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Federal Law Flashcards

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
Definition of bioequivalence?
Same rate and extent of absorption
26
What do the letters of an Orange Book rating meean?
A or B (first letter) indicates therapeutic equivalence Second letter indicates which dosage form it is
27
Definition of theapeutic equivalence?
Pharmaceutical and bioequivalence
28
What application is submitted when changes are made to a product's indication, active ingredients, manufacture, or labeling?
Supplemental NDA
29
How soon must manufacturers report adverse effects to the FDA?
If life-threatening - 15 business days If not serious - quarterly (for 3 years)
30
What did the Durham-Humphrey Amendment do?
Specified criteria to make drugs prescription-only status
31
What did the Kefauver-Harris Amendment do?
For the first time, drug manufacturers are required to prove to FDA the effectiveness of their products before marketing them (came from thalidomide)
32
How long does the FDA have to issue a warning letter after an inspection and how long does the complany have to respond?
15 days for both
33
Why were Tamper-resistant Packing Regulations issued?
To prevent poisonings after many died after cyanide placed in Tylenol capsules
34
What did the Federal Food, Drug, and Cosmetic (FDC) Act do?
Required new drugs to be proven safe before marketing and allowed FDA to inspect factories (due to diethylene glycol disaster)
35
How long must records be kept according to the DEA manual?
2 years
36
How often does a DEA registration number need to be renewed?
Every 3 years
37
How long does a written prescription have to arrive after an oral prescription for a C-II (in an emergency)?
7 days
38
What must be written on the written prescription that comes after an emergency C-II oral prescription?
Authorization for Emergency Dispensing
39
What are the 2 ways C-II drugs can be ordered?
DEA form 222 or CSOS
40
Refill limit on C-V drugs?
None
41
Transfer limit on C-V drugs?
1
42
Maximum codeine concentration so as not to require a prescription?
Less than 200 mg/100 mL
43
Can central fill pharmacies dispense controlled substances?
No
44
What is the max number of controlled substances that can be transferred between DEA registered practitioners?
5% of the total number of controlled substances dispensed
45
What do the first two letters in a DEA number represent?
A, B, or M indicates type of practitioner (M for mid-level) Second letter is the first initial of last name
46
DEA number formulat
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
What DEA form is used for a pharmacy to register for a DEA number?
DEA form 224
48
Types of mid-level practitioners
Nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists, physician assistants, optometrists
49
What act required child-resistant closures?
Poison Prevention Act of 1970
50
How many orders lines are on a 222 form?
20
51
Who keeps the original 222 and who keeps a copy?
The purchaser makes a copy and keeps it, sends the original to the supplier
52
Non-sterile BUDs
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
Sterile Category 1 BUD
12 hours or less at CRT 24 hours or less in a refrigerator
54
Sterile Category 2 BUD
1-4 days at CRT 4-10 days in a refrigerator 45 days in a freezer
55
Sterile Category 3 BUD
60-90 days at CRT 90-120 days in a refrigerator 120-180 days in a freezer
56
How often must the ceiling of a sterile compounding area be cleaned?
Monthly
57
How often must the walls/shelving/chairs in a sterile compounding area be cleaned?
Weekly
58
Steps of cleaning hazardous drug spill
Deactivate (2% bleach or peroxide) Decontaminate (ammonia) Clean (water) Disinfect (70% sterile isopropyl alcohol)
59
What bin is trace hazardous waste put in?
Yellow bin
60
What bin is bulk hazardous waste put in?
Black bin
61
How often must schedule II-V drugs be inventoried (federally)?
Biannually
62
How long must a Sudafed logbook be kept?
2 years
63
What is required for a minor to receive narcotic maintenance treatment?
2 attempts at detox within 12 months
64
Which clinical trial phase is used to determine dose?
IIa
65
Do CS not yet picked up by patient need to be included in inventory?
Yes
66
Where is self-prescribing allowed?
In most states
67
How much aspirin or tylenol exempts a product from child-proof packaging?
15% or less
68
When can ephedra be sold?
If the label does not indicate the the product is a dietary suplement (must be a traditional food product, OCT, or prescription)
69
What form is for narcotic treatment programs?
363
70
How soon must the DEA be notified before transfering business to another registrant?
14 days
71
What drugs must be locked up per federal law?
None
72
Which schedules require the "do not transfer" warning?
II-IV
73
How can a community pharmacy send a CS to a central fill pharmacy?
Electronic or fax
74
What happens if CMEA rules are violated?
Your pharmacy may no longer be able to cell precursor drugs
75
DEA form 225 vs 224
224: retail pharmacy, hospital, practitioner, teaching institution 225: manufacturer, distributor, researcher, analytical library, importer/exporter
76
Can a pharmacy take back unwanted or unused CS?
Yes, if DEA-authorized
77
Who regulates OTC drugs?
The FTC
78
How long to report to DEA that pseudoephedrine was stolen?
15 days
79
What is the max number of patients one provider can see for treatment of OUD with buprenorphine?
None
80
How often must a pharmacy undergo self-certification for CMEA?
Annually
81
Max aspirin tablets in an OTC container of pediatric aspirin?
36
82
How often must gloving/garbing technique, fingertip and media-fill testing be done?
Semi-annually
83
Which book is for vet med?
Green
84
What components are required to makeup a product identifier?
Serialized Numerical Identifier, lot number, expiration date
85
How soon must those involved in a data breach be notified?
60 days
86
At what point must a data breach be reported to local media?
If it affects over 500 people
87
How many days to retrieve records from central location for DEA?
2 days
88

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