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CO rules and regs
Colorado Pharmacy Law State Board
| Question | Answer |
|---|---|
| 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 |
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nickh88
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