Pharmacy Regulatory Bodies Flashcards
Food and Drug Administration (FDA)
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
Drug Enforcement Administration (DEA)
Oversee and enforce legislation relating to controlled substances
Form 106
If controlled substances go missing or are stolen within the pharmacy setting
Form 222
When ordering C-II drugs
3 total copies valid for 60 days
Form 41
Damaged controlled substances must be destroyed and recorded
The Joint Commission (TJC)
Accredits and certifies healthcare organizations and ensures the best possible treatment outcomes
Site surveys every 3 years
State Boards of Pharmacy (BOP)
Establishing state-specific laws and regulations
Certifying and licensing pharmacy personnel
National Association of the Boards of Pharmacy (NABP)
Acts as a professional means to discuss the trajectory of pharmacy and how best to improve it on a state-by-state level
United States Pharmacopoeia (USP)
Sets standards in OTC, prescriptions, & dietary supplements
USP 795
Non-sterile compounding formulations such as cough meds in safe environment
Beyond-use dating
USP 797
Sterile compounding
Ensure that no contaminants enter compounded medicines. Strict controls of clean rooms, ventilation, quality assurance, and microbial levels
USP 800
Handling hazardous drugs
Minimize the possibility of harm from a hazardous drug or substance to healthcare workers
Environmental Protection Agency (EPA)
Disposal of hazardous waste
P,U,K,F
P-list pharmaceutical waste (acutely hazardous)
Warfarin
Nicotine patches, gum, or lozenges
Physostigmine
Arsenic trioxide
Nitroglycerin
Epinephrine
U-list pharmaceutical waste
Lindane
Selenium sulfide
Chloral hydrate
Mitomycin C
Formaldehyde
Benzene
Resource Conservation and Recovery Act,
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.
