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Flashcards in Time Requirements Deck (47)
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1
Q

If revoked, the board may prohibit a licensee from reapplying for licensure for up to…

A

7 years

2
Q

Proof of CE must be maintained by licensee for

A

2 renewal cycles (4 years)

3
Q

Notify board of employment change within…

A

15 days

4
Q

Notify the board if stop serving as PIC…

A

Immediately

5
Q

Control substance inventory…

A

At time of a PIC change
at least yearly
at termination of business

6
Q

Annual Review Required for pharmacy classes:

A

H - sterile compounding
L - vet
M - bleeding disorder

7
Q

Annual Review required for policies:

A

Administration by medical prescription order
Electronic record keeping system
Automated filing systems (maintain for 2 years)

8
Q

Offsite warehouse or storage

A

no records less than 2 years old may be stored there

All records available for inspection within 2 business days

9
Q

Termination of business - after permit holder stops operating

A

submit out-of-business notification form within 15 days of stopping operations

10
Q

A closing pharmacy must designate a secure location where pharmacy records will be kept and retrieve them within _____ days if requested?

A

7 business days

11
Q

Mandatory reporting of pharmacist or technician discipline within____?
(Final disciplinary action or voluntary resignation due to complaints/reports)

A

15 days of final action/resignation

12
Q

Class L can operate without pharmacist physically present if PIC review activities and records how often?

A

Monthly

Not exempted if controls are stored, dispensed, or provided on site or when compounding is performed

13
Q

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.

A

2 business days for established patients
12 hours for established patients in emergency
3 business days for new patients

14
Q

Transfers must be completed within ____

A

1 business day of request

15
Q

Consolidation of refills rules

A

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
16
Q

When is a drug distributer license required?

A

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

17
Q

Prepackaging (automated dispensing system) expiration date rules

A

12 months or manufacturer’s expiration date, whichever is less

18
Q

Patient med paks rules

A

-Beyond use date no later than 60 days from the date of the preparation on each pack

19
Q

Return to stock dating

A

expiration date either 1 year from dispensing date or manufacturer’s original expiration date, whichever is less

20
Q

Emergency fill rules

A

Not to exceed a 7 day supply

If prescriber is deceased/etc, up to 30 day supply

21
Q

Compounding (sterile and non sterile) rules for “limited quantity” definition

A

3 month supply of a batched product or

1 year supply for external use products

22
Q

Sterile Compounding Risk Level 1

A

Room temp - BUD of 48 hours or less
Refrigeration - BUD of 7 days or less
Frozen - BUD of 30 days or less

23
Q

Sterile Compounding Risk Level 2

A

Room temp - BUD of greater than 48 hours
Refrigeration - BUD of greater than 7 days
Frozen - BUD of greater than 30 days

24
Q

Prescription originals or orders must be maintained by pharmacy for…

A

at least 5 years

25
Q

Keep Audit of Class I records

A
3 years
(consult pharmacy class)
26
Q

Keep Compounding logs

A

2 years

27
Q

Keep Compounding records

A

2 years

28
Q

Keep Controlled substance prescription orders

A

5 years

29
Q

Keep Controlled substance transfer records/ DEA 222 forms

A

2 years

30
Q

Keep Controlled substance inventories

A

2 years

31
Q

Keep Distribution records

A

2 years

32
Q

Keep Drug invoices

A

2 years

33
Q

Keep Immunization or other med administration records

A

2 years

34
Q

Keep Immunization protocols

A

8 years AFTER termination

35
Q

Keep Medication Therapy Services (MTS) Protocols

A

8 years after termination

36
Q

Keep MTS patient records and prescription orders for MT services

A

7 years (generally)

37
Q

Keep Sterile Compounding records

A

2 years

38
Q

Immunization age limit

A

at least 12 years old if by protocol

39
Q

Immunization by protocol (intent to immunize) requirements

A

notification of intent filed annually

2 hours vaccination CE within the prior 12 months

40
Q

Immunization by protocol, protocol requirements

A
  • Authorizing physician practice location no more than 50 miles by road
  • Valid for (and must be reviewed every) no longer than 1 year
41
Q

Immunization notification - authorizing protocol physician

A

Within 72 hours of administration

or if by Rx, notify prescriber within 72 hours

42
Q

Immunization notification - patient’s PCP

A

Within 14 days of administration *if PCP known and different from authorizing/prescribing physician)

43
Q

Immunization notification - adverse events

A

Notify authorizing physician and PCP within 24 hours of learning of event

44
Q

MTS CE requirement

A

6 hours CE in courses/programs related to medication therapy management for each biennial renewal period

45
Q

MTS protocol requirements

A
  • 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
46
Q

MTS notification timeframes

A

24 hours for therapy modifications or severe adverse reactions to authorizing physician (In writing unless otherwise authorized by protocol)

47
Q

Technician registration valid for…

A

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)