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CO Pharmacy Law Rules & Regs
Colorado, Pharmacy, Law, Rules and Regulations, 2011
77
Law
Professional
07/17/2011

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Term
A written or oral order must contain
Definition
Initial interpretation
Pharmacist's name/initials (ID)
Dispensing date
Quantity (if not what was ordered)
CS: patient and prescriber address, DEA#
LTCF: assigned serial number
Term
Clarifications should include ____ on the script
Definition
Initials of intern/pharmacist, date contacted, name of person contacted
Term
When a substitution is made to an order the following must be recorded
Definition
1. Name of drug and generic (if substituted for)
2. Name of distributor or NDC
3. For a CII, must not be an alteration
4. on subsequent refills, any change of NDC shall be recorded and not alter previous entries
Term
Refills must be recorded with the following information
Definition
1. date and quantity
2. person authorizing refill
3. pharmacist's name/initials (ID)
Term
Refills must be recorded where?
Definition
On the back of the RX order or in the daily computer printout
Term
If a copy is made for the patient what must appear on the copy?
Definition
"Copy for Reference Only"
Initials, date and copy indication must be marked by pharmacist on original
Term
When a script is transferred, how many interns may be involved?
Definition
Only 1, transfer is not allowed between two interns.
Term
Electronic transfer orders may be made by 2 technicians if:
Definition
There are 2 compatible systems and no changes are made
Term
How many times may a CIII CIV or CV be transferred?
Definition
Unlimited if Rx # is the same
1 time only (when serial number changes upon transfer)
Term
Transferring pharmacist must record a transfer by:
Definition
Writing void on original RX along with name, name of receiving pharmacist, PDO name address and phone #, date of transfer, if CS DEA number of receiving PDO

OR in a computer system that records all of the above
Term
Receiving pharmacist of TX prescription should record
Definition
"transfer" on original RX, issue and dispense date, # of refills authorized and remaining, Date of last refill, original RX #, name of transferring pharmacist, address and phone # of transferring PDO
Term
A non-controlled substance may be transferred how many times?
Definition
as long as there are refills remaining
Term
When a PDO discontinues business it may transfer files to another PDO and the following rules apply
Definition
1. all RXs transferred become void
2. if authorized for refill original RX number must be recorded along with new
3. Receiving PDO must maintain records for 2 years
Term
Drug regimen review includes
Definition
Allergies, therapy and contraindications, dose, duration of use, route of administration, reasonable directions, ADEs, interactions, CI, duplication, proper utilization, abuse/misuse
Term
For initial interpretation and final evaluation what must be recorded?
Definition
Pharmacist's name, initials or other ID
Term
Record of initial evaluation and final interpretation must be kept for ___
Definition
2 years
Term
II/FE notice must be signed and dated by manager and must:
Definition
1. Have a policy outlining procedures
2. be posted next to bldg registration
3. be kept for 3 years from last date used
Term
PDO may accept returned drugs for:
Definition
Return, dispensing, and donation
Term
Drugs are not eligible for return if:
Definition
1. Controlled substances
2. dispensed in traditional dispensing system
3. in a customized patient package
4. unit of use packaging w/o labeling
5. compounded drug
6. adulterated or misbranded drugs
7. special storage requirements
8. special registration with manufacturer
9. expiration date is less than 6 months
10. received from anywhere outside of CO
11. drug not dispensed pursuant to an order
Term
Donated medication records must include:
Definition
1. Name and strength of drug 2. dosage form 3. quantity of drug 4. NDC or manufacturer 5. date of donation 6. name and address of donating PDO 7. name, address, and registration # of receiving 8. name and address of origninating PDO 9. RX # 10. exp date 11. name and address of each PDO that possessed it
Term
Records of donation must be kept for ____ years
Definition
3 years
Term
Drugs can only be returned to the ____
Definition
dispensing outlet
Term
Pharmacies can take back controlled substances when?
Definition
Drug recall or dispensing error
Term
Medications returned to stock must record:
Definition
RX number
drug name and strength
quantity
date of return
location of central fill (if applies)
Term
___ may not be packaged in an automated cassette
Definition
Controlled substances that are CII
Term
Preceptors
Definition
1. oversee pharmacy intern
2. 2 years licensed and in practice
3. no board discipline or criminal conviction in 5 years
4. approved by SBOP or pharmacy school
Term
Address or employment change must be updated to the SBOP in ____
Definition
30 days
(including location move in same employer)
Term
When a pharmacist manager changes what kind of inventory must take place?
Definition
CII inventory within 72 hours by the new manager
Term
Compounding or dispensing area must have:
Definition
1. >225 continuous square feet
2. sink with hot and cold water, drain, vent
3. 24" free floor space between shelf sections
4. Minimum work surfaces: 24", 6sq. feet per person, 30" free floor space behind
Term
Minimum compounding equipment required
Definition
graduated measuring devices (1-250ml), spatula, ointment slab, glassine papers, RX balance, suitable containers, weights, drug fridge, drug freezer (with daily monitoring)
Term
Reference library includes
Definition
CRS PPA
CRS UCSA
Rules and Regs of SBOP
Current Federal regulations
Guide to parenteral admixtures (sterile)
Technical Manual or ASHP guide to cytotoxic
Term
Pharmacies must be open at least
Definition
2 days per week for at least 4 continuous hours at a time
Term
If the pharmacy is entered w/o a pharmacist ___ must be reported to the SBOP within ____
Definition
Name of person authorizing opening, name of person opening, description of situation within 10 days
Term
CDTM refers to
Definition
care & drug therapy management
Pharmacist review and evaluation of medication regimens to achieve specific outcomes
Term
CDTM protocols are _________ between pharmacist and physician that must be reviewed _____
Definition
written agreements reviewed yearly
Term
To treat a patient per CDTM protocol what must the pharmacist have?
Definition
1. initial diagnosis by physician
2. valid order specific to patient specifying protocols
3. informed patient (pt may refuse)
Term
A pharmacist practicing CDTM must have an unrestricted license AND ONE of six qualifications that include:
Definition
1. Residency in the specialty
2. ACPE cert. program and 40 hours supervised training
3. 40 hours of CE and 40 hours supervised training
4. BCPS or NISPC certification
5. Be grandfathered in (8/05)
6. In-patient or HMO: 40 hours of supervised practice protocol approved by P&T, documented competency
Term
Pharmacy Manager must report violations:
Definition
1. diversion
2. security breaches
3. loss of medications
4. any pharmacist who works impaired due to drugs/alcohol
5. significant errors resulting in injury or death
Term
For each technician, the manager must post in the dispensing area
Definition
1. certification by national board
2. diploma from pharm tech school
3. documentation of 500 hours in pharmacy
4. documentation that there is none of the above
Term
Board must be notified within 30 days of what kind of legal proceedings
Definition
disposition, disciplinary action from another state, conviction of criminal acts, settlement of malpractice cases
Term
Notice to the Board of legal proceedings should include:
Definition
Court/state
Case name and number
Description of case
Copy of charges or indictment
Copy of verdict
Proof of completion of any requirements
Term
Emergency kits may contain:
Definition
maximum of 60 drugs, 12 may be controlled substances, NO oral dosage forms, no more than 30 doses of any single drug
Term
Records to be available to SBOP immediately include:
Definition
(2 years prior of each)
1. DEA-222 forms
2. CS inventory, dispensing, receipt
3. RX drug orders
4. distribution, loss, disposal (all RX and CS)
5. licensed employees list, including part time, relief with name license number example of initials and signature and start date
6. manufacturer, distributor or repackager
Term
Records to be
Definition
Term
Inventory must be taken at least every ___
Definition
2 years
Term
Inventory of ____ must be exact, but inventory of ____ may be estimated so long as the stock bottle is less than 1000
Definition
CII, CIII-CV
Term
Records may be kept by either a daily ____ or on computer provided ____
Definition
"printout" OR provided computer is online retrieval with daily backup, printable upon request
Term
Immunization records must be kept for 3 years and include:
Definition
Pt name, address, DOB
Responses to indication/CI questions
Date and site of injection
Name, dose, manufacturer, lot #, exp date
Name and address of PCP
Name/initials of pharmacist (intern)
Informed consent
VIS version and date provided
Term
Up to a ____ supply may be compounded for a patient pursuant to an order
Definition
90 day supply
Term
Compounded prescriptions for chart order, hospital order, for practicioner, and hospital stock shall include
Definition
Batch (lot) number
Beyond use date
Storage directions
"This product was compounded by the pharmacy" (for LTCF chart order or distributed to practicioner)
Term
Policy and Procedure Manual shall be kept for non-sterile and sterile products and requires
Definition
Annual review
Signed and dated by pharmacist manager
Pharmacist manager ensures compliance
Term
Beyond Use Date for immediate use
Definition
1 hour in room temp or fridge
Term
Beyond Use Date for Low risk (>12 hour)
Definition
48 hours at room temp
14 days in fridge
45 days frozen
Term
Beyond Use Date for Low risk
Definition
Term
Beyond Use Date for Medium risk
Definition
30 hours at room temp
9 days in fridge
45 days frozen
Term
Beyond Use Date for High risk
Definition
24 hours at room temp
3 days in fridge
45 days frozen
Term
PDOs must report to PDMP how often?
Definition
TWICE monthly (submitted by the 10th and 25th of each month)
Term
Schedule I drugs include
Definition
Heroin, LSD, Peyote, Mescaline, MDMA,
Term
Schedule II drugs include
Definition
Opium, morphine, fentanyl,cocaine, amphetamines, oxycodone, methylphenidate, pure codeine, pure hydrocodone
Term
Schedule III drugs include
Definition
Fiorinal, buprenorphine, anabolic steroids, vicodin, T3, ketamine, marinol, paregoric,
Term
Schedule IV drugs include
Definition
Benzodiazepines, Phenobarbital, zolpidemn, zopiclone, zaleplon, eszopiclone, pentazocine, modafinil, diphenoxylate
Term
Schedule V drugs include
Definition
Robitussin AC, pregabalin, lomotil
Term
A license may be revoked/suspended if the registrant:
Definition
1. falsifies application
2. convicted of a CS felony
3. federal registration is revoked
4. committed acts inconsistent w/ public interest
Term
CO SBOP must notify DEA of all _____ reguarding controlled substances
Definition
restriction, suspension, or revocation of registration OR any forfeiture of controlled substances
Term
Colorado CSA establishes it is unlawful to:
Definition
1. dispense C-I
2. refill CIII-CV more than 5 times or more than 6 months after initial date
3. failure to keep license and/or records
4. failure to properly label
Term
Sale of a C-V drug OTC is considered _____ in Colorado
Definition
ILLEGAL!
Term
Prescription orders in CO must be filed for 2 years in _____ files
Definition
3 separate files (CII, CII-CV and all non controlled)
Term
The prescriber of an emergency oral C-II must provide signed, writte RX to pharmacist within ____
Definition
72 hours (CO LAW)
7 days (federal law)
Term
CO pharmacist licenses are renewed every ____
Definition
2 years, every ODD numbered year
Term
Colorado PDOs must register every
Definition
1 year, annual renewal
Term
___% of pharmcist may be audited and required to prove CE requirements
Definition
5%
Term
____ hours of CME are accepted as credit toward 24 hours of CE required for license renewal
Definition
6 hours
Term
Medical professionals allowed to prescribe in CO include
Definition
APRN, Dentist, Optometrist, physician, PA, podiatrist, veterinarian
Term
APRNs must ____ in order to prescribe
Definition
1. be listed on Board of nursing registry as APN
2. have a written collaborative agreement with a CO physician
3. have a RXN # from board of nursing
Term
Dentist (DDS or DMD) may not prescribe ______
Definition
1. drug that is unnecessary for practice of dentistry
2. C-II for self or family
Term
Optometrist may prescribe ____
Definition
mydraitics, miotics, cycloplegics, anesthetics, antibiotics, anti-inflammatories, antihistamines, analgesics (NO CII), antiglaucoma
Term
Physicians assistants have what limits on their prescriptive authority
Definition
1. must prescribe within practice area
2. written RX must be on supervising physician RX forms including name address and phone # of supervising MD and PA
3. own DEA for CS
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