CPJE Study Guide

Any change of PIC must be reported by the pharmacy and departing PIC to the board in writing within how many days?

30 days (in writing)

How often must a PIC complete a Self-Assessment form for their pharmacy?

Every 2 years

When must. a PIC complete a Self-Assessment form by?

July 1 (each odd numbered years)

If a new permit is issued to a pharmacy, within how many days must the PIC complete an additional Self-Assessment form?

30 days

How many hours of CE must a pharmacist complete during each 2-year licensing period?

30 hours

How many hows of CE must be in law & ethics

2 hours

When does a pharmacist's license expire?

Last day of the pharmacist's birth month

How long must a pharmacist keep their certificates for completed CEs?

4 years

How many additional hours of CEs must a APh complete to maintain their license?

10 hours

If a pharmacist suspects another pharmacist is impaired at work, they must report this to the board within how long?

14 days

How long must a hospital pharmacy retain record for chart orders for controlled substances?

7 years

How long must a pharmacy keeps records of patient HIPAA acknowledgement?

6 years

How long must a pharmacy keeps records of transaction information, history and statement for most prescription drugs as required under the Drug Supply Chain Security Act?

6 years

How long must a pharmacy keeps records of community or clinical pharmacy prescriptions?

3 years

How long must a hospital pharmacy keeps records of chart orders for non-controlled drugs?

3 years

How long must a pharmacy keeps records of quarterly schedule 2 CS inventory (state requirement)?

3 years

How long must a pharmacy keeps records of DEA Forms 222, CSOS records, PoA forms

3 years

How long must a pharmacy keeps records of purchase invoices for all prescription drugs?

3 years

How long must a pharmacy keeps records of documentation of the return of drugs to wholesaler or manufacturer?

3 years

How long must a pharmacy keeps records of documentation of transfers or sale to other pharmacies, lincensees & prescribers?

3 years

How long must a pharmacy keeps records of theft and loss reports of controlled substances (DEA forms 106)?

3 years

How long must a pharmacy keeps records of biennial CS inventory (all schedules, federal requirement)?

2 years

How long must a pharmacy keeps records of pseudoephedrine, ephedrine, phenylpropanolamine and norpseudoephedrine sales logs?

2 years

How long must a pharmacy keeps records of patient medication profiles?

1 year

How long must a pharmacy keeps records of medication error/quality assurance reports?

1 year

Within how long must a pharmacy report a change of pharmacist address or name?

30 days

Within how long must a pharmacy report a change of PIC?

30 days

Within how long must a pharmacy report a change in pharmacy permit?

30 days

Within how long must a pharmacy report theft by or impairment of a licensee?

14 days

Within how long must a pharmacy report theft/loss of controlled drugs to the DEA?

Immediately (w/n 1 business day)

Within how long must a pharmacy report theft/loss of controlled drugs to the California SBOP?

30 days

Within how long must a pharmacy report bankruptcy, insolvency, receivership?

Immediately

How often must a schedule 2 controlled substances inventory be done per state requirements?

every 3 months

How soon within an error being discovered must a medication error investigation be conducted?

2 days

How soon within dispensing any schedule 2 to 5 drug must the dispensing data be submitted to CURES?

1 day

If prescriptions for CS 3-5 are filed with non-controlled prescriptions, what is used to mark them so that they are readily retrievable?

red C stamp (must be at least 1" high)

How often often must a inventory for all controlled substances be conducted?

every 2 years

Within how long must a new PIC complete a CS 2 inventory after starting?

30 days

If a drug changes schedules, a pharmacist must complete an inventory of the newly scheduled drug when?

the date the scheduling becomes effective

Within how long will a signed copy of a waiver for off-site storage of records be returned to the requesting pharmacy if approved?

30 days

With how long must a pharmacy be able to produce the records stored in off-site secured storage upon request from the board or authorized law official?

2 days

How long (total) must prescription records be kept?

3 years (in total, for all prescriptions)

How long must non-controlled prescriptions be kept at the pharmacy?

1 year (then can be moved to secured, off-site storage for at least 2 more years)

How long must controlled prescriptions be kept at the pharmacy?

2 years (then can be moved to secured, off-site storage for at least 1 more year)

What Act was passed in 2013 to track and trace drugs, such as prescription drugs, for human use to prevent counterfeit, misbranded, adulterated and diverted prescription drugs from entering the drug supply?

Drug Supply Chain Security Act (DSCSA)

How often must a hospital drug supply be inspected by a pharmacist, intern or technician?

every 30 days

Records of hospital drug supply inspection should be kept at least how long?

3 years

Irregularities discovered during a hospital drug supply inspection should be records to the PIC or CEO within how long?

24 hours

Who is responsible for notifying customers/patients & distributors when a drug is recalled?

Manufacturer

In a Class I recall, pharmacists are responsible to notify who if a patient received the affected drug?

Prescriber (the prescriber must decide if they would like to notify the patient)

A pharmacy must issue a notice to recipient (pharmacy, patient, provider) of a recall of a compounded drug product within how long of recall issue?

12 hours

A pharmacy must issue a notice the SBOP of a recall of a compounded drug product within how long of recall issue?

24 hours

Within how long must a pharmacy report to the FDA MedWatch that a patient was harmed due to using a recalled compounded drug product ?

72 hours

Within how long must a outsourcing pharmacy facility report to the FDA MedWatch that a patient was harmed due to using a recalled compounded drug product ?

15 days

Within how long must a pharmacy notify the SBOP of establishment of drug take-back services?

30 days

Within how long must a pharmacy notify the SBOP of discontinuation of drug take-back services?

30 days

Within how long must a pharmacy notify the SBOP of any tampering with collection bin for drug take-back services?

14 days

Within how long must a pharmacy notify the SBOP of theft of deposited drugs for drug take-back collection?

14 days

Within how long must a pharmacy notify the SBOP of any tampering, damage, or theft of a removed linear in a collection bin for drug take-back services?

14 days

Within how long must a pharmacy notify the SBOP of disclosure of service and location of each receptacle for drug take-back services?

annually (at time of facility license renewal)

Within how long must a pharmacy notify law enforcement or CPS of suspected child and elder abuse and/or neglect after receiving information?

2 days (or 36 hours)

What is the day supply limit that optometrist have for prescribing codeine- and hydrocodone-containing products?

3 days

How long are all CS prescriptions valid (C2-C5) from the written date?

6 months

How long are non-CS prescriptions valid (from the written date)?

12 months

Within how long must a prescriber countersign a verbal order that was entered by a nurse/pharmacist (in a hospital setting)?

2 days

What does the FDA require to be given for all oral contraceptives prescriptions each time they are dispensed?

Patient package insert (PPI; considered misbranding if not given)

Which form of written information for patients is approved by the FDA: Consumer Medication Information (CMI) leaflet or Medication Guide?

Medication Guide (CMIs are not reviewed/approved by the FDA)

What drug has a REMS program that prohibits patients from using alcohol while taking the medication d/t the risk of hypotension and syncope d/t an interaction with alcohol?

Addyi (Flibanserin)

How long after a patient makes a written request for a copy of their medical records must they be able to inspect them? And within how long must the patient be given copies of their records?

5 days; 15 days

What is another name for the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations?

The Orange Book

True/False: A pharmacist can substitute products with biosimiliar products?

FALSE (Biosimilars ARE NOT considered therapeutically equivalent, but rather, "highly similar")

True/False: There are currently no FDA-approved interchangeable biosimilar products?

True

What is the more common name for the reference "List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations"?

The Purple Book

How long must video recordings that monitor management of controlled substances at a remote telepharmacy site be kept?

120 days

How often must a pharmacist from a supervising pharmacy conduct an inspection of a remote telepharmacy site?

Once monthly

How long after a state of emergency is over must a mobile pharmacy cease activities?

2 days

To receive aid-in-dying medications, a person must be diagnosed with a terminal illness that will lead to death within how long?

6 months (confirmed by 2 physicians)

The BUD for unit-dose containers is no later than how long from the date the drug is repackaged per USP guidelines (or the expiration date of the drug, whichever comes first)?

6 months

What section of the Drug Quality and Security Act (DQSA) is for traditional compounding & is regulated by the SBOP?

503A

What section of the Drug Quality and Security Act is for outsourcing facilities & is regulated by the SBOP and FDA?

503B

The California SBOP standard for handling drugs on the NIOSH list closely mirror what USP standards?

USP 800 (Chapter 800)

Within how long of test ordering, interpreting and management must it be documented in an accessible system for the healthcare team?

24 hours

Within how long of administering a vaccine must a pharmacist notify the patient's prescriber?

14 days

How many additional CE hours every 2 years must be completed to administer vaccines, dispense birth control and EC?

1 hour

Levonorgestrel & ulipristal have similar efficacy if used within how long after unprotected sex?

72 hours

How long can levonorgestrel and ulipristal be recommended for after having unprotected sex?

120 hours

How long should records be kept after dispensing naloxone to a patient?

3 years

How many CE credits must a pharmacist who wishes to provide smoking cessation therapy complete?

2 hours

How long should records be kept after dispensing NRT for a patient?

3 years

How long should records be kept after dispensing birth control?

3 years

How many CE credits must a pharmacist who wishes to prescribe travel meds complete every 2 years?

2 hours

True or False? A birth control prescription is considered misbranded if a patient package insert is not given to the patient?

True

DEA form for registration for retail pharmacies, hospitals/clinics, teaching institutions, practitioners or mid-level preactitioners

Form 224

DEA Form for registering for drug manufacturers, distributers & researchers?

Form 225

DEA Form for registering for narcotic (opioid) treatment clinics

Form 363

DEA Form for registering for bulk chemical manufacturers & distributers

Form 510

What DEA form is used to register retail pharmacies, hospitals/clinics, teaching institutions, practitioners or mid-level practitioners?

Form 224

What DEA form is the registration form for drug manufacturers, distributors & researchers?

Form 225

What DEA form is the registration form for narcotic (opioid) treatment clinics?

Form 363

What DEA form is for the registration form for bulk chemical manufacturers and distributors?

Form 510