QUESTIONS & 100% CORRECT ANSWERS
GRADED A+
requirements for class C pharmacy
wholesaler/distributer or manuf
-seperate license for each seperate location
-facility does not need supervision of a licensed pharmacist but designated representative (who should
be on license)
(>21,employed for at least 3 yrs in a pharmacy or wholesaler, full time managerial level position)
-each facility must have an inspection by division PT initial licensure
-post all licenses and most recent inspection report
-criminal background check on applicant and all key personnel
-quarantine area for storage of rx drugs and rx drug precursors that are damaged, outdated, misbranded
or adulterated
-secure from unauthorized entry
-well lit on outside perimeter
-alarm system to detect entry
-person engaged in wholesale distribution shall provide a pedigree to the person who receives such drug
**
-shall maintain inventory records (2yrs) and records of transactions (5yrs) (must be avail within 2
working days or request)
-upon reciept containers should be examined for contamination, damange
-when ready to ship check to verify product and that there is no damage
-if identify inventory discrepancies must investigate and report to division w/in 3 business days
what needs to be included on the drug pedigree from the pharmaceutical wholesaler?
,how long should the purchaser and wholesaler maintain this?
-info concerning each sale in the chain of distribution
(info:name/address/tele# of each owner, name/address from each location shipped, transaction dates,
name of drug, dosage form/strength, size of container, number of containers, lot number, NDC & name
of manuf)
-5 years from the date of transfer
note:wholesaler must also have the identity of the person who accepted the shipment
what does an application for a class D pharmacy include
-pharmacy care protocol
-PIC license
-copy of the most recent state inspection showing the status of compliance with laws and regulations
what is the min that should be on a rx order per PPA
-dr name/address/tele# (not reqd for inpt orders)
-if controlled pts age and dr dea #
-pt name and address (of pet name of owner and species)
-date
-name of med and sig
-dr signature (of if electronic the drs elec. sig)(if hard copy printed the drs electronic or manual
signature)
-pharmacist or intern may make corrections on rx w/ permission of dr
rx label min info as reqd by PPA
-name/address/phone of pharmacy
-rx #
-filling date
,-name of pt
-name of dr
-sig and cautions if any
-drug name (trade,generic or chemical), strength and quant dispensed
-BUD
according to PPA how long should prescription files and refill info be maintained
5 yrs and readily retrievale **
transfer info per PPA
-directly between pharmacist or interns
-maintainedd for a period of 5 yrs from date of last refill
-void electronically or write void on face
-may not refuse to transfer
refill info per PPA
-if no refills must get authorization from dr
-may not be refilled after 1 yr from date issued
CAN refill w/o dr approval if (NOT C2s)
-disaster and can no contact dr
-failure to refill could lead to pt suffering
-refill does not exceed 3 day supple (unless packaging is greater)
-inform pt that of situation and can not refill again w/o dr approval
-informs dr as soon as possible
-affixes label to container
-maintains a record with all info of a rx
, note:can do this from another pharmacy if can not contact other pharmacy for transfer or transfer from
other pharmacy with no refills, USE JUDGEMENT
electronic rxs must have this info
-all info reqd from a rx
-time and date of transmission
-if faxed have data and time and fax number from where it was sent
-name of pharmacy intended to receive
-drs or their agents are to provide voice verification when requested by pharmacy
-electronic signature of dr
-all hardcopies or electronic copies readily retrievable for 5 years**
-if sent by pt do not fill or dispense
identification of pharmacy personnel
-all employed must wear a clearly visable and readable identification showing name and position
-when communicating (written,verbal,electronic) must identify themselves and title on license
may not discuss or release info on prescription or med profile to anyone but...
-pt or legal guardian
-enforcement officer
-thrid party payment program (auth by pt- hippa)
-any pharmacy staff allowed in system or dr
-when pt has requested a transfer
-pt attorney after written authorization signed by:
pt (before notary) or guardian or personal rep if deceased