml morphine to be c2 |
50 mg/100ml |
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hydrocodone syrup is now C___ |
C2 |
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___ ml of control that can be OTC |
120 ml /48hr (federal) |
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Tylenol No. 3 tablet contains ____ of Codeine |
30mg |
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Dingle Bill Act |
prohibits the shipping of drugs between two states w/o registration |
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who must you notify if change in Pharmacist in Charge? |
Board of Pharmacy |
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OTC insulins? |
Regular and NPH |
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Administer influenza require authorization form Dr?
|
yup |
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FTC regulates ___ advertising |
OTC advertising |
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lasix #30 with 4 refills. how many can the pharmacist dispense the day they bring in Rx? |
150 |
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too much water added to antibiotic misbranded or adulterated? |
both |
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Novolin N OTC? |
yes |
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Ipecac max Ml? |
1 oz (30 mL) |
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Who asigns the middle NDC number |
manufacturer |
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Last month to renew license? |
July 31of every odd year |
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Dr get DEA from ____ |
federal gov |
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can physician prescribe for dogs? |
no |
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Dr dies. How long is scrip good for? |
void instantly, but can give 6 month buffer for pt to find new Dr |
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1. ASA cannot be sold in containers holding more than ___ tablets |
36 |
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Lotronex indication? |
women with Severe diarrhea |
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Tikosyn generic? indication? |
dofetilide arrhythmia (severe A fib) TIPS stamp |
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orange book AA AN AO AP AT |
AA = conventional N = aerosol (Nasal) O = Oil P = Parenteral T = Topical |
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BZP are schedule |
4 |
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phenobarb is schedule |
4 |
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When closing pharmacy, must notify DEA ___ days in advanced
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14 (2 weeks) |
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May use previous DEA permit for ___ |
45 days |
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OTC max dose of opium ___ oz OTC max dose of control ___ oz |
Opium: 8 oz or 48 dosage units Other control: 4 oz or 24 dosage units |
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If retired license > ___ years, must pass MPJE and Naplex |
5 yrs
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Rx requires ___ hr CE Consultant requires ____ hr CE Rx Consultant requires ___ hr total CE |
30
24 54 |
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Nuclear pharmacist ___ additional CE ___ hr didactic training ___ hr internship |
24 hr 200 hr 500 hr |
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regular Dr can prescribe methadone for addiction for ___ days |
3 days MAX |
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manufacturer inventory their samples every ___ |
1 year |
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FDA will approve/deny NDA within ___ (time) |
6 month 180 days |
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record of distribution samples kept for ___ (time) |
3 years |
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which law provides framework for DUR? |
OBRA 90 |
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< ___ % control can be compounded without being a manufacturer |
20% |
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control inventory performed every ___ |
2 years |
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how many drug test per year are required at OTPs? |
8 |
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how long after chagning pharmacy mangers does a pharmacy have to notify the BOP? |
10 days |
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___ CE hours required for lab tests? |
3 initially then 1 |
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who approved CE provdiers? |
tripartite CE committee |
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what OTC are except from tamper resistant packaging? |
insulin dermatologies dentifrice lozenge |
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how long must documents outlining CQI plans be kept? |
2 years |
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pharmacies are inspected every ___
|
1 year |
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opioid maintenance treatment is > ___ days |
21 |
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list some examples of mid-level practitioners |
Nurse practitioners, PA, midwife |
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Rx prescribe antihistamine to pt. pt must be > ___ y/o |
6 |
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distribution Check ___ q3 years check ___ q4 years check ___ q5 years |
drug sample distribution prescription drug distributions record of manufacturers |
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Which law provides framework for DUR? |
obra |
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Loss of Data. The prescriptiondepartment manager shall report to ___ in writing any significant loss ofinformation from the data processing system within ___ of discovery of theloss. |
the Board 10 days |
