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Pharmacy Law > Federal Law > Flashcards

Federal Law Flashcards

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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
Q

ANDA

A

application to make a generic version of an FDA approved brand drug

26
Q

SNDA

A

application to request a change in production, manufacturing, or labeling of FDA approved drug

27
Q

REMS

A

benefits outweight risk.

found at REMS@FDA

28
Q

New Drug Development Process

A

Pre-clinical testing
file IND
clinical trials
file NDA

29
Q

Kefauver-Harris Amendment of 1962

A
  • drugs are safe and effective
  • established Good Manufacturing Practices
  • NDA process
  • established advertising procedures (FDA - legend drugs. FTC - OTC drugs).
30
Q

What is the goal of the Controlled Substances Act?

A

trace a CS from the time it is manufactured to the time it is dispensed to the ultimate user

31
Q

Who can dispense CS?

A

registered prescribers and pharmacies

32
Q

which individual practitioners must register with the DEA?

A

physician, dentist, vet, podiatrist, NP, nurse midwife, CRNA, specialist, PA

33
Q

who needs to include a 2 digit suffix while under a hospital registration?

A

intern, resident, foreign trained physician (IP)

34
Q

DEA 224

A

new registration

35
Q

DEA 224a

A

renewal application

36
Q

DEA 224b

A

renewal of chain pharmacy

37
Q

DEA number

A

second letter must be the last name of the registrant

38
Q

DEA 106

A

report of theft or loss

39
Q

which DEA form do you use for theft or loss?

A

106

40
Q

which DEA form do you use for destruction or narcotics?

A

41

41
Q

which DEA form is used when sending drugs to another company to be destroyed?

A

222, because you’ll be a distributor

42
Q

which DEA form is used to order narcotics?

A

222

43
Q

which class of CS needs a DEA 222?

A

CII

44
Q

what kind of record is required for CIII-CV?

A

invoice

45
Q

CII inventory requirements

A

actual physical count

46
Q

CIII-V inventory requirements

A
  • can estimate
  • required if 1000+ unites and opened
  • newly scheduled on effective day
47
Q

steps to ordering a cs

A

supplier keeps copy 1 and fwd copy 2 to DEA

purcahser keeps copy 3 for 2 years

48
Q

suppliers can fill in:

A
  • 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
Q

requirements of prescription

A

quantity

50
Q

medication order

A

weight

Pharmacy Law (3 decks)

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