CPJE Secrets - California Pharmacy Law
Questions and Answers
What does a Recall invole? Remove a product from the market by a firm's own initiative,
by FDA request, or by FDA order under statutory authority.
What is a Class I recall? Reasonable probability of serious adverse health consequences or
death.
What is a Class II recall? May cause temporary or reversible S.E.; probability of serious
adverse health consequences is remote
What is a Class III recall? Not likely to cause adverse health consequences.
What is a Market Withdrawal? The firm removes the product from the market and/or
corrects a minor violation. I.e. tampering.
What is a Medical Device Safety Alert? Unreasonable risk of substantial harm. In some
case, these situations also are considered recalls.
, What is the California State BOARD OF PHARMACY? Agency authorized to enact rules
and regulations pertaining to the practice of pharmacy
What is a Pharmacy Board of Inspector? Not required to be an RPh
Inspects any site in which drugs or devices are compounded, stored, dispensed or sold, including
vet drug retailers, physician offices, etc.
What is an order of abatement and who issues it? a Pharmacy Board Inspector issues it
and it is a request by means of citation that something be corrected/taken care of
How long does a person/entity served with a citation have to appeal the Board? within 30
days in writing
How long does the Board need to be notified within if Change of Ownership, address or
name/pharmacist-in-charge/pharmacy permit/theft/diversion/drug loss occurs? 30 days
Questions and Answers
What does a Recall invole? Remove a product from the market by a firm's own initiative,
by FDA request, or by FDA order under statutory authority.
What is a Class I recall? Reasonable probability of serious adverse health consequences or
death.
What is a Class II recall? May cause temporary or reversible S.E.; probability of serious
adverse health consequences is remote
What is a Class III recall? Not likely to cause adverse health consequences.
What is a Market Withdrawal? The firm removes the product from the market and/or
corrects a minor violation. I.e. tampering.
What is a Medical Device Safety Alert? Unreasonable risk of substantial harm. In some
case, these situations also are considered recalls.
, What is the California State BOARD OF PHARMACY? Agency authorized to enact rules
and regulations pertaining to the practice of pharmacy
What is a Pharmacy Board of Inspector? Not required to be an RPh
Inspects any site in which drugs or devices are compounded, stored, dispensed or sold, including
vet drug retailers, physician offices, etc.
What is an order of abatement and who issues it? a Pharmacy Board Inspector issues it
and it is a request by means of citation that something be corrected/taken care of
How long does a person/entity served with a citation have to appeal the Board? within 30
days in writing
How long does the Board need to be notified within if Change of Ownership, address or
name/pharmacist-in-charge/pharmacy permit/theft/diversion/drug loss occurs? 30 days
