Pharmacy Law Flashcards

1
Q

Administrative Law

A

from executive branch

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2
Q

common law

A

case law/ from judicial branch

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3
Q

Food Drug & Cosmetic Act

FD&C

A

requires proper labeling or branding of products & inside the container cannot be changed from the label

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4
Q

Durham-Humphrey Amendment

A

prohibits dispensing legend drugs without a prescription

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5
Q

Kefauver- Harris Amendment

A

all medications must be pure, effective, and safe to use on humans
prescription drug advertising under the FDA
manufactures must have inspections

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6
Q

Controlled Substance Act

CSA

A

requires the pharmaceutical industry to keep records and maintain security measures for certain medications

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7
Q

Poison Prevention Packing Act

PPPA

A

standards for child resistant packaging

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8
Q

Occupational Safety and Health Act

OSHA

A

prevent workplace disease and injury

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9
Q

Drug List Act

A

assigns the unique and permanent NDC

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10
Q

Federal Hazardous Substance Act

FHSA

A

use & disposal of hazardous material

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11
Q

Personal Protective Equipment

PPE

A

mask, gowns, gloves, etc.

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12
Q

Orphan Drug Act

ODA

A

offers financial help to organizations that develop Orphan drugs

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13
Q

Omnibus Budget Reconciliation Act

OBRA

A

maintaining patient profiles
offer counseling to patients
DUR

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14
Q

Drug Utilization Reviews

DUR

A

reviews of patient profiles to ensure medications dispensed were correct

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15
Q

Anabolic Steroids Control Act

A

allows the CSA to regulate anabolic steroids

became CIII drug

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16
Q

Health Insurance Portability and Accountability Act

HIPAA

A

PHI
patient privacy, security, and transaction regulations
PT must know

17
Q

PHI

A

Protected health information

18
Q

FDA Modernization Act

A

reformed the old FDA

safe pharmacy compounding and the regulation of medical devices

19
Q

Combat Methamphetamine Epidemic Act

A

intended to stop the use of illegal drug methamphetamine
regulates drug trafficking that is used to finance terrorism
controls purchases of drugs listed

20
Q

State Pharmacy Board

BOP

A

every state has one
establish state-specific pharmacy laws & regulations
licenses/certification and board exams

21
Q

Drug Enforcement Agency

DEA

A

federal body that regulates controlled substance laws

22
Q

Food and Drug Administration

FDA

A

the safety and effectiveness of foods, med, cosmetics and radioactive substances

23
Q

MedWatch

A

info about adverse events or product problems

24
Q

Joint Commission on Accreditation of Health Organizations

JCAHO

A

accredits and certifies healthcare organizations in the U.S.
independent/ non-profit
improve safety and quality of healthcare

25
Q

National Association of the Board of Pharmacy

NABP

A

assists the BOP to protect public health by developing uniform standards
reduce the likelihood of errors and public harm