Time Requirements Flashcards
(47 cards)
If revoked, the board may prohibit a licensee from reapplying for licensure for up to…
7 years
Proof of CE must be maintained by licensee for
2 renewal cycles (4 years)
Notify board of employment change within…
15 days
Notify the board if stop serving as PIC…
Immediately
Control substance inventory…
At time of a PIC change
at least yearly
at termination of business
Annual Review Required for pharmacy classes:
H - sterile compounding
L - vet
M - bleeding disorder
Annual Review required for policies:
Administration by medical prescription order
Electronic record keeping system
Automated filing systems (maintain for 2 years)
Offsite warehouse or storage
no records less than 2 years old may be stored there
All records available for inspection within 2 business days
Termination of business - after permit holder stops operating
submit out-of-business notification form within 15 days of stopping operations
A closing pharmacy must designate a secure location where pharmacy records will be kept and retrieve them within _____ days if requested?
7 business days
Mandatory reporting of pharmacist or technician discipline within____?
(Final disciplinary action or voluntary resignation due to complaints/reports)
15 days of final action/resignation
Class L can operate without pharmacist physically present if PIC review activities and records how often?
Monthly
Not exempted if controls are stored, dispensed, or provided on site or when compounding is performed
Class M - if requested, blood clotting factor concentrates must be shipped and delivered within ___ for established patients in non-emergency situations, within ____ for established patients in an emergency, and _____ for new patients.
2 business days for established patients
12 hours for established patients in emergency
3 business days for new patients
Transfers must be completed within ____
1 business day of request
Consolidation of refills rules
non controlled meds ONLY
- must be previously prescribed for at least 3 months
- may dispense no more than a 90 day supply at one time
When is a drug distributer license required?
if pharmacy annually transfers 5% or more of total gross sales/drug purchases
(otherwise, transfer meds by involve or 222)
Must be registered as repackager with FDA if no transferring in original containers
Prepackaging (automated dispensing system) expiration date rules
12 months or manufacturer’s expiration date, whichever is less
Patient med paks rules
-Beyond use date no later than 60 days from the date of the preparation on each pack
Return to stock dating
expiration date either 1 year from dispensing date or manufacturer’s original expiration date, whichever is less
Emergency fill rules
Not to exceed a 7 day supply
If prescriber is deceased/etc, up to 30 day supply
Compounding (sterile and non sterile) rules for “limited quantity” definition
3 month supply of a batched product or
1 year supply for external use products
Sterile Compounding Risk Level 1
Room temp - BUD of 48 hours or less
Refrigeration - BUD of 7 days or less
Frozen - BUD of 30 days or less
Sterile Compounding Risk Level 2
Room temp - BUD of greater than 48 hours
Refrigeration - BUD of greater than 7 days
Frozen - BUD of greater than 30 days
Prescription originals or orders must be maintained by pharmacy for…
at least 5 years
