Time Requirements Flashcards
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
Keep Audit of Class I records
3 years (consult pharmacy class)
Keep Compounding logs
2 years
Keep Compounding records
2 years
Keep Controlled substance prescription orders
5 years
Keep Controlled substance transfer records/ DEA 222 forms
2 years
Keep Controlled substance inventories
2 years
Keep Distribution records
2 years
Keep Drug invoices
2 years
Keep Immunization or other med administration records
2 years
Keep Immunization protocols
8 years AFTER termination
Keep Medication Therapy Services (MTS) Protocols
8 years after termination
Keep MTS patient records and prescription orders for MT services
7 years (generally)
Keep Sterile Compounding records
2 years
Immunization age limit
at least 12 years old if by protocol
Immunization by protocol (intent to immunize) requirements
notification of intent filed annually
2 hours vaccination CE within the prior 12 months
Immunization by protocol, protocol requirements
- Authorizing physician practice location no more than 50 miles by road
- Valid for (and must be reviewed every) no longer than 1 year
Immunization notification - authorizing protocol physician
Within 72 hours of administration
or if by Rx, notify prescriber within 72 hours
Immunization notification - patient’s PCP
Within 14 days of administration *if PCP known and different from authorizing/prescribing physician)
Immunization notification - adverse events
Notify authorizing physician and PCP within 24 hours of learning of event
MTS CE requirement
6 hours CE in courses/programs related to medication therapy management for each biennial renewal period
MTS protocol requirements
- collaborating physician practice location no more than 50 miles by road from pharmacist
- must be reviewed and signed annually by all parties, with annual review date documented within the protocol
MTS notification timeframes
24 hours for therapy modifications or severe adverse reactions to authorizing physician (In writing unless otherwise authorized by protocol)
Technician registration valid for…
1 year, expire annually on May 31st (may not work after this date if not renewed, but may submit for late renewal until June 30th)
