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Phamacy Technician Exam > Pharmacy Law > Flashcards

Flashcards in Pharmacy Law Deck (25):
1

Administrative Law

from executive branch

2

common law

case law/ from judicial branch

3

Food Drug & Cosmetic Act
(FD&C)

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

4

Durham-Humphrey Amendment

prohibits dispensing legend drugs without a prescription

5

Kefauver- Harris Amendment

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

6

Controlled Substance Act
(CSA)

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

7

Poison Prevention Packing Act
(PPPA)

standards for child resistant packaging

8

Occupational Safety and Health Act
(OSHA)

prevent workplace disease and injury

9

Drug List Act

assigns the unique and permanent NDC

10

Federal Hazardous Substance Act
(FHSA)

use & disposal of hazardous material

11

Personal Protective Equipment
(PPE)

mask, gowns, gloves, etc.

12

Orphan Drug Act
(ODA)

offers financial help to organizations that develop Orphan drugs

13

Omnibus Budget Reconciliation Act
(OBRA)

maintaining patient profiles
offer counseling to patients
DUR

14

Drug Utilization Reviews
(DUR)

reviews of patient profiles to ensure medications dispensed were correct

15

Anabolic Steroids Control Act

allows the CSA to regulate anabolic steroids
became CIII drug

16

Health Insurance Portability and Accountability Act
(HIPAA)

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

17

PHI

Protected health information

18

FDA Modernization Act

reformed the old FDA
safe pharmacy compounding and the regulation of medical devices

19

Combat Methamphetamine Epidemic Act

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

20

State Pharmacy Board
(BOP)

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

21

Drug Enforcement Agency
(DEA)

federal body that regulates controlled substance laws

22

Food and Drug Administration
(FDA)

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

23

MedWatch

info about adverse events or product problems

24

Joint Commission on Accreditation of Health Organizations
(JCAHO)

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

25

National Association of the Board of Pharmacy
(NABP)

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