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CO rules and regs

Colorado Pharmacy Law State Board

Max ownership of prescribers in a CO pharmacy? 10% alone or combined.
Who gets counseling per CO law? when the patient seeks advice or when the pharmacist deems it necessary
Who can reduce an oral order to writing? only pharmacist or intern
WHo can transfer prescriptions? only pharmacist or intern
What can technicians transfer? computer based orders between pharmacies
first 5 things needed on a transfer 1-date of original order, 2-date of initial dispensing, 3-original quantity prescribed, 4-number of valid refills remaining, 5-date of last refill
2nd five things needed on a transfer 6-original rx number, 7-name of the transferring pharmacist, 8-name of transferring outlet, 9-address/phone of the transfering outlet, 10-DEA of prescriber and transferring outlet if controlled
expiration date of non-controlled prescriptions? 1 year
page 8 - can a pharmacist dispense for "office use"? nope, not a valid order
CO law says what about records of initial and final verification? 2 years from last activity on the order: need to know ID of initial and final verifying pharmacist
How long to keep the verification practices and where must they be posted? required to keep for 3 years. They must be posted next to most current board registration
If a charity is going to accept donated meds, how long must they be good for? Must be good for at least 6 months; cannot be in regular stock
Do donated drugs have to be identified at the point of redispensing? yes, must say on the label: "donated or returned drug"
How can the state board access pharmacy electronic records? 2 ways: system must be capable of printing desired records of the board within 2 hours; w/in 72 hours it must be able to sort info. OR provide a terminal and a person for up to 2 hours for the board to collect what it needs
what are robo-refill machine requirements? must have manufacturer manual on site and know exp dates of meds in machine
what about med pack labeling? serial number for both the package and the individual prescription orders in the package
How long are med packs good for? 60 days from the date of packaging
Do interns have to be enrolled in a college of pharmacy? No, a person in good standing with the school may be an intern
In colorado, how many years as a licensed pharmacist must be completed immediately prior to preceptor application? at least 2 years. must have a clean record for previous 5 years (other than letter of admonition).
what's the pharmacist to intern ratio? 1:2 pharm:intern
how much time is allowed to transfer rx's from a closed pharmacy to an open one? 72 hours; it's the responsibility of the pharmacy manager
how much time is allowed to take a cds inventory when a pharmacy changes managers? 72 hours; pharmacy must notify the board within 14 days of manager d/c
what is the minimum square footage of a pharmacy? 225 continuous square feet; satellite areas must not be less than 100 square feet
for compounding/dispensing areas, what's the min square ft? 12 ft min and at least 6 feet for each person engaged in compounding/dispensing
is a sink required? Yes, must have hot and cold running water
are graduated cylinders required? yes, measure 1mL to at least 250mL; you need a balance as well!
what are the cold storage req's? fridge and freezer dedicated to drugs; must keep a log of temperatures. if the temp is unsatisfactory, then record must be kept for 2 years
minimum 4 references required in a library 1-pharmaceuticals/pharmacists act 2-uniform CSA of 1992 3-current board rules 4- 21 CFR part 1300 to end (DEA rules for CDS)
written refill requests while the pharmacy is closed? yes, a slot/drop box is provided for the RX order.
What report must be displayed? either the most recent inspection report or self-inspection report
who is allowed in pharmacy? only pharmacist or intern is allowed. PIC must give consent for others
What are the minimum hours of a CO pharmacy?? at least 2 days/week and 4 continuous hours on each day; if less than 32 hours, the board must be notified
What do staff have to do if pharmacist steps out to use bathroom? when a dispensing area is occupied by an employee, a pharmacist must be in the building
what does the pharmacy manager have to do when the pharmacy is opened by someone besides the pharmacist? notify the board in writing within 10 days
When can locked pharmacies in a hospital be accessed by a authorized RN? in case of emergency, RN may access certain prepackaged drugs. Documentation should be made of when and what was used; stored for 2 years
How often do protocols need to be reviewed? clinical protocols should be reviewed annually
what type of pharmacist can be engaged in drug therapy management? completion of residency or ACPE certificate or 40 hours of ACPE CE and 40 hours of onsite training.
how long must protocol data be retained? 7 years from the last patient visit or 7 years from the patient's 18th birthday
What is the pharmacist manager in charge of reporting? any type of security breach, impaired pharmacist, or significant error; also report immediately when he/she ceases to be PM
other pharmacy manager reporting duties take cds inventory within 72 hours, move rx records of a closed pharmacy
PM responsibilities for technicians DOCUMENT if national cert, diploma of accredited school, 500 hours of experiential training, or no experience
what names can be used to advertise a pharmacy? only the name listed on the license
legal proceedings against a pharmacy? notify the board within 72 hours in writing of alleged medical wronging; within 30 days of receiving a judgement; individuals have 30 days as well
how many outlets can supply a LTCF with an emergency kit? only 1; note that paper or tape seals are unacceptable as tamper-evident
LTCF documenting duties of emergency kits notify the board w/in 30 days: change of ownership, or change of consultant pharmacist
How often is an emergency kit inspected? at least annually and within 72 hours of kit being used; physician must provide order withing 72 hours
what records must be maintained on site? 222 forms, inventories of cds for previous 2 years, rx/ltcf orders during last 2 years, all dispensing receipts or loss/disposal records
what is important for CDS inventories? count every cds (including out of dates) except those in a hospital waiting to be administered to a patient and those waiting to be delivered. Must complete CDS q 2 years
what about previously unscheduled meds? an inventory should be taken on the day it becomes controlled and thereafter with the rest of the cds
What about more than 1000 count bottles of cds's during inventory? any cds in a bottle of more than 1000 must have an exact count
Per Colorado law, how many prescription files should be kept? 3 different files: II's, III-V's, and non-controlled's
cds verification pharmacist is important, how is this noted? final verification pharmacist can sign daily printout or outlet shall maintain a bound log book, signed by pharmacists who have refilled cds's
how can hospital chart orders be maintained? chrono order by date of discharge, alphabetically by surname and month of discharge, or date of dispensing transaction
what pharmacist should be recorded on order record in hospital? both initial and final verification pharmacist
how often should backup be preformed on chart orders? at least every 24 hours
how should wholesale receipts be logged? in the same manner as prescriptions, 3 separate files for not less than 2 years. hard copies need not be kept on premises, provided they can be accessed within 48 hours
what are some requirements for cds dispensed to hospital floor stock? make sure to identify who placed the drug in floor stock and the person who issued the drug
what sort of employee list needs to be maintained in colorado? list of every licensed pharmacist and intern who has practiced pharmacy in the previous 2 years including all part-time personnel. need name, license #, initials/signature, date started
what special book is required for nuclear pharmacy? rules and regs of state radiation control agency and nuclear commission
does a nuclear pharmacist need special licensing? yes, must be authorized by a radioactive materials license from CO department of public health
what is the special 10% rule for nuclear pharmacy? 10% max of compounded prescriptions/year of total rx's
how many copies of an "other outlet" protocol are required when applying for an original license? 2 copies needed
what is in the written protocol of the other outlet? (4 things) 1-system of record keeping to document movement of drugs 2-system to ensure no expired meds will be dispensed 3-system ensuring proper labeling as required by law 4-duties of the consulting pharmacist
how much time is allowed for an other outlet to give notice of a consultant leaving? notice prior to the leave should be given, no later than 30 days
What amount of ownership must change hands in order for the board to be notified 20% of ownership change or incorporation of a pharmacy? notify the board in writing. page 78 doesn't list a timeframe
how much time is allowed for a pharmacist to notify the board of becoming an other outlet consultant? pharmacist shall notify the board within 7 days
If board requests other outlet protocols, how much time is given to comply? protocol copies must be submitted within 30 days
How often does the consultant have to review the protocols of an other outlet? at least annual review; on the protocols he will document the number of dispensing units from a calendar year jan 1 - dec 31
How often are jails, county health departments, schools k-12, hospitals, and family clinics inspected? quarterly inspections by consultant for these other outlets
what clinics get inspected based on their number of units dispensed? community clinics, rural health clinics, colleges, and universities.
what is the inspection schedule for other outlet with 2500 units or less dispensed? more than 2500 but less than 7501? monthly if less than 2500; q other week if 2500 to 7501
what is the inspection schedule for other outlet with 7501-12500 units dispensed? 12501-25000units/year? 7501-12500: weekly inspections 12501-25001: twice weekly inspections
What about other outlets dispensing greater than 25000 units? it is no longer an other outlet, it is a retail outlet
What is the consultant pharmacist's role in the other outlet? responsibility of records of drug movement as well as 2 year retention requirement. must be notified within 72 hours of casual sale of medications
For other outlets, what record may be presented within 48 hours or 2 business days, whichever is longer? unexecuted dea-222 forms; executed forms must be immediately retrievable
How long does an other outlet have to provide other specific records? 48 hours to provide the inspector with requested documents
In what way are other outlets similar to hospitals with regard to controlled substance refill records? both must maintain either a daily printout or a log book that every pharmacist refilling cds's must sign. if electronic, system must make backups every 24 hours
for other outlet invoices, how many separate files must be used? 2 separate files, II's and III-V's with everything else. must be able to identify controlled's
How many addresses may appear on an rx label? only 1. it must be the address of the other outlet from which it was dispensed
are other outlets allowed to advertise as a pharmacy? No, per page 92, they may not advertise as a pharmacy
can other outlets act as emergency distributors? yes, as authorized by cdc or colorado dept of public health; II's can only be moved as a result of a 222
How long must wholesalers retain records? per page 106 - all executed 222's, inventories, records of receipt, lists of symbols and codes
how much training is required for vaccine administration privileges? 12 hours of didactic training and 8 hours of live training
can interns give vaccines? yes, provided they have the required training and administer vaccine under supervision of an authorized pharmacist
How long are pharmacies required to keep vaccine records? 3 years. this is different than the standard 2 years of most other record-keeping requirements
Can vaccine records be stored with other pharmacy records? No, they must be stored separately
Are vaccines allowed to be administered at a site other than the pharmacy? Yes, vaccines can be given off site. They must be returned to the pharmacy the same day they left.
What notice need be given to patients who have prescription meds filled at a central fill location? Either a one time written notice or a sign posted at the pharmacy
What special label requirements are needed for central fill prescriptions? name and address of the originating pharmacy and the telephone number a patient or caregiver can call regarding refills/questions
What must be written on the face of every central fill controlled substance prescription? "Central Fill"
What must be recorded by orginating pharmacy? name/address of fulfillment pharmacy, dea if controlled, name of pharmacist transmitting the order, date of transmission
Who is responsible for maintaining of the original pharmacy order? orginating pharmacy is in charge of maintaining original order for 2 years
Upon receipt of the prescription from the fulfillment pharmacy, what does the orginating pharmacy record? date of receipt, method of delivery, name of employee accepting delivery. keep records for 2 years
Regarding central fill pharmacies, how often should the policies and procedures manual be updated? policy should be reviewed annually by the pharmacy manager and a signed note of the date of review should be made
How much compounded medication can be on-hand in advance of prescription orders? no preparation can be made that would exceed a 90 day supply or is necessary to compound the medication
what rules pertain to a compounding manual? shall be reviewed on an annual basis, signed and dated by the pharmacist manager. New PM must sign/date manual w/in 30 days of taking job.
does compound pharmacy training need to be documented? Yes, must be documented and available for inspection. page 134
How are non-FDA approved ingredients verified in the pharmacy? pharmacist shall obtain purity certificate from the supplier. maintain this record for 2 years
What is the max expiration date for ingredients without one listed? Pharmacist must label the container with the date of receipt and assign a conservative expiration date not to exceed 3 years
What are other references for ingredients that must be used if no USP standard exists? Chemically Pure (CP), analytical reagent (AR), American Chemical Society (ACS), Food Chemical Codex.
what is the beyond-use date for non-aqueous liquids and solid formulations if the API is a manufactured drug product? 25% of the remaining time before the expiration date or 6 months, whichever is earlier
what is the beyond-use date for non-aqueous liquids and solid formulations if the API is a USP/NF product? no greater than 6 months
can the BUD be extended beyond 14 days for water-containing formulations? yes, provided it is supported by literature
What special labeling is required of non-sterile compounded preps? clear statement that the product was compounded by the pharmacy; assigned BUD; storage directions when appropriate; if dispensed to a practitioners office: "RX only"
do compounding pharmacies need to keep recall records? yes, adverse effects and recalls must be maintained at the outlet for 2 years
What size filter pore is considered sterilizing? 0.2 micron filter size is sterilizing (0.22 micron is also acceptable)
What is a low risk compounded sterile product (CSP)? aseptic manipulations of sterile products in class 5 air quality; no more than 3 sterile products added to one container; may be good beyond 12 hours
What cannot be in the segregated compounding area? page 146 - no unsealed windows/doors that open to the outside; no high traffic; no food prep; no sink!
What is a medium risk CSP? multiple individual doses from same sterile container; anything besides single volume transfer; compounding process that requires long duration
What is a high risk CSP? anything sterile product made using non-sterile ingredients;
what is the BUD of a multi-dose container for IV use? page 147 - 28 days BUD max (unless otherwise determined by the manufacturer)
Is a policy manual required for sterile preparations of IV's? Yes, reviewed on an annual basis by the pharmacy manager. New pharmacy manager must sign and date the manual within 30 days of becoming PM.
What documentation of employee education of IV prep is needed? didactic review and pass written/media-fill/glove tests initially, and annually for low/med CSP's; every 6 months if tech is preparing high risk CSP - retain records for 2 years
What is the minimum air quality required to compound CSP's? minimum of class 5
are sinks/drains allowed in the buffer area or clean room? No, neither is allowed in the buffer area/clean room
what is the anteroom? an area where people can sanitize and gown; supplies are also uncartoned and disinfected here. it may be distinguished from the buffer room by a line on the floor
How often must clean rooms be certified? ISO class 5 (class 100) areas must be certified every 6 months.
How often must the direct and continuous compounding area (DCCA) be cleaned? it must be cleaned at the beginning of every shift
how often must the class 7 buffer areas and class 8 anteroom areas be cleaned? must be claned at least daily; includes a mopping of the floors
how are ingredients (other than FDA-approved ones) certified? certificate of purity and stability must be obtained by the supplier and kept for a minimum of 2 years
How often must automated compounding devices (ACD) be checked for accuracy? checked daily at a minimum
what USP chapters describes sterility tests and bacterial pyrogen tests? USP chapter 71 - sterility tests USP chapter 85 - pyrogen tests (usually both are done for high risk batches larger than 25 vials)
What is the room temp BUD of a >12 hour low risk csp? NMT 48 hours
What is the refridgerated BUD of a medium risk csp? no more than 9 days
What is the frozen BUD of a high risk CSP? no more than 45 days
Do CSP's require labeling that they are compounded in the pharmacy? Yes, if they are dispensed due to a LTCF chart order or prescription, a clear statement of compounding is required, as are storage instructions
Are pharmacies that compound CSP's using only closed/sealed systems exempt from CSP rules? Yes, provided that only closed system compounding takes place
What is the minimum hood standard for cytotoxic drug preparation? vertical flow, class II biological safety cabinet or CACI (Compounding Aseptic Containment Isolator).
What is considered valid photo ID for the prescription drug monitoring program? valid driver's license, state ID, official passport from any nation, US armed forces ID card
When should dispensing actions from the 1st to the 15th be submitted to the PDMP? transmission should occur between the 16th and the 25th
When should dispensing actions from the 15th to the last day be submitted to the PDMP? transmission should occur between the 1st and the 10th of the following month
When does law enforcement have access to the PDMP? access is granted by court order or subpoena
Can an individual access his/her PDMP profile? Yes, provided a written request to the BOARD and valid photo ID
Created by: nickh88
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