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Pharmacy Law > Federal Law > Flashcards

Federal Law Flashcards

1
Q

What are statutes?

A

Laws made by legislatures and defined by administrators, administrative agencies (SBP).

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2
Q

What are some examples of Administrative Agencies?

A

Dept of Health and Human Services, Health Care Financing Admin., FDA, FDCA, Federal Trade Commission, US Justice Department.

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3
Q

What is negligence?

A

Omission: failing to do something that a reasonable person would do.

Commission: doing something that a reasonable person would not do.

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4
Q

Duty Owed

A

legal obligation to care for the patient while performing acts that could potentially harm them

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5
Q

Breach of Duty

A

violation of the duty of care

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6
Q

Causation

A

law requires proof that the pharmacist’s misconduct caused the alleged damage

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7
Q

Damage

A

loss or injury to the person or property

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8
Q

What is considered a drug?

A
  • recognized in the USP and NF
  • use for disease diagnosis, cure, mitigation, treatment, or prevention
  • affect structure or any function of the body
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9
Q

What is a new drug?

A

Not yet recognized as safe or effective by an expert

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10
Q

What is considered a device?

A

-recognized in official NF or USP

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11
Q

Cosmetic

A

for beautifying purposes

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12
Q

Prescription Drug

A
  • habit forming
  • toxic
  • limited approved application
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13
Q

OTC

A
  • recognized as safe and effective for use by experts
  • complies with CGMP
  • “adequate directions for use”
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14
Q

What must OTC drugs contain?

A

adequate directions for use

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15
Q

NDA

A

New Drug Application

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16
Q

New Drug Development Process

A
  1. Pre-clinical testing (animal testing)
  2. File IND
  3. Clinical Trials
  4. File NDA
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17
Q

What are the 3 phases of clinical trials?

A

Phase I: healthy volunteers
Phase II: small scale trials in pt with disease
Phase III: large scale clinical trials

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18
Q

In which phase do you file NDA?

A

Phase IV: post-marketing trials

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19
Q

What is the main goal of IND application?

A

safety of the individual in clinical studies.

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20
Q

GMP

A

regulations to ensure drug is safe, quality, and pure

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21
Q

Purple book

A

List of biologics

22
Q

Orange book

A

generic is bioequivalent to brand

23
Q

MedWatch

A

report “serious and adverse” event to a medication

24
Q

VAERS

A

report adverse reaction to a vaccine

25
ANDA
application to make a generic version of an FDA approved brand drug
26
SNDA
application to request a change in production, manufacturing, or labeling of FDA approved drug
27
REMS
benefits outweight risk. | found at REMS@FDA
28
New Drug Development Process
Pre-clinical testing file IND clinical trials file NDA
29
Kefauver-Harris Amendment of 1962
- drugs are safe and effective - established Good Manufacturing Practices - NDA process - established advertising procedures (FDA - legend drugs. FTC - OTC drugs).
30
What is the goal of the Controlled Substances Act?
trace a CS from the time it is manufactured to the time it is dispensed to the ultimate user
31
Who can dispense CS?
registered prescribers and pharmacies
32
which individual practitioners must register with the DEA?
physician, dentist, vet, podiatrist, NP, nurse midwife, CRNA, specialist, PA
33
who needs to include a 2 digit suffix while under a hospital registration?
intern, resident, foreign trained physician (IP)
34
DEA 224
new registration
35
DEA 224a
renewal application
36
DEA 224b
renewal of chain pharmacy
37
DEA number
second letter must be the last name of the registrant
38
DEA 106
report of theft or loss
39
which DEA form do you use for theft or loss?
106
40
which DEA form do you use for destruction or narcotics?
41
41
which DEA form is used when sending drugs to another company to be destroyed?
222, because you'll be a distributor
42
which DEA form is used to order narcotics?
222
43
which class of CS needs a DEA 222?
CII
44
what kind of record is required for CIII-CV?
invoice
45
CII inventory requirements
actual physical count
46
CIII-V inventory requirements
- can estimate - required if 1000+ unites and opened - newly scheduled on effective day
47
steps to ordering a cs
supplier keeps copy 1 and fwd copy 2 to DEA | purcahser keeps copy 3 for 2 years
48
suppliers can fill in:
- misspelled name if obvious - date missing if less than 60 days after receipt - package size missing if only one package size - strength of drug missing if only one strength
49
requirements of prescription
quantity
50
medication order
weight

Pharmacy Law (3 decks)

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