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More Drugs > Law > Flashcards

Law Flashcards

1
Q

Cesamet

A

Nabilone c2

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2
Q

Marinol

A

Donabinol cap

C3

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3
Q

Syndros

A

Dronabibol solution

C2

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4
Q

Epidolex

A

Cannabis derived

CV?

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5
Q

Farm bill

A

Removed hemp from definition of marijuanna

So cbd can be extracted and added to creams (topicals only)

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6
Q

Gamma hydroxybuyric acid

A

GHB C1

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7
Q

Sodium oxybate

A

C3

Zyrtec

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8
Q

Levophanol

A

C2

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9
Q

Hysingla

A

Hydrocodone

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10
Q

Zohydro

A

C2

Hydrocodone

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11
Q

Kadian

A

Morphine

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12
Q

Nucynta

A

Tapentadol

C2

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13
Q

Methamphetamine

A

C2

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14
Q

Tussicaps

A

Hydrocodone

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15
Q

Cocaine

A

C2

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16
Q

Codeine

A

C2

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17
Q

Levo alpha methanol LAAM

A

C2

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18
Q

Pentobarbital

A

C2

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19
Q

Secobarbital

A

C2

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20
Q

Benzphetamine

A

C3

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21
Q

Butrans

A

Buprenorphrine

C3

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22
Q

Butabarbital

A

C3

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23
Q

Fioricet (with codeine) fiorinal,

A

C3

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24
Q

Codeine/APAP

A

C3

1.8 g/100 mL codeine is C3 or 90 or less me/dosage unit

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25
Q

Ketamine

A

C3

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26
Q

Paregoric

A

C3

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27
Q

Fycompa

A

Peranpanel

C3

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28
Q

Peranpanel

A

Fycompa

C3

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29
Q

Phendimetrazine

A

C3

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30
Q

Testosterone

A

C3

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31
Q

Sonata

A

Zaleplon

C4

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32
Q

Adipex

A

Phentermine

C4

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33
Q

Qsymia

A

Phentermine/topirimate

C4

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34
Q

Edluar

A

Zolpidem c4

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35
Q

Intermezzo

A

Zolpidem

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36
Q

Suvorexant

A

C4

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37
Q

Nuvigil

A

Armodafinil

C4

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38
Q

Armodafinil

A

Nuvigil c4

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39
Q

Butorphanol

A

Stadol

C4

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40
Q

Stadol

A

Butorphanol

C4

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41
Q

Difenoxil/atropine

A

C4
Not more than 1 mg difenox and not less than 25 mcg atropine
***if difenoxil is less than 0.5 is is C5

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42
Q

Modafinil

A

Provigil

C4

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43
Q

Phenobarbital

A

C4

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44
Q

Tramadol

A

C4

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45
Q

Ultracet

A

Tramadol and apap

C4

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46
Q

Brivaracetam

A

C5

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47
Q

Epidiolex

A

Cannabidiol

CV

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48
Q

Codeine cough syrups

A

C5

Not more than 200 mg/100ml or 100g

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49
Q

Lomitil

A

Diphenoxylate/atropine
C5
Not more than 2.5 mg and not less than 25 mcg atropine

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50
Q

Lacisamide

A

Vimpat

C5

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51
Q

224

A

Requests 222 forms

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52
Q

222 forms

A 
Copy 1 (brown): entity giving drugs
Copy 2 (brown): DEA
Copy 3 (blue): entity getting drugs
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53
Q

Opioid addiction buprenorphine

A

Probuphine and sublocade

With naloxone: suboxone, bunavail, zubsolv

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54
Q

Pain buprenorphine

A

Butrans belbuca, buprenex

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55
Q

Salagen

A

Pilocarpine
Cholinergic
Increases salivation often for chemo induced dry mouth

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56
Q

Palmar-plantar erythrofyesthesia

A

Capecitabine and fluoouracil

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57
Q

C2 barbs in combo or as suppository

A

C3

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58
Q

Diethylpropion

A

C4

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59
Q

Lorcaserin

A

C4

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60
Q

Carisoprodol

A

C4

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61
Q

Eluxadoline

A

C4

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62
Q

Ezogabine

A

C5

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63
Q

Meprobomate

A

C4

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64
Q

Prandin

A

Rapglinide
Meglitinides
Secretagogues
Before meals

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65
Q

Pure food and drug act

A

Wiley act
Ingredients meet standards of strength, quality, purity. Label can’t be false or misleading. Must list 11 dangerous ingredients. No adulterated or misbranded drugs can be sent through interstate commerce (FDCA did that too)

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66
Q

Food, drug, and cosmetic act

A

Must prove safety. Must list ingredients and not have misleading labeling. Birth of FDA

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67
Q

Adulterated

A

Identity, STRENGTH, quality, purity

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68
Q

Misbranding

A

Any lack in labeling or warnings, illegible, if ingredients differ from standard in USP monograph (strength, quality, purity), non packaged right according to poison prevention packaging act

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69
Q

Durham-Humphrey

A

Otc and RX
3 conditions make a drug rx: 1 habit forming 2 unsafe without supervision 3 limited to prescription use under NDA
Otc need adequate directions for use.
Labeling of unit dose

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70
Q

Kefauver Harris

A

Manufacture must prove safe AND effective
Phase 4 side effect reporting (manufacturer) and retrospective efficacy analysis (FDA 1938-1962). Informed consent. cGMP!
FDA to regular RX advertising and FTC for OTC advertising.

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71
Q

Drug listing act

A

Manufacturers must register drugs with FDA. Created NDC #

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72
Q

Anti tampering act

A

Required tamper resistant features for OTCs. Must list features on label. Exempt products include: insulin, lozenges and tooth cleaning powder

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73
Q

Orphan drug act

A

7 year exclusivity and 50%tax credit of clinical testing costs. Dx of <200,000 people in US. Or products with no reasonable expectation will pay off

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74
Q

Hatch waxman

A

Drug price competition and patent term restoration act. ANDA (or 505b2-paperNDA) and patent protection for innovators. Prove same API, route, dosage form, strength, and bio equivalent. Made 5 year patent exclusivity for brands.

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75
Q

Prescription drug marketing act

A

Can no reimport drugs. Sale of drug samples prohibited. Sale of coupons prohibited. Can no bring drug in US unless <90/day, only for pt, no trmt in US, serous condition, no risk. Wholesalers must be licensed. Hospitals can’t resell drugs

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76
Q

Omnibus budgeting act

A

Prospective DUR, counseling for all Medicaid beneficiaries.

States required to perform retrospective DUR

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77
Q

Dietary supplement and health education act

A

Considers supplements as food. Adulteration and misbranding still prohibited. FDA requires premarket review of safety data for new ingredients but doesn’t need FDA approval(must say on label). Cant make dx claims. Must say supplement on label. Must have supplement facts and ingredients list

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78
Q

FDA modernization act

A

Clinical trial registry, extended PDUFA, changed legend sentence to “RX only”, fast track approval of drugs

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79
Q

Drug addiction treatment act (DATA)

A

Allowed physicians to prescribe CS in office setting to treat opioid addition.

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80
Q

Comprehensive addiction recovery act (CARA)

A

Amendment of CS act
Allowed NP and PA to treat patients for opioid dependence
Allow partial fills of C2 (30 days)
Authorizes funding and regulatory help in response to opioid epidemic

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81
Q

FDA am me demented act (FDAAA)

A

FDA more power to ensure safety including REMS program

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82
Q

Biological price competition and innovation act

A

Abbreviated licensure pathways for biosimilars

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83
Q

Drug quality and security act

A

Response to NE compounding center incident. It’s an amendment to FDCA that includes: 1. Compounding quality act (traditional compounding vs outsourcing facility), 2. Drug supply chain security act (documentation of transactions through distribution chain-6 YEARS!!

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84
Q

Pregnancy and nursing labeling final rule

A

June 2020 replace ABCDX with: 1. Pregnancy (includes L&D) 2. Lactation (nursing mothers) 3. Females and males reproductive potential

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85
Q

Form 224

A

Applying for DEA registration or ordering 222 forms (check box 3) after that can order online (need DEA#, business name, telephone#), or call headquarters or specialist

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86
Q

225

A

Applying for DEA registration for manufacturer

225a for renewal every year

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87
Q

363

A

Applying for DEA registration for narcotic treatment programs
363a for renewal every year

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88
Q

Exempt from DEA registration

A

EMPLOYED BY( need dea reg if working at outside private practice): US Public Health Service, Federal bureau of prison, armed forces, Indian reservations

For administering, dispensing, or prescribing NOT to procure or purchase

Must give service ID number instead

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89
Q

224a

A

Renewal of DEA registration
224b for chains
Every 3 years

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90
Q

Medpak label

A

Pt name, serial # for medpak AND each drug, drug name/strength/description/quantity, directions, cautionary statement, storage, MD for EACH drug, prep date, BUD of pak (DNE 60 days), pharmacy name, address, telephone #, DEA # if applicable

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91
Q

Med pak record

A

Pt name and address, serial #for each drug, manufacturer name and lot #’s, info on design characteristics specs to help recreate it, prep date and BUD, special labeling, RPH initials

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92
Q

Hospice quantities in ADD

A

Analgesic c2-5: 50, 100, 150

Sedative/ANticonvuls c2-5 30, 60, 90

Ancillary c6: 25, 50, 75

Beds: 21

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93
Q

E-rx req going into effect 1/1/21 exemptions

A

C6, tech failure, waiver, out of state (or fed facility like veterans or Indians), LTC/nursing home to 1/1/23, compounded drugs, EPT, emergency, urgent public health matters, medical equipment, state/federal law (REMS), veterinarians

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94
Q

LTCF emergency kits

A

Analgesics c2-5: 45, 60, 75, 90

Sed/anticonvus c2-5: 15, 20, 25, 30

Beds: <50, 51-100, 101-150, >150

3:1

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95
Q

Methaqualone

A

C1

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96
Q

Sublimaze

A

Fentanyl

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97
Q

Codeine

A

Less than or equal to 90 mg per dosage unit is c3 I think-these are combination products

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98
Q

Didrix

A

Benzphetamine

C3

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99
Q

Oxandrin

A

Ocandrolone

C3

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100
Q

Propoxyphene

A

Darvon, darvocet

C4

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101
Q

Darvon

A

Propoxyphene

C4

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102
Q

TranXene

A

Clorazepate

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103
Q

223

A

Duplicate certificate of registration

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104
Q

510

A

DEA chemical distributor registration

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105
Q

CSR protection act

A

Federal investigation in robbery if more than 500 taken, interest ate or foreign commerce used, someone hurt or killed….25000 fine and/or 20 years, 35000 and/or 25 years of weapon used, 50000 and/ or life if death

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106
Q

Requires DEA records

A

222, invoices, POA, inventory, dispensed, distributed, self-certification (pse), 106, 41, DEA registration, transfers of CS

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107
Q

222

A

Has7 sets of forms, each pharmacy gets 6 books max unless need exceed limits

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108
Q

PSE rules

A

3.6/day
9/mo
7.5/ mo mail order

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109
Q

PSE amount per 3.6 grams

A

Ephedrine hcl 25: 175
Ephedrine sulfate 25: 186
Sudafed hcl 30: 146
Sudafed sulfate 30: 155

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110
Q

When can a fax be original for C2

A
  1. Compounded narcotic for direct administration parenteral
  2. LTCF
  3. Hospice narcotic RX certified and/or paid for by Medicare
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111
Q

Ryan haight

A

CSA amendment
Online pharmacy consumer protection act
Need a MODIFICATION of DEA registration

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112
Q

Medguides

A

Antipsyches, NSAIDS, estrogen, antidepressants, anticonvulsants, long acting opioids, amiodarone , ADHD stimulants, atomoxetine, antiarrythmics, REMS drugs

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113
Q

Form 130

A

When you want to manufacture a new CS that you aren’t register to manufacture

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114
Q

DATA waived patient limits

A

30, after 1 year 100, after another year 275

If not data waived can administer but not prescribe 1 days worth for up to 3 days til referral is arranged

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115
Q

Online reporting reqs

A

If over 100 CS rx or 5000+ dosage units

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116
Q

Peanuts/ soy allergy drugs

A

Cleidipine, propofol, progesterone

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117
Q

Egg allergy drugs

A

Propofol, clevidipine, yellow fever vaccine.

Flublok is egg free influenza vaccine

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118
Q

Luminal

A

Phenobarbital

C4

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119
Q

Mebaral

A

Mephobarbital

C4

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120
Q

Mephobarbital

A

Mebaral

C4

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121
Q

Brevital

A

Methohexital

C4

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122
Q

Methohexital

A

Brevital

C4

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123
Q

Prosom

A

Estazolam

C4

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124
Q

Dalmane

A

Flurazepam

C4

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125
Q

Dolene

A

Dextropropoxyphene
C4
Propocacet

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126
Q

Amobarbital

A

C2

Amytal

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127
Q

Critical info on med label

A

Patient name, drug name (brand and generic), strength, directions

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128
Q

Consumer medication information

A

Leaflet stapled to bag
Required for each NEW rx
Required for first fill
Not reviewed or approved by FDA

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129
Q

Patient package insert

A

Voluntarily provided by manufacturer
Require FDA approval
Given with new AND refills
LTC/hospital prior to first dose and every 30 days thereafter

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130
Q

Medguide reqs

A

FDA approved
Drug with serious health concerns- adherence necessary or serious ADR
Supplied by manufacture
Give with new AND refill rx, first time given to provider for outpatient administration, pt asks, medguide revised

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131
Q

REMs

A
  1. Communications plans
  2. Elements to assure safe use
  3. Implementation systems
  4. Medguides
    Developed by manufacturer and approved by FDA
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132
Q

Who can you share PHI with

A

Patient, those authorized by patient, other healthcare providing care, for treatment, payment, or operational purposes. Law enforcement: DEA FDA medical board inspectors/pharmacy board inspectors (for public health or abuse concern), limited data for research, public health, or institutional operations

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133
Q

Patient written authorization for PHI disclosure

A
  1. Who it’s being shared with
  2. Purpose
  3. Expiration
  4. Patient signature
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134
Q

HIPAA privacy notice

A

Given in first day of care and whenever there are Changes. Try to get signature acknowledging but can still give care without it. Patient can request privacy disclosures for past 6 years so keep HIPAA signed privacy disclosure form for 6 years.
Contain contact for department of health and human services as well as for someone in pharmacy

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135
Q

Certificate of fitness log book

A

Date, name and address of person, kind, quantity, price, intended use

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136
Q

Closing pharmacy

A

14+ days before give board: name, address, phone#, MCSR#, certificate of fitness#, pharmacy permit#, date of closure, procedures, adequate Notice, procedures for disposal/transfer of cs

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137
Q

Transferring CS to different pharmacy

A

Give to board in 14 days: name/address/phone# (both) pharmacy permit# (both), MCRS# (both), name/RPH registration# of manager(both), date, and intended security procedures. Send copy of inventory over in 10 days(note for manager change inventory doesn’t get sent to board, just sworn statement kept on file)

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138
Q

Transferring rx

A

CS: void, on back: pharmacy, RPH (receiving), DEA, address- on back

CS/C6: log: pharmacy, RPH transferring, date, RX number

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139
Q

Advertising

A

NO: safety, efficacy, indications

YES: proprietary name, generic, quantity of API when one API, strength when more than one API, dosage form, price for filling RX

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140
Q

Prospective DUR

A

Duplication, over/under utilization, drug drug, drug-dx, drug-allergy, abuse, incorrect dose/duration, any changes in drug/dose/directions

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141
Q

Counseling

A

Name/description, DF dose route duration, instructions for prep/admin/use, missed dose, storage, self monitoring, ADR/CI/interaction/precautions, refills

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142
Q

Nuclear pharmacy record retention

A

3 years

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143
Q

Form 483

A

Deficiencies from FDA inspection

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144
Q

RPH vaccines

A

Flu, TD/Tdap, varicella, HPV, zoster, MMR, PSV23, meningococcal, HepA, HepB, polio

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145
Q

Vaccine class

A

12 hours self study with assessment

8 hours live with final exam

Hands on

CDC, ACoR approved

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146
Q

Rx can’t change

A

Pt name, md name, drug, signature, earliest fill date

Note: date written can be changed
And supervising MD can be changed

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147
Q

Rx changes without consultation

A

DEA#: can add if omitted
Pt address: add if omitted( must consult to change)
“No sub” “pt can request less” if omitted

Can change 30 to 90 days supply if not a PMP drug

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148
Q

Documentation for RX changed

A

Date, change, MD, RPh

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149
Q

License reactivation reqs

A

How loss has affected you, activities since loss, remedial activities, plans to resume and measures to ensure following law, have they engaged in pharmacy activity since, document of completion of out of state reqs, reinstatement questionnaire, resume with employment since loss, 3 recs one must be RPH must know you since loss of license. Valid for 90 days. Must send within 90 days. If denied must wait 2 more years

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150
Q

License reactivation after expiration

A

Documentation of CEs in past 2 years, written statement from each employer since expiration, statement from each state where licensed. retake MPJE. If not been practicing in pharmacy May require personal appearance, retraining, and/or naplex

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151
Q

Fridge/freezer temps

A

Fridge: 2-8 Celsius

Freezer: -25 to -10

Note for naplex freezer is -50 to -15

Check at least daily

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152
Q

Failure to follow up with c2 HC

A

Report to DEA, US department of justice, commissioner of public health, Mass department of public health

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153
Q

Date to send plan B report by

A

8/1 for period of 7/1-6/30 of prior year

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154
Q

Prescriber d/c practice

A

Can fill up to 90 days but only 30 days at a time unless insurance wants more

155
Q

Pilot or demonstration research project

A

Can not exceed 18 months

156
Q

Advanced standing status

A

Dx stats credentials. Can also get if at least 1 year part time totally 400 hours working in particular dx

Don’t have to complete training program, can just take the exam

Can not retake exam UNLIKE people who took the program:Can retake exam twice without having to retake program

157
Q

Dx credentialing

A

Recertification every 4 years. Need 12 CEs (max of 3 per year for 4 years) they can count towards regular CEs
Must take and pass exam again too

158
Q

CE audits

A

Deficient <5: complete 3 CE for each deficient

Deficient >= 5: 3 for each Deficient and discipline which may include 2+ wk suspension

Board will audit you for next 3 cycles

159
Q

Vet e-kit

A

Can dispense 120 hour supply if can’t get to compounding pharmacy

Pharmacy must get pt specific rx for each med removed within 7 days

RPH must reconcile, inspect and restock every 10 days

160
Q

When do pharmacist need to register with the commissioner

A

CDTM

161
Q

Registration with the commissioner

A

Good for 1 year (except c1 research registrations- max of one year)

Must re-register no more than 60 days before expiration

162
Q

Manufacture quarterly report for commissioner

A

Sent on 15th of the month following

Stocks of Non-narcotic substances C1-3 on hand at beginning and end of quarter. receipts, dispositions, manufacturing and packaging of all CS

163
Q

Notice of inspection

A

Name/title of registrant, name/title of owner or operator if different from registrant, name/address of premises, date, acknowledgment of right to decline

164
Q

Nursing quality assurance

A

Weekly

165
Q

Non resident pharmacies

A

Submit annually and 30 days after change in office: letter certifying good standing from in stare board

Record of drugs dispensed to MA sent to BOP annually

166
Q

Rx label reqs

A

Pt name, MD name, pharmacy name and address, drug, directions, cautionary statements, quantity, RPH initials, date, serial#

For compounds: should say it’s a compound and have telephone

C2-4: federal transfer sticker

167
Q

Practitioner dispensing drug label

A

MD name and address, pt name, date, drug name/dose/strength per unit, directions, cautionary statement

Cmr says expiration for samples

168
Q

Physician record for dispensing drug

A

Drug name/dose/strength, volume of units, date, name and address of pt

169
Q

Rx reqs

A

MD: name/address/ registration #, name of MD rep if oral, date, drug name/dose/strength per unit, (DF and quantity per federal), serial # if oral, pt name and address (DOB per federal), directions, cautionary statements, refills

MLP/RPH name of supervising MD (unless PA) and MLP phone#
Midwives not included

If C2 statement about partial fill

170
Q

PSE self certification

A

Renew every year (online)

171
Q

Loss/theft of PSE

A

Notify in 15 days

172
Q

Tech training program

A

120 theoretical, 120 practice

173
Q

Nuclear pharmacist training

A

200 hours formal training (no more than 60 in lab)

3 months OR 500 hours on the job

174
Q

Clinic or hospital pharmacies can dispense to…

A

Inpatients/outpatients,

Employees, employee spouse/children that live in same household

175
Q

Receiving transfer info

A

Original date of issuance, original dispensing date, last refill, original refills, refills remaining, Pharmacy name/address/DEA#, rx #, transferor pharmacist name

176
Q

Board submits report to DPH

A

Annually before 12/31 detailing investigatory and discipline actions

177
Q

Scientist CS registration for quantitative and qualitative analysis

A

Annual

178
Q

Retail sterile/non sterile and institution sterile compounding license

A

Renew annually

179
Q

Naloxone reporting

A

January 15th

Name and zip code of pharmacy, number of doses dispensed and number of doses paid for by insurance

180
Q

CE grace period

A

Pharmacist granted license on or after 10/1. Granted grace through 4/30 to get previous years CEs

181
Q

Non resident outsourcing facility

A

Requires proof of good standing from their state licensing/registration authority within 3 months

182
Q

Compounding pharmacy telephone

A

For sterile or non-complex must staff telephone every day and not less than 56 hours per week

183
Q

Drug formulary commission

A

Create the orange book with the DPH

Comprised of nine people

184
Q

Community program rx limitations

A

37 day supply with one refill

185
Q

CEs for post graduate academic programs

A

3 CE for each academic credit

186
Q

Pharmacist absence

A

Do not exceed 30 mins for each shift of at least 6 consecutive hours

187
Q

How can electronic copies of rx be sorted

A

Patient name, MD name, drug name, date filled

188
Q

Biennial inventory

A

Does not need to be submitted to DEA

Neither is POA

189
Q

Partially filling a C2 for LTCF or terminally ill

A

Must document that on rx (unlike adhd for C2 med)

Must also write: date, quantity dispensed, quantity remaining; RPh ID

190
Q

Who can prescribe EPT

A

Physician, PA, NP, nurse midwife

191
Q

CS registration for charitable events/volunteer activities

A

If practitioner has current CS registration, does not need separate registration when activities do not exceed 10 hours/month

192
Q

PMP addiction drug

A

Used recreationally, diverged for misuse, contribute to OD/seen in blood of OD

193
Q

When prescribers use PMP

A

First time prescribing C4 or C5

Each time prescribing C2, C3, or BZD

194
Q

Opioid red flags

A

3 or more early refills, focusing on opioid in visits beyond 3 visits

195
Q

Who issues MCSR

A

DPH drug control program

196
Q

SeParate MCSR / DEA registration reqs

A

Need separate for for each location

Also need separate MCSR for each activity

197
Q

Physician follow up times

A

C2: every 4 months

C3-6: every 6 months

198
Q

Independent pharmacy

A

Less than or equally to 9 stores. No more than 20 RPhs

199
Q

BOP term

A

3 years
Can serve 2 consecutive and can be re-elected after not serving 1

Hearing for removal: 21 day notice

200
Q

Rehab committee

A

Term is 4 years

1 chairperson and 1 vice chairperson

3 members are a quarum

201
Q

BOP advisory committee

A

7 members plus commissioner or rep

Ch. 71, ch. 797, ch. 795, microbiologist, phamacoeconomics, cGMP for aseptic processing, clinical pharmacology,

Term is 3 years: If filling vacancy it’s for remainder of term

Meet semi-annually, no compensation, no liability, can be reappointed

202
Q

CS exempted from scheduling drug limitations

A

4 ounces in 48 hours

203
Q

Low risk sterile compounds

A

1-3 sterile additives
No more than 2 entries into sterile container

14 days in fridge, 48 hours room temperature

204
Q

Medium risk sterile compounds

A

More than 3 sterile additives

Parenteral nutrition

IV batches

9 days in fridge, 30 hours room temperature

205
Q

High risk sterile compounds

A

Non sterile ingredients or equipment is used

3 days in fridge, 24 hours room temperature

End product must be sterilized

Should be tested for sterility

206
Q

Consent agreement

A
  1. In writing and signed by board and licensed
  2. Facts upon which the agreement is based, provisions/conditions for reinstatement
  3. States that voluntary surrender deprives registrant from rights and is not subject to judicial review
  4. Placed in permanent record
207
Q

Restricted pharmacy

A

Trust, fund, pension plan, combination plan, profit sharing plan

208
Q

Nuclear pharmacy required texts

A

USP, remingtons, texts on the practice of nuclear pharmacy and radiation safety

209
Q

Nuclear pharmacy must have stuff

A

Dose prep station, dose calibrator, exhaust hood, refrigerator, chromatographic apparatus, portable radiation survey meter canals of detecting 0.005 microcuries of radio-nuclides, area radiation detection room monitors, personnel dosimeters, scintillation analyzer, necessary supplies: multi dose vials, syringes, etoh swabs, shielding

210
Q

Emergency radiopharmaceutical timeframe

A

Need rx in 72 hours

211
Q

Radiopharmaceutical emergency dispensing records

A

Name of MD and institution, amount, date supplied, date administered, rx #

Should also have md verification when bulk. Radioactivity is not used

212
Q

Radiopharmaceutical label

A

Radioation symbol, caution radioactive material, name, chemical or common name, amount, if liquid-volume, auxiliary labels/warning, expiration

213
Q

HD list

A

Update every 12 months

214
Q

HD risk assessment plan

A

Reviewed every 12 months

215
Q

HD storage

A

Antineoplastics and HD api must be stored separately and 12 ACPH, reproductive risk only and final DF antineoplastic can be stored with regular stuff

Fridge in negative pressure 12 ACPH

Can store sterile and non sterile together

216
Q

Negative pressure

A

0.01-0.03 inches of water column relative to adjacent areas

217
Q

Water sources and drains location

A

At least one meter away from C-pec

218
Q

External ventilation

A

Required for sterile HD, non sterile can also use redundant HEPA filter

219
Q

BSC

A

Non sterile can use class 1 or 2, sterile uses class 2 or 3

For class 2: types A2, B1, B2

220
Q

HD SCA

A

Needs 12 ACPH, still must be in negative pressure area (0.01-0.03)

Sink must be a meter away

Only category 1 HD can be prepared here

221
Q

Sterile HD pressure

A

I buffer room is 0.01-0.03 and ante room is minimum 0.02

222
Q

Sterile HD sink

A

In ante-room at least one meter away from buffer room

223
Q

Containment supplemental engineering controls

A

CSTDs

Can’t replace c-pec, limited evidence

Use when DF allows and use when administering antineoplastics

224
Q

HD environmental wipe sampling

A

Done every 6 months at least

Do detect HD contamination

225
Q

Changing PPE HD

A

Gloves every 30 mins

Gowns every 2-3 hours or per manufacturer

226
Q

Respirators

A

Unpacking HD: elastomeric half mask with multi-gas cartridge and p100filter

N95 do not protect against gases and vapors

227
Q

HD training

A

Must be reassessed every 12 months

228
Q

Deactivating and decontaminating HD areas

A

Under c-pec work tray-monthly -must use respiratory protection

229
Q

Compounding personnel

A

Evaluated at least annually

230
Q

Withdrawal time

A

How long to withhold animal treated tissues from human food supply

Must be on label of food producing animal patient

231
Q

Tech programs

A

Must submit materials at least every 5 years

Maintain documents for at least 5 years

232
Q

Above actionable EM

A

If more than once in 60 days must engage industrial hygeinist, microbiologist, or infection control professional

Must stop compounding in ISO 5 (one the affected one) until remediation complete

Iso7: high risk bud until remediation complete

ISO8: high risk for items made from non sterile components
Medium rush for items made from sterile starting components

233
Q

Vet e-kits

A

Agreement/formulary reviewer annually

It’s for compounded medications only in C6

Vet must have MCSR

234
Q

Central fill pharmacies

A

C2-5 must be delivered to original pharmacy

C6 May be delivered to the patient

Can no be done for sterile or complex non sterile compounds

235
Q

C2 loss extra reqs

A

Attestation of perpetual inventory every 10 days

Reconcile 222 forms for 3 months back- say what it revealed

236
Q

Technician license by reciprocity

A

At least one license must have been active for at least one full year

237
Q

Psych med ADR after RPh administration

A

Report within 24 hours unless: death, life threatening, hospitalization , addition testing/monitoring in hospital/ED, incapacitating - then much tell MD immediately

238
Q

CSP strength percent variance

A

10%

239
Q

Water containing csps that are non sterile during any point

A

Are sterilized within 6 hours

240
Q

Media fill test

A

Done at least annually for low risk and medium risk, semi annually for high risk

Also done initially, along with written tests

Incubated first 14 days, if two temps required do 7 days each

241
Q

Sterility tests for autoclave CSPs

A

Required for batches of more than 25 under

242
Q

Exposing sterile ingredients to worse than iso 5 air for more than one hour

A

High risk

Also assuming contents of ingredients without evidence and what not

243
Q

Immediate use CSP

A

Can only be low risk, not medium or high, can not be HD

Preparation can not exceed one hour

Bud: 1 hour

244
Q

Single dose vials expiration after opening

A

Use in 1 hour if less than iso 5, can use up to 6 hours if opened in iso 5

Ampules can not be stored for any amount of time

245
Q

Multi dose vial bud

A

28 days or per manufacturer

246
Q

Compounding facility temperature

A

20 degrees or cooler

247
Q

Positive pressure

A

0.02-0.05 inch water column

248
Q

ACPH iso 7 sterile compounding

A

30

If iso 5 is used the area can have 15 ACPH as long as combined is at least 30

249
Q

HEPA filtered air

A

Introduced at the ceiling with returns low on the wall

250
Q

Sterile compounding water sources

A

Buffer area shall not contain drains or water sources

251
Q

Iso class for presterilzation and weighing and mixing

A

Iso 8 or better

252
Q

Environmental sampling

A

Every 6 months as part of recertification

253
Q

Recertification of pecs

A

Every 6 months

254
Q

Air velocity between buffer area and ante area

A

0.2 m/s or 40ft/min

255
Q

Non viable particle testing

A

To test pecs

256
Q

Viable airborn particle testing

A

To test personnel and hygiene

257
Q

Air sampling frequency

A

Semi annually

258
Q

Actionable air cfu

A

Iso 5, 7, 8

> 1, 10, 100

259
Q

Cleaning frequency

A

Pec- view picture
Counters/surfaces-daily
Floors- daily
Walls, ceilings, storage shelving-monthly

260
Q

Gloves fingertip test

A

Low/medium risk- annually

High risk- semi annually

Initially for everyone

3 times each hand
ACTIONABLE level is >3 cfu total

261
Q

Surface sampling sterile compounding frequency

A

Periodically

262
Q

Sterile compounding ingredients without expiration

A

Max 1 year expiration

Non sterile is 3 years

263
Q

Automatic compounding device accuracy assessment

A

Reviewed at least weekly

264
Q

POison preventionpackaging goal

A

Stop 80% of children under 5 while allowing 90% of adults to open it

265
Q

Sterility testing for high risk

A

More than 25 packages prepared in fridge for more than 12 hours or at room temp for more than 6 hours before they are sterilized shall meet sterility test (same for bacterial endotoxins)

If it goes out before results, test specimens must be monitored and it should be recalled if needed

Alert patient and Md

266
Q

Room temperature

A

20-25 degrees

267
Q

Sterile compounding QA programs

A

Reassessed on an annual basis

268
Q

How many days to send board documentation of CEs when requested

A

7 days

269
Q

Searchable website that includes enforceable actions, ADRs, and compounding facilities

A

Searchable by pharmacy, pharmacist, or medication

Must include information for at least 10 years

All data should be provided to the commissioner within 30 days that it becomes available

270
Q

If board assesses pharmacy and orders correction

A

Penalty not more than 24k, not more than 1k/day for each day after

Hearing upon written request within 15 business days

Assessment made 30 days after notification or 15 days after resolution of appeal

271
Q

How long can people in Community programs who were trained to administer medications do so?

A

2 years, then mist get recertification

272
Q

Storage of meds in community program

A

Non self administering meds must be locked

Self administering C2-c5 must be lock and C6 can be unlocked if determined that there is no risk

273
Q

Community program documentation of meds

A

Med and dose, indication, possible ADRs and staff response, CI, possible allergic rxns, special instructions, missed dose instructions

274
Q

Community programs documentation of administration

A

Required for non self administrating including off site administration and OTC. Also day programs must communicate with residential programs and vice Versa.

No required for self administering

275
Q

Community programs accounting of meds

A

Required for non self administering patients meds in c2-c5

Reconciled at the end of each shift

276
Q

What can optometrists prescribe

A

Topical agents in C6 for things other than glaucoma

277
Q

Weird department registration with the commissioner rules

A

Chemical analyst and lab must register

Teacher using CS must register but facility doesn’t have to

Note: pharmacist instructors for pharmacy programs are exempt when purchasing C6 for educational purposes

278
Q

Who is automatically registered with the commissioner

A

Physicians, podiatrists, dentists, vets

But only for C6

279
Q

Registration with the commisioner: when to notify of termination of it

A

30 days before

280
Q

Registration with the commissioner: when to apply for new one in event of name/address change

A

Can apply up to 90 days in advance

Note: 60 days in advance for DEA registration. They send form 50 days before, call if not received 30 days before

281
Q

When to report theft or loss to the commissioner

A

Within 24 hours of discovery

282
Q

If picking up PMP drug without ID and Rph belies withholding the drug would result in serious hardship

A

Patient must print name and address on back of rx and sign name

283
Q

When must you submit written request for hearing of summary suspension of registration with commissioner?

A

Within 14 days

284
Q

Additions and exceptions list

A

No drugs on exceptions list

Exception: A rated but can not be interchanged

Additions: not A rated but can be interchanged

285
Q

Glutethimide

A

C2

286
Q

Transferring CS not c2, needed documentation

A

Drug, DF, strength, quantity, date.

Name/address/DEA registration of parties involved

287
Q

Registration requires to wholesale PSE

A

Chemical distributor

Form 510

288
Q

Theft or loss how soon to notify DEA

A

One business day

289
Q

CS inventory reqs

A

Date, time (opening or close), drug, finished form (ex 10 mg tablet), number of units per container, number or containers, count

290
Q

222 form purchased required to fill in

A

Name of item, quantity, package size

Upon receipt document actual quantity received and date of receipt

291
Q

Cancelling c2 order

A

Notify supplier in writing and they will draw line through item and write “cancelled” on items shipped space on copies one and two

If the supplier cancels order they write “void” and they notify purchaser in writing

292
Q

Lost order form

A

Prepare statement with date and serial number and verify drugs ordered were not received and attach it to second order form sent to supplier and retain a copy of statement with both copy 3’s

Immediately notify DEA

Same for electronic but everything is electronic and you use a tracking number instead of a serial number. First order is “not accepted” if subsequently received. Attach that to record of the statement and order record.

293
Q

Invoice reqs

A

Date received, name, finished form, number of units per container, number or containers

294
Q

Cs refill printout report

A

Within 72 hours

295
Q

LTCF partial fill documentation

A

Must put on back: date, RPh, quantity filled, quantity remaining

Must put “LTCF” or “terminally ill”

296
Q

How soon must you complete modification of DEA application before using internet to sell CS

A

30 days. Filling out the app constitutes notifying the DEA

Mist also notify states boards 30 days in advance

Can perform activity of retail pharmacy and internet pharmacy at the same time

Notify DEA 30 days prior to changing web address

297
Q

Central fill pharmacy: what must be written on script?

A

Central fill, name/address/DEA reg of Central fill pharmacy, date, name of RPh sending it over

298
Q

PSE log

A

Name, address, signature, product, quantity, date, time

Not needed if not more than 60 mg

Only armed forces can accept military Id

Don’t have to be 18

299
Q

What must advertising contain? (Not pharmacy advertising)

A

Name, at least kind indication, most significant risks

300
Q

False or misleading statements about advertising

A

Misbranding

301
Q

Drug strength different from official standards

A

Adulterated

302
Q

Purity or quality lower than what’s listed on label or compendia

A

Adulterated

303
Q

If ingredients differ from strength quality and purity as determined by the test laid in the usp monograph

A

Misbranding

304
Q

Unit dose label requirements

A

Drug, quantity of active ingredient, manufacturer, lot number, BUD, any cautionary statements

305
Q

What does it mean if a drug is listed in the orange book

A

It means the generic has demonstrated pharmaceutical equivalence and bioequivalence

306
Q

Expiration of donated drugs

A

Must be at least 6 months away

Can not donate CS

307
Q

When can manufacturers give out samples?

A

Only to prescribers, hospital pharmacy, or other healthcare entity at the written request of the prescriber

This does NOT include retail pharmacies

308
Q

Drugs except from security track and tracing

A

Providing drugs to provider for office use, ultimate user, and drug samples

309
Q

Defective drug prep log

A

Drug, potency, DF, reason for recall, amount made, amount dispensed/distributed, actual potency and DF, and ADRs

Retain for 10 years

Made available to the board in 7 days or recall

310
Q

Significant loss of control in ISO 5

A

> 15 CFU

Recall csps, provide adverse event surveillance, contact prescribers, and engage microbiologist/industrial hygeinist/ID professional

311
Q

Above actionable level EM must include what are the minimum

A

Root cause analysis, repeat EM, corrective action and preventable action plan

312
Q

If you have only one iso 5 workbench or a non commercially available workbench and you failed EM testing and are remediating, what is the BUD?

A

Immediate use

313
Q

Vet e-kit label

A

Generic name, strength, date of prep, lot number, BUD, storage/handling, cautionary, statement that it is compounded preparation

314
Q

ADD record

A

ID of person accessing, location, type of transaction with date/time, name/strength/DF/quantity, name or other identifier of patient, reconciliation of all inventory activities

315
Q

What is included in the email of notification of loss/theft

A

Pharmacy name, address, pharmacy license number, manger name, date of possible loss, drug name/strength/DF, reason for loss

316
Q

When double dipping for law and compounding CE, what must the course be titled

A

Must be “law” and have compounding requirements necessary

317
Q

When does manager of record have to ATTEST to training of staff in lean concepts

A

Upon renewal of pharmacy license

For complex non sterile and sterile compounding

318
Q

When does a petition for license reinstatement expire?

A

90 days

Note: one extension per petitioner may be considered

When denied: its 2 years from the date of denial NOT original submission

319
Q

When a pharmacist or intern has a question about the interval between mental health injections they are administering

A

It is recommended but NOT required to contact MD

Note: pharmacies must be CPR certified

320
Q

Does an optometrist require MCSR to get and use drugs for diagnostic purposes?

A

No

321
Q

How long is an out of stare c3-5 script good for

A

30 days

322
Q

Who can write scripts for out of state c3-5

A

Authorized practitioners

323
Q

Who can write scripts for out of state c2s

A

Physicians

Maybe NP and PA too?

324
Q

When can a doctor only prescribe a 7 day supply of opioid?

A

Opioid naive

Every time prescribing for a minor

If giving more must document reason in medical record and indicate than a non-opioid alternative was not acceptable

This is for pain not SUD

325
Q

When must pharmacist give pamphlet about opioids?

A

When dispensing narcotic or CS in schedule 2 or 3

326
Q

How is a toll free number provided for counseling getting meds delivered

A

It’s printed on label that goes on bottle

Must also do this for drugs that are sterile and complex-non sterile compounds

327
Q

For which schedules does the department calculate mean and median prescribing percentile for opioids

A

Schedule 2 and 3

Done annually

328
Q

Master formulation record

A

Name/strength/DF, calculations needed, description of ingredients and quantities, compatibility, stability, storage, references, equipment needed, mixing instructions (order, temp, duration)

329
Q

Compounding record

A

Official/assigned name, strength, DF, master formulation referenced, names and quantities of components, sources/lots/expirations of components, total quantity compounded, name of: preparer, person who did quality control, and RPh who approved, date, rx#, BUD, duplicate container label, description, results of quality control procedures, documentation of quality control issues/ADRs/preparation problems reported by patient or caregiver

330
Q

222: when must supplier report transaction to dea

A

By the end of the month

331
Q

CSOS: when must the supplier report transaction to DEA

A

Working 2 business days of filling the order

Other downside is it can’t be endorsed to another supplier

All schedules can be ordered here

332
Q

What must be on an rx for buprenorphine that doesn’t include and X DEA#

A

“For pain”

333
Q

What schedules need back up method for recording refills when computer is down?

A

C3 and c4

334
Q

When do c5s have a 6 month expiration?

A

When transferred or partially filled

335
Q

Institutional limits

A

C2: 7 day

C3-5: 34 day supply or 100 dosage units

336
Q

When can a pharmacy compound c2-5?

A

Aqueous, oleaginous, or solid DF

Does not contain more than 20% CS

Only distributed to prescribers registered to dispense CS

337
Q

Can 222, original rxs, and inventory records be stored at a central location?

A

No

338
Q

What is required on an OTC label?

A

Principle display panel large enough to have all required info: drug name-drug class, quantity, name/address of manufacturer/packer/distributor, Directions, drug facts panel,

NDC requested NOT required

339
Q

What is on a drug facts panel that goes on OTC label?

A

API, purpose, uses, warnings, directions, other info, contact info

340
Q

What are some things that central pharmacies can not do?

A

Fill emergency c2

Dispense controls without RX (c5 sale allowed in some states)

341
Q

PSE mail order report

A

Submitted to DEA on 15th day of month following

Not needed if: samples of2 solid dosage units or equivalent (10 mL or less). Not more than once in 30 days
Not needed if distribution by retail distributors
Not needed for LTCF
Not need if there’s an RX

342
Q

Do technicians from other states and territories need to take a test for licensure in mass?

A

No as long as requirements are similar

343
Q

Who has the final say in decisions about rehab of pharmacist/interns/techs?

A

The BOP. The rehab committee give recommendations

344
Q

Who appoints the members of the advisory committee of the board?

A

Commissioner

345
Q

Independent pharmacy: where are the store counts included?

A

Just in Massachusetts

346
Q

When does BOP member term start

A

1st day of month following appointment

347
Q

Who can sell alcohol?

A

Pharmacist or non pharmacist adult under the supervision of a pharmacist

Can not sell to a minor, just like the controls, UNLIKE pse I think

348
Q

How often does a CIVAS or sterile compounding pharmacy have to report to the board all that stuff?

A

Every 6 months

349
Q

What extra step must be completed when you inter change a drug to the generic?

A

Document manufacturer on the label and RX!

350
Q

Can a midwife write an RX?

A

Must be nurse midwife not regular midwife!

351
Q

When do wholesalers have to submit changes to the board by?

A

Within 30 days of the change

352
Q

Hood certification and status reporting

A

Should be certified annually, but it’s one of the things that gets reported every 6 months (along with number and type of scripts, states they went to, iso, status of CIVAS approvals, attestation of following 797

353
Q

Traditional compounding 3 exemptions

A

CGMP, labeling with adequate directions for use, need for FDA approval

354
Q

What must be done when you can not provide the remainder of a partially filled c2 within 72 hours of partially dispensing it?

A

You must notify the MD!

Note: when partially filling a c2 you note the quantity supplied on the front of the rx

355
Q

What does not need to be on a label?

A

DF and dose

Medpak: DF

Doctor dispense: DF

356
Q

QRE: when does pharmacy’s have to notify patient / doctor

A

Immediately

357
Q

When does QRE have to be documented?

A

On the same day of discovery

Documented by the DISCOVERING pharmacist

358
Q

How often do CDTM pharmacists have to complete opioid training

A

Initially prior to obtaining Cs registration and then biennially

359
Q

When must physician remain within their scope of practice?

A

CDTM

360
Q

Do non resident outsourcing facilities requires a MCSR?

A

No

361
Q

What can prescribers not own?

A

Outsourcing facility, pharmacy

362
Q

FDA records retention time

A

5 years

363
Q

BOP inspection form record retention time

A

2 years

364
Q

What is excluded from scheduling if it can be sold over the counter

A

Non-narcotic

365
Q

Who does commissioner notify of temporary scheduling of a substance?

A

Inpatient hospitals in MA, chairs of the joint committee of public health, attorney general of US, all local and regional boards of health

366
Q

Who has to file 106 with local police?

A

Dispensers

Distributors just have to do state police

367
Q

What must be noted when partially filling a c2 upon patient request

A

The fact that it was partially filled and the quantity dispensed

Must be available to the MD upon REQUEST

368
Q

Which schedules is lock box sign needed for?

A

C2-5

369
Q

Should a new POA be filed for each renewal of the DEa registration?

A

No, only if the renewal is signed by a different person

370
Q

Does a central fill pharmacy need a separate DEA# to do retail work?

A

Nope

371
Q

Are LTCF registered with dea ?

A

Not usually

Note: ADS electronically records dispensing thus maintaining records for the pharmacy

372
Q

Bla

A

Biologic application

373
Q

Nembutal

A

Secobarbital

374
Q

Electrolyte limits on OTCs

A

Sodium: 140
Calcium: 3.2g
Magnesium: 600
Potassium: 975

375
Q

PPI and medguide directed at who?

A

PPI: healthcare

Medguide: patient

376
Q

Who needs a machine specific dea # and MCSR for add?

A

Retail pharmacies-They must also monitor machine by video

Hospice ADDs-also video monitor

377
Q

What schedules can be stored in LTCF emergency kits?

A

2,3,4,5,6

378
Q

Vet e kit label

A

Generic name, strength, quantity, date of prep, BUD, lot number, storage handling, cautionary, name/address/telephone of pharmacy, compounded drug

379
Q

When to submit application for waiver in by for requirement to use electronic ordering for controls starting January 2021

A

By October 1st to get waiver in time

380
Q

What schedules can you fill a failover for?

A

C6

381
Q

“Partial fill upon request” required for which scripts?

A

ALL SCHEDULE 2s

was previously just opioid c2s but was expanded

382
Q

Fax rx to hospice or, what kind of drug must it be?

A

C2 NARCOTIC! Same for compounded parenteral

Note LTCF it can be any c2

383
Q

When do IC rules not have to be followed?

A

Medical emergency

Patient must print name on rx

RPh must document: date, hour, nature of emergency on Back

384
Q

For CDTM when must patients be at least 18?

A

Community

Also need referral and consent

More Drugs (4 decks)

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