Overview Of Standards Guidelines Regulations And Best Practices Flashcards
What is USP?
Scientific, non-profit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients and dietary supplements.
Which USP chapters are federally enforceable?
Chapters numbered <1000
List USP requirements in order from most specific to least specific.
Monograph -> General Chapter -> General Notice
What is the focus of ISMP guidelines for safe preparation of compounded sterile preparations?
Preventing harm due to medication errors and to provide the best practice guidelines to ensure the safe preparation of compounded sterile preparations.
What is the purpose of the CDC Safe Injection Practices?
Preventing transmission of infectious agents from inappropriate sharing or reuse of needles, syringes, single dose and multiple dose vials
Which guidance document created a list of hazardous drugs which is recognized by USP <800>
NIOSH alert
Which federal law recognizes USP monographs for bulk drug substances and USP chapters on pharmacy compounding?
Drug Quality and Security Act (DQSA)
Traditional drug compounding falls under what section of the Federal Food, Drug & Cosmetic Act (FDCA)
503(a)
Which section of the FDCA requires certain compounders to register with the FDA?
503(b)
A key difference between a compounder operating under section 503(b) vs 503(a) is that the compounder is subject to ____.
cGMP
Which federal agency oversees regulations related to personal protective equipment, respiratory protection, and the hazard communication standard?
OSHA
In general, compounders operating under section 503(a) of the FDCA are subject to regulation and inspection by what entity?
State Board of Pharmacy
What document is issued at the end of an FDA inspection?
FDA form 483
