Term
does excutive officer of the board has to be a pharmacist? |
|
Definition
no
(involved in board policy develoement and institute accusations against pharmacist) |
|
|
Term
board pharmacy member are consist of |
|
Definition
13 members
11 appointed my governer (7 pharmacist and 4 non)
2 member are appointed by speaker and senate of assembly
6 of 13 are non pharmacists |
|
|
Term
board members, how many terms can they serve |
|
Definition
they can serve 2 terms of 4 years each |
|
|
Term
a quorum is at least of how many board members |
|
Definition
|
|
Term
responsibilty of a board director
do they have to be pharmacist? |
|
Definition
inspect all licensed site for violations
does not have to be pharmacist
|
|
|
Term
|
Definition
optometrist (special license with "T" after license number)
physicians
dentist
podiatrist
vetenarian |
|
|
Term
can you fill a prescription from a prescriber who is deceased? |
|
Definition
|
|
Term
a certified optometrist can prescribe what? |
|
Definition
topical: antiallergy,anti inflammatory including topical steroid,antiviral, antiglaucoma (only one at a time)
oral: antihistamine,acyclovir
codeine or hydrocodone with a non analgesic (no more than three days supply, must reg with DEA) |
|
|
Term
optometrist can prescribe which antibiotics |
|
Definition
tetracycline
dicloxacillin
amoxicillin (or augmentin)
macrolides (azith only for eye)
cephalexin
cephadroxil
cefaclor
trimethroprim
ciprofloxacin
|
|
|
Term
naturopathic doctors can prescribe what? |
|
Definition
work with MDs under a protocal to furnis CIII-V and non controlled drugs
-Must have furnish number must preceed by "NDF" by bureau of naturopathic medicine
-independently prescribe epinephrine and hormones
-may prescribe thyroid tablets without protocol
- may apply for the dea registration |
|
|
Term
who may prescribe under MDs authorized protocol |
|
Definition
PA
NP
CNM (writing for females partner for STD)
Rph
ND |
|
|
Term
requirement to be a license as a pharmacist |
|
Definition
at least 18 yo
graduate for accredited school of pharm
complete 1500 hours
pass Naplex and CPJE |
|
|
Term
Continuing education requirement for pharmacist |
|
Definition
-30 hours of ce course during two years of license
renew on date of birth
-record of course must be kept for 4 years
-after 3 years if not renew,likely have to retake board
-during the the 3 years, a fine a impose
|
|
|
Term
when will a license not be renewed |
|
Definition
outstanding
child support
alimony
governement loan |
|
|
Term
one hour of of credit is how many ceu |
|
Definition
|
|
Term
if no proof of 30 hours in the two years.. |
|
Definition
board to issue inactive license
(so pay the renew fees and submit the CEs) |
|
|
Term
every pharmacy must have a |
|
Definition
|
|
Term
if change pic must notify board within |
|
Definition
|
|
Term
PIC may be PIC for nor more than__ pharmacies
how far apart are the pharmacies?
at the same time pic cannot be? |
|
Definition
2 pharmacies
50 miles apart
can not be exemptee in charge |
|
|
Term
if pic resign, a interim PIC can be up __ before indentifying a permanent pic |
|
Definition
|
|
Term
|
Definition
any conduct that violate pharmacy practice
must reports violation within 72 hours
take action to stop and correct violation |
|
|
Term
how is a pic selected
who must approve
if dispprove
if unable to approve |
|
Definition
board must approve
if disapprove have 15 days to select another
unable to approve: select an interim for 120 days
|
|
|
Term
for an intern to become an applicant they must |
|
Definition
have 1500 hours to site for exam
(900 pharmcies, 600 related)
|
|
|
Term
if interm fail exams 4 time they must
intern status will not be renewed after |
|
Definition
take 16 units of course
intern status will not be renew after 3 exams
|
|
|
Term
can a pharmacist intern have the key to the pharmacy |
|
Definition
|
|
Term
how many interns per each pharmacist at a pharmacy |
|
Definition
|
|
Term
at the discretion of the board how many year can intern obtain the license |
|
Definition
|
|
Term
intern pharmacist who change address must notify board within __ |
|
Definition
|
|
Term
if intern is no longer enrolled in school, must |
|
Definition
return license within 30 days |
|
|
Term
intern who are unable to complete experiences requirement can have their intern license extended for up to ___ |
|
Definition
|
|
Term
is a board exam required for pharm tech |
|
Definition
no,
must have an AA or pharm tech program |
|
|
Term
how many pharm tech per pharmacist |
|
Definition
one pharm tech per single pharmacist
or two pharm tech for any additional pharmacist
|
|
|
Term
tech performance must be evaluated and keep record every ___ |
|
Definition
|
|
Term
can a tech check drug filling of another tech |
|
Definition
yes, only if drugs is originally approved by pharmacist
-allow in acute hospital setting
-pharmacy must have "tech-check-tech" program
-tech must have special training |
|
|
Term
ratio of clerk to pharmacist |
|
Definition
|
|
Term
who is exemptee in charge (represenative in charge)
- how often to renew license |
|
Definition
-veterinary drug retailer
- renew license annually
-must be at least high school grad
- does not have to be a pharmacist |
|
|
Term
pharmacist tech or clerk calling on refills |
|
Definition
yes
but only pharmacist can call for expired prescription |
|
|
Term
who may phone in a prescription from a prescriber's office
what about CII |
|
Definition
prescriber or employee designated by prescriber
CII: must be called in by prescriber
|
|
|
Term
party receiving phone in prescription must |
|
Definition
record name and initial of sender
(address,phone,license,DEA,pt address if available in computer system) |
|
|
Term
who may receive an orally transmitted Rx from prescribers office
what must be noted on prescription
if call for a refill, who may receive? |
|
Definition
only pharmacist or intern
-ID of party calling
- pharm tech and clerk may receive
|
|
|
Term
may rx from prescribers be electronically transmitted to pharmacy?
do you need a hard copy to be stored
can we make changes to them |
|
Definition
all except CII
hard copy is not required, unless request by board
may make change, but pharmacist must approve
must have name and initial of party transmitting RX
|
|
|
Term
if a prescription is transmitted via a computer from the prescriber to pharmacy's fax, it is considered as...
what about fax to a fax
|
|
Definition
electronic data: digital signiture may be used
fax to fax: originally written: written signiture is required |
|
|
Term
what if the prescription is out of the state or out of the country |
|
Definition
out of country can not be filled
if called in: yes or obtain a california security form to fill ( can be filled including CII) |
|
|
Term
exception for filling prescription from outside the country |
|
Definition
if from district of columbia,guam,purto rico, virgin island, american somoa
|
|
|
Term
can a prescription container that have already been dispensed be reused? |
|
Definition
only when:
- in a multiple-drug package
-same patient
-no more than one month supply
- med pack must carry label" store in a cool dry place"
-non liquid |
|
|
Term
what rx pick up arrangement can be made after pharmacy hours |
|
Definition
- must have written info about the drug
-phone number to call if they have any questions |
|
|
Term
what expiration dates can appear on the label of a prescription |
|
Definition
manufacture: good till end of the month
or 1 year expiration date |
|
|
Term
compounded products expiration dates
what about extemporaneous unit dose drug package |
|
Definition
up to 6 months
one year for unit dose
|
|
|
Term
what if drug product does not have an expiration date |
|
Definition
it is considered expired
unless: human otc product with no dosage limitation and they are stable for at least three years supported by stability data |
|
|
Term
how may a preprinted, multiple check off prescription for non controlled substance be used?
(prescription blanks) |
|
Definition
can not be used for controlled
number of drug items must be indicated on rx by prescriber |
|
|
Term
refill limits on PRN refill or "One PRN" |
|
Definition
good up to one year
in direction say " one tablet PRN" |
|
|
Term
may a pharmacist place a false label on prescription |
|
Definition
only when:
-clinical or investigational study through FDA
-in medical judgement of presciber |
|
|
Term
can a profit pharmacy attempting to buy drugs from a non-profit pharmacy |
|
Definition
no
however: a for profit may borrow and return the exact.
(cannot substitute or purchase) |
|
|
Term
|
Definition
employee assistant program agency
- use to rehabilitate pharmacist
-requires a manager to perform quarterly reviews of all cases
-contract with pharmacies/pharmacist |
|
|
Term
can a pharmacy-related disciplinary action in another state be acted upon in california |
|
Definition
|
|
Term
must a resistant container be used for each drug dispensed? |
|
Definition
yes,
exception: topical or non oral products
- nitroglycerin tablets
- patient request, pt must sign waiver |
|
|
Term
is a full-time pharmacist required in hospitals of 100 or fewer beds
what about purchase of drugs at wholsale and dispensing |
|
Definition
does not require full time or part time, but must have a consultant pharmacist who does at least quarterly reviews
-may dispense to pt upon discharge
-may dispense in emrgency cases when tx in hostpital
-dispensing to outpatient under the following:
* no pharmacy withing 30min or miles
*no more than 72 hours of drugs is provided
*properly lableled |
|
|
Term
may a pharmacist leave the pharmacy while other personnel remain? |
|
Definition
yes, up to 30 minutes
no, med may be dispense check and approved and check by pharmacist |
|
|
Term
citation and orders of abatement issued by board
must be fix... |
|
Definition
must be correct with completion of 6 hours of C.E in the subject matter |
|
|
Term
is there a procedure for contesting a board issued citation |
|
Definition
may appeal to the board in writing withing 30 days or
may request of board within 14 days an office conference |
|
|
Term
what if a pharmacy hired an employee with crimminally related problem |
|
Definition
emplyer must have pace procedure for taking action to protect the public |
|
|
Term
when should a pharmacist report a lawsuit settlement in a pharmacy related matter |
|
Definition
if the settlement is $3000 or more
must report within 30 days |
|
|
Term
what if a pharmacist forgets to renew his or her license |
|
Definition
if not renewed for 3 years after expiration, may have to take the board again |
|
|
Term
what situation may prevent pharmacist from renewing license |
|
Definition
-license is suspended for revoke
-owes child support money
-owes student loans |
|
|
Term
what categorize as an inactive license |
|
Definition
-may be renewed
-no licensees who license revoke,suspended or placed on probation may obtain inactive liscense
-pharmacist have 15 days to correct or license is inactive (do you CEs) |
|
|
Term
what categorize a retired pharmacist license |
|
Definition
-issue to pharmacist who wish to retire
-must retake board exam for reinstatement |
|
|
Term
new requirements on license renewal |
|
Definition
- disclosure on any violation of the law in this or another state (not include:traffic violation under $300,dangerous drugs or controlled substance
requires
-finger is required |
|
|
Term
dishonest conduct on exams |
|
Definition
exam will not be graded
not approved to take exam for three years
surrender intern license |
|
|
Term
can a pharmacist refuse to fill a prescription |
|
Definition
-yes
-religious purpose
-must make reasonable accomodation so the patient can get prescription on a timely manner
-must develop procedure and policies |
|
|
Term
when medication is out of stock pharmacist is expected to |
|
Definition
-notify patients
-transfer prescription
-return prescription to the patient |
|
|
Term
reporting to the board on theft or impairment problems related issues |
|
Definition
must report within 30 days of having the knowledge |
|
|
Term
may a prescriber use the internet to send prescription to pharmacist |
|
Definition
yes including (C III-V)
must have appropriate prior exam |
|
|
Term
what is an appropriate prior exam |
|
Definition
-existence of a prescriber-patient relationship
-medical records kept by prescriber
-physical exam or at least a line of questioning by prescriber
|
|
|
Term
new rules on internet prescribing |
|
Definition
-prescriber must have conducted at least one in person medical exam on the patient
-meet the definition of a covering pharmacist
* one who conduct a medical eval within the previous 24 months
-online pharmacy must reg to DEA
-pharmacy will responsible for monthly dispensing of 100 or more controlled or 5,000 or more non controlled
|
|
|
Term
exception to operating an online pharmacy |
|
Definition
read on this when have time |
|
|
Term
adulterated,misbranded,and counterfeit drugs and board inspectors |
|
Definition
inspector may remove and secure sample, but must leave receipt describing what was taken |
|
|
Term
pharmaceutical waste management |
|
Definition
pharmacies must provide either...
-safe take back for no additional cost
- entity preventing drug diversion
-provide notice and information materials for consumers
-assurance of enhancement of public health
|
|
|
Term
manufactures who sell syringe must |
|
Definition
provide a plan that describe process of safe collection and proper disposal |
|
|
Term
each med error shall be reported not later then |
|
Definition
2 days from the time the error was discovered |
|
|
Term
|
Definition
date
location
participant
pertinent data
findings and determination
recommended changes to policy,procedure,system |
|
|
Term
records of QA shall be kept for |
|
Definition
|
|
Term
every new prescription must be counseled except |
|
Definition
|
|
Term
mandatory counseling point include |
|
Definition
-how to use the med
-importance of complying with directions on the label
-how to store the medication
-common severe adverse drug reaction
|
|
|
Term
what is the consultation requirement if a prescriptio is delivered or mailed |
|
Definition
must provide written notice of the patients rights to request a consultation on any new drug
-must provide a phone number that a patient can contact |
|
|
Term
must a pharmacist consult pt who is being discharged with medications
|
|
Definition
not must by may
a facility policy and procedure must exist |
|
|
Term
is a medication profile require for every patient |
|
Definition
|
|
Term
|
Definition
-patient's name,address,dob,gender
-name,strength,dosage form,qty,direction
-prescriber info
-date drug first disp/refill&disp pharm
-any allergies
* only use for the purpose of dur |
|
|
Term
may a pharmacist perform skin puncture on a patient |
|
Definition
yes
(glucose,cholesterol) |
|
|
Term
can a pharmacist provide an emergency supply if there are no remaining refill |
|
Definition
yes
nonscheduled drugs- may give part or full amount
sched III,IV,V- reasonable qty |
|
|
Term
can a pharmacist provide medication to a pt never seen before during a state of emergency |
|
Definition
yes
-pt already receive and have proof of receiving the drug
-must indicate reason
-state of emergency in the area |
|
|
Term
mobile pharmacies during state of emergencies |
|
Definition
-mobile pharmacies must share common pharmacies that is in good standing
-pharmacist must be on premise
must cease withing 48 hours following the termination of declared emergency |
|
|
Term
emergency contraception
age?
limit?
consultation? |
|
Definition
age
no limit on qty purchased
no consultation required
|
|
|
Term
what information is required on a prescription |
|
Definition
sign of prescriber or furnisher
name and address
name and qty
direction for use
date written
name,address,phone
license &DEA (if applicable)
|
|
|
Term
what information must be place on the prescription label |
|
Definition
name and address of pharmacy
prescription number
name of patient
name of prescriber, or other furnisher
date of issue
name,strength, and qty
expiration date
color and shape of tablet
id code on tab/cap |
|
|
Term
a new prescription must be created if change in |
|
Definition
drug
strenght
prescriber or directions for use |
|
|
Term
fax transmission from prescriber office, handle it like a |
|
Definition
like a telephone order
fascimile can serve as official record
must record name and initial of party sending |
|
|
Term
fax transmission from a pharmacy to pharmacy,handle like a... |
|
Definition
tx like a telephone order
|
|
|
Term
rx refill between independent pharmacies
for non scheldule |
|
Definition
record name and address of pharmacy
record name of receiving pharmacist
mark void
on receiving end:
name and address of sending pharmacy
name of sending pharmacist
remaining refills,date of oring rx,LF
indicate that it is a transferred prescription |
|
|
Term
transferring controlled substance between independent pharmacies |
|
Definition
one time only
from sending pharmacy:
-DEA of pharmacy
From receiving pharmacy:
-DEA of sending pharmacy
* common network system is considered as one pharmacy (pt to sign waiver if wish not to be in network) |
|
|
Term
dispensing hypodermic needles
log book required?
|
|
Definition
|
|
Term
when can needle be dispense otc |
|
Definition
person is know to furnisher with legitamite medical need
pharmacist reg with county (aid,hep c,older than 18) |
|
|
Term
what documentation must be kept by pharmacy |
|
Definition
-record of drug selling,buying,lending, or borrowing between pharmacy
-pharmacy self assessment survey
|
|
|
Term
self assessment survey is must be completed
by who?
how often?
new pic must complete within?
how long must record be kept? |
|
Definition
by pic every two odd year
new pic must complet in 30 days
record kept for three years |
|
|
Term
record involved in the preparation of extemporaneous unit dose packaging. |
|
Definition
record must have:
date of preparation
party preparing extempor unit
lot number
name and strength of drugs used
manufacture's name
supervising pharm initial or signiture |
|
|
Term
extemporaneous unit dose label to contain |
|
Definition
name and strength of drug
lot number of drug
expiration date- cannot exceed one year |
|
|
Term
community pharmacy prescription must be kept for |
|
Definition
|
|
Term
clinic pharmacy prescription must be kept for |
|
Definition
|
|
Term
patient medication profile must be kept for |
|
Definition
|
|
Term
q.a medication error report must be kept for |
|
Definition
|
|
Term
hippa notice-patient acknowledgement must be kept for |
|
Definition
|
|
Term
controlled substance inventory record must be kept for |
|
Definition
|
|
Term
DEA form 222 record must be kept for |
|
Definition
|
|
Term
self-Assessment of pharmacy record must be kept for |
|
Definition
|
|
Term
pharmacy change of address or name must report to board in __ days |
|
Definition
|
|
Term
change in pharmcist in charge must report to board in __ days |
|
Definition
|
|
Term
reporting of drug loss must report to |
|
Definition
|
|
Term
change in pharmacy permit must report to board __ days |
|
Definition
|
|
Term
filing bankruptcy must report to the board___ days |
|
Definition
|
|
Term
what kind of information must be provided to consumers regarding a pharmacy service |
|
Definition
|
|
Term
"notice to consumer" should include |
|
Definition
enrourage patient to ask questions regarding to medications |
|
|
Term
what is obligation of pharmacist in giving prescription prince information to a requesting customer
what if the request is more than five prescription
what bout more than three request from on pharmacist |
|
Definition
pharmacist or clerk can give it
-pharmacist can response in ten days
-pharmacaist can charge for qoute, but fee must be inform prior to dispensing
-if more than three request from one pharmacist (have 6 months to respond)
|
|
|
Term
pharmacist is not required to respond to price when |
|
Definition
-controlled substance over the phone
-price request from competitor
- price request from out of state |
|
|
Term
labels that are required by manufacture |
|
Definition
shake well
refridge
for external use |
|
|
Term
aux label required by law |
|
Definition
drowsiness drugs
if drug effect vision
drugs /alcohol
|
|
|
Term
which drug requires patient package insert
by law
by manufacture |
|
Definition
by law: all estrogenic
by manufacture: check fda |
|
|
Term
are there restriction on the name a pharmacy may use? |
|
Definition
names are exclusive to pharmacies only
must names themselves as provider of drug |
|
|
Term
do you have to be a pharmacist to own a pharmacy |
|
Definition
|
|
Term
license prescriber can own up to how many percent of the pharmacy |
|
Definition
|
|
Term
exception to physician ownership of pharmacy |
|
Definition
physician groups can own hospitals and pharmacist within
can own HMO with pharmacies within |
|
|
Term
what building standards must a pharmacy meet
what if a pharmacy is within a store |
|
Definition
-must have reasonable space
must have a barriers of 5 ft to preven public from -having free access
- within a store must have barriers from floor to ceiling and have a door with a lock
|
|
|
Term
who may enter into pharmacy area |
|
Definition
anyone having business in the pharmacy that pharmacist on duty allows to come in |
|
|
Term
who may sign for ordered drugs from a wholsaler when they arrive at the pharmacy |
|
Definition
by pharmacist or a designated represenative |
|
|
Term
who is a designated represenative |
|
Definition
an individual to whom a license has been granted
ex) represenative in charge
veterinary food-drug animal drug business |
|
|
Term
requirement for closed pharmacy or pharmacist not on duty delivery |
|
Definition
- secure storage facility in the same building are the pharmacy
-only pic or pharmacist may have access
- indicator if it has been access
-has policy on the delivery |
|
|
Term
does a clinic require a permit to stock and dispense drugs |
|
Definition
-must have board and DEA permit
-cII is not allowed
-must have a consultant pharmacist (part time not require)
*pharmacist visits quarterly
*report kept 3 years |
|
|
Term
clinics
dispense how many day of supplies to patient? |
|
Definition
|
|
Term
hospital pharmacies drug delivery |
|
Definition
may be made to a central receiving location withing the hospital
drug shall be delivered to pharmacy within one working day |
|
|
Term
does out of state manufactures,wholesalers doing business in california requires a permit to operate in this state |
|
Definition
must have "out of state distribution license"
renewed annually |
|
|
Term
who requires a " non-resident pharmacy reistration permit" |
|
Definition
|
|
Term
must a pharmacy located outside the physical plant of a hospital serving that hospital be separately licensed |
|
Definition
no
yes: if serve as outpatient |
|
|
Term
is there a waiver arrangement for an off site storage of pharmacy records |
|
Definition
yes,
with condition:
- storage must be secure
-records must be confidential
-produce record to board in 48 hours |
|
|
Term
off site storage prescription record |
|
Definition
1 year for non controlled
2 years for controlled
* both from last dispense |
|
|
Term
what is a close door pharmacy |
|
Definition
engaged in specialty practices such as
-compounding
|
|
|
Term
what is a "non resident wholesaler" |
|
Definition
out of state wholsaler of drugs or devices that is licensed in california
license is renewed annually
|
|
|
Term
manufactures who ship their own product directly into california is |
|
Definition
exempt from the license requirement
registered pharmacist (or represenative in charge) must be present on premise during business |
|
|
Term
what happen to a pharmacy permit if pharmacy closes or is closed by board
notify board within
transferring drugs within |
|
Definition
must notify board within 30 days of closure
transfer of drug must be within 10 days |
|
|
Term
what is the definition of closure |
|
Definition
not engaged in ordinary activity for at least one day each week during any 120 day period |
|
|
Term
when board confiscate and sell drug, holder has ___ days to claim |
|
Definition
|
|
Term
the change drugs they must have same |
|
Definition
|
|
Term
do not substitute rules on
rx vs electronic |
|
Definition
rx requires initial
eletronic prescription does not require inititial |
|
|
Term
may sample be stored and dispense in pharmacy |
|
Definition
yes, rare
emergency,prescriber must send to the pharmacy
prescriber must state intent in writing |
|
|
Term
prior to dispensing ephedrine product pharmacy must |
|
Definition
train their employee and keep record |
|
|
Term
what is required from patient to dispense ephedrine
what should be on the log book |
|
Definition
18 years old
ID
log book: name,address,date&time of sale, and pt signiture |
|
|
Term
what is the limit on epherine |
|
Definition
daily limit 3.6
montly 9 grams
single purchase of 60 mg does not require a log book |
|
|
Term
what is the restriction on iodide substance |
|
Definition
no OTC sale as betadine or povidine solution that has excess of 1% or 8 oz or more
no OTC tinture of iodide that is 2% or 1 oz (or more)
if these products are sold or transferred, provide must submit to DOJ |
|
|
Term
may prescription drugs that are returned by a patient to the pharmacy be sold by the pharmacy |
|
Definition
once dispense, regardless of time, it can not be reused under both federal and state law |
|
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Term
what is allowed regarding the redistribution of unused prescription drugs |
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Definition
for county pharmacy or pharmacy who have contracted with county
-patient are not to be charge for the drug
- must have formulary of medication developed that will be used in program |
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Term
any drugs donated medication to the country must |
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Definition
-not be a controlled substance, nor adulterated
- not have been in possession of patient
-unopen/ and untampered
-segregrated from the pharmacies other drug stock
- may not dispense if expired
-pharmacy must keep record and dispense drug
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Term
what temperature must drugs be stored under |
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Definition
Fridge: 36-46 F
Room temp: 59-80 F
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Term
can a compounded drug be packaged or prepared prior to receipt of a prescription |
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Definition
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Term
can a second pharmacy compound for a primary pharmacy? |
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Definition
yes
must fixed a label to the coumpounded prescription of the pharmacy involved in compounding |
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Term
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Definition
altering dosage form or delivery system
altering strength of drug
combining components or active ingredient
preparing drug product form bulk substance |
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Term
exclusion from compounding definition |
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Definition
reconstitution for oral,rectal,topical,or injectable pursuant to manufactures direction
adding of flavoring
preparation of commercially available products |
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Term
when a product is compounded by a pharmacist where the final product contain two FDA approved drugs
the resulting is refferred to as |
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Definition
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Term
what are requirements on compounding unapproved drugs for a prescriber's office use |
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Definition
must expiration not exceed 6 months
consistent with scope of practice
may use of office or not no more than 72 days supply |
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Term
when a pharmacy compound a drug in quanities larger than what is required for immediate use, or intended for future dispensing what record must be kept? |
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Definition
date of prep
intial of pharmacist
lot
expiration date
name of manufacture of raw materials
quanity in units or grams
package size & number of units |
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Term
pharmacy engage in sterile compounding must have |
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Definition
a separate license from the board
license renew annually and inspection prior to each licensing period
special license is not required if accredited by JCAHO |
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Term
inappropriate compounding of sterile product will be |
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Definition
cease and desist
effective no more than 30 days or until dat of a hearing which is earlier
owner may contest within 15 days of receipt by requesting hearing to the president of the board |
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Term
requirements to operate sterile injectable compounding service
(9 things) |
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Definition
flow hood certified annually and keep record for 3 years
- have policies and procedures (read pg 23)
-labeling requirement
-record keeping requirement
-attire
-training of staff,patient,caregiver
-disposal of waste material
-QA
-reference materials |
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Term
no separate license is required for the reconstitution of a sterile power if |
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Definition
-sterile power was obtained from manufacture
-if drug is administer by health care professional license to admin drug by injection |
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Term
how should a PIC complete self assessment on non sterile products |
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Definition
-must be completed before july 1st of odd-number years
or
-within 30 days of new PIC and within 30 days of issuance of a new pharmacy license |
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Term
non sterile compounding pharmacies must have
4 things |
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Definition
-records of compounding (formula,ingredient,lot,quanity,equipments)
-labeling of compound product
-policies and procedure
-training programs for compounding staff
-QA |
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