Federal and Quality assurance

Question 1

What is the FDA

Answer 1

The FDA (Food and Drug Administration) is a U.S. government agency responsible for protecting public health by regulating stuff
Reviewing and approving REMS.
Enforces standards

Question 2

REMS is..

Answer 2

A REMS (Risk Evaluation and Mitigation Strategy) is a drug safety program required by the Food and Drug Administration (FDA) to manage serious risks associated with specific prescription drugs.

These programs ensure that the BENFITS of a medication OUTWEIGHS its risks

Question 3

Where do u report drug reactions

Answer 3

MedWatch

Question 4

The DEA..

Answer 4

The Drug Enforcement Administration (DEA) enforces the United States’ controlled substance laws and regulations

• Prevent drug abuse

Question 5

Who gives prescribers special numbers when prescribing controlled medicine

Answer 5

DEA- DEA number

Question 6

What are the DEA class schedule classifications

Answer 6

classifies controlled substances into five schedules based on their potential for abuse and whether they have a currently accepted medical use
C I-V

Question 7

C I

Answer 7

drugs with no currently accepted medical use and a high potential for abuse. Some examples of

Schedule I drugs are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote.

Question 8

C II

Answer 8

high potential for abuse, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous.

hydrocodone per dosage unit (Vicodin), cocaine, methamphetamine, methadone, hydromorphone (Dilaudid), meperidine (Demerol), oxycodone (OxyContin), fentanyl, Dexedrine, Adderall, and Ritalin

Question 9

C-III

Answer 9

drugs with a moderate to low potential for physical and psychological dependence.

codeine per dosage unit (Tylenol with codeine), ketamine, anabolic steroids, testosterone

Question 10

C IV

Answer 10

drugs with a low potential for abuse and low risk of dependence.

Some examples of Schedule IV drugs are: Xanax, Soma, Darvon, Darvocet, Valium, Ativan, Talwin, Ambien, Tramadol

Question 11

C V

Answer 11

lower potential for abuse, (Robitussin AC), Lomotil, Motofen, Lyrica (pregabalin) , Parepectolin

Question 12

What is the (USP) - United states Pharmacopeia

Answer 12

Publish official stajdards for prescirptionand OTC meds

• Testing and verification

Question 13

USP Chapter 795 are for what type of compounding

Answer 13

Nonsterile

Question 14

USP 797

Answer 14

Sterile Compounding

Question 15

USP 800

Answer 15

Hazardous drugs

Question 16

USP 1075

Answer 16

Good compounding practices

Question 17

(TJC) The joint Commission

Answer 17

Non profit organization that certifies programs and healthcare organizations

Question 18

OSHA

Answer 18

ENFORCES= make sure rules are folloed and CAN FINE companies

• enforces and requires data

Question 19

NIOSH

Answer 19

Research = STUDIES work place risks and suggest safer practices and equipment

Question 20

Board of Pharmacy

Answer 20

BOPs are the state-level entities responsible for regulating pharmacy practice within their specific jurisdictions, including licensing and enforcement.

Question 21

NABP- National Association of Boards of Pharmacy

Answer 21

NABP is a national organization that supports and collaborates with BOPs to ensure consistent standards and practices across the country.

Question 22

What are 2 ways C-II can be provided to the pharmacy

Answer 22

1. Paper
2. E- Rx