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184 Cards in this Set
- Front
- Back
What is casual sale
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transfer, delivery or distribution of RX drugs to non-consumers
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What percentage can casual sale NOT EXCEED
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10% of total # of drugs dispensed and distributed on an ANNUAL basis
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What is compounding
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prepartion, mixing, asembling, packaging or labeling of a drug
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What is required for compounding
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must be patient specific
from RX order cannot distribute to Dr for treating patients |
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Can compounds be prepared in advance under certain condition
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YES
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When must purose for drug appear on label
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pt requests or provided by doctor
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Do pharmacist have precirptive authority
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NO
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How many drug outlets can a pharmacy manger direct control of?
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ONLY 1 pharmacy
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What is a pharmacy technician
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unlicensed person who performs duties under supervision of pharmacist
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What are duties of pharmacy technician
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labeling, delivery, storage adn record keeping, adn compound
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Must a pharmacist always be on location?
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YES
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What are powers dutes of state board
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grant and renew licenses, or deny, suspend or revoke, and keep records and collect fees, and investiage violations
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Can state board subpoena witness and embargo misbranded/adulterated drugs
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YES
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Must you tell state board when you settle of malpractice claim or judgements
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YES
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Must you send into to state board reguarding insurance
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YES
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After your license is revokes, you cannot reappy for licensure for at least
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2 years
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Must the pharmacy manager be a pharmacist
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YES
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IF a pharamcy mangers terminates empolyements that must
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OWNER must transfer state borad registration to new manager within 14 days, adn
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When does new pharmacy manager need to notify board
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immediately
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What must RX outlets display in regards to registrations
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owner and magager's name, pharmacist, and intern licences
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Do you need to apply to board to transfer ownership or change name or location of RX outelt
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YES
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Who can manufactors or wholesalers sell drugs to
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wholesalers, hospitals, RX drug outlets, and practioners's
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Who can make casual sales
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Rx drug outlet, or hospital
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Who can Rx drug outlet or hospital makes sales to
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Wholesaler,praticioner, or other rx drug outlets
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Is it in progress for authorizing pharmcist to compound drugs for "office use"
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yes
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Pharmacy give 24 hr drug supply to reistered ER patient by employee if
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ordered by pracitioners, or if employee can administer or dispense meds
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What can interns do
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all parts of pharmacy as long as under direct and immediate supervision
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What is max amount of tech a pharmacist can supervise
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3
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If pharamcist supervises 3 tech, what is required
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1 tech, has certification by board, training degree or 500 hrs expericence certified by pharmacy manager
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What is max amount of interns a pharamcist can supervise
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2 interns-but also 1 tech
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When may a pharmacist refill w/o prescriber authorization if
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resonablly tried to contact Dr
med is necessary for pts health and old rx does not state "no emergency filling" |
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What is max amount of days for an emergency refill, any liability if doc refuses after filling
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72 hours supply, NO
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Is there any liability to pharmacist or drug outlet to refuse emergency refill
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NO
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For labeling what needs to be on bottle
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1. Pharmacies name and full addresss
2. patietn name 3. Doc's Name 4. Rx #, 5. Date 6. Directions 7. Drug 8. Cautionary Statements |
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Can RX labels use the title Dr. for nurse practitioners or PA
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NO
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What needs to be on label for anabolic steriods
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purpose must be on label
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4 Ways a pharmacist MAY substitue generic drug
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-equivalent
-communicated to patient -if its on RX/file -cost to patient is less than prescribed |
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Does patient have to consent if lower cost drug is not in stock, and only higher price drug is
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YES
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When MAY NOT a pharmacist substitute a generic
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"DAW"
hand-written, intialed by prescriber or orally |
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Do you have to follow DAW for facsimle?
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no
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Can you lose your license if you commint of felony or do not notify board within 30 days of any criminal convictions
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YES
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Can you lose you licence if your deemed unfit or incompetent
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YES
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Can you lose your licence is you fail to notify pharmacy of disapline in another state
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YES
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What are types of disciplines
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refusal to renew, suspension, revocation
LOA, conditions on license fines on pharmacies |
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What is letter of admonitions
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confidential letter of concern
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What is condition on license
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make you retake exam, training, supervision or restrictions
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How much pharamcies may be fined for violations
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500-5000
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What is only thing in law that allows you not to dispense something
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to coerce a pharmacist to dispense against his/her better judgement, or coerce a non-pharamcist to practice pharmacy
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Can pt of licensed facility or pt's family donate unused meds
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YES
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Only what type of medications can be resipensed for LTC, adn to who
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NON-controlled meds from nursing homes, in-pt hospice, assisted can donate to another pt of same facility or medcial ssistance program
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Examples of licensed facility
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hospital, hospice LTC, and assisted living
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Requirement of meds in order to be redispensed
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unopened and sealed or individually packaged-unit dose, and customized patitient medication packages
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When do meds expire after donation date
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< 6 months
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What is Colorado Cancer Drug repository program
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PHARMACIES may accept prescription drugs to be re-dispensed from cancer pts or families
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Requirements of meds in order to be redispensed
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unopened, sealed containers FROM MANUFACTURER, unit-dose, does not require refirgeration or patient registration
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What patietns can recieve the cancer meds and cost
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uninsured/underinsured, can only charge a HANDLING fee
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On Controlled substances records they MUST show
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DATE, pt's name, address, CS kind and #
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How many days to you have to report CS theft to law enforecement and board
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30 days
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Is there is an AD for a brand name drug is must include
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THE GENERIC name
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Must CS records be kept confidential
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YES
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Must the borad develop adn maintain a CS prescription tracking program
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YES
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What must board develop in CS RX tracking program
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Pharmacy Name and Addres, Pt name, Docs Name, Date, Drug, QUANTITY, method of payment
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What other data is needed for CS RX tracking program
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other data to determine if a pit is using multiple precribers or pahramcies for same or similar med
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For electronic moitinoring of CS RX drugs who should that data be available to
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DR's prescribing or moinitoring abuse, pharamcies dispencing to patient, law enforcement with court order, adn patient
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Can a pharmacist be EMPLOYED and dispense for a prescriber
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NO
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Can a Rx drug outlet have referall fees to other health profession persons
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NO
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WHen do you have to timely report to board pattern of misconduct if
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dangeer to health, safety or patietn or public welfare
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Who are the only people that can take an oral order
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intern/pharmacist--electronic ok
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If there is an order clafification or change what needs to be on hard copy
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initals, date and person conveying change
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What needs to be on RX process ordered for substituted drugs
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Dates, BOTH drug names, and NDC# OR distributors
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Can a computer alter prior transcations?
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NO
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How long should we keep refill info
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2 years
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What type refill info is needed
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rx order, or daily computer prinout, person who authorized refill, pharmaicist name or license #, date adn quantity if changed
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Can tech entry?
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Yes, as long as no intrepration
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If patient wants a copy of orginal script what must we do
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have COPY FOR REFERENCE ONLY, and initals and date
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What does an Rx transfer require
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ONE pharmacist--can't have 2 interns
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Can electronic tranfers be done by techs
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yes if no changes are made
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How many times can a CIII-CV be transferred
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ONCE--unless RX does not change (kaiser)
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Can Non-CS drugs be transfered as long as refill remain
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YES
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Must pharmacist name inital or license # be on final evaulation of dispensing record
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YES
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Can drugs be dispensed if no recognized medical utility or application
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NO
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Must pharamcist ensure drugs are issued for a "legitimate medical purpose
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YES
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Can an internet pharmacy dispense if no valid preexisting patient-practitoiner relationship
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NO
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Pharmacies cannot dispense on basis of what 3 thigns
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Internet based questions
Internet based consultation or Telephonic consulation |
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What is expection to rule that drug name on container must drug IN container
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research with placebo
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What are only drugs that can be returned
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Unit dose
Customized patient medications RTS (patient never picked up_ |
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If a pharamcy accets unused meds for resdispensing what must this have
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RETURN protocols approved by SBOP
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What are automated cassettes
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containers that counts, packages for dispensing and labels RX drugs
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Can automated cassettes be used for CS
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NO
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When can you compound for <90 supply
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based on prior 6 month history, for RX, adn formulations and compounding records are kept
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Can you do causal sales to practitioners if <10%
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yes--still fine pointing
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What must be on labeling of compounded product
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quantity, Quantity of active ingredient, beyond-use-date, and this product was compounded by pharamcy, and lot number, and storage
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How many hours are require for internship, max hours with drug manufactor or reserach
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1500, max 450
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How long does a preceptor need to be licensed and in practice, and w/o disciple
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2 years--5 w/o disipline (LOA dont count)
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When must interns notify SBOP of address change or another empolyer
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30 days
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Are pharamcist and interns required to wear ID badge with license #
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YES
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When must a CS take place with a manager change, and by who
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72 hours, new manager/ or owner
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How many pharmacies in same physical place
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only 1
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Minimum pharamcy hours, when must submit hours to board
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2 days per week, and 4 hours, must submit if less than 32 hours
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Does State board require professional reference library, is electronic ok
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YES
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What needs to be in professional reference library?
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CO Pharmacy Practice ACT
CO. Controlled Substance ACT Board Rules and Regulations DEA CS Rules |
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Can only pharamcist unlock pharmacy
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YES
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If there are any security breaches, when must they be written to SBOP
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within 10 days, even if no one entered--security breech anytime someone unlicensed enters pharmacy
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Are prescription drugs outlest requied to adequate inventory, pharmacetuial servieces, adn have no contidtions likely to lead to error
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YES
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What is CDTM
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Collaborative Drug Therapy Managment
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What do pharamcist do in CDTM
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provide, monith and implement and modify drug therpay
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How can pharmacist perform of roles of CDTM
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after physican diagnosis, order and written agreement adn follow protocol, and inform patient
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What must pharamists following when monitoring and implementing drug theraphy
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protocol with clear criteria, and specific directions for pharamcist to follow
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Do protocls have to be consistant with evidence-base medicine
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YES
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Must protocols be signed and dated by authorizing physician
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YES
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How often is CDTM reviewed
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annually
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What must a CDTM pharamcist submit
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notification form, and written agreeemtn w/ physican or gernal authorization plan
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How long must CDTM records be maintained
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7 years
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How much libability insurance must CDTM pharmacist have
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1 millon dollars
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For each tech, the manager must post
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1. Certification
2. Training program degree 3. 500 hrs expereince 4. Documentation that tech has no of the above |
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For CDTM access to protocols at pratice location are required what else
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scietific literature which protocols are derived
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What are one of 5 qualifications you must meet to be CDTM pharmacost
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1. Accredited pharmacy practice residency
2.BS Degree 3. Pharm D. 4.BCPS or National INstutie for standards in Pharmacist 5. In-pt and HMO |
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For CDTM if you have a BS what else do you need
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ACPE certificate program and 40 hrs superivsed
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What else is needed for Pharm D. and CDTM
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40 of CE clinical practice, and 40 of supervised clinical training
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What is gradnfather clause for CDTM 8/1/05
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needs attest adn certify clinical traning, doc needs to attrest and, yo need to attest and show documentation
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Do you have to have procedures for RX delivery/stroage outside pharmacy at request
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yes
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IF you Pharamcy drug outlet goes out of buiness do you have to removed RX to another outlet
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YES
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Where does ID of final evaulation pharmcists need to be
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on daily printout, or other maintain and easily accessed record
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Can pharmacy give RX order form with pharmcy or pharmcist name on
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NO
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If in legal proceedings allegin a drug or device law when must you notify board
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in writing within 72 hrs of knowledgle
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When must you notify board of disposition
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within 30 days
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Who determines contents of emergency kits of approved facilites (nursing, intermeidate and extended)
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Medical director and pharmacist
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What are approved facilites emergency kits limited to
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60 drugs/12 CS
<30 doses of one drug dosage or strength orals allows |
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Who approves home health and hospice kit contents
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Pharmacist and nursing director
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What are emergency kits contents of home health and hospice
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60 drugs
<30 dosages of any doage or strenth ONLY injectables |
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Expections not to have drug records not immediately retriveable
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off-site storage approved
board approval to not keep orgainal ns records--can instead be online |
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What are 5 things that need to be immeditely available to SBOP
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1. DEA 222 forms
2. CS inventories 3. RX and CS-distribution, losss and surender or disposal 4. Pharmcist/intern list x2years 5.Manufactor or distributor |
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For CS inventories do you need to include drugs dispensed, but not yet given?
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NO
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What needs to be on pharmacist intern employee list
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name, license #, sample of initials, signature and starting date
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What is method A
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produces daily prinout
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For daily documentation of CIII-CV what do you need 1 of
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either final evaultion of hard-copy
or sign a separate bood attesting computer info is correct and reviewd |
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When must manual data be restored in event of computer failure
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7 days
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What is Method B
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online-RX info retrival
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At inspectors requests when must you print RX orders with, adn sorted by
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within 2 hrs, adn sorted by variable in 72 hrs
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If you do not print RX orders for inspect in method B, then what must you do
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provide an assiatnt to help inspect review RX orders by computer
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IF non-CS are off premises, when must they be availabe to inspector
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2 business days
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In the Voluntary peer health assiatnace organization, who are the 5 memebers
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3 RPHS (1 recovered)
1 Bd staff member (non-voting) 1 Pyschiatrist or MH provider (non-voting) |
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What do rehabilitation evaulation committe members do
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reccomed to board if they can pracitce again, and magaing contract with program
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What are examples of PHI
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name, address, name or relativies, DOB, email, picture
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What is only way you can disclose an invidiauls PHI
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if for treatment, paymentment or operations of your job
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Can you disclose an individuals PHI to the invidual
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YES
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How many years must we have of information of the disclosures we make
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6 years
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Must a business have written policies and prodcedure for follwoing hippa, adn must we train ALL employees
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YES
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How long is a Colorado pharmcist licenesed issued for and when expire
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2 years, expires on ODD years
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How long are Colorado outlet registered for
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1 years, expire also 10/31, must be renewed annually
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How many CE are required every 2 years by who
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24hrs CE by ACPE
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When do not need CE
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if you renew licence within 1 year of completing pharamcy school
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How many hours does SBOP accepts of CME for doctors
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6 hrs
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What is APN,RN, CPN, and requirements
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listed on board of Nursing APN registry
written collabtive agreement with DOC, adn RXN # from board or nursin |
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What are limits of ANP prescriptive authority
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within practice, w/o docs supervision, and has own DEA #
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What is DDS or DMD, and requirements
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Denstist, and colorado license
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Limits of DDS prescriptive authority
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any drug within practice, can do CII--not self unless emergencies
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What is OD, and requirements
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Colorado License, adn certified as Therapeutic Optometirst TPA
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What are OD limits on prescriptive aurhtority
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antibiotics, antihistamines, anit-inflamm, and analgesics, and anti-glucoma
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Can an OD prescribe CII
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NO
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Limits on Exams of OD
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mydratitics, mitotics, cycloplegics, and anesthetics
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What are requirement for MD DO
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colorado license
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What are requirements for PA
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CO certification by board of medical examiners
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Limits on PA
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within doc's practicing area
written RX on supervising RX form-own DEA # |
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What is required for presciption with PA
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must be on supervising docs rx form, with docs preprinted name, address and telephone #
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Any limits on DPM or DVM
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any drug within practice
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Must state license wholesales or distributors if in complinace with federal guidelines
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YES
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Can community pharmacist receive any drug samples
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NO prescriptions---only OTCs
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Are trafficking in drug coupans for a free drug ok
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NO--banned
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Who can receive drug samples
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prescribers or hospitals/health care providers at written request
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Can drugs samples be sold,purchased or traded
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NO
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Must medical decvies be safe and effective, and can require pre-market approved
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YES--IUD
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3 Classes of medical devices
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1. Minor potential
2. Moderate 3 Major potential impact |
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Can pharamcist stock hazardous substances
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YES
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Are child resistant containers required for all ORAL RX drugs
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YES
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What OTCs requries requires child resistant containers
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ASA, motrin, APAP, Fe+, lidocaine, naproxen, benadryl, adn loperamide
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What is exception to child resistant containers
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if labeled not children resistant, or upon patients request or docs request
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Does child resitant apply to tocial or non-orals
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NO--injectable ok
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Is federal antitampering act enforecd by FDA, FBI,a dn Dept of Agriculture
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YES
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Does 190 proof ethyl alcohol require a deal stamp or taxes
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NO
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Do hopitals require a special AFT permit for tax-free etoh, should it be labeled to prevent unauthorized access
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YES
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Can abortive drugs or devices be mailed
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NO
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How must CII be mailed
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2 wrappers, one plain outer, adn 1 inner with pharmacy
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What is national practitioner data bank?
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inhibts interstate movement of incompetent practicioners
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