Pharmacy Regulatory Bodies

Question 1

Food and Drug Administration (FDA)

Answer 1

Ensuring safety in food, medicines, biologic/radioactive products, & cosmetics
MedWatch - a system in which the FDA is informed of any adverse effects that patients experience

Question 2

Drug Enforcement Administration (DEA)

Answer 2

Oversee and enforce legislation relating to controlled substances

Question 3

Form 106

Answer 3

If controlled substances go missing or are stolen within the pharmacy setting

Question 4

Form 222

Answer 4

When ordering C-II drugs
3 total copies valid for 60 days

Question 5

Form 41

Answer 5

Damaged controlled substances must be destroyed and recorded

Question 6

The Joint Commission (TJC)

Answer 6

Accredits and certifies healthcare organizations and ensures the best possible treatment outcomes
Site surveys every 3 years

Question 7

State Boards of Pharmacy (BOP)

Answer 7

Establishing state-specific laws and regulations
Certifying and licensing pharmacy personnel

Question 8

National Association of the Boards of Pharmacy (NABP)

Answer 8

Acts as a professional means to discuss the trajectory of pharmacy and how best to improve it on a state-by-state level

Question 9

United States Pharmacopoeia (USP)

Answer 9

Sets standards in OTC, prescriptions, & dietary supplements

Question 10

USP 795

Answer 10

Non-sterile compounding formulations such as cough meds in safe environment
Beyond-use dating

Question 11

USP 797

Answer 11

Sterile compounding
Ensure that no contaminants enter compounded medicines. Strict controls of clean rooms, ventilation, quality assurance, and microbial levels

Question 12

USP 800

Answer 12

Handling hazardous drugs
Minimize the possibility of harm from a hazardous drug or substance to healthcare workers

Question 13

Environmental Protection Agency (EPA)

Answer 13

Disposal of hazardous waste
P,U,K,F

Question 14

P-list pharmaceutical waste (acutely hazardous)

Answer 14

Warfarin
Nicotine patches, gum, or lozenges
Physostigmine
Arsenic trioxide
Nitroglycerin
Epinephrine

Question 15

U-list pharmaceutical waste

Answer 15

Lindane
Selenium sulfide
Chloral hydrate
Mitomycin C
Formaldehyde
Benzene

Question 16

Resource Conservation and Recovery Act,

Answer 16

Ignitability – include liquids with flash points below 60-degree Celsius, non-liquids that cause fire through specific conditions, ignitable compressed gases, and oxidizers
Toxicity – harmful when ingested or absorbed. Toxic wastes present a concern as they may be able to leach from waste and pollute groundwater.
Corrosivity – include aqueous wastes with a pH of less than or equal to 2, a pH greater than or equal to 12.5 or based on the liquids ability to corrode steel.
Reactivity – may be unstable under normal conditions, may react with water, may give off toxic gases and may be capable of detonation or explosion under normal conditions or when heated. EPA assigned D003 as the waste code for reactive hazardous wastes.