Law Exam 1 - Lecture 8 (Inspections, Generic Equivalency) Flashcards
(33 cards)
part of USP that is considered to have the force of law
drug monographs, not following them leaves a drug adulterated or misbranded
part of USP that is not considered to have the force of law
information on appropriate means for drug preparation and drug storage
USP 795 covers what
nonsterile compounding
USP 797 covers what
sterile compounding
USP 800 covers what
hazardous drugs
USP 795 - nonsterile compounding covers what
quality and safety
BUDs
USP 797 - sterile compounding covers what
numerous sterile compounding requirements, including personnel, training, facilities, environmental monitoring, and storage and testing of finished products
USP 800 - hazardous substances covers what
handling of hazardous materials in healthcare setting
hazardous means what 6 things
carcinogenic
teratogenic
reproductive tox.
organ tox. at low doses
genotox.
new drugs that mimic existing hazardous drugs
expiration date definition
last date when the product will meet the requirements of the USP monograph for strength or stability
BUDs definition
date after which a product should not be used. Cannot be later than an expiration date.
exemptions to repackaging guidelines (4)
- a prescription drug on the drug shortage list
- a drug product repackaged under direct supervision of a licensed pharmacist
- if repackaged by a pharmacy, only distributed upon receipt of a valid prescription for an individual patient
- repackaged product is assigned a BUD as described in the repackaging guidance
BUD for non aqueous formulation
no more than 6 months or the expiration date, whichever is sooner
BUD for water containing oral formulations
no more than 14 days or the expiration date, whichever is sooner
BUD for water containing topical, mucosal, and semisolid formulations
no more than 30 days or the product expiration date, whichever is sooner
2 types of inspections
routine
triggered by suspicion or formal complaint
who can do inspections
FDA, DEA, State board of pharmacy
FDA inspectors must show what 2 things to request entry into a pharmacy for an inspection
their credentials
notice of inspections
When requesting inspection, a DEA inspector must: (3)
- state the purpose of their inspection
- show their credentials
- provide written notice of inspection to the pharmacy owner or pharmacist in charge
DEA notice of inspection (NOI) lists out what 5 rights?
- right to require the DEA to get an administrative inspection warrant (AIW)
- the right to refuse an inspection (at which point they will acquire a AIW)
- anything incriminating found can be seized and used against you in prosecution
- you will get a copy of the NOI
- you may withdraw your consent to inspection at any time
what is the bar for AIW?
provided for anything considered a valid public interest (low bar)
what is the bar for search warrants?
a reasonable person would believe that a crime has been or will be committed (higher bar)
_____ can only be served during regular business hours, _____ can be served anytime
AIW, search warrants
can you deny a Board of Pharmacy (BoP) inspection?
no, they can inspect without a warrant
