Final Law Exam 1

Question 1

What law to use if there is a difference in state and federal law

Answer 1

whichever is MORE STRICT

Question 2

you break the law and are punished by FINES or JAIL time

Answer 2

Criminal Action

Question 3

individual SUES another party

Answer 3

Civil Action

Question 4

violate a law or regulation and the board of pharmacy

Answer 4

Administrative Action

Question 5

Device NOT used for supporting life, does NOT present risk of illness or injury (just has to be registered w/ FDA and follow cGMP!!)

Answer 5

Class I

Question 6

• Device has moderate risk to use, requires special controls to assure safety
• Have published performance standards that MUST be met

Answer 6

Class II

Question 7

• Device has high risk to use, supports or sustains human lie
• have to be proven safe and effective

Answer 7

Class III

Question 8

Pharmacy or Traditional Compounding 503a

Answer 8

• community pharm compounding at an as needed basis
• for individual pts
• can be done in advance, but only if prescriber orders a lot
• EXEMPT from cGMP, misbranding, and new drug requirements

Question 9

Outsourcing Facilities 503b

Answer 9

• large batches with or without Rx’s
• to be sold to facilities for office use only
• cGMP and labeling/packaging requirements

Question 10

Grandfathered drugs

Answer 10

• came out before 1983 and is still on the market
• ex: Digoxin, codeine

Question 11

Drug Efficacy Study Implementation (DESI) drugs

Answer 11

• drugs that came out between 1938-1962
• investigated the efficacy of the drugs

Question 12

in vivo animal testing, record data on Tox and pharmacology

Answer 12

Step 1: Preclinical Research

Question 13

IND submission

Answer 13

Step 2: Submission of Investigational New Drug (IND)

Question 14

20-100 HEALTHY volunteers

Answer 14

• Step 3: Clinical Research
• Phase I

Question 15

• several hundred volunteers with the disease state being studied
• expand on safety, AE, and efficacy

Answer 15

• Step 3: Clinical Research
• Phase II

Question 16

Citizen of IN is represented by:

Answer 16

• ONE Indiana state Representative
• ONE US Representative
• TWO US Senators

Question 17

Orphan Drug Act

Answer 17

• lower stat burden and proof of safety for drugs that treat RARE DISEASE STATES

Question 18

What do you have to prove for generic drug approval?

Answer 18

-Bioequivalence
- acceptable manufacturing practices and controls

Question 19

what drugs require special packaging?

Answer 19

• Oral Admin (unless bulk product or unit dose containers)

Question 20

Recall for drug that may cause serious health consequences

Answer 20

Class I recall

Question 21

what drugs NEED a Patient Package Insert to be dispensed with the drug?

Answer 21

• Estrogens
• Oral Contraceptives

Question 22

REMS: info sent to practitioners informing about drugs and to mitigate issues for pts (all on the practitioner, nothing for the pt to do)

Answer 22

Communication Plan

Question 23

REMS: required activities that must be done before prescribing or dispensing (Pt has to do something) (ex: BG, pregancy test, verifying understanding)

Answer 23

Elements to assure safe use

Question 24

REMS: quality assurance process to ensure that risk are being mitigated successfully

Answer 24

Implentation system

Question 25

MedWatch forms

Answer 25

- Professional form 3500 - Patient form 3500B

Question 26

Big four prescribers

Answer 26

- Physicians - Dentists - Podiatrists - Veterinarians

Question 27

Rx, OTC, and C-II refill exp date

Answer 27

ONE YEAR

Question 28

C-III, C-IV, C-V refill exp date

Answer 28

SIX MONTHS

Question 29

How many refills are allowed for C-III, C-IV, and C-V?

Answer 29

FIVE

Question 30

How many refills allowed for C-II?

Answer 30

NO REFILLS

Question 31

NDC # meanings

Answer 31

11 total - First 5: ID manufacturer - middle 4: ID drug, strength, dosage form, and formulation - last 2: ID package size Add ZERO to the front of whatever section is missing a number

Question 32

HIPAA Privacy Rule

Answer 32

- can only disclose PHI in certain situations (pt request, investigation)

Question 33

HIPAA Security Rule

Answer 33

maintain reasonable and appropriate safeguards

Question 34

HIPAA Breach Notification Rule

Answer 34

- Affects fewer than 500: notify SHHS within 60 days of the end of the year - Affects 500 or more pts: notify SHHS within 60 days from discovery

Question 35

BUD: non-aqueous formation

Answer 35

no more than SIX MONTHS or exp date

Question 36

BUD: Water-containing ORAL fomulation

Answer 36

No more than 14 DAYS or exp date

Question 37

BUD: water containing topical, mucosal formulations

Answer 37

no more than 30 days or exp date

Question 38

When can warrants be served?

Answer 38

- AIW: regular business hours - Search warrants: ANY TIME