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Federal Law Flashcards

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1
Q

What form do pharmacies use to register with the DEA?

A

DEA form 224

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2
Q

How often must DEA registration be renewed?

A

Every 3 years

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3
Q

Do pharmacies under the same owner each need to register with the DEA?

A

Yes

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4
Q

How long can pharmacies handle CS if their registration expires?

A

No amount of time

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5
Q

What form is used to transfer C-II drugs between pharmacies?

A

DEA form 222

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6
Q

What happens if a DEA 222 form is lost or stolen?

A

Must immediately report to the DEA with the serial number of each form

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7
Q

How many pages is the DEA 222 form?

A

1 (used to be triplicate)

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8
Q

When can an estimate be used for CS inventories?

A

Only for CIII-V when an open bottle contains 1000 tablets or less (if > 1000 tablets, must have an exact count)

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9
Q

Can shipping and finanial records be kept at a central location?

A

Yes, as long as the pharmacy submits written notification to the DEA

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10
Q

Can a prescriber write for a CS under the DEA of the hospital?

A

Yes

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11
Q

Can a C-II be transferred?

A

Yes, only if it is transferred electronically (and it can’t have already been filled because there are no refills, duh)

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12
Q

How many times can a CIII-V be transferred?

A

1 time (if electronically, it doesn’t have to have been filled at the transferring pharmacy first)

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13
Q

What is the preclinical investigation phase?

A

Phase before any manufacturer can start human testing on a new drug (must provide evidence that the drug can be used safely in humans)

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14
Q

What application is submitted after the preclinical investigation phase?

A

Investigational New Drug Application

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15
Q

What is phase 1 of clinical trials?

A

Small brief study in healthy individuals (determines safety and early evidence of efficacy)

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16
Q

What is phase 2 of clinical trials?

A

Medium sized controlled clinical study in subjects who have the disesase (determines effectivenes and safety)

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17
Q

What is phase 3 of clinical trials?

A

Large trial that collects all the necessary data to meet the safety and efficacy regulations governed by the FDA (tests against gold standard)

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18
Q

What application is submitted after phase 3 of clinical trials?

A

New Drug Application

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19
Q

What is phase 4 of clinical trials?

A

Post-marketing evaluation

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20
Q

What is the definition of a rare disease?

A

Occuring in less than 200,000 people in the US

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21
Q

What is the incentive for researching orphan drugs?

A

Assistance for clinical research, tax credits for research, and 7 years of market-exclusivity

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22
Q

How long is a drug patent good for?

A

20 years

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23
Q

What application is submitted to bring a generic to the market?

A

Abbreviated New Drug Application

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24
Q

Definition of pharmaceutical equivalence?

A

Same dose, dosage form, and stregth

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25
Q

Definition of bioequivalence?

A

Same rate and extent of absorption

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26
Q

What do the letters of an Orange Book rating meean?

A

A or B (first letter) indicates therapeutic equivalence
Second letter indicates which dosage form it is

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27
Q

Definition of theapeutic equivalence?

A

Pharmaceutical and bioequivalence

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28
Q

What application is submitted when changes are made to a product’s indication, active ingredients, manufacture, or labeling?

A

Supplemental NDA

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29
Q

How soon must manufacturers report adverse effects to the FDA?

A

If life-threatening - 15 business days
If not serious - quarterly (for 3 years)

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30
Q

What did the Durham-Humphrey Amendment do?

A

Specified criteria to make drugs prescription-only status

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31
Q

What did the Kefauver-Harris Amendment do?

A

For the first time, drug manufacturers are required to prove to FDA the effectiveness of their products before marketing them (came from thalidomide)

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32
Q

How long does the FDA have to issue a warning letter after an inspection and how long does the complany have to respond?

A

15 days for both

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33
Q

Why were Tamper-resistant Packing Regulations issued?

A

To prevent poisonings after many died after cyanide placed in Tylenol capsules

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34
Q

What did the Federal Food, Drug, and Cosmetic (FDC) Act do?

A

Required new drugs to be proven safe before marketing and allowed FDA to inspect factories (due to diethylene glycol disaster)

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35
Q

How long must records be kept according to the DEA manual?

A

2 years

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36
Q

How often does a DEA registration number need to be renewed?

A

Every 3 years

37
Q

How long does a written prescription have to arrive after an oral prescription for a C-II (in an emergency)?

A

7 days

38
Q

What must be written on the written prescription that comes after an emergency C-II oral prescription?

A

Authorization for Emergency Dispensing

39
Q

What are the 2 ways C-II drugs can be ordered?

A

DEA form 222 or CSOS

40
Q

Refill limit on C-V drugs?

A

None

41
Q

Transfer limit on C-V drugs?

A

1

42
Q

Maximum codeine concentration so as not to require a prescription?

A

Less than 200 mg/100 mL

43
Q

Can central fill pharmacies dispense controlled substances?

A

No

44
Q

What is the max number of controlled substances that can be transferred between DEA registered practitioners?

A

5% of the total number of controlled substances dispensed

45
Q

What do the first two letters in a DEA number represent?

A

A, B, or M indicates type of practitioner (M for mid-level)
Second letter is the first initial of last name

46
Q

DEA number formulat

A

Add all the odds
Add all the evens and multiply by 2
Add evens and odds together
Last digit should be last digit of the DEA number

47
Q

What DEA form is used for a pharmacy to register for a DEA number?

A

DEA form 224

48
Q

Types of mid-level practitioners

A

Nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists, physician assistants, optometrists

49
Q

What act required child-resistant closures?

A

Poison Prevention Act of 1970

50
Q

How many orders lines are on a 222 form?

A

20

51
Q

Who keeps the original 222 and who keeps a copy?

A

The purchaser makes a copy and keeps it, sends the original to the supplier

52
Q

Non-sterile BUDs

A

Non-preserved aqueous: 14 days (refrigerator)
Preserved aqueous: 35 days (CRT or refrigerator)
Oral nonaqueous: 90 days (CRT or refrigerator)
Other nonaqueous: 180 days (CRT or refrigerator)

53
Q

Sterile Category 1 BUD

A

12 hours or less at CRT
24 hours or less in a refrigerator

54
Q

Sterile Category 2 BUD

A

1-4 days at CRT
4-10 days in a refrigerator
45 days in a freezer

55
Q

Sterile Category 3 BUD

A

60-90 days at CRT
90-120 days in a refrigerator
120-180 days in a freezer

56
Q

How often must the ceiling of a sterile compounding area be cleaned?

A

Monthly

57
Q

How often must the walls/shelving/chairs in a sterile compounding area be cleaned?

A

Weekly

58
Q

Steps of cleaning hazardous drug spill

A

Deactivate (2% bleach or peroxide)
Decontaminate (ammonia)
Clean (water)
Disinfect (70% sterile isopropyl alcohol)

59
Q

What bin is trace hazardous waste put in?

A

Yellow bin

60
Q

What bin is bulk hazardous waste put in?

A

Black bin

61
Q

How often must schedule II-V drugs be inventoried (federally)?

A

Biannually

62
Q

How long must a Sudafed logbook be kept?

A

2 years

63
Q

What is required for a minor to receive narcotic maintenance treatment?

A

2 attempts at detox within 12 months

64
Q

Which clinical trial phase is used to determine dose?

A

IIa

65
Q

Do CS not yet picked up by patient need to be included in inventory?

A

Yes

66
Q

Where is self-prescribing allowed?

A

In most states

67
Q

How much aspirin or tylenol exempts a product from child-proof packaging?

A

15% or less

68
Q

When can ephedra be sold?

A

If the label does not indicate the the product is a dietary suplement (must be a traditional food product, OCT, or prescription)

69
Q

What form is for narcotic treatment programs?

A

363

70
Q

How soon must the DEA be notified before transfering business to another registrant?

A

14 days

71
Q

What drugs must be locked up per federal law?

A

None

72
Q

Which schedules require the “do not transfer” warning?

A

II-IV

73
Q

How can a community pharmacy send a CS to a central fill pharmacy?

A

Electronic or fax

74
Q

What happens if CMEA rules are violated?

A

Your pharmacy may no longer be able to cell precursor drugs

75
Q

DEA form 225 vs 224

A

224: retail pharmacy, hospital, practitioner, teaching institution
225: manufacturer, distributor, researcher, analytical library, importer/exporter

76
Q

Can a pharmacy take back unwanted or unused CS?

A

Yes, if DEA-authorized

77
Q

Who regulates OTC drugs?

A

The FTC

78
Q

How long to report to DEA that pseudoephedrine was stolen?

A

15 days

79
Q

What is the max number of patients one provider can see for treatment of OUD with buprenorphine?

A

None

80
Q

How often must a pharmacy undergo self-certification for CMEA?

A

Annually

81
Q

Max aspirin tablets in an OTC container of pediatric aspirin?

A

36

82
Q

How often must gloving/garbing technique, fingertip and media-fill testing be done?

A

Semi-annually

83
Q

Which book is for vet med?

A

Green

84
Q

What components are required to makeup a product identifier?

A

Serialized Numerical Identifier, lot number, expiration date

85
Q

How soon must those involved in a data breach be notified?

A

60 days

86
Q

At what point must a data breach be reported to local media?

A

If it affects over 500 people

87
Q

How many days to retrieve records from central location for DEA?

A

2 days

88
Q
A

Law (5 decks)

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