Utah Mpje

Front 1

Food and Drug Cosmetic Act

Back 1

SAFETY

Narc "may be habit forming"

expand definition of misbrand/adulteration

Front 2

Durham-Humphrey

Back 2

ORAL ORDER

allowed doctor dispensing for administration

"caution: federal law prohibits dispensing without a prescription"

Front 3

Kefauver-Harris

Back 3

EFFICACY

standards for GMP (good mfg practices)

advertising - FDA:RX FTC:OTC

new drug approval process

Front 4

Control Substance Act

Back 4

created DEA

scheduleing of drugs

resigrations

Front 5

Poison Prevention Packaging Act

Back 5

child-resistant

no more than 20% of kids <5 yo can open in <10 min

Front 6

Patient can make blanket request for easy off caps?

Back 6

True

Front 7

Doc can only make specific drug requests for easy off?

Back 7

True

Front 8

Medical device Class I

Back 8

Low risk, no safety testing

scissors, needles, hemostat

Front 9

Medical device Class II

Back 9

Medium risk, safety testing required

hearing aid, sun lamp, tampon, thermometer, catheter

Front 10

Medical device Class III

Back 10

High risk, safety testing required

Life supporing equiptment

Front 11

FDA Recall

Class I

Back 11

Worst case

serious ADR

death

Front 12

FDA REcall

Class II

Back 12

Medium

temporary or reverisble damage

remote chance of ADR

Front 13

FDA REcall

Class III

Back 13

Low

not likely ADR

Front 14

ORphan Drug Act

Back 14

incentive for new drugs for rare disease (<200,000 ppl)

Front 15

Drug Price Competition Act

Back 15

accelerated generic approval

ANDA (abbreviated new drug application)

Front 16

Prescription Drug Marketing Act

Back 16

federal standard storage, distrib, record keeping of rx drugs

ban reimporting drugs back into USA

Front 17

Dietary Supplement and Health Edu ACt

Back 17

deregulated herbal remedies

cannot make claims of dx, tx, cure

must state that "not regulated by FDA and not meant to dx, tx, cure"

supplements no longer classified as food

Front 18

FDA Modernization Act

Back 18

"Rx only" replaces warning

improve efficiency

incentive for pediatric clin studies

pharm cmpnding regulations

Front 19

Class A Pharmacy

Back 19

retail

Front 20

Class B Pharmacy

Back 20

institutional

hospital, clinic, closed door, nuclear, branch, pharm admin, sterile product

Front 21

Class C

Back 21

mfg, productions, wholesale, distribution of drugs and devices

Front 22

Class D

Back 22

non- residential (mail order)

Front 23

Class E

Back 23

other pharmacy

Front 24

DEA Form 41

Back 24

DESTRUCTION

notify DOPL and send copy

keep records 5 years

Front 25

DEA Form 224

Back 25

New Pharmacy Registration

Front 26

DEA Form 224a

How often?

Back 26

Renewal pharmacy registration

Every 3 year

Receive renewal form 45 day prior to exp

Front 27

DEA Form 510

Back 27

DEA Chemical Distributor Registration

Front 28

If change of business address

Back 28

Get a new DEA certif with new address

Front 29

DEA Form 224b

Back 29

Renewal chain pharmacies

Front 30

Termination of Registration

Back 30

1. Notify nearest DEA Registation Field office in writing before termination
2. send DEA certif of registration
3. return unused 222 forms with VOID printed on them
4. indicate where control substance inventories will be kept
5. indicate how CS destroyed
6. keep record for 2 years (federal)

Front 31

Transfer of Business

Back 31

1. notify at least 14 days before date
2. name, address, registration # of discontinuing business and acquiring business
3. address of new location if applicable
4.date of CS transfer to person acquiring the pharmacy
5. CS inventory taken and kept by both parties

Front 32

DEA Form 222

Back 32

Ordering or Transfering CII

Front 33

DEA Form 222a

Back 33

Ordering more 222 forms

limit of 6 books with 7 forms each

Front 34

Who keeps what parts of 222 form?

Who initiates the 222 form?

Back 34

1. DEA
2. Supplier
3. Receiver - initiates the form

Front 35

Form 222

transfer CS to another pharmacy

Back 35

inventory of name, form, strength, quantity, date transfered

222 form

both party keeps record

don't need to send to DEA

receiver needs to keep record for 2 years federally, 5 years utah)

pharmacy can only transfer out <5% of CS that are dispensed in a year - or else need to register as "distributor" with DEA

Front 36

Form 222

transfer to supplier or mfg

Back 36

1. date of transaction
2. name, form, strength, quantity
3. supplier or mfg name, address, registration #
4. form 222

Front 37

Form 222

transfer to reverse distributor

Back 37

1. contact DEA Diversion Field office
2. RD issues 222 form to pharmacy
3. RD fills out form 41 or have DEA agent or state law enforcement witness destruction

keep records for 2 yrs federally and 5 yrs utah

Front 38

Two options for pharmacy storage of controls?

Back 38

1. locked cabinet

2. dispersed through out legend drugs

Front 39

DEA Form 106

Back 39

report theft or loss of CS

notify DEA w/in 1 day of discovery

notify DOPL (send copy)

includes shipping losses

notify local police and get case #

Front 40

DEA Form 106 Must include

Back 40

1. Name and address of pharmacy
2. DEA #
3. Date of theft
4. Name and phone # of local police notified
5. Type of theft
6. Listing of symbols or cost code used by pharmacy in marking containers
7. Listing of missing controls

Front 41

DEA Form 363

Back 41

narcotic treatment program

Front 42

Inventory Requirement

CII?

CIII-V?

Back 42

CII: actual count

CIII-V: estimate okay unless container is >1000 units and has been opened

Front 43

Inventory Requirements

Back 43

1. Annually
2. Kept for 5 years
3. CI & CII kept separate from CIII - V

Front 44

CE Requirement

Total per 2 year period

Back 44

30 hours

Front 45

CE Requirement

Live

Back 45

12 hours

Front 46

CE Requirement

Drug therapy or pt mgt

Back 46

15 hours

Front 47

CE Requirement

Law

Back 47

1 hour

Front 48

Pharmacy intern hour requirements

Total?

Back 48

1500 hours

Front 49

Pharmacy intern hour requirements

PEP Program total?

3 required sites and hours?

Back 49

360-900 hours

120 Hospital
120 Clinical
120 Retail

Front 50

Unlawful vs. Unprofessional Conduct

Knowingly preventing or refusing to
permit a lawfully authorized inspection

Back 50

Unlawful

Front 51

Unlawful vs. Unprofessional Conduct

Failing to deliver a license, or certificate
to the division, upon demand

Back 51

Unlawful

Front 52

Unlawful vs. Unprofessional Conduct

•Buying or selling any drug that is marked
– Sample, not for resale, or investigational

Back 52

Unlawful

Front 53

Unlawful vs. Unprofessional Conduct

being in possession of a prescription drug for any unlawful purpose

Back 53

Unlawful

Front 54

Unlawful vs. Unprofessional Conduct

dispensing a rx drug to anyone who does not have a prescription or to anyone who attempting to obtain drugs by fraud or misrepresentation

Back 54

Unlawful

Front 55

Unlawful vs. Unprofessional Conduct

selling, dispensing, or trafficking in prescription drugs when not licensed to do so or when not exempted from licensure

Back 55

Unlawful

Front 56

Unlawful vs. Unprofessional Conduct

using a prescription drug or controlled substance that was not lawfully prescribed for him by a practitioner

Back 56

Unlawful

Front 57

Unlawful vs. Unprofessional Conduct

Willfully deceiving or attempting to deceive the board

Back 57

Unprofessional

Front 58

Unlawful vs. Unprofessional Conduct

Paying rebates to practitioners - kickbacks

Back 58

Unprofessional

Front 59

Unlawful vs. Unprofessional Conduct

Misbranding/adulteration of drug
– dispensing an expired drug

Back 59

Unprofessional

Front 60

Unlawful vs. Unprofessional Conduct

Accepting back and redistributing any unused drug

Back 60

Unprofessional

Front 61

Unlawful vs. Unprofessional Conduct

Violating the CSA

Back 61

Unprofessional

Front 62

Unlawful vs. Unprofessional Conduct

Requiring interns/techs to work outside scope of practice

Back 62

Unprofessional

Front 63

Unlawful vs. Unprofessional Conduct

Disclosing confidential information in violation of HIPPA

Back 63

Unprofessional

Front 64

Unlawful vs. Unprofessional Conduct

Pharmacy with no PIC

Back 64

Unprofessional

Front 65

Unlawful vs. Unprofessional Conduct

Preparing a prescription drug which is commonly available

Back 65

Unprofessional

Front 66

Unlawful vs. Unprofessional Conduct

violating Code of Ethics for Pharmacists

failing to comply with USP Chapters 795 and 797

failing to comply with the CE requirements

Back 66

Unprofessional

Front 67

Unlawful vs. Unprofessional Conduct

failing to provide a current mailing address within a 10 business day period of time
following any change

Back 67

Unprofessional

Front 68

Unlawful vs. Unprofessional Conduct

defaulting on a student loan

Back 68

Unprofessional

Front 69

Unlawful vs. Unprofessional Conduct

failing to abide by all applicable federal and state law regarding the practice of pharmacy;

Back 69

Unprofessional

Front 70

Unlawful vs. Unprofessional Conduct

failing to comply with administrative inspections;

Back 70

Unprofessional

Front 71

Unlawful vs. Unprofessional Conduct

abandoning a pharmacy or leaving prescription drugs accessible to the public;

Back 71

Unprofessional

Front 72

Prescription Transfers

Who to who?

Keep record how long?

Back 72

Pharmacist to pharmacist (or intern)

5 years keep records

Must void rx and write "void" on original

Front 73

Record on transfered Rx

Back 73

1. Date of issue, first and last fill
2. Original rx #
3. Original refills and amt remaining
4. Name, address of sending pharmacy
5. Name of both pharmacists/interns

Front 74

E-scrips require same info as written rx and also...

Back 74

1. time and date transmitted
2. name of intended pharmacy
3. deemed original rx
4. record kept for 5 years

*e-script presented physically by pt can NOT be filled*

Front 75

Prescription requirements

Back 75

Name of Doc
Address
Phone
(DEA if control)

Name of Pt Date issued
Address (DOB if control)


Name of drug

(quantity if control)

Directions (specific if control)


Doc Signature

Front 76

Label requirements

Back 76

Pharmacy Name
Address, Phone

Rx # Filling date or last dispense

Pt Name Doc Name

Directions, cautionary statements

Drug Name, Strength, Quantity

Expiration Date (fed only)

Front 77

Generic Sub allowed if

Back 77

1. PT requests or consents
2. A/B rated in orange book
3. Pharmacist/intern counsels pt on use and expected response
4. Not DAW rx

Front 78

Emergency Refills Allowed if...

Day supply limit?

Back 78

1. Can NOT reach prescriber and pharmacist judgement says pt shouldn't stop med
2. 72 hour limit
3. Contact prescriber ASAP

Front 79

Drug samples okay to dispense by doc if...

Back 79

1. not CII, benzo, opioid
2. in original mfg container
3. marked as sample on container OR marked in pt chart sample was given (name and quantity)
4. 30 day sup limit on controls
5. free of charge to pt

Front 80

Patient counseling by pharmacist should include

Back 80

1. Name and description of drug
2. form, ROA, dose, duration of therapy
3. indication and expected action
4. special directions
5. common, serious ADR
6. self-monitoring
7. storage
8. missed dose
9. expiration date/BUD

Front 81

Schedule I

Back 81

1. no medical use
2. can NOT be prescribed or dispensed
3. for research/lab/analysis only

heroin, marijuana, mathaqualone, LSD, etc

Front 82

Schedule II

Back 82

1. medical use
2. high abuse potential
3. severe pysch or physical dependence

cocaine, fentanyl, secobarbital, hydrocodone, poppy, coca leaves, amobarbital, pentobarbital, phencyclidine,

Front 83

Schedule III

Back 83

1. medical use
2. less abuse potential than CII
3. high psych, moderate-low physical dependence

anabolic steroids, ketamine, hydrocodone combos, dronabinaol, amobarbital, benzphetamine, chlorphentermine, buprenorphine,

<1.8 g codeine/100ml (or 90mg per unit)

<1.8 g dihydroco/100ml (or 90mg per unit)

<300 mg dyhydro/100ml (or 15mg per unit)

<300 mg ethylmorphine/100ml (or 15 mg/unit)

Front 84

Schedule IV

Back 84

1. Medical use
2. less abuse potential than CIII
3. limited psych or physical dependence

soma (carisoprodol), lunesta (eszopiclone), sonata (zaleplon), benzo's, nuvigil, provigil (modafinil), fenfluamine, phenteramine, sibutramine

Front 85

Schedule V

Back 85

1. medical use
2. low abuse
3. limited psych or physical dependence

lomotil, phenergan with codeine, pyrovalerone

<200mg codeine/100ml or g
(Cheratussin, Pediacof)

<100mg hydrocodone/100ml or g
(Cophene-s)

<100mg ethylmorphine/100ml or g

<2.5 mg diphenoxylate and 25mg atropine per unit
(lomotil)

Front 86

DEA Number Check

Back 86

two letters and 7 #'s

first letter ID's registrant

- A,B,F: hospital, clinic, practitioner, pharmacy, teaching institution

- M: midlevel practioner (PA, NP, OD, APN, CNP,

- P, R: mfg, distrib, research, analytical, importer/exporter

-X: DATA doc

AB1111119

1st + 3rd + 5th = 3

2nd + 4th+ 6th = 3 x 2 = 6

3+6 = 9 (last number of DEA)

Front 87

DATA - Drug Addiction Tx Act

Back 87

don't need 363 form

apply for DHHS waiver

can treat 30 pts (up to 100 pts)

DEA number start with "X"

only suboxone for use

Front 88

Combat Meth Epidemic Act

Back 88

3.6 g per day

9 g per month

ephedrine, phenylpropanolamine, pseudoephedrine

log book not required for sale <60mg

Front 89

Rx Requirements

Back 89

Must be written
except - oral emergency CII
- verbal order for CIII-V
- fax for LTCF, hospice, home IV

Front 90

True or False

Only pharmacist/intern may dispense control in Utah

Back 90

True

Front 91

CII Requirements

Back 91

1. no refills
2. 30 day sup
3. exp 30 days from date written
4. can NOT be filled after 30 days from last dispense date if separately indicated from issue date
5. may not contain another rx

Front 92

CII Multiple RX requirements

Back 92

1. limit 3 rx's
2. limit 30 days each
3. date of issue and date to be filled on 2nd and 3rd
4. can NOT dispense sooner than 30 days from date last filled

Front 93

CIII-IV rx requirements

Back 93

1. 6 month expiration from date of issue
2. only refill 5 times
3. can NOT contain another rx

Front 94

CV rx requirements

Back 94

1. rx in utah
2. 1 year expiration from date of issue
3. refills as doc directs
4. can NOT contain another rx

Front 95

True or False

Can prescribe, administer, dispense to minor a control without parental consent

Back 95

FALSE

must have parental consent on controls

Front 96

True or False

Cocaine can only be to prescribed for topical anesthetic in surgery and laceration repair

Back 96

True

Front 97

True or False

Control rx must contain specific sig for use

Back 97

True

cannot just be UD

Front 98

Emergency verbal CII okay if...

Back 98

1. Limit 72 hour sup
2. cover to follow in 7 days
3. report to dea if no cover, or else pharmacist cannot accept oral CII orders
4. prescriber-pt relationship (seen w/in last 30 days)

Front 99

Partial CII okay if

Back 99

1. can NOT supply full quantity
2. must dispense remaining in 72 hours
3. pharmacist notes quantity given on front of rx
4. contact prescriber if can't supply in 72 hours - need new rx now

Front 100

Partial CIII-V okay if

Back 100

1. noted dispensed quantity and initials back of rx
2. may not exceed total amt auth on rx
3. may not be filled after 6 months from issue

Front 101

What can pharmacist change or add on CII rx with verification with doc or pt (when applicable)?

Back 101

1. Pt address or DOB
2. Dosage form, strength, quantity, directions
- must write changes on rx

Front 102

If made changes to CII rx with auth from doc pharmacist must note

Back 102

1. WHO
2. WHAT
3. WHEN
4. WHY
5. Signature of pharmacist

Front 103

What can NOT be changed on a CII

Back 103

1. Pt Name
2. Drug Name (generic sub ok)
3. Date Written
4. Doc's Signature

Front 104

True or False

If theft or loss is > $500 then needs to be investigated by FBI

Back 104

TRUE

Front 105

CS Database

Pharmacist submits how often?

Back 105

Weekly

Electronically

Front 106

CS Database

Cover page should include

Back 106

1. Pharmacy name
2. NABP#
3. Period of time of submission
4. Date prepared
5. Date Submitted
6. Number of rx's
7. RPh signature

Front 107

CS Database

For each rx info submitted:

Back 107

1. Name of doctor, pharmacy, RPh
2. Date issued and filled
3. Name of patient
4. Their form of ID and ID number
5. Name of drug, strength, quantity, directions

Front 108

CS Database

Who has access?

Back 108

1. pharmacist
2. doc (may designate 3 ppl)
3. mental health therapist
4. DOPL investicational staff
5. DOPL and health dept authorized to analyze CS rx's
6. ultimate user with DOPL approval

***3rd degree felony if access illegally***

Front 109

How soon may a control rx be filled?

Back 109

Not until 80% of the drug should be gone

Front 110

True or False

It is unlawful or unprofessional to prescribe or dispense for "the partner of ____".

Back 110

False

Partner's ID can be omitted from rx and label

Must counsel person picking up