3 Colo. Code Regs. § 719-1-14.00.00

Current through Register Vol. 48, No. 1, January 10, 2025

Section 3 CCR 719-1-14.00.00 - OTHER OUTLETS

14.00.05 Eligibility for registration. The following facilities may register as other outlets provided all requirements are met:

a. Hospitals that do not operate registered prescription drug outlets. For such hospitals, dispensing shall be limited as provided in section 12-280-120(10), C.R.S.;

b. Federal Federally Qualified Health Centers, as defined by the federal "Social Security Act";

c. Family Planning Clinics;

d. Colleges, universities and schools (grades kindergarten through twelve) which operate a school-based clinic for students and faculty of that school. Schools must submit any contractual affiliations to the Board prior to registration;

e. Jails. A jail which obtains prescription drugs solely on the basis of individual prescription orders which have been compounded in and dispensed from a registered prescription drug outlet do not need registration;

f. County or district public health agencies;

g. Community and Rural Health Clinics, registered, certified, or licensed as such as by the Colorado Department of Public Health and Environment;

h. Ambulatory Surgical Centers licensed pursuant to Part 1 of Article 3 of Title 25, C.R.S., that engage in the compounding, dispensing, and delivery of drugs or devices for administration to patients while being treated in the facility;

i. Medical Clinics operated by a hospital that engage in the compounding, dispensing, and delivery of drugs or devices for administration to patients while being treated in the facility;

j. Hospices licensed pursuant to Part 1 of Article 3 of Title 25, C.R.S., that engage in the compounding, dispensing, and delivery of drugs or devices for administration to patients while being treated in the facility;

k. Acute treatment units, registered, certified, or licensed as such by the Colorado Department of Public Health and Environment;

l. Convalescent centers registered, certified, or licensed as such by the Colorado Department of Public Health and Environment;

m. Community Mental Health Clinic having the same meaning as set for in section 25-27.6-102(9), C.R.S.;

n. Behavioral Health Entity as defined in section 25-27.6-102(6), licensed pursuant to Article 27.6 of Title 25, C.R.S.; and

o. Approved Treatment Facility that is an approved private or public treatment facility, as described in section 27-81-102(2) and (3) that adheres to the standards set forth in section 27-81-106, C.R.S.

14.00.10 General Criteria. Unless otherwise exempted, the general criteria, which shall be met by other outlets herein enumerated, which are seeking to be registered by the Board pursuant to section 12-280-119(1)(d), C.R.S., are stated below.

a. For the purpose of this section, the consultant pharmacist is the pharmacist responsible for the other outlet registration and the overall operation pertaining to drug receipt and distribution.

b. Except as provided in Rule 14.07.00, all prescription drugs utilized by the outlet shall be obtained from an entity or individual registered with the Board or a state or local health agency.

c. For the purposes of this Rule, "dispensing unit" means a container or containers of a drug, either packaged pursuant to Rule 3.01.00 or the manufacturer's original container(s), containing a quantity suitable for the prescribed treatment or condition.

14.00.20 Policy and Procedure Manual. Written policies shall be developed by the consultant pharmacist and the consultant pharmacist shall assure that the Other Outlet has policy and procedure manual available for inspection which addresses the receipt, storage, dispensing, prepackaging, compounding and other disposition of prescription drugs and controlled substances, and that that the consultant pharmacist reviews, dates and signs the manual at least once annually. These policies shall include:

a. A system of recordkeeping to document the procurement, administration, compounding, dispensing, and/or distribution, including the return to the original source, of all prescription drugs and devices, including recalled items.

b. A system to ensure that no drug or device shall be dispensed which will be outdated prior to utilization by the consumer, based on the practitioner's directions for use.

c. A system by which drugs are dispensed complying with the labeling, drug identification and container requirements imposed by law.

d. The duties of the consulting pharmacist.

14.00.40 Application Procedure.

a. Original application. Original application for registration as an other outlet shall be made on a form provided by the Board. This application shall be accompanied by the appropriate fee.

b. If a CDPHE Certificate is required by law, then a copy of the CDPHE certificate will be provided as part of the application.

c. Other outlet relocation. When an other outlet changes location, the outlet shall submit an application on a form provided by the Board within thirty (30) days prior to the expected outlet relocation.

d. Change of ownerships of other outlet. Application to transfer registration of an other outlet shall be submitted on a form provided by the Board within thirty (30) days prior to the expected change of ownership. This application shall be accompanied by the appropriate fee. Transfer of ownership shall be deemed to have occurred:

(1) In the event the other outlet is owned by a corporation, upon sale or transfer of twenty percent or more of the shares of said corporation to a single individual or entity.

(2) In the event the other outlet is owned by a partnership, upon sale or transfer of twenty percent or more of any ownership interest.

(3) In the event the other outlet is owned by a limited liability company (LLC), upon sale or transfer of twenty percent or more of the membership interests.

(4) Upon incorporation of an existing other outlet.

e. Change of name of other outlet. Changes in the name of an other outlet shall be submitted to the Board on a form provided by the Board.

f. Change of consultant pharmacist.

(1) A new application shall be submitted to the Board within thirty days after the former consultant pharmacist ceases to be the consultant pharmacist.

(2) If an application is not submitted within thirty days, the other outlet registration shall become void and the Board shall be informed in writing by the person responsible for the overall operation of the other outlet of the disposition of all drug stock possessed by the other outlet.

(3) The other outlet registration shall be issued in the name of the consultant pharmacist. At such time as the consultant pharmacist ceases to be engaged in said position, he/she shall immediately upon knowledge thereof, notify the Board in writing. The person responsible for the overall operation of the other outlet shall immediately notify the Board in writing when the consultant pharmacist ceases to function as such.

(4) A pharmacist assuming the duties as a consultant pharmacist for an other outlet shall notify the Board in writing within seven days of assuming said position.

(5) A pharmacist assuming duties as a consultant pharmacist for an other outlet shall review the current internal policies and document the review within thirty days of assuming said position. Documentation shall include the date of review and the consultant pharmacist's signature. Said documentation shall be retained with the consultant pharmacist's record of inspection.

g. Change of Registration.

(1) Any other outlet located in a community health clinic, rural health clinic, college, or university which dispenses more than 25,000 dispensing units in a calendar year shall register with the Board as a prescription drug outlet.

(2) Any other outlet located in a hospital which has greater than 25 beds as stated on its license with the Colorado Department of Public Health and Environment shall register as a prescription drug outlet.

h. Reinstatement of Registration. If an Other Outlet registration has expired, a registrant wishing to reinstate such registration shall submit the following: The current reinstatement application with the required fee.

14.00.60 Registration posting. Every other outlet shall display in the primary drug storage area, or other readily accessible area, all licenses and registrations applicable to the possession and distribution of prescription drugs and controlled substances. Furthermore, every other outlet shall display in the primary drug storage area, or other readily accessible area, the report of the last inspection conducted by the Board and have readily available policies, consultant pharmacist reports of inspections and any other documents sent by the Board to clarify or assist in the legal operation of the other outlet.

14.00.70 Other required registrations. The other outlet shall obtain such state and/or federal registrations as may be required.

14.00.80 Consultant pharmacist.

a. A consultant pharmacist shall either:

(1) Initially interpret all prescription orders dispensed from the other outlet, or (2) Provide written policy for dispensing by unlicensed persons.

(2) Provide written protocols for dispensing by unlicensed persons.

b. A consultant pharmacist shall be available for professional consultation.

c. A consultant pharmacist shall annually review the policies for compliance with this Rule 14.00.00. The review shall be documented in writing, signed, and dated by the consultant pharmacist. The consultant pharmacist shall record on the protocols at least annually the number of dispensing units dispensed in a calendar year for the following facility types: community clinics, rural health clinics, colleges, and universities. A calendar year is considered to run from January 1 through December 31.

d. The consultant pharmacist shall develop an inspection form to document the visit and the results thereof. Such form shall be dated and signed by the consultant pharmacist and shall be maintained and available for inspection at the other outlet by the Board for a period of two years.

e. The consultant pharmacist shall inspect and document the inspection in writing as detailed in 14.00.80(d) the following other outlets at the following frequencies:

(1) Quarterly inspections and visits shall be conducted for the following:

(a) Jails;

(b) County health departments;

(c) Schools, grade kindergarten through twelve;

(d) Hospitals;

(e) Family planning clinics;

(f) Hospices;

(g) Medical clinics operated by hospitals;

(h) Ambulatory Surgical Centers;

(i) Convalescent centers;

(j) Community mental health clinic;

(k) Behavioral health entity; and

(l) Approved treatment facility.

(2) Community clinics, federally qualified health centers, rural health clinics, colleges, acute treatment units, and universities shall be inspected and visited as follows:

(a) Monthly if 2,500 or less dispensing units are dispensed in a calendar year. A calendar year is from January 1 through December 31.

(b) Every other week if 2,500 or more but less than 7,501 dispensing units are dispensed in a calendar year. A calendar year is from January 1 through December 31.

(c) Each week if 7,501 or more but less than 12,501 dispensing units are dispensed in a calendar year. A calendar year is from January 1 through December 31.

(d) Twice each week if 12,501 or more but less than 25,001 dispensing units are dispensed in a calendar year. A calendar year is from January 1 through December 31.

f. The consultant pharmacist shall be responsible for the accuracy of records pertaining to drug stock returned to the original supplier, the manufacturer, or via a reverse distributor. The record of any returned drug stock shall indicate, as a minimum, the name and address of the original supplier, manufacturer or reverse distributor, the date of return, and the name, strength, and quantity of the drug returned. This record shall be signed by the consultant pharmacist, and shall be maintained on the premises for a minimum of two years.

g. The consultant pharmacist for a licensed hospital other outlet shall be notified of any casual sale or loan of a drug made by the licensed hospital other outlet to a practitioner authorized by law to prescribe the same prior to the transaction. The consultant pharmacist for a licensed hospital other outlet shall be notified within seventy-two hours of any casual sale or loan of a drug to a registered other outlet, a prescription drug outlet, or a mobile emergency care unit.

h. The consultant pharmacist is responsible for ensuring all prescription drugs obtained by the other outlet are procured from an individual or entity registered by the Board or a state or local health agency.

i. The consultant pharmacist shall be responsible for ensuring any significant errors related to the practice of pharmacy, such as those that result in significant harm to a patient or the death of a patient, are immediately reported to the Board upon discovery.

j. The consultant pharmacist shall be responsible for assuring that the other outlet complies with all applicable provisions of Rule 21.00.00 when compounding non-sterile and sterile products.

k. The consultant pharmacist shall be responsible for reporting diversion, theft or significant unaccountable loss of prescription drugs or controlled substances from the other outlet, hospital or health maintenance organization (as defined in section 10-16-102, C.R.S.) within one business day of discovery. When a Drug Enforcement Administration (DEA) Form 106 is submitted to the DEA in instances involving controlled substances, a copy of the completed DEA Form 106 along with a detailed written explanation shall be submitted to the Board. When determining whether an unaccountable loss is significant, the consultant pharmacist shall consider, among others factors, the following:

(1) The actual quantity of drug lost in relation to the type of business;

(2) The specific drug lost;

(3) Whether the loss of the drug can be associated with access to those drugs by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the drug;

(4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses;

(5) Whether the specific drug is a likely candidate for diversion; and

(6) Local trends and other indicators of the diversion potential of the missing drug.

14.01.00 Interim designated consultant pharmacist. 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 ninety consecutive days. The consultant pharmacist in whose name the other outlet registration is issued shall notify the Board in writing within ten days of designating an individual pharmacist to assume said consultant pharmacist's duties. Said written notification shall include, as a minimum, the name and license number of the individual pharmacist, the beginning and ending dates 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. 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 ninety days, an application identifying a new consultant pharmacist shall be submitted to the Board no later than thirty days following the end of the original ninety day period.

14.02.00 Records and recordkeeping in other outlets.

14.02.10 Records in general. All other outlets registered and/or licensed by the Board shall maintain such records and inventories of prescription drugs as may be required by these Rules or any other state or federal law or rule pertaining to such drugs. Such records shall be maintained on a current basis and shall be complete and accurate for all drugs which the outlet manufactures, receives, dispenses, distributes or otherwise disposes of in any other manner. Records and inventories of controlled substances shall be deemed to be "complete" only if each individual record and inventory contains all required information regarding each specific transaction, and if the set of records and inventories contains all information and documents required to be kept by state and federal laws, rules, and rules. A record or inventory shall be deemed to be "accurate" only if it is a complete, true and factual statement regarding or reflecting each specific transaction. A set of records or inventories shall be deemed to be "accurate" only if they are complete, and, when considered as a whole, they demonstrate that the controlled substances and/or the records and inventories pertaining thereto have been handled in compliance with all applicable laws or rules and that all such controlled substances are properly accounted for.

14.02.20 Retrievability of records. For the purposes of these Rules, records and inventories shall be deemed "readily retrievable" if they meet the following requirements:

a. For all other outlets:

(1) The following records shall be maintained on the premises of the other outlet at all times and shall be made available for inspection by the Board or its inspectors immediately upon request.

(a) All DEA-222 forms executed during the two years preceding the request;

(b) All inventories of controlled substances required to be taken during the two years preceding the request;

(c) All records of dispensing, receipt (invoices for drugs received and drugs credited), distribution, loss, surrender or disposal in any other manner of prescription drugs and controlled substances during the two years preceding the request;

(2) The following records shall be made available within forty-eight hours or two business days, whichever is longer, on request by the Board or its inspectors:

(a) All unexecuted DEA-222 forms.

b. In the case of a request by the inspector for specific records:

(1) Records shall be maintained in such a manner as to permit the inspector to retrieve specific records immediately.

(2) If the inspector determines the records are not maintained in the manner specified in (1) above, the inspector may give the consultant pharmacist or outlet staff a list of the items to be retrieved. The requested records shall be made available to the inspector within forty-eight hours of the request.

14.02.30 Inventories of controlled substances. Any inventory of controlled substances shall comply with the following:

a. If the outlet is registered with the Drug Enforcement Administration as a "hospital/clinic", the inventory shall include all drugs located throughout the facility, excluding any drug which has been dispensed pursuant to a lawful chart order but which has not yet been administered to the patient.

b. Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date(s) the inventory is taken. The inventory shall be maintained in written, typewritten, electronic, or printed form at the other outlet. Schedule II drugs shall be separated from schedule III, IV, and V drugs. Controlled substances shall be deemed to be "on hand" if they are in the possession of or under the control of the outlet. However, the inventory shall exclude any drug that has been dispensed pursuant to a lawful order but which has not yet been delivered.

c. The inventory shall be taken either as of opening of business or as of the close of business on the inventory date and this shall be recorded on the inventory. In the event the other outlet is open twenty-four hours per day, the inventory shall specify the time the inventory was conducted.

d. If the outlet is registered with the Drug Enforcement Administration as a "hospital/clinic", or is owned and operated by a health maintenance organization (as defined in section 10-16-102, C.R.S), or the veterinary hospital owned and operated by Colorado State University or its successor organization, the inventory may be taken over 72 hours multiple days if:

(1) Inventory is secured in automated dispensing machines

(2) Inventory is counted with a witness

(3) The date, time and users performing the count are electronically recorded and reported separately on the inventory for each medication storage bin

e. After the initial inventory is taken, the other outlet shall take a new inventory of all stocks of controlled substances on hand at each consultant pharmacist visit at a frequency determined pursuant to Rule 14.00.80(e). The inventory shall be recorded on a uniform and readily retrievable record, and this record shall be signed by the consultant pharmacist of the other outlet.

f. On the effective date of a law or rule on which a previously non-scheduled drug is added to any schedule of controlled substances, every other outlet that possesses that drug shall take an inventory of all stocks of the drug on hand. Thereafter, that drug shall be included in each inventory made by the other outlet.

g. The following information shall be recorded on the inventory.

(1) The name of the drug;

(2) Each finished form of the drug (strength and dosage form);

(3) The number of units or volume of each finished form;

(4) All outdated controlled substances.

h. In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the other outlet shall do as follows:

(1) If the drug is a schedule II drug, an exact count of the contents shall be made.

(2) If the substance is listed in schedule III, IV, or V, an estimated count of the measure of the contents may be made, unless the container holds more than 1000 tablets or capsules, in which case an exact count of the contents must be made.

i. All controlled substance inventories shall be retained at the other outlet for at least two years from the date of such inventory.

14.03.00 Dispensing records.

a. At minimum, dispensing records must include the following information for every transaction:

(1) Unique serial number;

(2) Patient name;

(3) Prescriber;

(4) Date dispensed;

(5) Name and strength of drug dispensed;

(6) Quantity dispensed;

(7) Whether the transaction is a new or refill transaction;

(8) If refill transaction, the date of the initial order;

(9) Number of refills authorized;

(10) Number of refills dispensed to date;

(11) Identification of individual responsible for dispensing;

(12) If a controlled substance, the Drug Enforcement Administration registration number of the prescriber;

Records must be current and show all dispensing transactions, new and refill.

(13) In the case of other outlet off-site dispensing, dispensing records shall distinguish between on-site and off-site transactions.

14.03.10 Computer use for dispensing transactions. An other outlet may utilize a computer (automated data processing system) for storage and retrieval of information regarding dispensing transactions. The following requirements shall be met:

a. All new and refill transactions shall be entered into the system at the time of the transaction, except as provided in Rule 14.03.10 i.

b. Every twenty-four hours, except as provided in Rule 14.03.20, the system must produce a hard-copy document which, for the purposes of these Rules, shall be known as the "daily printout". It shall consist of a single, uniform, complete document, except as otherwise permitted by this Rule. The daily printout shall list, separately, each prescription order transaction for the previous twenty-four hours and shall contain all information required by this Rule. Daily printouts shall be retained in a chronological manner. If the printouts are bound, the sheets shall be separated into individual pages which are then placed in the same order as printed and bound uniformly. If the pages are bound in any other manner so that they are not uniform in placement or appearance, they shall be deemed not readily retrievable and available.

c. The daily printout shall contain all of the following information for each dispensing transaction and shall differentiate between new and refill transactions. As an alternative, new and refill transactions may be separated into two separate uniform and complete documents which contain the following:

(1) The serial number;

(2) The name of the patient;

(3) The name of the practitioner;

(4) For each controlled substance dispensed, the practitioner's Drug Enforcement Administration registration number;

(5) The date of issue by the practitioner. If the date is omitted by the practitioner, the date dispensed shall be presumed to be the date of issue;

(6) The total number of refills authorized;

(7) The date dispensed;

(8) The initials, name, or secure electronic identifier of the individual making the final evaluation;

(9) The name and strength of the drug dispensed;

(10) The quantity of the drug dispensed;

(11) In the case of a refill, the total number of refills dispensed to date.

(12) In the case of other outlet off-site dispensing, dispensing records shall distinguish between on-site and off-site transactions.

d. Records of dispensing transactions involving controlled substances shall be identifiable from those involving non-controlled substances. Alternatively, a separate complete printout listing only controlled substance transactions may be produced.

e. The daily printout shall be available for inspection by the Board within seventy-two hours from the most recent date recorded on the printout. In the case of other outlet off-site dispensing, dispensing records shall distinguish between on-site and off-site transactions.

f. Documentation of the fact that the refill information entered into the automated data processing system each time a person refills an original prescription order for a schedule III, IV, or V controlled substance is correct must be provided by the individual who makes the final evaluation. This documentation may be retained in the following manner:

(1) If such a system provides a hard-copy printout of each day's controlled substance prescription order refill data, the controlled substance refill information shall be verified, dated, and signed by the person making the final evaluation. This individual shall verify that the date indicated is correct and then sign this document in the same manner as he/she should sign a check or legal document. This document shall be maintained in a separate file at the other outlet for a period of two years from the dispensing date. The printout of the day's controlled substance dispensing transaction must be generated by the other outlet within seventy-two hours of the date on which the refill was dispensed. It must be verified and signed by each person who is involved in dispensing controlled substance refills.

(2) The other outlet shall maintain a bound log book, or separate file, in which each person involved in dispensing controlled substance refills shall sign attesting to the fact that the refill information entered into the computer that day has been reviewed by him/her and is correct as shown. Such a book or file must be maintained at the other outlet for a period of two years after the date of dispensing the appropriately authorized refill.

g. The daily printout shall contain all information as required by this Rule except that the identity of the person who makes the final evaluation may appear either on the daily printout or on another separate, uniformly maintained and readily retrievable record. The consultant pharmacist shall determine which of the two methods for identifying the responsible person is more appropriate for the outlet, and only that method for recording such information shall be used.

h. Because of the potential for a system malfunction or failure, the other outlet must have a manual procedure for recording all dispensing transactions during the system failure or malfunction. All recoverable transaction data and all manually recorded transaction data shall be entered or restored into the system within a reasonable period of time not to exceed seven days following the restoration of operation of the system.

i. Any automated data processing system used by an outlet shall maintain the confidentiality of records in accordance with applicable laws, rules and regulations.

14.03.20 Electronic maintenance of dispensing records. An other outlet which utilizes a computer (automated data processing system) for storage and retrieval of information regarding dispensing transactions need not print the daily printout required by Rule 14.03.10 if the other outlet and the computer system utilized are capable of complying with the following requirements:

a. The other outlet must be able to provide on-line retrieval of all information required by this Rule for all dispensing transactions during the two years preceding the request.

b. The other outlet must ensure a daily (i.e., every twenty-four hours) back up is performed for use in restoring required information in case of a system failure.

c. The other outlet must:

(1) Have and maintain a complete on-line transaction file that is printable on the inspector's request,

(2) Have a "lock-out" feature that prevents editing of dispensing information.

d. The Board or its inspectors must be able to inspect and review the dispensing transactions of the other outlet. Therefore, immediately upon the oral or written request of the Board or its inspectors, the other outlet shall either:

(1) Print a report of all dispensing transactions for such period of time as the Board or its inspector(s) may specify. The system must be capable of retrieving and printing such a report within a limited time not to exceed two hours. Additionally, the system must be capable of retrieving and printing the information sorted according to variables which include, but are not limited to, date dispensed; drug name, strength and dosage form; patient name, and practitioner name;

(2) Provide a computer terminal and monitor for the sole use of the Board or its inspector(s) to inspect and review dispensing transactions, and, if necessary, provide a person to assist the Board or its inspector(s) for a period of time not to exceed two hours in operating the system. If the other outlet elects to comply with this subparagraph (d), the system must also be capable of printing the same reports described in subparagraph (1).

(3) It is the responsibility of the consultant pharmacist to ensure that all outlet staff are aware of the requirements of subparagraphs (1) and (2). Any failure or refusal by the consultant pharmacist and/or outlet staff to comply with a request by the Board or its inspector(s) will be deemed to be a willful violation of these Rules.

e. Whether the other outlet elects to comply with Rule 14.03.20, the system and any reports printed on request shall contain, as a minimum, the following information for each transaction:

(1) The prescription order serial number;

(2) The name of the patient;

(3) The name of the practitioner;

(4) For each controlled substance dispensed, the practitioner's Drug Enforcement Administration registration number;

(5) The date of issue by the practitioner; if the date is omitted by the practitioner, the date dispensed shall be presumed to be the date of issue;

(6) The total number of refills authorized;

(7) Date dispensed;

(8) The initials or other means of identification of the individual dispensing the order;

(9) The name and strength of the drug dispensed;

(10) The quantity of the drug dispensed;

(11) In the case of a refill, the total number of refills dispensed to date;

(12) Whether the prescription order is a new or refill transaction;

(13) In the case of a controlled substance, a means of visually identifying orders for such substances and differentiating them from non-controlled substances.

14.03.30 Off-Site Administration and Dispensing of Medication.

a. An other outlet may allow a designated individual to remove medications for the purpose of dispensing and administering at an Off-Site location, provided the following requirements are met:

(1) The other outlet maintains records which detail the removal of the medications with at least the following information:

(a) Name, strength, dosage form, and NDC number of the medication removed;

(b) Quantity removed;

(c) Date removed;

(d) Name and title of designated individual removing the medication.

(2) The medications are properly stored at compendial temperatures during transport and storage at the off-site location.

(3) The medications shall be secured during transport and stored at the off-site location so as to allow only persons affiliated with the other outlet to have access to them.

(4) The remaining medications shall be returned to the other outlet the day they were removed.

(5) The other outlet shall maintain records detailing the medications returned with at least the following information:

(a) Name, strength, dosage form, and NDC number of the medications returned;

(b) Quantity returned;

(c) Date returned; and

(d) Name and title of designated individual returning the medication.

(6) All requirements for labeling (3.00.30) and dispensing logs (14.03.00) are satisfied and shall reflect the registered on-site location address in all transactions.

(7) All required records shall be maintained in a manner that is uniformly maintained, readily retrievable, and available for inspection for a period of two years from the date of removal of medications for off-site administration and dispensing.

14.04.00 Receipts.

14.04.10 Records of receipts of prescription drugs and controlled substances shall contain the following information for each such substance received:

a. Name of the drug;

b. Strength of the drug;

c. Dosage form if appropriate;

d. Quantity received;

e. Date received if a controlled substance;

f. Name of the labeler of the drug if it is labeled only with its generic name;

g. Name of the distributor;

h. Drug Enforcement Administration number of distributor if a controlled substance.

i. The DEA form 222 or a copy of the DEA form 222 and the corresponding invoice shall be attached to each other.

14.04.20 All records of receipt of prescription drugs and controlled substances shall be maintained at the other outlet for a period of time not less than two years from the date the drugs were received.

14.04.30 All credit invoices of prescription drugs and controlled substances shall be maintained at the other outlet for a period of time not less than two years from the date of the invoice.

14.04.40 All records of receipt of schedule II controlled substances shall be maintained separately from all other records.

14.04.50 Records of receipt of schedule III, IV, and V controlled substances may be maintained with other records of receipt. However, the record shall be readily identifiable from the records of receipt of non-controlled drugs.

14.05.00 Distribution.

14.05.10 Records of distribution of controlled substances and prescription drugs within hospital other outlets. Records of distribution of controlled substances and prescription drugs shall comply with the following:

a. In a hospital which operates a registered hospital other outlet, a controlled substance or prescription drug may be distributed for floor stock to appropriate areas of the facility. A record of any such distribution shall be made and retained for a period of time not less than two years and shall include the following information:

(1) The location receiving the drug;

(2) The name of the drug;

(3) The strength of the drug;

(4) The quantity of the drug;

(5) The dosage form if appropriate;

(6) The date the drug was supplied;

(7) The identity of the person in the prescription drug outlet who issued the drug;

(8) The identity of the person who received the drug into floor stock.

b. These records of distribution may be retained electronically provided the following requirements are met:

(1) The other outlet must ensure a daily (i.e., every twenty-four hours) back up is performed for use in restoring required information in case of a system failure.

(2) The other outlet must:

(a) Have and maintain a complete on-line distribution file that is printable on the inspector's request,

(b) Have a "lock-out" feature that prevents editing of distribution information.

(3) The Board or its inspectors must be able to inspect and review the distribution transactions of the other outlet. Therefore, immediately upon the oral or written request of the Board or its inspectors, the prescription drug outlet shall either:

(a) Print a report of all distribution transactions for such period of time as the Board or its inspector(s) may specify. The system must be capable of retrieving and printing such a report within a limited time not to exceed two hours. Additionally, the system must be capable of retrieving and printing the information sorted according to variables which include, but are not limited to, date distributed, drug name, strength and dosage form;

(b) Provide a computer terminal and monitor for the sole use of the Board or its inspector(s) to inspect and review distribution transactions, and, if necessary, provide a person to assist the Board or its inspector(s) for a period of time not to exceed two hours in operating the system. If the other outlet elects to comply with this subparagraph (2), the system must also be capable of printing the same reports described in subparagraph (1).

(c) It is the responsibility of the consultant pharmacist to ensure that all other outlet staff are aware of the requirements of subparagraphs (1) and (2). Any failure or refusal by the consultant pharmacist and/or outlet staff to comply with a request by the Board or its inspector(s) will be deemed to be a willful violation of these Rules.

(4) If the other outlet chooses to maintain records of distribution electronically, any reports printed upon request shall contain, as a minimum, the following information for each transaction:

(a) The location receiving the drug;

(b) The name of the drug;

(c) The strength of the drug;

(d) The quantity of the drug;

(e) The dosage form if appropriate;

(f) The date the drug was supplied;

(g) The identity of the person in the prescription drug outlet who issued the drug;

(h) The identity of the person who received the drug into floor stock.

14.05.11 A registered other outlet may distribute prescription drugs to another registered other outlet. The drug shall be distributed in the original sealed container in which it was received from the wholesaler.

14.05.20 Records of distribution (casual sales) of controlled substances and prescription drugs. A registered other outlet which distributes prescription drugs and/or controlled substances shall record the following:

a. The name of the drug;

b. The strength of the drug;

c. The dosage form if appropriate;

d. The quantity of the drug;

e. The manufacturer name or NDC number of the labeler of the drug if labeled only with its generic name;

f. The date of distribution;

g. The name, and address of the distributing outlet;

h. The name, and address of the receiving practitioner or registered outlet.

i. If a controlled substance is distributed, the record shall also indicate the Drug Enforcement registration number of the distributing outlet and the receiving practitioner or registered outlet.

j. A schedule II controlled substance shall only be distributed pursuant to receipt of a properly executed DEA-222 form.

14.05.21 These records of distribution (casual sales) required by Rule 14.05.20 shall be retained for a period of time not less than two years from the date of the distribution.

14.05.22 Records of distribution (casual sales) required by Rule 14.04.20 may be maintained electronically if the following requirements are met:

a. The other outlet must ensure a daily (i.e., every twenty-four hours) back up is performed for use in restoring required information in case of a system failure.

b. Have and maintain a complete on-line distribution file that is printable on the inspector's request,

c. Have a "lock-out" feature that prevents editing of distribution information.

d. The Board or its inspectors must be able to inspect and review the distribution transactions of the other outlet. Therefore, immediately upon the oral or written request of the Board or its inspectors, the other outlet shall either:

(1) Print a report of all distribution transactions for such period of time as the Board or its inspector(s) may specify. The system must be capable of retrieving and printing such a report within a limited time not to exceed two hours. Additionally, the system must be capable of retrieving and printing the information sorted according to variables which include, but are not limited to, date of distribution; drug name, strength and dosage form; and licensee receiving the distribution;

(2) Provide a computer terminal and monitor for the sole use of the Board or its inspector(s) to inspect and review distribution transactions, and, if necessary, provide a person to assist the Board or its inspector(s) for a period of time not to exceed two hours in operating the system. If the other outlet elects to comply with this subparagraph (2), the system must also be capable of printing the same reports described in subparagraph (1).

e. If the other outlet chooses to maintain records of distribution electronically, any reports printed upon request shall contain, as a minimum, the following information for each transaction:

(1) The name of the drug;

(2) The strength of the drug;

(3) The dosage form if appropriate;

(4) The quantity of the drug;

(5) The manufacturer name or NDC number of the labeler of the drug if labeled only with its generic name;

(6) The date of distribution;

(7) The name, and address of the distributing outlet;

(8) The name, and address of the receiving practitioner or registered outlet;

(9) If a controlled substance is distributed, the record shall also indicate the Drug Enforcement registration number of the distributing outlet and the receiving practitioner or registered outlet.

14.05.24 Advertising.

a. Only one address shall appear on a prescription label and that shall be the address of the other outlet from which the prescription was dispensed.

b. An other outlet shall only use, operate or advertise under the name that appears on the current registration issued by the Board.

c. An other outlet may not advertise, either orally or in writing, that it is a prescription drug outlet (pharmacy).

14.06.00 Petition for a Reduced /Inspection Schedule.

a. The consultant pharmacist of an other outlet may petition the Board for a reduced inspection schedule by submitting a written request to the Board detailing the procedures or technology the other outlet has in place which eliminate the need for the required frequency of inspection. The Board will review these requests in the ordinary course of business. No other outlet may change its inspection schedule without receiving written notification from the Board approving the outlet's alternative inspection schedule. Such written notification shall be maintained in the other outlet posted next to the other outlet registration.

14.07.00 Emergency Redistribution of Prescription Drugs

a. In the event of a shortage of medication or state or national emergency as dictated by either the Centers for Disease Control and Prevention (CDC) or the Colorado Department of Public Health and Environment (CDPHE), an other outlet located in a county health department or public health agency as defined in CRS 25-1-502 may obtain medications from facilities, physicians, and other entities in possession of the drugs, and redistribute the medication as directed by the CDC or CDPHE. The other outlet shall not be required to become licensed as a wholesaler to conduct distribution of drugs for the limited purpose set forth in this Rule. The other outlet shall maintain written records of the distributions detailing the following:

a. The name of the drug;

b. The strength of the drug;

c. The dosage form if appropriate;

d. The quantity of the drug;

e. Lot number of the drug;

f. Expiration date of the drug;

g. The name of the manufacturer or the NDC number of the drug if labeled only with its generic name.

h. The date of distribution;

i. The name and address of the distributing outlet;

j. The name and address of the receiver;

k. If a controlled substance is distributed, the record shall also indicate the drug enforcement administration registration number of the distributing outlet and the receiver.

l. A schedule II controlled substance shall only be distributed pursuant to receipt of a properly executed DEA-222 form.

3 CCR 719-1-14.00.00

37 CR 18, September 25, 2014, effective 10/15/2014

38 CR 16, August 25, 2015, effective 9/14/2015

39 CR 04, February 25, 2016, effective 3/16/2016

39 CR 19, October 10, 2016, effective 11/14/2016

40 CR 04, February 25, 2017, effective 3/17/2017

40 CR 20, October 25, 2017, effective 11/14/2017

41 CR 16, August 25, 2018, effective 9/17/2018

42 CR 21, November 10, 2019, effective 11/30/2019

43 CR 10, May 25, 2020, effective 5/1/2020

43 CR 08, April 25, 2020, effective 5/15/2020

43 CR 15, August 10, 2020, effective 8/30/2020

43 CR 20, October 25, 2020, effective 11/14/2020

44 CR 04, February 25, 2021, effective 3/17/2021

44 CR 08, April 25, 2021, effective 5/15/2021

44 CR 21, November 10, 2021, effective 11/30/2021

45 CR 20, October 25, 2022, effective 9/29/2022

45 CR 21, November 10, 2022, effective 11/30/2022

46 CR 21, November 10, 2023, effective 11/30/2023

47 CR 04, February 25, 2024, effective 3/16/2024