Law Flashcards

Question

Ketamine

Answer 1

Peranpanel | C3

Answer 2

Fycompa | C3

Answer 3

Zaleplon | C4

Answer 4

Phentermine | C4

Answer 5

Phentermine/topirimate | C4

Answer 6

Zolpidem c4

Answer 7

Armodafinil | C4

Answer 8

Nuvigil c4

Answer 9

Stadol | C4

Answer 10

Butorphanol | C4

Answer 11

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

Answer 12

Provigil | C4

Answer 13

Tramadol and apap | C4

Answer 14

Cannabidiol | CV

Answer 15

C5 | Not more than 200 mg/100ml or 100g

Answer 16

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

Answer 17

Vimpat | C5

Answer 18

Requests 222 forms

Answer 19

``` Copy 1 (brown): entity giving drugs Copy 2 (brown): DEA Copy 3 (blue): entity getting drugs ```

Answer 20

Probuphine and sublocade | With naloxone: suboxone, bunavail, zubsolv

Answer 21

Butrans belbuca, buprenex

Answer 22

Pilocarpine Cholinergic Increases salivation often for chemo induced dry mouth

Answer 23

Capecitabine and fluoouracil

Answer 24

Rapglinide Meglitinides Secretagogues Before meals

Answer 25

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)

Answer 26

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

Answer 27

Identity, STRENGTH, quality, purity

Answer 28

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

Answer 29

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

Answer 30

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.

Answer 31

Manufacturers must register drugs with FDA. Created NDC #

Answer 32

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

Answer 33

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

Answer 34

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.

Answer 35

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

Answer 36

Prospective DUR, counseling for all Medicaid beneficiaries. | States required to perform retrospective DUR

Answer 37

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

Answer 38

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

Answer 39

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

Answer 40

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

Answer 41

FDA more power to ensure safety including REMS program

Answer 42

Abbreviated licensure pathways for biosimilars

Answer 43

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!!

Answer 44

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

Answer 45

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

Answer 46

Applying for DEA registration for manufacturer | 225a for renewal every year

Answer 47

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

Answer 48

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

Answer 49

Renewal of DEA registration 224b for chains Every 3 years

Answer 50

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

Answer 51

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

Answer 52

Analgesic c2-5: 50, 100, 150 Sedative/ANticonvuls c2-5 30, 60, 90 Ancillary c6: 25, 50, 75 Beds: 21

Answer 53

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

Answer 54

Analgesics c2-5: 45, 60, 75, 90 Sed/anticonvus c2-5: 15, 20, 25, 30 Beds: <50, 51-100, 101-150, >150 3:1

Answer 55

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

Answer 56

Benzphetamine | C3

Answer 57

Ocandrolone | C3

Answer 58

Darvon, darvocet | C4

Answer 59

Propoxyphene | C4

Answer 60

Clorazepate

Answer 61

Duplicate certificate of registration

Answer 62

DEA chemical distributor registration

Answer 63

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

Answer 64

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

Answer 65

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

Answer 66

3.6/day 9/mo 7.5/ mo mail order

Answer 67

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

Answer 68

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

Answer 69

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

Answer 70

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

Answer 71

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

Answer 72

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

Answer 73

If over 100 CS rx or 5000+ dosage units

Answer 74

Cleidipine, propofol, progesterone

Answer 75

Propofol, clevidipine, yellow fever vaccine. Flublok is egg free influenza vaccine

Answer 76

Phenobarbital | C4

Answer 77

Mephobarbital | C4

Answer 78

Mebaral | C4

Answer 79

Methohexital | C4

Answer 80

Brevital | C4

Answer 81

Estazolam | C4

Answer 82

Flurazepam | C4

Answer 83

Dextropropoxyphene C4 Propocacet

Answer 84

C2 | Amytal

Answer 85

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

Answer 86

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

Answer 87

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

Answer 88

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

Answer 89

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

Answer 90

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

Answer 91

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

Answer 92

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

Answer 93

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

Answer 94

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

Answer 95

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)

Answer 96

CS: void, on back: pharmacy, RPH (receiving), DEA, address- on back CS/C6: log: pharmacy, RPH transferring, date, RX number

Answer 97

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

Answer 98

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

Answer 99

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

Answer 100

Deficiencies from FDA inspection

Answer 101

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

Answer 102

12 hours self study with assessment 8 hours live with final exam Hands on CDC, ACoR approved

Answer 103

Pt name, md name, drug, signature, earliest fill date Note: date written can be changed And supervising MD can be changed

Answer 104

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

Answer 105

Date, change, MD, RPh

Answer 106

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

Answer 107

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

Answer 108

Fridge: 2-8 Celsius Freezer: -25 to -10 Note for naplex freezer is -50 to -15 Check at least daily

Answer 109

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

Answer 110

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

Answer 111

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

Answer 112

Can not exceed 18 months

Answer 113

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

Answer 114

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

Answer 115

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

Answer 116

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

Answer 117

Good for 1 year (except c1 research registrations- max of one year) Must re-register no more than 60 days before expiration

Answer 118

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

Answer 119

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

Answer 120

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

Answer 121

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

Answer 122

MD name and address, pt name, date, drug name/dose/strength per unit, directions, cautionary statement Cmr says expiration for samples

Answer 123

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

Answer 124

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

Answer 125

Renew every year (online)

Answer 126

Notify in 15 days

Answer 127

120 theoretical, 120 practice

Answer 128

200 hours formal training (no more than 60 in lab) 3 months OR 500 hours on the job

Answer 129

Inpatients/outpatients, | Employees, employee spouse/children that live in same household

Answer 130

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

Answer 131

Annually before 12/31 detailing investigatory and discipline actions

Answer 132

Renew annually

Answer 133

January 15th | Name and zip code of pharmacy, number of doses dispensed and number of doses paid for by insurance

Answer 134

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

Answer 135

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

Answer 136

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

Answer 137

Create the orange book with the DPH Comprised of nine people

Answer 138

37 day supply with one refill

Answer 139

3 CE for each academic credit

Answer 140

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

Answer 141

Patient name, MD name, drug name, date filled

Answer 142

Does not need to be submitted to DEA Neither is POA

Answer 143

Must document that on rx (unlike adhd for C2 med) Must also write: date, quantity dispensed, quantity remaining; RPh ID

Answer 144

Physician, PA, NP, nurse midwife

Answer 145

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

Answer 146

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

Answer 147

First time prescribing C4 or C5 Each time prescribing C2, C3, or BZD

Answer 148

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

Answer 149

DPH drug control program

Answer 150

Need separate for for each location Also need separate MCSR for each activity

Answer 151

C2: every 4 months C3-6: every 6 months

Answer 152

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

Answer 153

3 years Can serve 2 consecutive and can be re-elected after not serving 1 Hearing for removal: 21 day notice

Answer 154

Term is 4 years 1 chairperson and 1 vice chairperson 3 members are a quarum

Answer 155

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

Answer 156

4 ounces in 48 hours

Answer 157

1-3 sterile additives No more than 2 entries into sterile container 14 days in fridge, 48 hours room temperature

Answer 158

More than 3 sterile additives Parenteral nutrition IV batches 9 days in fridge, 30 hours room temperature

Answer 159

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

Answer 160

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

Answer 161

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

Answer 162

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

Answer 163

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

Answer 164

Need rx in 72 hours

Answer 165

Name of MD and institution, amount, date supplied, date administered, rx # Should also have md verification when bulk. Radioactivity is not used

Answer 166

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

Answer 167

Update every 12 months

Answer 168

Reviewed every 12 months

Answer 169

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

Answer 170

0.01-0.03 inches of water column relative to adjacent areas

Answer 171

At least one meter away from C-pec

Answer 172

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

Answer 173

Non sterile can use class 1 or 2, sterile uses class 2 or 3 For class 2: types A2, B1, B2

Answer 174

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

Answer 175

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

Answer 176

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

Answer 177

CSTDs Can’t replace c-pec, limited evidence Use when DF allows and use when administering antineoplastics

Answer 178

Done every 6 months at least Do detect HD contamination

Answer 179

Gloves every 30 mins Gowns every 2-3 hours or per manufacturer

Answer 180

Unpacking HD: elastomeric half mask with multi-gas cartridge and p100filter N95 do not protect against gases and vapors

Answer 181

Must be reassessed every 12 months

Answer 182

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

Answer 183

Evaluated at least annually

Answer 184

How long to withhold animal treated tissues from human food supply Must be on label of food producing animal patient

Answer 185

Must submit materials at least every 5 years Maintain documents for at least 5 years

Answer 186

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

Answer 187

Agreement/formulary reviewer annually It’s for compounded medications only in C6 Vet must have MCSR

Answer 188

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

Answer 189

Attestation of perpetual inventory every 10 days Reconcile 222 forms for 3 months back- say what it revealed

Answer 190

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

Answer 191

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

Answer 192

Are sterilized within 6 hours

Answer 193

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

Answer 194

Required for batches of more than 25 under

Answer 195

High risk Also assuming contents of ingredients without evidence and what not

Answer 196

Can only be low risk, not medium or high, can not be HD Preparation can not exceed one hour Bud: 1 hour

Answer 197

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

Answer 198

28 days or per manufacturer

Answer 199

20 degrees or cooler

Answer 200

0.02-0.05 inch water column

Answer 201

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

Answer 202

Introduced at the ceiling with returns low on the wall

Answer 203

Buffer area shall not contain drains or water sources

Answer 204

Iso 8 or better

Answer 205

Every 6 months as part of recertification

Answer 206

Every 6 months

Answer 207

0.2 m/s or 40ft/min

Answer 208

To test pecs

Answer 209

To test personnel and hygiene

Answer 210

Semi annually

Answer 211

Iso 5, 7, 8 | > 1, 10, 100

Answer 212

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

Answer 213

Low/medium risk- annually High risk- semi annually Initially for everyone 3 times each hand ACTIONABLE level is >3 cfu total

Answer 214

Periodically

Answer 215

Max 1 year expiration Non sterile is 3 years

Answer 216

Reviewed at least weekly

Answer 217

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

Answer 218

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

Answer 219

20-25 degrees

Answer 220

Reassessed on an annual basis

Answer 221

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

Answer 222

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

Answer 223

2 years, then mist get recertification

Answer 224

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

Answer 225

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

Answer 226

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

Answer 227

Required for non self administering patients meds in c2-c5 Reconciled at the end of each shift

Answer 228

Topical agents in C6 for things other than glaucoma

Answer 229

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

Answer 230

Physicians, podiatrists, dentists, vets But only for C6

Answer 231

30 days before

Answer 232

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

Answer 233

Within 24 hours of discovery

Answer 234

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

Answer 235

Within 14 days

Answer 236

No drugs on exceptions list Exception: A rated but can not be interchanged Additions: not A rated but can be interchanged

Answer 237

Drug, DF, strength, quantity, date. | Name/address/DEA registration of parties involved

Answer 238

Chemical distributor | Form 510

Answer 239

One business day

Answer 240

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

Answer 241

Name of item, quantity, package size Upon receipt document actual quantity received and date of receipt

Answer 242

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

Answer 243

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.

Answer 244

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

Answer 245

Within 72 hours

Answer 246

Must put on back: date, RPh, quantity filled, quantity remaining Must put “LTCF” or “terminally ill”

Answer 247

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

Answer 248

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

Answer 249

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

Answer 250

Name, at least kind indication, most significant risks

Answer 251

Misbranding

Answer 252

Adulterated

Answer 253

Adulterated

Answer 254

Misbranding

Answer 255

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

Answer 256

It means the generic has demonstrated pharmaceutical equivalence and bioequivalence

Answer 257

Must be at least 6 months away Can not donate CS

Answer 258

Only to prescribers, hospital pharmacy, or other healthcare entity at the written request of the prescriber This does NOT include retail pharmacies

Answer 259

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

Answer 260

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

Answer 261

>15 CFU Recall csps, provide adverse event surveillance, contact prescribers, and engage microbiologist/industrial hygeinist/ID professional

Answer 262

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

Answer 263

Immediate use

Answer 264

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

Answer 265

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

Answer 266

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

Answer 267

Must be “law” and have compounding requirements necessary

Answer 268

Upon renewal of pharmacy license For complex non sterile and sterile compounding

Answer 269

90 days Note: one extension per petitioner may be considered When denied: its 2 years from the date of denial NOT original submission

Answer 270

It is recommended but NOT required to contact MD Note: pharmacies must be CPR certified

Answer 271

Authorized practitioners

Answer 272

Physicians Maybe NP and PA too?

Answer 273

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

Answer 274

When dispensing narcotic or CS in schedule 2 or 3

Answer 275

It’s printed on label that goes on bottle Must also do this for drugs that are sterile and complex-non sterile compounds

Answer 276

Schedule 2 and 3 Done annually

Answer 277

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

Answer 278

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

Answer 279

By the end of the month

Answer 280

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

Answer 281

“For pain”

Answer 282

When transferred or partially filled

Answer 283

C2: 7 day C3-5: 34 day supply or 100 dosage units

Answer 284

Aqueous, oleaginous, or solid DF Does not contain more than 20% CS Only distributed to prescribers registered to dispense CS

Answer 285

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

Answer 286

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

Answer 287

# Fill emergency c2 Dispense controls without RX (c5 sale allowed in some states)

Answer 288

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

Answer 289

No as long as requirements are similar

Answer 290

The BOP. The rehab committee give recommendations

Answer 291

Commissioner

Answer 292

Just in Massachusetts

Answer 293

1st day of month following appointment

Answer 294

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

Answer 295

Every 6 months

Answer 296

Document manufacturer on the label and RX!

Answer 297

Must be nurse midwife not regular midwife!

Answer 298

Within 30 days of the change

Answer 299

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

Answer 300

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

Answer 301

You must notify the MD! Note: when partially filling a c2 you note the quantity supplied on the front of the rx

Answer 302

DF and dose Medpak: DF Doctor dispense: DF

Answer 303

Immediately

Answer 304

On the same day of discovery Documented by the DISCOVERING pharmacist

Answer 305

Initially prior to obtaining Cs registration and then biennially

Answer 306

Outsourcing facility, pharmacy

Answer 307

Non-narcotic

Answer 308

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

Answer 309

Dispensers Distributors just have to do state police

Answer 310

The fact that it was partially filled and the quantity dispensed Must be available to the MD upon REQUEST

Answer 311

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

Answer 312

Not usually Note: ADS electronically records dispensing thus maintaining records for the pharmacy

Answer 313

Biologic application

Answer 314

Secobarbital

Answer 315

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

Answer 316

PPI: healthcare Medguide: patient

Answer 317

Retail pharmacies-They must also monitor machine by video Hospice ADDs-also video monitor

Answer 318

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

Answer 319

By October 1st to get waiver in time

Answer 320

ALL SCHEDULE 2s was previously just opioid c2s but was expanded

Answer 321

C2 NARCOTIC! Same for compounded parenteral Note LTCF it can be any c2

Answer 322

Medical emergency Patient must print name on rx RPh must document: date, hour, nature of emergency on Back

Answer 323

Community Also need referral and consent

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