Use LEFT and RIGHT arrow keys to navigate between flashcards;
Use UP and DOWN arrow keys to flip the card;
H to show hint;
A reads text to speech;
149 Cards in this Set
- Front
- Back
ONE RPh can supervise how many pharmacy techs and interns at one time?
|
3 total
NMT 2 interns/ rph Ancilary staff dont count |
|
If 3 techs are one duty what is required?
|
ONE:
1. Must be certified by a tech board 2. graduate from an accredited tech prgm 3. 500 hrs of trainign |
|
Emergency supply for Rx Drugs?
|
ANY Rx drug
Unable to reach doctor after trying Needs to be vital to the patient's health/ wellbeing NMT 72 hours dispensed and of course you dont do this if the doctor says dont! |
|
What drugs absolutely necessitate the purpose for use?
|
Anabolic steroids
|
|
What are the bare minimum labeling requirements as per the statutes?
|
1. Pharmacy Name
2. Pharmacy Addy 3. Patient Name 4. Prescription Number 5. Drug dispensed 6. Doctor's name 7. Date of either dispensing or initial date written 8. Directions for use (if on the script) |
|
What are the bare minimum labeling requirements pursuant to a hospital order?
|
1. Patient location
2. Hospital name 3. Patient name 4. Drug identifaction Plus/ minus: (depends on the situation) Exp dates Control/lot numbers Warnings/precautions |
|
Requirements for generic substitution?
|
1. AB rating
2. Doctor doesnt do a DAW code 3. Generic is cheaper (OK to dispense more expsensive if it's all that's available) 4. Written and oral communication is made to patient (not needed for refills or institutionalized patients) |
|
When do you need a new Pharmacy Manager if the old one quits?
|
Within 30 Days
|
|
How many COBOP members are pharmacists? Non pharmacists?
|
5; 2
|
|
How many years experience for a COBOP member?
|
AL 5
|
|
How long is a CO BOP term?
|
4 years
|
|
How many consecutive BOP terms can one serve?
|
NMT 2
|
|
For how long are Rx records kept?
|
2 years
|
|
If the COBOP allows a wholesaler to keep records centrally what is the turn around time needed if records are to be produced?
|
w/in 48 hours
|
|
If you have CDS stolen when must you report the theft to the COBOP?
|
w/in 30 days
|
|
How many intern hours are needed to become RPh?
|
1500
|
|
What is required to appear on a pharmacist's name badge?
|
Name and license number at a minimum
|
|
What is required to appear on an intern's name badge?
|
intern pharmacist
|
|
WHen must you notify board if you:
1. Have a change in names? 2. Change in address or employment? 3. Change in Pharmacist Manager? |
1. Doesn't specify
2. Within 30 days 3. Immediately notify BOP of the date when he ceases to be manager |
|
If a pharmacist manager ceases to be manager, HOW (not when) must he contact the BOP?
|
In writing
|
|
Upon the change of pharmacist manager of a prescription drug outlet, the new pharmacist manager or the new pharmacist manager’s designee shall take an inventory of all controlled substances within ____?
|
72 hours
|
|
Upon the transfer of ownership of a prescription drug outlet, the pharmacist manager or the pharmacist manager’s designee shall ________________
|
Take a CDS inventory
|
|
It is the responsibility of the pharmacist manager to maintain and to assure the outlet’s compliance with a policy and procedure manual, where applicable, encompassing all aspects of non-sterile and sterile compounding as required by rules 21.10.10 and 21.20.30, respectively.
1. How often must this P&P be reviewed? 2. What if the PIC changes? |
1. One time per year. Must sign and date.
2. New PIC reviews, signs, and dates within 30 days |
|
What must be documented WRT technicians in a compounding/ dispensing area?
|
Choose 1:
1. 500 hours of expeirence 2. Certified thru a tech board 3. Graduated from an accredited tech program 4. not credentialed |
|
Who can provide E-kits?
|
Hospital or PDO
|
|
To whom may E-kits be provided?
|
LTCF
Hospice Home health agency |
|
How many facilities may provide an E-kit to the same LTCF?
|
ONLY 1 PROVIDER!
|
|
For Long-Term Care Facilities and Inpatient Hospices, the _____________ of the facility, or equivalent, and the ______________ shall determine the specific drugs to be kept in the kit.
|
Medical director
Consultant pharmacist |
|
For LTCF or Hospice:
The number of drugs allowed in the kit shall be limited to _________. Of the _________, ________ may be controlled substances. The kit may contain no more than ________ doses of any separate drug dosage form or strength for each drug. The container size for each drug shall be limited to __________. |
1. 60
2. 60 3. 12 4. 30 5. Unit dose |
|
In the case of a Certified Home Health Agency or an Outpatient Hospice, the ______________ of the Certified Home Health Agency or of the Licensed Hospice, and _____________ employed and designated by the prescription drug outlet or hospital other outlet providing the kit shall determine the specific drugs to be kept in the kit.
|
1. Director of nursing
2. Pharmacist |
|
A Certified Home Health Agency or Outpatient Hospice may not have___________ or ____________ in the kit. The container size for each injectable drug shall be limited to __________. The number of drugs allowed in the kit shall be limited to _______. The kit may contain only _________ doses of any separate drug dosage form or strength for each drug.
|
1. Oral dosage forms
2. Controlled substances 3. Unit dose packaging 4. 60 5. 30 |
|
The kit shall be sealed with a _________ or _________ which notifies the pharmacy when the kit has been accessed. ____________ seals are unacceptable. If an ___________ is utilized, the pharmacy and facility must maintain a written procedure for how the kit can be accessed in the event of downtime.
|
1. Tamper evident seal
2. An electronic system 3. Paper or tape 4. Electronic system |
|
WRT an emergency kit what info needs to be readily retrievable?
|
1. Where did it come from? Name + address + Phone number of pharmacy providing kit.
2. When was it sealed? 3. When does the kit expire? NMT 1 year of sealing or expiry w/ earliest expired drug. 4. Who is the designated pharmacist associated with the kit? |
|
True or false: you need a copy of the kit contents to be attached to the kit.
|
True
|
|
A prescription drug outlet or hospital other outlet which supplies an emergency drug kit to a Long-Term Care Facility, Hospice, or home health agency shall notify the Board in writing within ________ that it has done so, specifying the _________.
|
7 days; name + address of facility.
|
|
Under what 2 circumstances must you re-notify BOP regarding emergency kits? Under what timeframe?
|
W.in 30 days:
1. change in ownership of kit 2. change in pahrmacist |
|
If the e-kit has been accessed who must inspect kit? and in what tiemframe?
|
1. Pharmacist of the supplying agency
2. w/in 72 hours |
|
What is the minimum amount of time that a pharmacist inspect the e-kits
|
at least annually
|
|
Documentaiton of inspection of e-kits should be maintained for______
|
2 years.
|
|
When a drug is removed for administration the prescription drug outlet or hospital other outlet shall obtain a___________ or _____________ for the drug within _________ after being notified that the kit was opened and the drug was used. The order shall indicate ______________. The order shall be assigned a _______and the order shall be retained as required by rule 11.04.10.
|
1. Rx or LTCF order
2. 72 hours 3. Number of doses administered. 4. Serial number |
|
What other information must appear on a label if somehting is packaged by a PDO?
|
1. Exp dates: 1 year rule
2. Name + strength of medication 3. Total number of tablets/ dose (if a unit dose medication) 4.Date of packaging* 5. ID of packer* 6. MFGR ID* 7. MFGR lot* 8. MFGR expy* 9. Name + Addy of the PDO/ hospital (i.e., the repaker) * As long as there is an INTERNAL record of this information that is maintained, the repacker can just assign an internal lot number as part of the labeling that specifies all of this information. THE SAME INFORMATION MUST APPEAR ON A CASSET FOR SOMETHING LIKE A SCRIP PRO MACHINE!!!! THE SAME INFORMATION CAN BE OMITTED AS WELL AS LONG AS THERE ARE INTERNAL RECORDS/ LOT NUMBER THAT CAN SPECIFY THIS INFORMATION! |
|
Each outlet engaged in sterile product packaging shall maintain a policy and procedure manual that shall be reviewed, signed and dated by the pharmacist manager at least __________, and within ________ of a new pharmacist manager assuming that position.
|
Annually
30 days |
|
Results of equipment calibration and appropriate maintenance reports shall be maintained on file at the outlet for at least ________ from the report date and shall be ________________.
|
2 years
available for inspection |
|
Accuracy assessments of automated sterile packaging devices shall be conducted _____ for each day used.
|
Daily
|
|
At least ___________, the _________________, shall review these assessments to avoid potentially significant errors. These assessments shall be documented and available for inspection at the outlet for at least __________
|
Annually
Pharmacist manager or designee 2 years |
|
The temperature of drug storage areas of sterile packaged products shall be monitored and recorded ________, either manually or electronically. Temperature records shall be maintained and available for inspection at the outlet for at least ________.
|
Daily
2 years |
|
BUDs for Low Risk 12+ hr stability in:
1. RT? 2. Refrigerated 3. Frozen |
1. 48 hours
2. 14 days 3. 45 days It should go without saying that if one were to have a drug with a <12 hr stability, the BUD must be <12 hours! |
|
Label requirements for Patient Med Packs?
8 major auspices |
1. Patient Name
2. Serial nUmber for the pack and for each drug in the pack 3. Name + strength + quantity of each drug in the pack 4. Directions for use 5. Storage statements 6. Name of doctor for each drug 7. Exp date (NTE 60 days!!!!!!) 8.Name + addy + # of dispensary |
|
Modification of a dispensed MedPack. What is OK?
|
Basically, it's not considered redispensing if you remove the d/c'ed drug from a dispensed medpack and destroy it. You need a new serial number for the pack and you can't add anything new to the pack.
|
|
Every __________ the system must produce a hard-copy document that, for the purposes of these rules, shall be known as the ―packaging printout‖. It shall consist of a single, uniform, complete document. The packaging printout shall list, separately, each packaging transaction for the _________ and shall contain all information required by this rule. Packaging printouts shall be retained in a __________.
|
24 hours
Previous 24 hours Chronological order |
|
A prescription drug outlet which utilizes a computer (automated data processing system) for storage and retrieval of information regarding packaging transactions need not print the packaging printout required by rule 3.01.23 if the prescription drug outlet and the computer system utilized are capable of complying with the following requirements:
|
1. Online retrieval from the past 2 years
2. Daily back up of information 3. The information is either printable upon request or it cannot be back-editied 4. At the board's request print out the information within 2 hours or provide a computer terminal for them for access the information within 2 hours |
|
What are the 3 conditions that must exist for 2 pharmacies to engage in central rx processing?
|
1. Appropriate technology/ interface
2. Both are registered w/ bop 3. Both have a written agreement/ p and p |
|
The pharmacist manager of the "fulfillment pharmacy" must assure what 2 things?
|
1. The drugs are shipped in a way that can show evidence of tapering
2. Shipping process allows for stability and potentcy of drugs to be maintained. |
|
How may patients be notified that their prescriptions will be processed centrally?
|
1. Sign
2. One time written notice |
|
What must the label of a centrally filled rx have on it?
|
Name
Address Phone of the ORIGINATING pharmacy |
|
I want to centrally fill an Rx. I'm at the originating pharmacy. What must I do?
|
1. Write "Central Fill" (if a control)
2. Identify the CF pharmacy (name, address) 3. DEA number of CFP (if controlled) 4. Date of Transmission 5. Pharmacist identity @ the originating pharmacy |
|
Upon receipt of the prescription from the fulfillment pharmacy, the originating pharmacy shall record:
|
1. Date of receipt?
2. Who received? 3. How was this delivered? |
|
How long must you keep CF records?
|
2 years, at least
|
|
What must the CFP record when it dispenses an RX?
|
1. Identity of originating pharmacy (name, addy, +/- DEA#)
2. Date Received 3. Date Fulfilled 4. ID of RPh doing the final review 5. Date sent 6. Method sent |
|
Unique way to file Rx in Colorado?
|
3 piles
CII CIII-CV Everything else |
|
The daily printout shall differentiate between ________________ transactions.
|
New and Refill
|
|
The daily printout shall contain:
|
1. Rx number
2. Patient 3. Doctor 4. Date of dispensing 5. Refills authorized 6. DEA of doctor if applicable 7. Name and strength of drug 8. Quantity dispensed 9. If a refill, number of refills dispensed to date 10. Date of issue of script |
|
Do you have to keep records of dispsening of CDS separate from legend drugs?
|
yes
|
|
The daily printout shall be available for inspection by the Board within __________ from the most recent date recorded on the printout.
|
72 horus .
|
|
Each prescription drug outlet shall keep and maintain on a current basis a list of every ___________ who has practiced pharmacy in that outlet at any time during the previous two years, including all _____________ or ________.
This list shall show: |
1.Pharmacist and intern
2. Part Time 3. Relief staff A. Printed Name B. License Number C. Initials and signature D. Date beginning the practice of pharmacy w/in that facility |
|
In the event the consultant pharmacist in whose name the other outlet registration is issued is unable to perform the duties of a consultant pharmacist, the consultant pharmacist shall designate an individual pharmacist to assume the consultant pharmacist’s duties for no more than ___________
|
90 consecutive days.
|
|
The consultant pharmacist in whose name the other outlet registration is issued shall notify the Board in writing within___________ of designating an individual pharmacist to assume said consultant pharmacist’s duties. Said written notification shall include, as a minimum, the _________and ___________of the individual pharmacist, the __________ for which said individual pharmacist assumes the consultant pharmacist’s duties, and the reason for which said individual pharmacist is designated to assume the consultant pharmacist’s duties.
|
1. 10 days
2. Name 3. License Number 4. Beginning and endng dates |
|
In the event the consultant pharmacist in whose name the other outlet registration is issued is unable to perform the duties of a consultant pharmacist for a period exceeding ___________, an application identifying a new consultant pharmacist shall be submitted to the Board no later than ________ following the end of the original ___________.
|
90 days
30 days 90 days |
|
Every prescription drug outlet must ensure controlled substance dispensing transactions are reported to the PDMP _______________
|
2x/month
|
|
For dispensing transactions from the first through the 15th day of each month, data shall be transmitted to the PDMP between the ____________ day of that month
|
16th to 25th
|
|
For dispensing transactions from the 16th through the last day of the month, data shall be transmitted to the PDMP between the __________ days of the subsequent month.
|
1st to 10th
|
|
If the prescription drug outlet does not dispense any controlled substances for the reporting period, it must enter _________ entry or will be considered non-compliant
|
zero
|
|
Who is exempt from reporting to PMP?
|
hospitals,
ERs, PDO in a hospital dispensing < 24 hour supply to an outpatient, EMS, a PDO if it gets a waiver from BOP |
|
Can patients access the PMP?
|
Yes so long as it pertains to them.
Must fill out specific paperwork and provide photo ID. A patient's POA can also access the PMP (also needs to provide a valid ID) |
|
What can veterinarians prescribe?
|
Pretty much ANY drug for usual course of practice
|
|
What can podiatrists prescribe?
|
Pretty much ANY drug for usual course of practice
|
|
What can PAs prescribe?
|
Anything in the usual course of practice so long as a few requirements are met:
1. Must be on the doctor's order form 2. Must have both the PA and Doctor's info: name, addy , DEA, phone number |
|
What are the prescribing limits for a medical/ osteopathic doctor?
|
Any drug; just can't really prescribe a CII for self or family unless it's a true emergency
|
|
What are the prescribing limits for an optometrist?
|
Must have at therapeutic Optometrist license (TPA) in addition to a CO license.
Can prescribe any CDS save for CIIs related to ocular dz. Can only prescribe epi as an injectable. |
|
What are the limits for a dentist?
|
Any drug thats needed for the proper practice of dentistry.
|
|
What are the prescribing limits for an RN?
|
Must have a RXN
Must have a DEA # for CDS Can practice alone w/o supervision of doctor! |
|
What must appear on each oral or written order? (I'm making the monstrous assumption that the law is referring to the "sticker" information put on the order in a retail setting...)
|
1. Date of dispensing
2. Quantity disp is differs from quantity prescribed 3. RX number +/- 4. DEA #, doctor addy, patient addy if a CDS 5. Drug prescribed vs. drug substituted if that happened 6. Distributor or NDC 7. |
|
Any change in or clarification of an order will need what documentation?
|
1. Who clairified it?
2. When was it clarified? 3. Who was the intern or rph? |
|
On subsequent refilling of any order, if you change the the distributor or the national drug code number do you have to document on the hard copy order?
|
No as long as the comp can identify that a change took place and it won't back edit the old Rxs that were filled.
|
|
In the case of a chart order for a hospitalized patient (hospital chart order), the following information need not necessarily appear on the chart order, provided that such information is recorded on another appropriate, uniformly maintained and readily retrievable permanent record which reflects:
|
1. Date
2. Quantity 3. RPh doing initial and final evals 4. CDS orders need to be kept in a readily retrivable form |
|
Each outlet shall maintain, in written format, a notice detailing how initial interpretations and final evaluations are documented in the outlet.In the event the pharmacist manager changes, the incoming pharmacist manager shall review, sign and date the notice within ________ of assuming the duties of pharmacist manager. In the event there is a lapse between the time one pharmacist manager ceases the duty and another assumes the duty, the previous method of recording initial interpretations and final evaluations shall remain in effect.
|
72 hours
|
|
Each outlet shall maintain, in written format, a notice detailing how initial interpretations and final evaluations are documented in the outlet. The outlet shall post these notices on ________ and retain all notices for a period of ____________
|
a wall directly next to the outlet’s most current Board registration.
3 years |
|
A hospital prescription drug outlet may accept prescriptions and drugs for dispensing or reissue from _______ areas of the hospital, provided that:
|
ANY AND ALL
1. The drugs are in good shape 2. There are records kept |
|
Any prescription returned for redispensing or donation from a facility or donated by a prescription drug outlet shall bear an expiration date that is at least ___________ after the date the prescription was returned.
|
6 months
|
|
The following may donate or return drugs to prescription drug outlets:
|
1. Prison/ Hospice/ home/ ltcf/ efc
2. prison/ Hospice/ home/ ltcf/ efc that has non profit status 3. PDO can return / donate drugs to non profits or a doc authorized for dispensing |
|
Drugs which have been dispensed to a resident of a correctional facility or licensed facility that are eligible for return or donation are as follows:
|
1. (l) w/ original seal
2. Solid in unit dose w/ packaging maintianed 3. Drugs in original container that havent been opened or tampered with |
|
Storage of Returned or Donated Prescription, Medical Devices, and Medical Supplies. Tell me about it.
|
Needs a special sign
needs a special place in pharmacy |
|
Drug products in manufacturer's unit dose or unit of issue packages may be redispensed how many times?
|
as many as needed
|
|
Drug products which have been packaged into unit of issue packages in the prescription drug outlet may be redispensed how many times?
|
Only once and only in their original packaging unless they are packaged into a traditional dispensing system, such as a retail amber vial....
|
|
What are labeling requirements for returned drugs?
|
"Returned drug" needs to be on the label
|
|
Records of donation need to be kept for _____
|
3 years
|
|
Deletes and return to stock.
Expiration date? Container requirements? |
NMT 1 year
Container in which it was dispensed |
|
Central fill RTS/deletes?
|
1. Label must have the MFGR lot + exp
2. NO CDS RTS 3. NO cmpds or flavor RTS |
|
Two types of drugs that can't be put into a script pro?
|
CIIs
Multisource generics |
|
What needs to be on the label of a ScriptPro cell?
|
Drug Name
Drug Strength Exp Date (NMT 1 year out) Some sort of lot number (if internal needs to include: MFGR, exp date, lot number of drug, ID of person packaging, date of loading of cell) |
|
You need to keep script pro cell-loading records for....
|
2 years
|
|
Who can administer vaccines in Calarada?
|
Pharm or intern
|
|
Amount of live training needed for vaccine administration?
|
8 hours hands on
|
|
Amount of didactic training needed for vaccine administration?
|
12 hours
|
|
Where must you provide proof of being trained to provide immunizations?
|
At your practice stie
|
|
4 Requirements in order to provide vaccines?
|
1. CPR card
2. Pharmacist-based immunization course was taken 3. CDC guidelines followed 4. Hard or e-copy of the CDC guidelines @ practice site |
|
How long do you keep vaccine records?
|
3 years
|
|
Flu clinic requirements?
|
1. What was removed/returned? (name/strength/dosage form/ NDC)
2. When was it removed/returned 3. Who removed/returned? (name plus license number) 4. How much was removed/returned? 5. Kept at proper temps in transit 6. Must return the vaccines the same day 7. Only rphs and interns can have access to the drugs @ the clinic |
|
I'm transferring a script IN. WHat info must I include?
|
1. Pharmacy name
2. Pharmacy addy 3. Pharmacy phone 4. Pharmacist giving 5. Date written 6. Last fill date 7. Original amount of refills auth. 8. Remaining refills on script 9. Rx number 10. Original date of dispensing 11. Must write transfer on top of script +/- 12. DEA numbers |
|
If you don't have a computer and you transfer something OUT, where must you write the information?
|
BACK of the script!
|
|
Information to be included when transferring something OUT?
|
1. Pharmacist at other pharmacy
2. Your name 3. Pharmacy name 4. Pharmacy addy 5. Pharmacy telephone 6. Maybe the pharmacy's DEA 7. DAte of transfer 8. Write void |
|
No preparation shall be compounded in advance in such quantity as may exceed a ___________ or is necessary to accurately compound the preparation. A ___________ shall be determined by the average number of dosage units dispensed or distributed of said preparation during the previous _______ period.
|
1. 90 days supply
2. 90 days suply 3. 6 month period |
|
Non-resident pharmacies and compounding?
|
Only can distribute them in state pursuant to a script
|
|
A manual, outlining policies and procedures encompassing all aspects of non- sterile compounding shall be available for inspection at the pharmacy. The manual shall be complied with and shall be reviewed on an _______ basis. Such review shall be signed and dated by the pharmacist manager. In the event the pharmacist manager changes, the new manager shall review, sign, and date the manual within _______ of becoming pharmacist manager.
|
1. annual
2. 30 days |
|
Talk about training WRT non-sterile compounding.
|
1. if you do NSC, you gotta train
2. You need to document the training occured |
|
Completed compounded preparations that are not immediately dispensed or distributed shall be stored .......
|
according to the guidelines in the formulati on record
|
|
BUD for non-aqueous liquids and solid formulations where a manufactured product is the source?
|
25% of the time remaining or 6 months, whichever sooner
|
|
BUD for non-aqueous liquids and solid formulations where a USP/NF product is the source?
|
NMT 6 months
|
|
BUD for For water-containing formulations prepared from ingredients in solid form
|
14 days IF fridgerated
|
|
BUD for all other formulations, the beyond-use date shall
|
not be greater than the intended duration of therapy or 30 days
|
|
The beyond-use date limits may be exceeded when
|
there's evidence to support longer BUDs. If youre gonna use longer BUDs you gotta have the evidence on hand though.
|
|
Compounding and formulation records: For each compounded preparation, a uniform, readily retrievable formulation record shall be maintained and available for inspection for ________ from the date last utilized or cmpded
|
2 years
|
|
Labeling of Non-Sterile Compounded Preparations pursuant to an RX ORDER OR LTCF ORDER. What about Hospital?
|
In addition to ALL OTHER REQUIREMENTS
1. BUD 2. Batch/lot 3. Storage directions 4. Clear statement that it had been compounded by the pharmacy For hospital, you dont have to state that it is a compound |
|
Labeling of non-sterile compounded products distributed to practitioners or other prescription drug outlets allowed by law or made in anticipation of orders shall include at least the following. WHat about hospitals?
|
1. Name/address of outlet
2. Name/ strength of drug 3. Quantity of drug 4. BUD 5. LOT 6. Storage 7. Compounded by pharmacy statement 8. route of admin 9. Rx only (Basically the same for CSPS) hospitals are basically the same except they do not require rx only or compounded by pharmacy statements |
|
Freezing temp?
|
C -25 to -10
F - 13 to 14 |
|
Refrigerated temp?
|
C 2 to 8
F 36 to 46 |
|
Room temp?
|
C 15 to 30
F 59 to 86 |
|
Low risk CSPs with greater than 12-hour BUD:
|
RT: 48 hours
REF: 14 days FRZ: 45 days |
|
Medium risk CSPs BUD:
|
RT: 30 hours
REF: 9 days FRZ: 45 days |
|
High risk CSPs BUD:
|
RT: 24 hours
REF: 3 days FRZ: 45 days |
|
Labeling of CSPs dispensed pursuant to a hospital chart order shall include in addition to BUD, lot, storage, and all other requirements...
|
The name of the base soln
name of drugs added quantity of drugs added if this is for parenteral admin |
|
Bulk Container label?
|
1. MFGR name and addy
2. Name of drug 3. Strength of drug (quantity in terms of weight, measure, proportion of the active ingredient) 4. Quantity in the container 5. Statement of usual dosage or referral to PI 6. If not oral dosage form, names of all inactives 7. Legend statement: Rx only 8. Route of admin if not oral 10. Lot number 11. Dispensing instructions (light resistant, original container, refrigerate etc) 12. Exp date 13. Must have adequate information for use somewhere in the labeling |
|
What products have bar code requirements?
|
1. Hospital drugs
2. OTC drugs dispensed pursuant to an order & are packaged for hospital use 3. biological products |
|
Minimum informational requirement in a barcode?
|
NDC
|
|
Exemptions to tamper-evident packaging act.
|
1. lozenges
2. derms 3. Dentrifices 4. insulin |
|
Who can make blanket requests for non-child resistant packaging?
|
1. head of household
2. patient 3. doctor CANNOT. only for the specific script |
|
Some OTCs can be without tamper/child resistant packaging. What are the rules?
|
Only 1 package size
There's a statement: for households without children |
|
True or false: non-resident PDOs need pharmacist managers?
|
TRUE
|
|
The registration of any in-state and non-resident prescription drug outlet shall __________ if the pharmacist manager in whose name the registration was issued ceases to be engaged as the manager, and the owner shall close the outlet unless such owner has ____________ and, within ____________ after termination of the former manager’s employment, ______________ and __________.
|
1. become void
2. found a new PIC 3. 30 days 4. Submitted the application 5. Paid the fee |
|
Any Board registered non-resident prescription drug outlet shall disclose to the Board, in writing, _____________ who are dispensing drugs to residents of this state on an____________ and within _________ after any change of office, officer or pharmacist
|
1. Principal entity officers and pharmacists
2. annual basis 3. 30 days |
|
Library needed for pharmacy?
|
1. Board statutes
2. Board Regs 3. CO controlled substance laws 4. CFR - DEA section 5. Guide to parenetal admix if needed 6. Chaper 2 in ASHPs Controlling occupational hazard for handling cytotoxic drugs, if needed 7. Any others deemed important |
|
A PDO must be open:
how many days/ week? |
1. at least 2
2. at least 4 consecutive hours |
|
Must let the BOP know ______ before you decide to have the pharmacy open for less than ______ hours/ week. Also, must let the BOP know ______
|
1. 30 days
2. 32 3. The date when this is occuring |
|
Scenario: the dispensing area has a technician in it. Where must the pharmacist be?
|
SOMEWHERE ON THE PREMESIS
|
|
Scenario: the Front end of rite aid is open, but the pharmacy is closed (the pharmacist isnt here).
|
The PHARMACY MUST BE ENCLOSED
|
|
If more than one prescription drug outlet is located within the same building.....
|
the pharmacist can't operate both at the same time.... if he leaves one to go to another, you gotta seal the one that is unoccupied off.
|
|
If any compounding/dispensing area is opened in the absence of a pharmacist or left unsecured from unauthorized entry when the pharmacist leaves the building, the pharmacist manager shall notify the Board in writing within ________ of the discovery of the occurrence
|
10 days
|
|
In an emergency situation and when a pharmacist is not on the premises of the hospital and administration of a drug to, or use of a device by or on, an in-patient is necessary pursuant to a chart order, and such drug or device is only available from a locked compounding/dispensing area, an authorized _______________ may enter a locked compounding/dispensing area to obtain the drug or device. In the case of a drug, only ________________, may be removed from the compounding/dispensing area.
Additionally, you gotta keep records of such entry for ______. Further, if some of the drug taken was unused....... |
1. RN
2. Prelabeled, unit of use 3. 2 years 4. you gotta return it |
|
relocation of records shall be made within _______ after closure. The pharmacist manager shall submit a notice, on a form and manner approved by the Board, detailing the closure of the prescription drug outlet or nonresident prescription drug outlet within _______ after closure.
|
72 hours for both
|