CPJE Law Summary Questions and Answers
100% Solved
Reporting Req: Immediately - loss/theft of CS (one business day)
- bankruptcy, insolvency, receivership
When should completion of the self-assessment form be done? - Every odd-numbered
year before July 1st
- W/i 30 days of change of pharmacy address, PIC, or new pharmacy permit
When should completion of the biennial CS inventory be done? q2years
special considerations:
- when opening a pharmacy
- on the date of a newly scheduled drug or rescheduled
When should completion of RPh CE be done? q2years (except 1st cycle)
,When should completion of CSII inventory be done in CA? q3mo and w/i 30 days of new
PIC
- a physical count must be done
When should completion of med error investigation be done? W/i 2 days of error
When should submission of dispensing date to CURES be done? W/i 1 business day of
dispensing any CSII-V drug
Paper Rx Recordkeeping - Opt 1: three separate bin (CII, CIII-CV, all else)
- Opt 2: two separate bin (CII, all else -- red C >1in high on CS)
DEA CS Inventory - For sealed, unopened containers, use count listed by manufacturer
- CSI and CSII: exact count of container
- CSIII-CSV: exact count of containers holding more than 1k unit or est count of <1l units
Off-Site Storage of Records - Pharmacy can request waiver to store some records off-site
in secure area
,- Signed copy of waiver will be returned within 30d (keep in pharmacy)
- Pharmacy must be able to retrieve records within 2 business days of request
- Keep Rx records for 3 years total
(1) non-controlled: must keep at pharmacy for >=1y, can keep off-site for 2y
(3) controlled: must keep at pharmacy for >=2y, can then keep off-site 1y
What drugs should be separate from other drug stock? - Investigation new drugs
- Repackaged or resold drugs (assigned BUD)
- Recalled drugs
- Expired Drugs
- Drug samples (not allowed in retail)
How should controlled drugs be stored? - Locked cabinet
- Dispersed through other drug stock (on the shelf)
How should drug supply at nursing stations for emergency use be stored at nursing stations?
- portable container that is sealed by RPh
- contents listed on outside cover with earliest exp date of any drugs w/i
, Drug Recall Classifications Class I recall: a situation in which there is a reasonable
probability that the use of or exposure to a violative product will cause serious adverse health
consequences or death.
Class II recall: a situation in which use of or exposure to a violative product may cause
temporary or medically reversible adverse health consequences or where the probability of
serious adverse health consequences is remote.
Class III recall: a situation in which use of or exposure to a violative product is not likely to
cause adverse health consequences.
FDA Flush List - Fentanyl containing products
- Hydrocodone containing products
- Oxycodone containing products
- Hydromorphone
- Methadone
- Methylphenidate (Daytrana patch)
- Morphine
100% Solved
Reporting Req: Immediately - loss/theft of CS (one business day)
- bankruptcy, insolvency, receivership
When should completion of the self-assessment form be done? - Every odd-numbered
year before July 1st
- W/i 30 days of change of pharmacy address, PIC, or new pharmacy permit
When should completion of the biennial CS inventory be done? q2years
special considerations:
- when opening a pharmacy
- on the date of a newly scheduled drug or rescheduled
When should completion of RPh CE be done? q2years (except 1st cycle)
,When should completion of CSII inventory be done in CA? q3mo and w/i 30 days of new
PIC
- a physical count must be done
When should completion of med error investigation be done? W/i 2 days of error
When should submission of dispensing date to CURES be done? W/i 1 business day of
dispensing any CSII-V drug
Paper Rx Recordkeeping - Opt 1: three separate bin (CII, CIII-CV, all else)
- Opt 2: two separate bin (CII, all else -- red C >1in high on CS)
DEA CS Inventory - For sealed, unopened containers, use count listed by manufacturer
- CSI and CSII: exact count of container
- CSIII-CSV: exact count of containers holding more than 1k unit or est count of <1l units
Off-Site Storage of Records - Pharmacy can request waiver to store some records off-site
in secure area
,- Signed copy of waiver will be returned within 30d (keep in pharmacy)
- Pharmacy must be able to retrieve records within 2 business days of request
- Keep Rx records for 3 years total
(1) non-controlled: must keep at pharmacy for >=1y, can keep off-site for 2y
(3) controlled: must keep at pharmacy for >=2y, can then keep off-site 1y
What drugs should be separate from other drug stock? - Investigation new drugs
- Repackaged or resold drugs (assigned BUD)
- Recalled drugs
- Expired Drugs
- Drug samples (not allowed in retail)
How should controlled drugs be stored? - Locked cabinet
- Dispersed through other drug stock (on the shelf)
How should drug supply at nursing stations for emergency use be stored at nursing stations?
- portable container that is sealed by RPh
- contents listed on outside cover with earliest exp date of any drugs w/i
, Drug Recall Classifications Class I recall: a situation in which there is a reasonable
probability that the use of or exposure to a violative product will cause serious adverse health
consequences or death.
Class II recall: a situation in which use of or exposure to a violative product may cause
temporary or medically reversible adverse health consequences or where the probability of
serious adverse health consequences is remote.
Class III recall: a situation in which use of or exposure to a violative product is not likely to
cause adverse health consequences.
FDA Flush List - Fentanyl containing products
- Hydrocodone containing products
- Oxycodone containing products
- Hydromorphone
- Methadone
- Methylphenidate (Daytrana patch)
- Morphine
