Shared Flashcard Set

Details

CPJE Time Allocations
Pharmacy Law
146
Medical
Post-Graduate
06/24/2016

Additional Medical Flashcards

 


 

Cards

Term
Within how many days must the SBoP be notified of a change of pharmacy ownership?
Definition
30 days(CCR § 1709)
Term
Within how many days must the SBoP be notified of a pharmacist change of name or address?
Definition
30 days (B&PC § 4100) 
Term
Within how many days must the SBoP be notified of a change of PIC? 
Definition
30 days (B&PC
§§ 4101, 4113) 
Term
Within how many days must the SBoP be notified of controlled substance loss (theft)? 
Definition
30 days (CCR § 1715.6)
Term
Within how many days must the DEA be notified of controlled substance loss (or theft)? 
Definition
upon discovery
(21 CFR § 1301.74[c]) 
Term
Within how many hours must the SBoP be notified of a reasonable cause to believe that
a dangerous drug or dangerous device in, or having been in, the possession of a
pharmacy is counterfeit or the subject of a fraudulent transaction? 

Definition
72 hours (B&PC § 4107.5) 
Term
Within how many days must the SBoP be notified of any admission by a licensed individual
of chemical, mental, or physical impairment affecting his or her ability to practice? 
Definition
14 days (B&PC § 4104[c])
Term
Within how many days must the SBoP be notified of any admission by a licensed individual
of theft, diversion, or self-use of dangerous drugs? 
Definition
14 days (B&PC § 4104[c]) 
Term
Within how many days must the SBoP be notified of any video or documentary evidence
demonstrating chemical, mental, or physical impairment of a licensed individual to the
extent it affects his or her ability to practice? 

Definition
14 days (B&PC § 4104[c]) 
Term
Within how many days must the SBoP be notified of any video or documentary evidence
demonstrating theft, diversion, or self-use of dangerous drugs by a licensed individual?
Definition
14 days (B&PC § 4104[c]) 
Term
Within how many days must the SBoP be notified of any termination based on chemica
mental, or physical impairment of a licensed individual to the extent it affects his or he
ability to practice? 

Definition
14 days (B&PC § 4104[c])
Term
Within how many days must the SBoP be notified of any termination of a licensed
individual based on theft, diversion, or self-use of dangerous drugs? 
Definition
14 days (B&PC § 4104[c]) 
Term
How long must community pharmacy prescription records be kept on file for inspection? 
Definition
3 years (B&PC § 4081[a])
Term
How long must hospital pharmacy order records be kept on file for inspection? 
Definition
3 years (B&PC § 4081[a]) 
Term
If not physically present at the time of prescribing, a prescriber has what time frame to
countersign the order of an inpatient in the chart or medical record within a hospital? 
Definition
48 hours (CCR § 70263[g]) 
Term
How long must a patient medication profile be kept on file for inspection? 
Definition
1 year following
last dispensing date
(CCR § 1707.1) 

Term
How long must controlled substance inventory records be kept on file for inspection? 
Definition
3 years (CCR § 1718) 
Term
When a pharmacy contracts to compound a drug for parenteral therapy, the contractual
arrangement is reported to the board within how many days of commencing compounding? 
Definition
30 days (B&PC § 4123) 
Term
How long must DEA Form 222 order records be kept on file for inspection? 
Definition
3 years (B&PC §§ 4801,
4105, 4333)
Term
When must the pharmacy conduct a Self-Assessment?  
Definition
Before July 1st every odd-numbered
year or within 30 days ofL (1) a new
parmit(2) change in PIC; (3) change in
location (CCR § 1715

Term
How long must the pharmacy Self-Assessment forms be kept on file for inspection? 
Definition
3 years (CCR § 1715)
Term
How often is a controlled substance inventory taken? 
Definition
2 yrs (21 CFR § 1304.11[b]) 
Term
Within how many days must a valid prescription for a controlled substance drug be filled?
Definition
6 months (H&SC §§
11164[a][1], 11120[e])
Term
How often must Schedule II, III and IV prescriptions be filed electronically to CURES? 
Definition
Weekly (H&SC § 11165[d]) 
Term
How long does a prescriber have to send the Schedule II security prescription to the
pharmacy following an emergency oral prescription? 
Definition
7 days (H&SC § 11167[d]) 
Term
If no security prescription for Schedule II drug is sent by prescriber to the pharmacy following
an emergency oral prescription, what is the time period the pharmacy must notify the DEA?
Definition
144 hours
(H&SC § 11167[d]) 
Term
If unable to supply the full quantity, a pharmacist may partially fills a Schedule II prescr
and the remaining portion of the prescription must be filled within what time frame?
Definition
72 hours
(21 CFR § 1306.13[a])
Term
How often does the pharmacy generate a controlled substance printout for refills of
Schedule III-V prescriptions which contains the signature of the dispensing pharmacist?
Definition
every 72 hours
(21 CFR § 1306.22) 
Term
What is the CE hours requirement for the 1st license pharmacist renewal after graduation? 
Definition
0 hours (B&PC § 4231) 
Term
What is the CE hours requirement for the 2nd and all subsequent pharmacist license renewals?
Definition
30 hours (B&PC § 4231) 
Term
How long must pharmacists retain CE certificates following completion of CE course? 
Definition
4 years (CCR § 1732.5[b])
Term
How often must a pharmacy license be renewed? 
Definition
every year 
Term
How often must a pharmacist license be renewed? 
Definition
every 2 years 
Term
How often must a pharmacy DEA registration be renewed? 
Definition
every 3 years 
Term
What is the maximum beyond-use-date (BUD) for any compounded prescription? 
Definition
180 days (CCR § 1735.2[h]) 
Term
What is the maximum BUD for multi-unit containers? 
Definition
Not later than (a) exp date on
manufacturer’s label or (b)1
year from date drug dispensed  

Term
What is the maximum amount of time a pharmacist may leave the pharmacy with
other non-pharmacist personnel present? 
Definition
30 minutes
(CCR § 1714.1) 
Term
How often must a pharmacist complete an inspection of all floor stock and drugs maintained
at a nursing station? 
Definition
every 30 days
CCR § 70263[q][10]) 
Term
What is the period of time prescription records must be produced from an off-site
storage facility when requested? 
Definition
2 business days (CCR §
1707)
Term
Records for non-controlled substances are maintained on the licensed premises for how long? 
Definition
least 1 year from date of
dispensing (CCR § 1707) 
Term
Records for controlled substances are maintained on the licensed premises for how long? 
Definition
least 2 years from date of
dispensing (CCR § 1707) 
Term
How quickly must a pharmacy conduct an investigation once a medication error
is discovered? 
Definition
2 business days (CCR §
1711[d])
Term
How long must a pharmacy keep the QA review on file after investigation? 
Definition
1 year from date it was
created (CCR § 1711[f]) 
Term
Substantial loss of controlled substance to the DEA
Definition
Immediately (1 day)
Term
Pharmacy bankruptcy, insolvency, receivership
Definition
Immediately
Term
Notification of drug transfer to another pharmacy or wholesaler upon pharmacy closure
Definition
Immediately
Term

# of transfers allowed for schedule 3-5 prescriptions unless transferred between pharmacies with electronic real time database sharing

 

Definition
1 transfer
Term
Correctional facilities: must furnish in (blank) hours (business hours) or (blank) hours (non-business hours) for STAT drugs
Definition
1 hours / 2 hours
Term
Correctional facilities: must furnish in (blank) hours for non-stat drugs (anti-infective, pain treatment, nausea, agitation, diarrhea MEDS), all others are day of order or next day if that is when treatment starts
Definition
4 hours
Term

# of keys maximum?

PIC + pharmacy owner / building owner / store manager / family member of pharmacist owner

Definition
2 keys max
Term
Minimum Break if working 5+ hours /day  (can be waived if only working 6 hours/day)
Definition
30 minute minimum
Term
# maximum hours worked per day
Definition
9 hours
Term
# maximum hours worked per 2 weeks
Definition
108 hours
Term
maximum # of full work days worked per 2 weeks
Definition
12 days
Term
Pharmacist must notify PIC within (blank) hours of schedule posting about concern on personnel supervision 
Definition
24 hours
Term
Pharmacist must provide written notification to a patient’s prescriber or update electronic record of any drug regimen initiation within (blank) hours
Definition
24 hours
Term
CE credits needed for pharmacist and advanced practice pharmacist
Definition

30 hours (+10 hours)

Term
Emergency supply of drugs at licensed facilities (how long)
Definition
48 hours
Term
Compound a reasonable quantity at (blank) hours or less supply for prescriber request
Definition
72 hours
Term
Supply a physician can dispense if pharmacy is closed, must be reported upon opening
Definition
72 hours
Term
Surgical clinics can supply MAX of (blank) hour drug supply
Definition
72 hour
Term
Sterile injectable compounding in hospital max (blank) hours
Definition
72 hours
Term

A tech trainee can extern a maximum of (blank) hours in community pharmacy

Definition
120 hours
Term
The PIC has (blank time) to investigate and report medication error to BOP
Definition
2 days
Term
Must provide Board or law enforcement with requested records/invoices of disposition/acquisition of drugs/devices in (blank time) 
Definition
3 days
Term

Board can shut down pharmacy if closed for this period

 

Definition
Closed: “Not engaged in ordinary activity for at least one day each week during any 120 day period.” 
Term
Upon pharmacy closure, must arrange transfer of drugs to another pharmacy or wholesaler by (blank time)
Definition
10 days
Term
Must notify DEA within (blank time) before transfer and termination of controlled substance inventories
Definition
10 days
Term
Must submit any changes to DOJ about CURES subscriber account within (blank time)
Definition
10 days
Term

(Blank time) to respond to board on petition,

Definition
10 days
Term
Board must post agenda for meetings with (blank time) notice.
Definition
10 days
Term
Part D enrollees in long-term care facilities, fill cycle of drugs is (blank time)
Definition
14 day supply
Term
Unprofessional Conduct: failure without lawful excuse to respond to board request within (blank time) or within time specified in request, whichever is longer
Definition
15 days
Term
(Blank time) to propose a replacement PIC if board disapproves selection
Definition
15 days
Term
(blank time) for an owner to contest a cease and desist order regarding inappropriate sterile compounding 
Definition
15 days
Term
Can donate hardware to promote electronic health record adoption and software at (blank percent) of cost (kickback)
Definition
15 percent
Term
Maximum patient limit during 1st year of practice in Drug Addiction Treatment Act programs
Definition
100 patients
Term
Can furnish (blank) amount of needles without prescription  
Definition
Unlimited
Term
Must notify board in (blank time) of change in Pharmacy Permit
Definition
30 days
Term
Must notify the board of pharmacy about pharmacy closure within (blank time)
Definition
30 days
Term
Must notify the board that pharmacy has stocked ocean vessels with dangerous dosages within (blank time)
Definition
30 days
Term
Internet pharmacies must register with DEA (blank time) before selling controlled substances and must report sales (blank time).
Definition
30 days / monthly
Term
Automated dispensing device must be reviewed monthly by pharmacist every (blank time)
Definition
30 days
Term
How often must a pharmacist complete an inspection of all floor stock and drugs maintained at a nursing station?
Definition
every 30 days
Term

Board required to notify applicant of application deficiencies within (blank time)

Definition
30 days
Term
Any pharmacy that inappropriately compounds a sterile product where there is a threat to the health of patients, will be susceptible to an immediate cease and desist order to be in effect for no more than (blank time) or until the date of a hearing whichever is earlier.
Definition
30 days
Term
Pharmacists have a right to disciplinary hearing within (blank time) of issuance of cease and desist sterile compounding order.
Definition
45 days
Term
Personal Medical Use (DEA), (blank) unit max for controlled substances allowed internationally for legitimate personal use
Definition
50 unit
Term
Max distance between 2 pharmacies in which a pharmacist can be PIC
Definition
50 miles
Term

(blank time) To fill controlled substance prescription for terminally ill patients in SNF facility

Definition
60 days
Term

(blank time) for new pharmacy to join board’s e-mail notification list once licensed

Definition
60 days
Term
The BOP can refuse to renew any license (except pharmacist license) expired (blank time)
Definition
60 days
Term
Licensee must notify BOP of active duty discharge within (blank time)
Definition
60 days
Term
Max supply of C2 drug for single prescription?
Definition
90 day supply
Term

100 beds

Or less

Hospital must maintain 1 licensed pharmacy or have waiver (section 4056)

Ø  Can buy drugs from wholesaler and dispense in-patient and out-patient

Ø  Does not require fulltime/part time Rph but require consultant Rph

Ø  Physician can dispense to outpatient

o   Cannot be any pharmacy within 30min or 30 miles

o   72 hour max supply given and properly  labeled

Definition
..
Term
Interim PIC (max time)
Definition
120 days
Term
Maximum number of day supply for C3-C4 to for prescription in 6 months
Definition
120 days
Term
Temporary pharmacy permit for change of ownership lasts (blank time)
Definition
180 days
Term
Active duty licensee must meet all renewal requirements within (blank time)
Definition
6 months
Term
Compassionate Use (FDA), (blank time) max supply of drug for serious condition with no satisfactory treatment option in the US
Definition
3 months
Term
Pharmacy experience hours to sit board exam
Definition
1500 hours
Term
Consulting pharmacist visits clinics/vet food-animal retailer/mental health rehabilitation center/? (how often)
Definition
4x a year
Term
Expiration on C2-C4 prescriptions
Definition
6 months
Term
Expiration date for compounded drug
Definition
6 months or less
Term
Expiration of prescriptions for veterinary food-animal drugs
Definition
6 months
Term
Out of state pharmacist spouse of military on active duty can have temporary CA license for (blank time) 
Definition
12 months
Term
Sterile compounding license renewal
Definition
Yearly
Term
Report of pharmacy services in correctional facility (every)?
Definition
year
Term
Expiration date for drugs on label (or can use manufacturing expiration)
Definition
1 year
Term
Keep patient medication profile from last entry
Definition
1 year
Term
Unit dose meds expiration
Definition
1 year
Term
Keep documentation of QA medication error reports
Definition
1 year
Term
 PIC performs self-assessment of pharmacy compliance with law every (how long) and is kept on file (how long)?
Definition
2 years/3 years
Term
Pseudoephedrine sale log kept for (how long)
Definition
2 years
Term
BOP can cancel pharmacist license and pharmacist may have to take board exam again if not renewed within (blank time) of expiration
Definition
3 years
Term
Pharmacy order records kept for Hospital pharmacies (hospital charts). for (how long) 
Definition
3 years
Term
Pharmacy order records kept for Hospital pharmacies (hospital charts) controlled substances? (how long)
Definition
7 years
Term
Prescription records kept for Clinic pharmacies + Veterinary food-animal drug retailer
Definition
3 years
Term
Pharmacy tech compliance records kept for how long
Definition
3 years
Term
Keep records of controlled substance inventory
Definition
3 years
Term
Keep documents of pharmacy self-assessment for how long
Definition
3 years
Term
Pharmacy and Ems keep records of dangerous drugs provided to ambulances for how long
Definition
3 years
Term
Manufacturer keeps records of distribution, loss, return and request for how long? 
Definition
3 years
Term
Retain record of placebo given for how long? 
Definition
3 years
Term
Pharmacy retain job description and written policies / procedures for technician’s role in pharmacy for how long?
Definition
3 years
Term
Keep CE certification documentation for how long
Definition
4 years
Term
Purged and destroyed records of impairment evidence that did not go anywhere (how long)
Definition
5 years
Term
HIPAA notice – patient acknowledgement
Definition
6 years
Term

FDA minimum age limit on emergency contraceptive provision for Plan B (2 pills and behind counter)

Definition
17 years of age
Term
If pharmacy related settlement over this amount then must report to BOP w/in 30 days
Definition
$3000
Term

 DEA form to report drugs disposed of or transferred to reverse distributer

  •  Pharmacy can obtain authority to destroy controlled substances 1x/year
  • Mfg. can dispose without prior approval if all records are kept
Definition
Form 41
Term
DEA form to order C1 and C2 substances. Anyone can order if registered with DEA and have power of attorney
Definition
Form 222
Term
Veterans Health Care Act of 1992, Mfg. sell drugs at no more than 76% of regular price to VA, military, Public health service, Indian health services, Cancer hospitals, rural centers, and community hospitals
Definition
340B Discount
Term
Controlled drug prescription for terminally ill need not be written on special script, exemption (# blank) need not be in prescriber handwriting
Definition
11159.2
Term
Nonprofit Institution Act prohibits resale of drugs acquired at preferentially low prices unless total sale is less than (what percent) purchased by the seller
Definition
1 percent
Term

Combat Methamphetamine  Epidemic Act (DEA) - pseudoephedrine sales

  • # grams in 24 hours?
  • # grams in 30 days?
Definition

3.6g/24 hours

9g/30 days

Term
MIN age to sit pharmacy licensing exam
Definition
18+ years
Term
MIN bachelors units in pharmacy to sit exam
Definition
150 units
Term

Intern license for current students lasts how many years?

Definition
6 years
Term
Intern license for graduates applying for CA license last how long?
Definition
2 years
Term
Extension for graduates that failed exam 4x and enrolled in 16 additional units
Definition
1 year
Term
Extension if proven student could not intern under previous intern license
Definition
2 years
Term
Bar from exam if caught cheating
Definition
3 years
Term

Pharmacist

On Duty

Technicians

(# Pharm x 2) – 1

Tech Trainees

# pharm x 1

Pharm Interns

# pharm x 2

Ancillary

No limit

1

1

1

2

-

2

3

2

4

-

3

5

3

6

-

4

7

4

8

-

Definition
..
Term

Pharmacists may…

WHERE

OTHER

Immunize

Anywhere

 

Skin puncture

Anywhere

For routine patient assessment

Test blood pressure

Anywhere

 

Provide information on drugs

Anywhere

With patient profile and medical information

Order lab tests

Clinical setting

Related to drug therapy

Temperature, pulse, respiratory rate

Clinical setting

Or other health care settings

Administer or inject drugs

Clinical setting

With prescriber order

Initiate or adjust drugs

Clinical setting

With order and protocol

Definition
..
Term

Health Care Provider Authority to Prescribe

Physicians

Prescribe

Within Scope of Practice

Veterinarians

Prescribe

Within Scope of Practice

Podiatrist

Prescribe

Within Scope of Practice

Dentist

Prescribe

Within Scope of Practice

Optometrists

Prescribe

If certified; topical antiallergy, topical antiglaucoma, oral antihistamines, oral abx, topical antiviral, oral acyclovir, codeine

Pharmacists

Furnish

Under protocol

Registered Nurses

Dispense

By physician order within clinic

Nurse Practitioner

Furnish

Physician supervision + protocol

Physician Assistants

Furnish

Protocol or physician approval

Controlled substances must be countersigned within 7 days

Certified Nurse Midwife

Furnish

For family planning if trained

C2-C3 requires protocol + physician supervision

Naturopaths

Furnish

With protocol w/physician; no C2; EXCEPTION: epinephrine for anaphylaxis and synthetic hormones (but not testosterone since it’s CIII)

Physical Therapist

CANNOT

 

Chiropractor

CANNOT

Topical products in practice only

Definition
..
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