# 3 CCR 719-1: STATE BOARD OF PHARMACY RULES AND REGULATIONS > Colorado · Regulations · In force URL: https://www.frixlaw.com/law-library/statutes/STATE_CO_CCR_3_CCR_719_1 ## Section - **Citation:** 3 CCR 719-1 - **Heading:** STATE BOARD OF PHARMACY RULES AND REGULATIONS - **Jurisdiction:** Colorado - **Kind:** Regulations - **Status:** In force - **Text as of:** August 14, 2026 - **Source:** Compiled text - **Location:** Code of Colorado Regulations / 700 Department of Regulatory Agencies / 719 Division of Professions and Occupations - State Board of Pharmacy / 3 CCR 719-1 ## Text 1 Department of Regulatory Agencies State Board of Pharmacy STATE BOARD OF PHARMACY RULES AND REGULATIONS 3 CCR 719-1 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] 1.00.00 RULES OF PROFESSIONAL CONDUCT. 1.00.11 A pharmacist shall at all times conduct his/her profession in conformity with all federal and state drug laws, rules and regulations; and shall uphold the legal standards of the current official compendia. 1.00.12 A pharmacist shall not be a party or accessory to nor engage in any fraudulent or deceitful practice or transaction in pharmacy, nor knowingly participate in any practice which detrimentally affects the patient, nor discredit his/her profession. 1.00.13 A pharmacist shall not enter into any agreement or arrangement with anyone for the compounding of secret formula or coded orders, except for investigational drugs. 1.00.16 Confidentiality. a. A pharmacist shall not exhibit, discuss, or reveal the contents of any order or prescription, the therapeutic effect thereof, the nature, extent, or degree of illness suffered by any patient or any medical information furnished by the practitioner with any person other than the patient or his authorized representative, the practitioner or another licensed practitioner then caring for the patient, another pharmacist or intern serving the patient, or a person duly authorized by law or by the patient to receive such information. b. A pharmacist may disclose patient information to pharmacy technicians, authorized law enforcement personnel, another pharmacist acquiring and maintaining the records, third party entities responsible for payment and any other parties allowed by federal privacy regulations. c. The pharmacist shall exercise his professional judgment in the release of patient information to a patient or his authorized agent. Code of Colorado Regulations Secretary of State State of Colorado CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy d maintaining the records, third party entities responsible for payment and any other parties allowed by federal privacy regulations. c. The pharmacist shall exercise his professional judgment in the release of patient information to a patient or his authorized agent. Code of Colorado Regulations Secretary of State State of Colorado CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 2 1.00.17 A pharmacist or prescription drug outlet shall not pay or offer to pay or imply that payment might be made of any sum of money or other thing of value to a practitioner, health care facility, nursing care or assisted living facility, or any other health care provider or entity as consideration for any referral to, or promotion of, a prescription drug outlet. 1.00.18 Patient Counseling. Except as specified in section 12-280-138, C.R.S., a pharmacist shall provide patient counseling on new medication therapy and, based on the pharmacist’s professional judgement and due diligence, may provide patient counseling for any other prescription. a. If a pharmacist is unable to provide patient counseling orally due to language barriers, a pharmacist shall use whatever alternative means are necessary to assure the patient is properly counseled as to the medication the patient is provided. This may include, but may not be limited to, written communication in the corresponding language that the patient understands. b. Any refusal on the part of the patient to accept patient counseling shall be clearly documented in the corresponding record, which may include an electronic record, directly linked to each affected corresponding order and such documented refusal shall be readily retrievable and available for inspection by the Board or its inspectors for at least two years following the date of the refusal. 1.00.21 Violation of Board Orders or Negotiated Stipulations or Diversion Program Contracts documented in the corresponding record, which may include an electronic record, directly linked to each affected corresponding order and such documented refusal shall be readily retrievable and available for inspection by the Board or its inspectors for at least two years following the date of the refusal. 1.00.21 Violation of Board Orders or Negotiated Stipulations or Diversion Program Contracts. It shall be considered unprofessional conduct for a Colorado-licensed pharmacist or intern to violate a lawful Board order or negotiated stipulation issued in result of a formal complaint against the licensee or to violate a peer health assistance diversion program contract. 1.00.22 A pharmacist has a professional responsibility to report to the Board in a timely manner any pattern of misconduct in the practice of pharmacy which constitutes a danger to the health, safety, or welfare of a patient or the public. 1.00.23 Severability Clause. If any word, clause, sentence, paragraph, or section of these Rules of Professional Conduct shall for any reason be adjudged by any court of competent jurisdiction to be unconstitutional or otherwise invalid, such judgment shall not affect, repeal, or invalidate the remainder thereof, but shall be confined in its operation to the word, clause, sentence, paragraph, section thereof so found to be unconstitutional or otherwise invalid. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy any reason be adjudged by any court of competent jurisdiction to be unconstitutional or otherwise invalid, such judgment shall not affect, repeal, or invalidate the remainder thereof, but shall be confined in its operation to the word, clause, sentence, paragraph, section thereof so found to be unconstitutional or otherwise invalid. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 3 1.00.24 Except as provided in sections 12-280-103(54)(b)(III) and 25.5-2.5-201 through 25.5-2.5-208, C.R.S., a prescription drug outlet shall ensure that all prescription drugs and controlled substances are procured from another entity or person registered by the Board. Any drug designated as an Investigational New Drug from the Federal Food and Drug Administration is exempt from this requirement provided the research requirements for the receipt of the product are followed and it meets the requirements of section 12-280-131(2), C.R.S. 1.00.25 Colorado-licensed pharmacists with appropriate training may order and administer CLIA-waived tests, including serology tests that have authorized by the Food and Drug Administration (FDA), or equivalent regulatory authorization, subject to the disclaimers and limitations required by the FDA for such tests. 1.00.26 REQUIRED DISCLOSURE TO PATIENTS – CONVICTION OF OR DISCIPLINE BASED ON SEXUAL MISCONDUCT (Section 12-30-115, C.R.S.) A. On or after March 1, 2021, a provider shall disclose to a patient, as defined in section 12-30-115(1)(a), C.R.S., instances of sexual misconduct, including a conviction or guilty plea as set forth in section 12-30-115 (2)(a), C.R.S., or final agency action resulting in probation or limitation of provider ability to practice as set forth is section 12-30-115(2)(b), C.R.S. B. Form of Disclosure: The written disclosure shall include all information specified in section 12-30-115(3), C.R.S., and consistent with the sample model disclosure form as set forth in Appendix D to these rules set forth in section 12-30-115 (2)(a), C.R.S., or final agency action resulting in probation or limitation of provider ability to practice as set forth is section 12-30-115(2)(b), C.R.S. B. Form of Disclosure: The written disclosure shall include all information specified in section 12-30-115(3), C.R.S., and consistent with the sample model disclosure form as set forth in Appendix D to these rules. The patient must, through his or her signature on the disclosure form, acknowledge the receipt of the disclosure and agree to treatment with the provider. C. Timing of Disclosure: This disclosure shall be provided to a patient the same day the patient schedules a “professional services” appointment with the provider. If an appointment is scheduled the same day that services will be provided, the disclosure must be provided in advance of the treatment. 1. The written disclosure and agreement to treatment must be completed prior to each treatment appointment with a patient/client, unless the treatment will occur in a series over multiple appointments or a patient/client schedules follow-up treatment appointments. 2. For treatment series or follow-up treatment appointments, one disclosure prior to the first appointment is sufficient, unless the information the provider is required to disclose pursuant to section 12-30-115, C.R.S., has changed since the most recent disclosure, in which case an updated disclosure must be provided to a patient/client and signed before treatment may continue. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy appointments, one disclosure prior to the first appointment is sufficient, unless the information the provider is required to disclose pursuant to section 12-30-115, C.R.S., has changed since the most recent disclosure, in which case an updated disclosure must be provided to a patient/client and signed before treatment may continue. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 4 3. For the purpose of this Rule 1.00.25, “professional services” shall include face-to-face counseling including, but not limited to, the administration of drugs and vaccines, collaborative pharmacy practice, and allowable testing and diagnostics. 4. A provider who does not have a direct treatment relationship or have direct contact with the patient is not required to make the disclosure required by this section. D. As set forth in section 12-30-115(3)(e), C.R.S., the requirement to disclose the conviction, guilty plea, or agency action ends when the provider has satisfied the requirements of the probation or other limitation and is no longer on probation or otherwise subject to a limitation on the ability to practice the provider's profession. E. A provider is not required to provide the written disclosure BEFORE providing professional services to the patient in the following instances as set forth in section 12-30-115(4), C.R.S.: 1. The patient is unconscious or otherwise unable to comprehend the disclosure and sign an acknowledgment of receipt of the disclosure pursuant to section 12-30-115(3)(d), C.R.S., and a guardian of the patient is unavailable to comprehend the disclosure and sign the acknowledgment; 2. The patient visit occurs in an emergency room or freestanding emergency department or the visit is unscheduled, including consultations in inpatient facilities; or 3. The provider who will be treating the patient during the visit is not known to the patient until immediately prior to the start of the visit. F f the patient is unavailable to comprehend the disclosure and sign the acknowledgment; 2. The patient visit occurs in an emergency room or freestanding emergency department or the visit is unscheduled, including consultations in inpatient facilities; or 3. The provider who will be treating the patient during the visit is not known to the patient until immediately prior to the start of the visit. F. The provider who does not have a direct treatment relationship or have direct contact with the patient is not required to make the disclosure required by this section. [Appendix D is located at the end of the Rules] 2.00.00 ORDERS. 2.00.10 Receipt of Order. a. Only a pharmacist or intern may receive and reduce to writing an oral order except for chart orders as provided in section 12-280-120(11), C.R.S. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 5 b. An electronically transmitted order (ETO) may be accepted in a PDO for dispensing. 2.01.10 Information to Appear on Each Order. The following information must appear on each written or oral order except as provided for chart orders for hospitalized patients (hospital chart orders): a. The date the order was compounded and dispensed; b. The assigned serial number (hospital chart orders are exempt from this requirement); c. The quantity dispensed if differs from the quantity ordered (LTCF chart orders are exempt from this requirement provided this information is recorded within another appropriate uniformly maintain and readily retrievable permanent record of the dispensing pharmacy); d. In the case of a controlled substance order, the patient address, prescriber address, and prescriber’s Drug Enforcement Administration (DEA) registration; e. Patient address, prescriber address, and prescriber DEA registration number need not appear on any type of order for a non-controlled substance prescription; and f ntain and readily retrievable permanent record of the dispensing pharmacy); d. In the case of a controlled substance order, the patient address, prescriber address, and prescriber’s Drug Enforcement Administration (DEA) registration; e. Patient address, prescriber address, and prescriber DEA registration number need not appear on any type of order for a non-controlled substance prescription; and f. Minor adaptations to an order as allowed pursuant to section 12-280- 125.3, C.R.S., which shall detail the date and identity of the pharmacist making the minor adaptations. 2.01.20 Additional Information. The following shall also appear on the prescription or LTCF chart order, or corresponding readily available and retrievable electronic record of the prescription or LTCF chart order, when appropriate: a. Any change in or clarification of an order shall be documented on the order and shall bear the initials or unique identifier of the responsible pharmacist, pharmacy intern, or pharmacy technician, the date contacted and the name of the individual conveying such change or clarification. b. When a substitution is made, the order shall indicate the following: (1) The names of both the drug prescribed and the drug actually dispensed, as well as the date on which such substitution was initially made. (2) The order shall also indicate the name of the distributor of the drug dispensed as it appears on the package or the national drug code number. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 6 (3) On an order for a schedule II controlled substance, substitution shall not be deemed to be an alteration of the order. (4) On subsequent refilling of any order, any change in the name of the distributor or the national drug code number as it appears on the package shall be recorded on the order unless the computer system used at that prescription drug outlet changes only the affected transaction(s) (any computer entry change must not alter previous transaction records). be deemed to be an alteration of the order. (4) On subsequent refilling of any order, any change in the name of the distributor or the national drug code number as it appears on the package shall be recorded on the order unless the computer system used at that prescription drug outlet changes only the affected transaction(s) (any computer entry change must not alter previous transaction records). (5) In addition to the information provided in this Rule 2.01.20(c), when a substitution is made on a prescription order pursuant to section 12-280-125(1)(a.5), C.R.S., the dispensing pharmacist shall clearly document that the prescription was an intentional substitution within the same therapeutic drug class by writing the words “Intentional Therapeutic Drug Class Substitution” or a substantially equivalent statement on the date the substitution occurred. c. In the case of a chart order for a hospitalized patient (hospital chart order), the following information need not necessarily appear on the chart order, provided that such information is recorded on another appropriate, uniformly maintained and readily retrievable permanent record which reflects: (1) The identity of the pharmacist making the initial interpretation; (2) The identity of the pharmacist making the final evaluation each time a drug is dispensed, if different from the pharmacist making the initial interpretation; (3) The quantity dispensed and (4) The date of dispensing. ecorded on another appropriate, uniformly maintained and readily retrievable permanent record which reflects: (1) The identity of the pharmacist making the initial interpretation; (2) The identity of the pharmacist making the final evaluation each time a drug is dispensed, if different from the pharmacist making the initial interpretation; (3) The quantity dispensed and (4) The date of dispensing. (5) Any record of a controlled substance dispensed pursuant to a chart order for an individual patient shall be visually identifiable from records of non-controlled substances. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 7 2.01.30 Responsibility of a Pharmacist in Recording Refills. When a prescription order is refilled, the following information must be recorded on the back of the prescription order, or on the daily computer printout as specified in Rule 11.00.00, and may be entered by a pharmacy technician if no interpretation is required: Date refilled and quantity, if different from the quantity shown on the face of the prescription order. If authority to refill is obtained, the name of the individual conveying such authority must be recorded. The entry shall also bear the name, initials, license number, or secure electronic identifier of the pharmacist making the final evaluation. This information shall be maintained and available for inspection for a period of two years from the date of any transaction relating to the order unless otherwise required by statute. 2.01.40 Prescription Order Copies. A pharmacist may issue a written copy conspicuously marked “COPY FOR REFERENCE ONLY” to the patient or patient's agent. A pharmacist who issues such a written copy of a prescription order shall place on the original prescription order his/her initials, the date, and an indication that a written copy has been issued. No information regarding authority to refill shall be issued in a written copy. 2.01.50 Transfer of Prescription Orders Between Prescription Drug Outlets. a ENCE ONLY” to the patient or patient's agent. A pharmacist who issues such a written copy of a prescription order shall place on the original prescription order his/her initials, the date, and an indication that a written copy has been issued. No information regarding authority to refill shall be issued in a written copy. 2.01.50 Transfer of Prescription Orders Between Prescription Drug Outlets. a. A prescription label or a written copy of a prescription order from another pharmacy may be used for informational purposes only and shall not be considered to be a valid prescription order. A pharmacist, pharmacy intern, or pharmacy technician who receives such a label or prescription order copy shall either contact the prescribing practitioner for authorization to dispense the prescription, or, alternatively, shall comply with 2.01.52 through 2.01.59. b. A pharmacist, pharmacy intern, or pharmacy technician may orally transfer prescription order information for non-controlled substances for the purpose of dispensing a prescription. c. A prescription drug outlet may transfer a prescription order electronically to another prescription drug outlet for the purpose of dispensing a prescription order. (1) If the prescription order information is transmitted by facsimile, the transferring pharmacist, pharmacy intern, or pharmacy technician shall comply with rule 2.01.52. (2) Prescription order information may be transmitted electronically between two compatible computer systems that are capable of complying with the requirements of rules 2.01.52 and 2.01.53 (1)- (10). In the case of electronic transfers, the transferring and receiving pharmacist, pharmacy intern, or pharmacy technician may be the same person. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 8 ion order information may be transmitted electronically between two compatible computer systems that are capable of complying with the requirements of rules 2.01.52 and 2.01.53 (1)- (10). In the case of electronic transfers, the transferring and receiving pharmacist, pharmacy intern, or pharmacy technician may be the same person. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 8 (3) In the case of prescription drug outlets that access and share the same data storage device and that can electronically retrieve all necessary information, if the original prescription order information is not invalidated, each dispensing prescription drug outlet shall be capable of accessing a transaction record that indicates the following information: (a) date, (b) time, and (c) location from which the prescription was dispensed. If the prescription order is assigned a new prescription number at the receiving pharmacy, the prescription information at the originating pharmacy shall be invalidated. d. The one-time transfer of original prescription information for a controlled substance listed in schedules III, IV, or V for the purpose of refill dispensing is permissible between pharmacies. However, pharmacies electronically sharing a real-time, on-line database may transfer up to the maximum refills permitted by law and the prescriber’s authorization. If the prescription order is assigned a new prescription number at the receiving pharmacy, the prescription may be transferred on a one-time basis only. Verbal transfers of CIII-CV electronically submitted prescriptions are permitted in Colorado. e. The one-time transfer of an electronic prescription for a schedule II-V controlled substance, for initial dispensing, is permissible if the transfer information is communicated between two licensed pharmacists; the transferred prescription remains in its electronic form; and the prescription information is not altered during the transmission. f submitted prescriptions are permitted in Colorado. e. The one-time transfer of an electronic prescription for a schedule II-V controlled substance, for initial dispensing, is permissible if the transfer information is communicated between two licensed pharmacists; the transferred prescription remains in its electronic form; and the prescription information is not altered during the transmission. f. A pharmacist may authorize pharmacy technician or pharmacy intern to electronically transfer an order, for the purpose of redispensing said order, provided that the electronic transfer is between two compatible computer systems and no changes are made. The pharmacist shall be identified on the transfer record as required by 2.01.52 and 2.01.53. 2.01.52 The transferring pharmacist, pharmacy intern, or pharmacy technician shall: a. Write the word “void” across the face of the original prescription order to make the order invalid; b. Record on the reverse side of the invalidated prescription order: (1) His/her name, license or certification number, initials, or secure electronic identifier; (2) The name, license number, initials, or secure electronic identifier of the receiving pharmacist or pharmacy intern or pharmacy technician; CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 9 (3) The name of the receiving prescription drug outlet; (4) The address and telephone number of the receiving prescription drug outlet; and (5) The date of the transfer. tronic identifier; (2) The name, license number, initials, or secure electronic identifier of the receiving pharmacist or pharmacy intern or pharmacy technician; CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 9 (3) The name of the receiving prescription drug outlet; (4) The address and telephone number of the receiving prescription drug outlet; and (5) The date of the transfer. (6) In the case of a controlled substance in schedule III through V, the Drug Enforcement Administration registration number of the receiving prescription drug outlet. c. A pharmacy utilizing a computer for storage and retrieval of information regarding prescription transactions shall be exempt from the requirements of paragraphs (a) and (b) of this rule if the computer is capable of invalidating the prescription order and retaining as part of the permanent record the information specified in paragraph (b) of this rule. 2.01.53 The pharmacist, pharmacy intern, or pharmacy technician receiving the transferred prescription order information shall: Reduce the transferred information to writing or print; write or print the word “transfer” on the face of the transferred prescription order; and provide all information required by law or rule to be on the prescription order, including: (1) The date of issue of the original prescription order; (2) The date of initial compounding and dispensing of the original prescription order; (3) The number of refills authorized and the original quantity prescribed or any limitations placed on the prescription; (4) The number of valid refills remaining; (5) The date of the last refill of the original prescription order; (6) The prescription order number from which the prescription order information was transferred; (7) The name, license or certification number, initials, or secure electronic identifier of the transferring pharmacist, pharmacy intern, or pharmacy technician; (8) The name of the transferring prescription drug outlet; lls remaining; (5) The date of the last refill of the original prescription order; (6) The prescription order number from which the prescription order information was transferred; (7) The name, license or certification number, initials, or secure electronic identifier of the transferring pharmacist, pharmacy intern, or pharmacy technician; (8) The name of the transferring prescription drug outlet; (9) The address and telephone number of the transferring prescription drug outlet; CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 10 (10) In the case of a controlled substance in schedules III through V, the Drug Enforcement Administration number of the transferring prescription drug outlet, and the practitioner's Drug Enforcement Administration number. 2.01.54 The transferring prescription drug outlet shall retain the original prescription order as required by Rule 11.04.10. 2.01.55 The receiving prescription drug outlet shall retain the transferred prescription order as required by Rule 11.04.10. 2.01.56 The pharmacist, pharmacy intern, or pharmacy technician at the receiving prescription drug outlet at the time of the dispensing of the transferred prescription, shall inform the patient that the prescription order is now invalid at the prescription drug outlet from which it was transferred. 2.01.59 A prescription order for a controlled substance in schedule III through V may be transferred only one time, that transfer being from the prescription drug outlet where the prescription was originally filled. It shall not be further transferred by, or to, any other prescription drug outlet. 2.01.60 A prescription order for a non-controlled prescription drug may be transferred from a prescription drug outlet to another prescription drug outlet as provided in Rule 2.01.50 only so long as there are refills remaining and each prescription drug outlet can establish that a valid refill existed at the time of dispensing t be further transferred by, or to, any other prescription drug outlet. 2.01.60 A prescription order for a non-controlled prescription drug may be transferred from a prescription drug outlet to another prescription drug outlet as provided in Rule 2.01.50 only so long as there are refills remaining and each prescription drug outlet can establish that a valid refill existed at the time of dispensing. 2.01.80 When a prescription drug outlet discontinues business and the prescription order files are moved to another prescription drug outlet, those orders shall be considered void and shall not be refilled. However, if the receiving pharmacist, pharmacy intern, or pharmacy technician can establish that an authorized refill or authorized refills remain on any such order, such authorization may, at the sole discretion of the pharmacist, be used to establish a new order. a. If the record which reflects the authorized refill or refills is the original prescription order, the serial number of the original prescription order shall be recorded on the new order, and the serial number of the new prescription order shall be recorded on the original order. b. If the record which reflects the authorized refill or refills is electronic, the pharmacist, pharmacy intern, or pharmacy technician shall maintain in written or printed form a record which indicates both the serial number of the original prescription order and the serial number of the new prescription order. This record may be made part of the daily printout required by Rule 11.04.20 if it is routinely recorded in such printout. The refill authorization(s) contained in the original electronic record must be invalidated to prevent further refilling. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 11 c. The files from the prescription drug outlet that has discontinued business may be transferred to another prescription drug outlet under the following conditions: it is routinely recorded in such printout. The refill authorization(s) contained in the original electronic record must be invalidated to prevent further refilling. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 11 c. The files from the prescription drug outlet that has discontinued business may be transferred to another prescription drug outlet under the following conditions: (1) The computer or electronic database from the prescription drug outlet that discontinued business is located and will remain at the pharmacy to which it is transferred for at least two years. (2) The computer or electronic database must be capable of complying with Rule 2.01.52(c). 3.00.00 DISPENSING. 3.00.10 Limitations. Except as provided in section 12-280-123(2), C.R.S., no order shall be dispensed or refilled after one year from the date of issue by the practitioner. 3.00.20 Medical Need. (a) No licensee or registrant shall prescribe, administer, compound, dispense, deliver or distribute any drug to any person in such quantity or in any situation where the licensee or registrant knows or reasonably should know said drug has no recognized medical utility or application. Violation of this Rule shall constitute prima facie proof of violation of section 12-280- 126, C.R.S. (b) One additional bottle of a prescription eye drop may be dispensed to a patient if the following conditions are met: 1. The corresponding patient’s health benefit plan provides coverage for the prescription eye drops; 2. The additional bottle is requested by the insured or the health care provider at the time the original prescription is dispensed; 3. The original order states that one additional bottle is needed by the insured for use in a day care center, school, or adult day program; 4. The additional bottle is limited to one additional bottle every three months; and 5 overage for the prescription eye drops; 2. The additional bottle is requested by the insured or the health care provider at the time the original prescription is dispensed; 3. The original order states that one additional bottle is needed by the insured for use in a day care center, school, or adult day program; 4. The additional bottle is limited to one additional bottle every three months; and 5. The total number of bottles dispensed does not exceed the total number of bottles prescribed as stated on the original order when accounting for authorized refills assigned to the original order by the prescriber, if applicable. (c) A prescription eye drop may be refilled if the following conditions are met: CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 12 1. The refill is requested by the insured at least twenty-one days for a thirty day supply of eye drops, forty-two days for a sixty day supply of eye drops, or sixtythree days for a ninety day supply of eye drops, from the later of the date that the original prescription was dispensed to the insured or the date that the last refill of the prescription was dispensed to the insured; and 2. The original prescription order states that additional quantities of prescription eye drops are needed and the refill requested by the insured does not exceed the number of additional quantities needed. (d) The pharmacist may not dispense a prescription drug or a controlled substance to a practitioner based on an order that does not list a specific patient. A prescription order for “office use” is not a valid order. Compounded prescription drugs distributed to veterinarians for “office stock” as defined in section 12-280-121(5)(b), C.R.S., must comply with the requirements of Rules 11.00.00 and 21.00.00. 3.00.21 A pharmacist shall make every reasonable effort to ensure that any order, regardless of the means of transmission, has been issued for a legitimate medical purpose by an authorized practitioner order. Compounded prescription drugs distributed to veterinarians for “office stock” as defined in section 12-280-121(5)(b), C.R.S., must comply with the requirements of Rules 11.00.00 and 21.00.00. 3.00.21 A pharmacist shall make every reasonable effort to ensure that any order, regardless of the means of transmission, has been issued for a legitimate medical purpose by an authorized practitioner. A pharmacist shall not dispense a prescription drug if the pharmacist knows or should know that the order for such drug was issued without a valid preexisting patient-practitioner relationship. Such relationship need not involve an in-person encounter between the patient and practitioner if otherwise permissible under Colorado law. A pharmacist may, in good faith, prescribe or dispense an opiate antagonist pursuant to an order that was issued without a valid preexisting patient-practitioner relationship that is approved by the Federal Food and Drug Administration for the treatment of a drug overdose. 3.00.22 The prescribing or dispensing of an opiate antagonist, as described in Rule 3.00.21, by a pharmacist shall not constitute unprofessional conduct pursuant to section 12-280-126, C.R.S., if he or she prescribed or dispensed the opiate antagonist in good faith pursuant to an order or standing orders and protocols issued to or for individuals or entities described in section 12-30-110, C.R.S. a. Each prescription drug outlet shall maintain, in a uniform and readily retrievable manner for at least two years from the date of latest transaction related to a pharmacist initiated order or standing order, the following record detailing the dispensing of an opioid antagonist pursuant to a pharmacist initiated order or standing order: CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy h prescription drug outlet shall maintain, in a uniform and readily retrievable manner for at least two years from the date of latest transaction related to a pharmacist initiated order or standing order, the following record detailing the dispensing of an opioid antagonist pursuant to a pharmacist initiated order or standing order: CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 13 1) The full name of the patient, person who is in a position to assist a person who is at increased risk of experiencing or likely to experience an opiate-related drug overdose event, first responder, unit of local government, or harm reduction organization receiving the drug; 2) The full address of the first responder, unit of local government, or harm reduction organization receiving the drug; 3) The name, strength and dosage form of the drug dispensed; 4) The quantity of drug dispensed; and 5) The date of dispensing. 3.00.23 Dispensing without an order. a. A pharmacist may dispense an emergency supply of a chronic maintenance drug, as defined in section 12-280-103(9.5)(a) and (b), C.R.S., to a patient without a current, valid order under the conditions set forth in section 12-280-125.5, C.R.S. When an emergency dispensing occurs, the dispensing pharmacist, or their designee, shall immediately notify the practitioner of record related to the emergency dispensing, in writing, detailing the: (1) Name, address, and telephone number of dispensing pharmacy; (2) Name, strength, dosage form, directions, and quantity of drug dispensed; (3) Name of patient and corresponding patient’s date of birth; and n emergency dispensing occurs, the dispensing pharmacist, or their designee, shall immediately notify the practitioner of record related to the emergency dispensing, in writing, detailing the: (1) Name, address, and telephone number of dispensing pharmacy; (2) Name, strength, dosage form, directions, and quantity of drug dispensed; (3) Name of patient and corresponding patient’s date of birth; and (4) Date of emergency dispensing. b. Records related to the dispensing of an emergency supply of a chronic maintenance drug shall be detailed and maintained in the same manner as all other dispensing transactions in compliance with all applicable provisions of Board Rules 2.00.00, 3.00.00, 11.00.00, 21.00.00, and 26.00.00. 3.00.25 First Dose Dispensing. A pharmacist at a prescription drug outlet may dispense up to a seventy- two hour supply of a non-controlled substance prescription drug to an LTCF resident pursuant to a duplicate copy of an LTCF chart order provided by another prescription drug outlet for the purpose of providing immediate patient care, on a one time per order basis, if the following conditions are met: CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 14 a. The receiving prescription drug outlet records on the prescription order the name and address of the originating prescription drug outlet and the date the order was received by the receiving prescription drug outlet; b. The receiving prescription drug outlet maintains the order as a prescription order and complies with all requirements for prescription orders specified in Rules 2.01.10 through 2.01.40, 3.00.10 through 3.00.51, and 11.04.10; and c. The originating prescription drug outlet records on the LTCF chart order the name and address of the receiving prescription drug outlet and the date the order was provided to the receiving prescription drug outlet. 3.00.27 Outlet to Outlet Drug Reconstitution lies with all requirements for prescription orders specified in Rules 2.01.10 through 2.01.40, 3.00.10 through 3.00.51, and 11.04.10; and c. The originating prescription drug outlet records on the LTCF chart order the name and address of the receiving prescription drug outlet and the date the order was provided to the receiving prescription drug outlet. 3.00.27 Outlet to Outlet Drug Reconstitution. A pharmacist at a prescription drug outlet may reconstitute a prescription originally dispensed in an unreconstituted form pursuant to a patient-specific order at another prescription drug outlet or nonresident prescription drug outlet provided the following conditions are met: a. The prescription is delivered directly from the originating outlet to the receiving outlet; b. The prescription is at no time in the physical possession of the patient until after the prescription has been reconstituted; c. The prescription is reconstituted according to the corresponding manufacturer’s directions; d. The prescription is not a controlled substance; e. The pharmacist at the receiving outlet does not alter the prescription or its original labeling in any way other than to reconstitute, re-label for re- dispensing for administration, and properly store the prescription; and f. The originating outlet is ultimately accountable to the Board for the accurate dispensing of the original prescription, and the receiving outlet is ultimately accountable for the accurate reconstitution and re-dispensing of the prescription. 3.00.30 Labeling. a. When a prescription drug is dispensed pursuant to an order, the name of the drug that appears on the container label shall correspond with the identity of the drug contained therein unless otherwise requested by the practitioner. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy accountable for the accurate reconstitution and re-dispensing of the prescription. 3.00.30 Labeling. a. When a prescription drug is dispensed pursuant to an order, the name of the drug that appears on the container label shall correspond with the identity of the drug contained therein unless otherwise requested by the practitioner. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 15 b. When a prescription drug is dispensed to a patient for outpatient use and contains an opioid that is not prescribed for the treatment of a substance use disorder or is a partial opioid antagonist, the label or container shall bear a notification that states, or is substantially equivalent to: “Caution: Opioids carry a risk of overdose and addiction.” c. In addition to complying with all applicable accessibility labeling requirements, including but not limited to requirements relating to visual impairment, pursuant to section 12-280-124, C.R.S., each prescription drug outlet shall apply to the Board, for its approval, if the prescription drug outlet offers a patient an alternative method to access a prescription drug label other than the methods specified in section 12-280-124(4)(b)(I) to (4)(b)(IV), C.R.S. When applying to the Board for an alternative method, each prescription drug outlet shall demonstrate to the Board that the method to access a prescription drug label is substantially similar to the method of access the patient requested and meets the needs of the patient. 3.00.40 Expiration Dating. 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. 3.00.50 Initial Interpretation and Final Evaluation. a. Initial interpretation means the review of an order accompanied by order entry. The pharmacist(s) conducting the initial interpretation shall be held accountable for the accuracy of the electronic order entry/manual transcription and for drug regimen review. b ior to utilization by the consumer, based on the practitioner's directions for use. 3.00.50 Initial Interpretation and Final Evaluation. a. Initial interpretation means the review of an order accompanied by order entry. The pharmacist(s) conducting the initial interpretation shall be held accountable for the accuracy of the electronic order entry/manual transcription and for drug regimen review. b. Final evaluation means the review of the final prescription to ensure that the ordered medication is properly prepared and placed in a suitable container with appropriate labeling. The pharmacist(s) conducting the final evaluation shall be held accountable for assuring that the identity of the drug that appears on the prescription label corresponds with identity of drug contained therein. When refills are dispensed, the pharmacist conducting the final evaluation shall be held accountable for the appropriate dispensing of refills including all drug utilization reviews as they pertain to refill dispensing. c. Drug regimen review includes but is not limited to the evaluation of order(s) and patient records(s) for: 1) Known allergies; 2) Rational therapy and contraindications; CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 16 3) Reasonable dose, duration of use, and route of administration considering age, gender, and other patient factors; 4) Reasonable directions for use; 5) Potential or actual adverse drug reactions; 6) Drug-drug interactions; 7) Drug-food interactions; 8) Drug-disease contraindications; 9) Therapeutic duplication; 10) Proper utilization (including over- or under-utilization) and optimum therapeutic outcomes; and 11) Abuse/misuse. d. A pharmacist shall conduct an initial interpretation of each new order and a pharmacist shall conduct the final evaluation of each order dispensed. When refills are dispensed, the pharmacist making the final evaluation shall be held accountable for the appropriate dispensing of refills per utilization (including over- or under-utilization) and optimum therapeutic outcomes; and 11) Abuse/misuse. d. A pharmacist shall conduct an initial interpretation of each new order and a pharmacist shall conduct the final evaluation of each order dispensed. When refills are dispensed, the pharmacist making the final evaluation shall be held accountable for the appropriate dispensing of refills. The pharmacist manager shall be held accountable for the maintenance of all appropriate records. e. The pharmacist making the initial interpretation and final evaluation on prescription or LTCF chart orders shall be identified by either license number, initials, name, or secure electronic identifier on a uniformly maintained, readily retrievable document. The uniformly maintained, readily retrievable document shall bear the license number, initials, name, or secure electronic identifier of any additional pharmacists involved in the dispensing of the order. The pharmacist conducting the initial interpretation and final evaluation may be the same person. f. In the case where the computer software utilized is not password protected, the initial interpretation and final evaluation shall be maintained in a handwritten format bearing the license number, initials, or name of the responsible pharmacist. In addition, the identification of any other pharmacists involved in the dispensing shall be maintained in the same handwritten format. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy ed is not password protected, the initial interpretation and final evaluation shall be maintained in a handwritten format bearing the license number, initials, or name of the responsible pharmacist. In addition, the identification of any other pharmacists involved in the dispensing shall be maintained in the same handwritten format. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 17 3.00.51 Records of Initial Interpretation and Final Evaluation. a. Records detailing both the initial interpretation and final evaluation shall be retained at the prescription drug outlet for each prescription dispensed and for at least two years from the date of any transaction pertaining to the order. These records shall include at least the following: 1) The license number, initials, name, or secure electronic identifier of the pharmacist conducting the initial interpretation for each new order; 2) The license number, initials, name, or secure electronic identifier of the pharmacist conducting the final evaluation for each new and refill prescription; and 3) The specific date on which each initial interpretation and final evaluation occurred. In the event the initial interpretation and final evaluation for a new order are conducted on separate dates, both dates shall be recorded to state specifically when both occurred. b. Each outlet shall maintain, in written format, a notice detailing how initial interpretations and final evaluations are documented in the outlet. Such notice shall include and comply with the following: 1) The manner in which initial interpretations are recorded and maintained in the outlet for all new orders. 2) The manner in which final evaluations are recorded in the outlet for all new and refill prescriptions. 3) A statement that all pharmacy personnel involved in the dispensing of prescriptions have the ability to print, upon request, a record detailing the initial interpretation for each new prescription dispensed and final evaluation for each new and refill prescription dispensed all new orders. 2) The manner in which final evaluations are recorded in the outlet for all new and refill prescriptions. 3) A statement that all pharmacy personnel involved in the dispensing of prescriptions have the ability to print, upon request, a record detailing the initial interpretation for each new prescription dispensed and final evaluation for each new and refill prescription dispensed. 4) Such written notice shall be signed and dated or electronically approved if version and approval histories are available by the pharmacist manager. In the event the pharmacist manager changes, the incoming pharmacist manager shall review, electronically approve, or sign and date the notice within seventy- two hours of assuming the duties of pharmacist manager. In the event there is a lapse between the time one pharmacist manager ceases the duty and another assumes the duty, the previous method of recording initial interpretations and final evaluations shall remain in effect. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 18 5) If there are any changes to the outlet’s method of documenting initial interpretations and final evaluations, a new written notice detailing the requirements of sections 1, 2, 3, and 4 above shall be executed. This notice shall detail the effective date of change. 6) The outlet shall post these notices on a wall directly next to the outlet’s most current Board registration or electronically publish a secure version of the notice. 7) These notices shall be retained at the outlet for a period of three years from the date last utilized. 8) In the event such notices are not posted or electronically published, the pharmacist manager shall be held accountable for the failure to post the required notice and any dispensing errors the outlet’s most current Board registration or electronically publish a secure version of the notice. 7) These notices shall be retained at the outlet for a period of three years from the date last utilized. 8) In the event such notices are not posted or electronically published, the pharmacist manager shall be held accountable for the failure to post the required notice and any dispensing errors. In the event such notices are not posted during the period of time between one pharmacist manager leaving the position and another assuming the position, the outlet shall be held accountable for the failure to post the required notice and any dispensing errors. 3.00.55 Prescription Flavoring. A flavor additive may be incorporated into a non- sterile prescription under the following conditions: a. The patient, patient’s caregiver, or practitioner who authorized the original prescription shall authorize the flavoring of each new and, if applicable, refilled prescription; b. The flavor additive shall in no way compromise the stability, safety, or efficacy of the dispensed drug. c. No expired flavor additive shall be incorporated into a prescription. No flavor additive shall be incorporated which will expire prior to utilization by the patient, based on the practitioner’s directions for use. d. For flavoring additives that do not have expiration dates assigned by the manufacturer or supplier, a pharmacist shall clearly and legibly label the container with the date of receipt and assign a conservative expiration date, not to exceed three years after receipt, to the flavoring additive. In no event shall the labeled date of receipt or assigned expiration date be later altered after originally labeling the container. e. The following information shall be recorded and maintained in a suitable hard-copy or electronic dispensing record for a period of two years from the date of flavoring the corresponding new or refilled prescription ee years after receipt, to the flavoring additive. In no event shall the labeled date of receipt or assigned expiration date be later altered after originally labeling the container. e. The following information shall be recorded and maintained in a suitable hard-copy or electronic dispensing record for a period of two years from the date of flavoring the corresponding new or refilled prescription. This record shall be made available, in printed form, for the Board or its representatives immediately upon the request of the Board or its representatives. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 19 1) Additive’s flavor; 2) Flavor additive’s manufacturer 3) Flavor additive’s lot number (if available); and 4) Flavor additive’s expiration date. f. The pharmacist responsible for conducting the final evaluation of a new or refilled prescription shall also be responsible for the flavoring of the prescription as specified in subsections a., b., and c. of this Rule 3.00.55. g. The pharmacist manager shall be responsible for subsection d. of this Rule 3.00.55 and the maintenance of records as specified in subsection e. of this Rule 3.00.55. 3.00.60 When a substitution is made on a prescription order, a patient shall be given oral and written notice of this fact at the time such substitution initially occurs, except as provided in section 12-280-125, C.R.S. On subsequent refilling of a prescription order, such oral and written notices shall not be required unless, in the professional judgment of the pharmacist, the best interest of the patient will be served by giving such notices. 3.00.70 Responsibility for pharmacy technicians. A pharmacist shall be responsible for pharmacy technicians and shall at all times comply with section 12-280-118(5), C.R.S On subsequent refilling of a prescription order, such oral and written notices shall not be required unless, in the professional judgment of the pharmacist, the best interest of the patient will be served by giving such notices. 3.00.70 Responsibility for pharmacy technicians. A pharmacist shall be responsible for pharmacy technicians and shall at all times comply with section 12-280-118(5), C.R.S. 3.00.75 The placement of a prescription into another outer container and the labeling of the container with the patient’s name or any other identifying information constitutes the “Practice of Pharmacy” as a function of preparation, packaging, labeling and delivery under section 12-280-103(39), C.R.S. Individuals who perform this function shall be included in the ratio of pharmacy technicians or interns a pharmacist is permitted to supervise pursuant to 12-280- 122(1), C.R.S. 3.00.80 Definition for Return or Exchange of Medicine, Prescriptions, Medical Devices, and Medical Supplies for Dispensing or Donation. The following definition applies to donors or donation recipients of medicine, medical supplies, or medical devices pursuant to Section 12-280-135, C.R.S. “Traditional dispensing system” means a drug package system in which individual doses are not packaged in unit dose packages or unit of issue packages. 3.00.81 General Provisions a. Rules 3.00.81 through 3.00.83 apply to donors or donation recipients of medicine pursuant to Section 12-280-135.5, C.R.S. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy to Section 12-280-135, C.R.S. “Traditional dispensing system” means a drug package system in which individual doses are not packaged in unit dose packages or unit of issue packages. 3.00.81 General Provisions a. Rules 3.00.81 through 3.00.83 apply to donors or donation recipients of medicine pursuant to Section 12-280-135.5, C.R.S. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 20 3.00.82 Donation Records of Medicine a. The donation recipient shall retain written or electronic donation records for at least two years that contain the following information: 1) For each accepted or transferred drug, the name, strength, and quantity. Lot number may be recorded, however, inclusion of lot number is not required. ; 2) The name, address and phone number of the donor, individual donor, or transferring entity; 3.00.83 Dispensing of Donated Medicine. a. Except as otherwise specified in Section 12-280-135.5, C.R.S., when administering or redispensing donated medicine, a donation recipient shall: 1) Ensure proper labeling in accordance with 3 CCR 719-1 3 3.00.30; 2) Maintain eligible patient-specific written or electronic records in accordance with 3 CCR 719-1-2-00-00, 3.00.00, and 11.00.00. 3.00.84 Record Retention a. All records of receipt and dispensing shall be maintained for a period of two years from the date of receipt, or from the last dispensing transaction date. Such records shall be maintained separately from all other records of the prescription drug outlet. b. All records of donation shall be maintained for a period of three years from the date of donation. Such records shall be maintained separately from all other records of the prescription drug outlet. 3.00.85 Prescriptions Dispensed but Not Delivered. When a drug has been dispensed pursuant to a prescription or LTCF chart order but has not been delivered to the ultimate consumer, the drug may be returned to stock for subsequent redispensing provided that: a three years from the date of donation. Such records shall be maintained separately from all other records of the prescription drug outlet. 3.00.85 Prescriptions Dispensed but Not Delivered. When a drug has been dispensed pursuant to a prescription or LTCF chart order but has not been delivered to the ultimate consumer, the drug may be returned to stock for subsequent redispensing provided that: a. It is stored in the container in which it was dispensed, and maintains a label that accurately identifies its contents with respect to the original prescription label. (1) A prescription label may be removed if the container is in the manufacturer’s original sealed packaging and the removal of the label does not cause an unreadable expiration date and lot number on the manufacturer’s packaging. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 21 b. A separate written record or a separate record printable upon request is maintained for prescriptions returned to stock. Such record shall indicate only prescriptions returned to stock and shall list at minimum the following: (1) Prescription number; (2) Drug name and strength; (3) Quantity returned to stock; (4) Date of return; and (5) If centrally filled, the location where filled. c. The expiration date of the drug shall not be more than one year from the date it was dispensed. Unless it was dispensed in the manufacturer’s original container and bears the manufacturer’s original label and expiration date; and d. The drug remains under the same ownership from which it was originally dispensed or is dispensed from a pharmacy in which the pharmacy has a contractual affiliation for central fill processing; e. If the drug was delivered to another prescription drug outlet for delivery to the ultimate consumer, the following apply: (1) The lot number and manufacturer’s expiration date must be placed on the label of the drug container by the original dispensing prescription drug outlet; or ed or is dispensed from a pharmacy in which the pharmacy has a contractual affiliation for central fill processing; e. If the drug was delivered to another prescription drug outlet for delivery to the ultimate consumer, the following apply: (1) The lot number and manufacturer’s expiration date must be placed on the label of the drug container by the original dispensing prescription drug outlet; or (2) The original dispensing prescription drug outlet can access and provide the expiration date and lot number upon request. (3) No controlled substance prescriptions may be returned to stock. (4) No compounded or flavored prescriptions may be returned to stock. 3.00.86 Prescriptions dispensed by prescription drug outlets for delivery to consumers in other other outlet settings. When a drug has been dispensed pursuant to prescription order at a prescription drug outlet but has not been delivered to the ultimate consumer at an other outlet, the drug may be returned to stock only at the originating Prescription Drug Outlet, for subsequent redispensing provided that: a. The prescription drug outlet complies with Rules 3.00.90(a), (b), and (c); CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 22 b. The storage conditions during the transport of the prescription to and from the other outlet do not in any way compromise the integrity or stability of the drug; c. No controlled substance prescriptions may be returned to stock; and d. No compounded or flavored prescription may be returned to stock. 3.00.87 A prescription drug that has been dispensed by an automated cassette device may be returned to a pharmacy cassette or any automated dispensing device receptacle for redispensing as long as the integrity of the medication has not been altered, bar code scanning technology is used for returning the drug, qualifications for returning the drug are maintained, and the expiration date of the drug has not passed. A pharmacy technician may carry out the process of prepackaging the drug into an automated cassette sette or any automated dispensing device receptacle for redispensing as long as the integrity of the medication has not been altered, bar code scanning technology is used for returning the drug, qualifications for returning the drug are maintained, and the expiration date of the drug has not passed. A pharmacy technician may carry out the process of prepackaging the drug into an automated cassette. 3.01.00 Packaging. 3.01.10 a. In a prescription drug outlet packaging shall only be done by a pharmacist, or by an intern or pharmacy technician under the supervision of a pharmacist. In an other outlet, packaging may be done by a person not licensed as a pharmacist pursuant to protocols approved by the Board. b. Such packaged drugs shall only be dispensed or distributed from the premises where packaged. Such packaged drugs shall only be distributed as provided in Rule 3.01.10(d). c. Any container used for packaging shall meet compendia requirements. d. The following prescription drug outlets may distribute packaged medications without limitation to prescription drug outlets and other outlets under common ownership: 1. Prescription drug outlets owned and operated by a hospital that is accredited by the joint commission on accreditation of healthcare organizations or a successor organization pursuant to 12-280- 120(15)(b), C.R.S; 2. Prescription drug outlets operated by a health maintenance organization as defined in section 10-16-102, C.R.S.; and 3. The Colorado Department of Corrections. 3.01.20 Each packaged container, whether for use in a unit dose distribution system or a traditional dispensing system, shall be labeled in accordance with this Rule. Any packaged unit dose, single dose or unit of issue container for CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy organization as defined in section 10-16-102, C.R.S.; and 3. The Colorado Department of Corrections. 3.01.20 Each packaged container, whether for use in a unit dose distribution system or a traditional dispensing system, shall be labeled in accordance with this Rule. Any packaged unit dose, single dose or unit of issue container for CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 23 which return for restocking and redispensing, pursuant to Rule 3.00.80, is anticipated, shall be labeled in accordance with this Rule. Additionally, any packaged container from which subsequent dispensing may occur, shall be labeled in accordance with this Rule. Such labeling shall include at least the following: a. If a suitable internal record is maintained in the prescription drug outlet or other outlet, the requirements of (d), (e), (f), (g), and (h) of this Rule may be omitted from the labeling and maintained in such record. An internal lot number shall be assigned and shall appear in the labeling. In a prescription drug outlet the record shall be signed by the pharmacist responsible for each lot packaged. In another outlet the record shall be signed by the person specified in the Board approved protocol. The record shall be retained for two years from the date of packaging unless otherwise required by law or rule. b. Name and strength of the medication, and, in the case of a single dose package, the total number of individual tablets or capsules per dose; c. A suitable expiration date, which shall be not later than the expiration date on the manufacturer’s container, or one year from the date the drug is packaged, whichever is less. Sterile packaged product beyond-use dating shall comply with Rule 3.01.34(h)(3)); d. The identity of the manufacturer or distributor; e. The manufacturer's or distributor's lot number; f. The manufacturer’s or distributor’s expiration date; g. The date the product was packaged; h the expiration date on the manufacturer’s container, or one year from the date the drug is packaged, whichever is less. Sterile packaged product beyond-use dating shall comply with Rule 3.01.34(h)(3)); d. The identity of the manufacturer or distributor; e. The manufacturer's or distributor's lot number; f. The manufacturer’s or distributor’s expiration date; g. The date the product was packaged; h. The identity of the pharmacist responsible for packaging in a prescription drug outlet, or, in the case of an other outlet, the identity of the non- pharmacist permitted to do so pursuant to protocols approved by the Board. i. The name and address of the packaging pharmacy if the drug is distributed by a prescription drug outlet owned and operated by a hospital that is accredited by the Joint Commission of Accreditation of Healthcare Organizations or a successor organization or by a prescription drug outlet operated by a health maintenance organization as defined in section 10- 16-102, C.R.S. Such drugs may only be distributed to prescription drug outlets under common ownership. 3.01.21 If the unit dose package or unit of issue package is obtained from the manufacturer or distributor and complies with applicable federal requirements, CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 24 such package may be dispensed without additional labeling as required in Rule 3.01.20 above. 3.01.22 Filling of automated cassettes. a. If a multi-source drug, the outlet may not use drugs in the same cassette from multiple manufacturers or distributors; b. Automated cassettes, without electronic maintenance or records, shall be labeled with the following: 1. If a suitable internal record is maintained in the prescription drug outlet or other outlet, the requirements of 4, 5, 6, 7, and 8 of this Rule may be omitted from the labeling and maintained in such record. The record shall be retained for two years from the date of packaging, unless otherwise required by law or rule. 2. Name and strength of the medication; 3 all be labeled with the following: 1. If a suitable internal record is maintained in the prescription drug outlet or other outlet, the requirements of 4, 5, 6, 7, and 8 of this Rule may be omitted from the labeling and maintained in such record. The record shall be retained for two years from the date of packaging, unless otherwise required by law or rule. 2. Name and strength of the medication; 3. A suitable expiration date, which shall be not later than the expiration date on the manufacturer’s container, or one year from the date the drug is packaged, whichever is sooner; 4. The identity of the manufacturer or distributor; 5. The manufacturer's or distributor's lot number(s); 6. The manufacturer’s or distributor’s expiration date; 7. The date the product was packaged; 8. The identity of the individual responsible for packaging, or in the case as provided in this Rule 3.01.22(f), the identity of the persons responsible for packaging; 9. All records detailing item 1-8 above, shall be retained at the pharmacy for at least two years. d. In the event that the automation associated with the cassettes deactivates the cassette when the suitable expiration date is reached, and the outlet either prints packaging printouts on a daily basis or is capable of electronically maintaining the packaging information, the cassette need only be labeled with the name and strength of the drug. e. In the event of a product recall, the pharmacist manager shall reasonably ensure that all recalled drug has been removed from the cassette. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy er prints packaging printouts on a daily basis or is capable of electronically maintaining the packaging information, the cassette need only be labeled with the name and strength of the drug. e. In the event of a product recall, the pharmacist manager shall reasonably ensure that all recalled drug has been removed from the cassette. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 25 f. A pharmacy technician or pharmacy intern may replenish automated cassettes without the need for a pharmacist’s verification as long as the pharmacy technician uses bar code technology that checks the accuracy of the medication or a second pharmacy technician performs the verification. 3.01.23 Maintenance of automated cassette records. A prescription drug outlet may utilize a computer (automated data processing system) for storage and retrieval of information regarding packaging in automated cassettes. The following requirements shall be met: a. All information required by Rule 3.01.22 c (1-8) shall be entered into the system at the time of the transaction. b. Every twenty-four hours the system must produce a hard-copy document that, for the purposes of these Rules, shall be known as the “packaging printout”. It shall consist of a single, uniform, complete document. The packaging printout shall list, separately, each packaging transaction for the previous twenty-four hours and shall contain all information required by this Rule. Packaging printouts shall be retained in a chronological manner. If the printouts are bound, the sheets shall be separated into individual pages that 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. 3.01.24 Electronic Maintenance of Packaging Records e retained in a chronological manner. If the printouts are bound, the sheets shall be separated into individual pages that 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. 3.01.24 Electronic Maintenance of Packaging Records. A prescription drug outlet which utilizes a computer (automated data processing system) for storage and retrieval of information regarding packaging transactions need not print the packaging printout required by Rule 3.01.23 if the prescription drug outlet and the computer system utilized are capable of complying with the following requirements: a. The prescription drug outlet must be able to provide on-line retrieval of all information required by this Rule for all packaging transactions during the two years preceding the request. b. The prescription drug 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 prescription drug outlet must: (1) Have and maintain a complete on-line transaction file that is printable on the inspector’s request, CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 26 Or (2) Have a “lock-out” feature that prevents editing of packaging information. d. The Board or its inspectors must be able to inspect and review the packaging transactions of the prescription drug outlet. Therefore, immediately upon the oral or written request of the Board or its inspectors, the prescription drug outlet shall either: F COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 26 Or (2) Have a “lock-out” feature that prevents editing of packaging information. d. The Board or its inspectors must be able to inspect and review the packaging transactions of the prescription drug outlet. Therefore, immediately upon the oral or written request of the Board or its inspectors, the prescription drug outlet shall either: (1) Print a report of all packaging 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 within seventy-two hours, the system must be capable of retrieving and printing the information sorted according to the variables which include, but are not limited to, date packaged; drug name, strength and dosage form; lot number, manufacturer/distributor; or expiration date. (2) Provide a computer terminal and monitor for the sole use of the Board or its inspector(s) to inspect and review packaging 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 prescription drug 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 prescription drug outlet manager to ensure that all prescription drug outlet staff are aware of the requirements of subparagraphs (1) and (2). Any failure or refusal by the prescription drug outlet manager and/or a staff pharmacist 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 prescription drug outlet elects to comply with Rule 3.01.24(d), the system and any reports printed on request shall contain, as a minimum, the following information for each transaction: 1. Name and strength of the medication; 2 outlet manager and/or a staff pharmacist 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 prescription drug outlet elects to comply with Rule 3.01.24(d), the system and any reports printed on request shall contain, as a minimum, the following information for each transaction: 1. Name and strength of the medication; 2. A suitable expiration date, which shall be not later than the expiration date on the manufacturer’s container, or one year from the date the drug is packaged, whichever is sooner; 3. The identity of the manufacturer or distributor; 4. The manufacturer's or distributor's lot number(s); CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 27 5. The manufacturer’s or distributor’s expiration date; 6. The date the product was packaged; 7. The identity of the pharmacist responsible for packaging in a prescription drug outlet, or, in the case of an other outlet, the identity of the non-pharmacist permitted to do so pursuant to protocols approved by the Board; 3.01.25 Maintenance and cleaning of automated cassettes a. The outlet must maintain, on-site and available for inspection, the manufacturer’s guidelines for maintenance and cleaning of the cassettes. b. The maintenance and cleaning schedule recommended by the manufacturer shall be adhered to and records of performed maintenance shall be available for inspection for a period of at least two years. c. If the outlet changes the drug used in a cassette, the cassette must be thoroughly cleaned per manufacturer’s recommendations prior to using the cassette for a different drug. 3.01.26 Responsibility for unit-dose medications packaged with automated cassettes is the responsibility of the pharmacist responsible for loading the cassette. 3.01.27 The pharmacist responsible for the final evaluation of any prescriptions dispensed using drugs packaged in automated cassettes shall be held accountable for the accuracy of the product or to using the cassette for a different drug. 3.01.26 Responsibility for unit-dose medications packaged with automated cassettes is the responsibility of the pharmacist responsible for loading the cassette. 3.01.27 The pharmacist responsible for the final evaluation of any prescriptions dispensed using drugs packaged in automated cassettes shall be held accountable for the accuracy of the product. 3.03.00 Customized Patient Medication Packages (Med Paks). 3.03.10 When a unit dose, single dose, unit of issue or customized patient medication package is dispensed pursuant to an order, the prescription shall comply with all requirements of section 12-280-124(2), C.R.S. Container requirements of a prescription for the purpose of unit dose systems may be broadened to include trays, bins, carts and locked cabinets or drawers. Additionally, a customized patient medication package shall comply with all the following requirements: a. Labeling The patient med pak shall bear a label stating (1) The name of the patient; (2) A serial number for each of the orders detailing the drug products contained therein; CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 28 (3) The name, strength, and total quantity of each drug product contained therein; (4) The directions for use and cautionary statements, if any, contained in the prescription order for each drug product therein; (5) Any storage instructions or cautionary statements; (6) The name of the prescriber of each drug product therein; (7) The date of preparation of the patient med pak, the expiration date shall not exceed 90 days from the date of preparation; and (8) The name, address, and telephone number of the dispenser. b. Record Keeping. (1) Patient name and address; (2) The serial number of the order for each drug in product contained therein; (3) Descriptive information sufficient to allow subsequent preparation of an identical patient med pak; (4) Date of preparation of the patient med pak and the expiration date assigned; date of preparation; and (8) The name, address, and telephone number of the dispenser. b. Record Keeping. (1) Patient name and address; (2) The serial number of the order for each drug in product contained therein; (3) Descriptive information sufficient to allow subsequent preparation of an identical patient med pak; (4) Date of preparation of the patient med pak and the expiration date assigned; (5) Any special labeling instructions; and (6) The identity of the pharmacist who prepared the patient med pak. c. Packaging (1) Each container shall meet or exceed United States Pharmacopoeia standards. (2) Each container shall be either not reclosable or so designed as to show evidence of having been opened. 3.03.20 It shall not be considered redispensing for a prescription drug outlet to modify a customized medication package which it has previously dispensed if the following criteria are met: a. The med pak is modified for the same patient for which it was originally dispensed. b. The med pak is returned to the prescription drug outlet from which it was originally dispensed. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 29 c. Only discontinued medication may be removed from the med pak. Additional medications may not be added. d. The medications removed from the med pak are destroyed. They may not be redispensed. e. The med pak is assigned a new serial number. f. The labeling of the med pak is modified to comply with Rule 3.03.10(a). The expiration date affixed to the label prior to modification must be retained. g. Records are maintained for the modified med pak which comply with Rule 3.03.10(b). 3.04.00 Colorado Cancer Drug Repository Program. [Repealed] 3.05.00 Pharmacist Prescribing and Dispensing Over-the-Counter Medications 3.05.10 Pharmacists, pursuant to 12-280-103(34), C.R.S., may prescribe and dispense certain over-the-counter medications (“OTC Medications”) to recipients under the Colorado Medical Assistance Act intained for the modified med pak which comply with Rule 3.03.10(b). 3.04.00 Colorado Cancer Drug Repository Program. [Repealed] 3.05.00 Pharmacist Prescribing and Dispensing Over-the-Counter Medications 3.05.10 Pharmacists, pursuant to 12-280-103(34), C.R.S., may prescribe and dispense certain over-the-counter medications (“OTC Medications”) to recipients under the Colorado Medical Assistance Act. 3.05.20 The formulary of the eligible OTC medications is determined by the Colorado Department of Health Care Policy and Financing or its successor agency. Pharmacists may only prescribe and dispense these eligible medications pursuant to the policies established by the Colorado Department of Health Care Policy and Financing or its successor agency. 3.05.30 When prescribing such OTC medications, the pharmacist shall issue a prescription order as defined in 12-280-103(31)(a), C.R.S. The prescribing pharmacist’s name shall be used on the prescription order as the name of the practitioner. 3.05.40 When issuing the prescription order, the pharmacist shall consult with the recipient to determine necessity and suitability of the medication for the recipient. Written documentation of the necessity and suitability of the medication shall be maintained with the prescription order. 3.05.50 Pharmacist prescribed OTC prescriptions shall require a written prescription order. 3.05.60 Written prescription orders are not eligible for prescription transfer and cannot be refilled. 3.05.70 The pharmacist shall review the recipient’s drug therapy history for potential drug interactions. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy ined with the prescription order. 3.05.50 Pharmacist prescribed OTC prescriptions shall require a written prescription order. 3.05.60 Written prescription orders are not eligible for prescription transfer and cannot be refilled. 3.05.70 The pharmacist shall review the recipient’s drug therapy history for potential drug interactions. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 30 3.05.80 When dispensing the medication, the pharmacist shall label the product with all labeling requirements of 12-280-124, C.R.S. The prescribing pharmacist’s name shall be used on the label as the name of the practitioner. 3.05.90 Upon delivery of the medication to the recipient, the pharmacist shall provide consultation with the recipient or his or her caregiver as required by the Colorado Department of Health Care Policy and Financing. The Colorado Department of Health Care Policy and Financing sets forth the requirements in 10 CCR 2505-10, 8.800 of June 30, 2018. This incorporation does not include later revisions of the rule. Copies of the rule are available for public inspection during regular business hours at 1570 Grant Street, Denver, Colorado, 80203. The rules are readily available in written or electronic form at http://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=7643&fileNa me=10%20CCR%202505-10%208.800. The rules are available for a reasonable fee from the Department of Regulatory Agencies, Division of Professions and Occupations. 3.05.95 The prescription order issued, documentation of medication necessity and suitability, and records of dispensing shall be maintained at the prescription drug outlet as required by Rule 11.00.00. 4.00.00 LICENSING. 4.00.10 Definitions a. “Academic examination” is the North American Pharmacist Licensure Examination. b. “Board-approved foreign pharmacy graduate certification” means the Foreign Pharmacy Graduate Equivalency Certification. c. “Board-approved jurisprudence examination” means the Colorado-specific Multistate Pharmacy Jurisprudence Examination outlet as required by Rule 11.00.00. 4.00.00 LICENSING. 4.00.10 Definitions a. “Academic examination” is the North American Pharmacist Licensure Examination. b. “Board-approved foreign pharmacy graduate certification” means the Foreign Pharmacy Graduate Equivalency Certification. c. “Board-approved jurisprudence examination” means the Colorado-specific Multistate Pharmacy Jurisprudence Examination. d. “Board-approved school or college of pharmacy” is a professional degree program of a school or college of pharmacy that has an accredited or preaccredited status from the Accreditation Council for Pharmacy Education (“ACPE”). e. “Board-designated clearinghouse for license transfer” means the National Association of Boards of Pharmacy Clearinghouse operated by the National Association of Boards of Pharmacy. f. “Disenrollment” means the current status of a pharmacy student who no longer possesses the right or capacity to complete the curriculum in the allotted time as set forth in the policies of the corresponding Board- approved school or college of pharmacy. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 31 g. “Enrollment” means the current status of a pharmacy student who possesses the right or capacity to complete the curriculum in the allotted time as set forth in the policies of the corresponding Board-approved school or college of pharmacy. h. “Intern” means a person who is: (1) Enrolled in a professional degree program of a Board-approved school or college of pharmacy, licensed by the Board to engage in the practice of pharmacy, and satisfactorily progressing toward meeting the requirements for licensure as a pharmacist; (2) A graduate of a Board-approved school or college of pharmacy or a graduate who has established education equivalency by obtaining a Board-approved foreign pharmacy graduate certification and who is currently licensed by the Board for the purpose of obtaining practical experience as a requirement for licensure as a pharmacist; or ng toward meeting the requirements for licensure as a pharmacist; (2) A graduate of a Board-approved school or college of pharmacy or a graduate who has established education equivalency by obtaining a Board-approved foreign pharmacy graduate certification and who is currently licensed by the Board for the purpose of obtaining practical experience as a requirement for licensure as a pharmacist; or (3) A qualified pharmacist applicant awaiting examination for licensure as a pharmacist or meeting Board requirements for pharmacist licensure. i. “License transfer or endorsement” is the licensing of an individual who is licensed as a pharmacist by examination in another state and whose license in that state is in good standing. j. For the purposes of this Rule 4.00.00, “manufacturer” means a manufacturer of prescription drugs which is registered by the Board. k. “Pharmacist” means an individual licensed by this state to engage in the practice of pharmacy. l. “Regulated individual” means any of the following individuals holding an active, unrestricted license, registration, or certification from the Colorado Department of Regulatory Agencies: (1) Clinical Social Worker; (2) Dentist; (3) Occupational Therapist; (4) Optometrist; (5) Physical Therapist; (6) Physician; CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 32 (7) Physician Assistant; (8) Podiatrist; (9) Psychologist; (10) Registered Nurse or Advanced Practice Nurse; (11) Respiratory Therapist; and rtification from the Colorado Department of Regulatory Agencies: (1) Clinical Social Worker; (2) Dentist; (3) Occupational Therapist; (4) Optometrist; (5) Physical Therapist; (6) Physician; CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 32 (7) Physician Assistant; (8) Podiatrist; (9) Psychologist; (10) Registered Nurse or Advanced Practice Nurse; (11) Respiratory Therapist; and (12) Veterinarian. m. “Score transfer” is the transfer of the academic examination score to Colorado by participation in the NAPLEX Score Transfer Program operated by the National Association of Boards of Pharmacy. 4.00.20 Requirements for Intern Licensure include the following; a) Submission of a completed application form provided by the Division of Professions and Occupations with the appropriate fee. b) Submission of one of the following: CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 33 1) Proof of enrollment in a Board-approved school or college of pharmacy. A person on suspension from a Board-approved school or college of pharmacy may not be licensed as an intern. A person in good standing with a Board-approved school or college of pharmacy may be licensed as an intern. 2) If a graduate of a foreign school or college of pharmacy, a Foreign Pharmacy Graduate Equivalency Certification; 3) Proof of graduation within the prior two years from a Board- approved school or college of pharmacy. If the applicant ceased to be enrolled in a Board-approved school or college of pharmacy more than two years prior to application, the applicant shall include an explanation of “good cause” for licensure which the Board or its designee shall review and act on in the normal course of business. 4) If a pharmacist in another state awaiting pharmacist licensure in Colorado, verification of an active, unrestricted license in another state. 4.00.25 Requirement for Intern Reporting pharmacy more than two years prior to application, the applicant shall include an explanation of “good cause” for licensure which the Board or its designee shall review and act on in the normal course of business. 4) If a pharmacist in another state awaiting pharmacist licensure in Colorado, verification of an active, unrestricted license in another state. 4.00.25 Requirement for Intern Reporting. An actively licensed intern shall report to the Board, in writing, within thirty days of meeting the definition of “Disenrollment” as defined in Rule 4.00.10(f) from a Board-approved school or college of pharmacy. 4.00.30 Requirements for Pharmacist License by Exam or Score Transfer include the following: a. Submission of a completed application form provided by the Division of Professions and Occupation with the appropriate fee. b. Submission of a transcript and proof of graduation from a Board-approved school or college of pharmacy or a Foreign Pharmacy Graduate Equivalency Certification. c. Successful passage of the academic examination and Board-approved jurisprudence examination. The passing scores for these examinations are set by the examining entity. If an applicant passes only one of the required examinations, the applicant shall be required to repeat the failed examination. If, within the previous twenty-four months, the applicant has not passed both required examinations, he or she shall be required to also repeat the previously passed examination. Score transfer applicants shall complete licensure within one year from the date their scores are received by the Division of Professions and Occupations. d. Proof of completion of 1500 intern hours completed no more than five years after graduation from a Board-approved school or college of CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy repeat the previously passed examination. Score transfer applicants shall complete licensure within one year from the date their scores are received by the Division of Professions and Occupations. d. Proof of completion of 1500 intern hours completed no more than five years after graduation from a Board-approved school or college of CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 34 pharmacy. If a graduate of an unapproved school or college of pharmacy, receipt of the Foreign Pharmacy Graduate Equivalency Certification. Intern hours must be obtained under one or more of the following conditions: (1) Engaged in the practice of pharmacy under the direct supervision of a pharmacist. (2) Directly supervised by a manufacturer as part of the curriculum of an approved school or college of pharmacy. (3) Directly supervised by a regulated individual as part of the curriculum of an approved school or college of pharmacy. The scope of practice of the regulated individual must overlap with that of a pharmacist for the course of the hours supervised. (4) One year of practice of pharmacy as a licensed pharmacist in another state may be accepted by the Board in lieu of the 1500 hours if the applicant has completed this year of pharmacy practice prior to taking the examination. e. Education, training, or service gained in military services or licensure, certification, registration, or enrolled in good standing through the federal government as outlined in section 12-20-202, C.R.S., to be accepted and applied towards receiving a license, must be substantially equivalent, as determined by the Board, to the qualifications otherwise applicable at the time of receipt of application. It is the applicant’s responsibility to provide timely and complete evidence for review and consideration. Satisfactory evidence of such education, training, or service will be assessed on a case by case basis. 4.00.40 Requirements for License Transfer or Endorsement are as follows: a ent, as determined by the Board, to the qualifications otherwise applicable at the time of receipt of application. It is the applicant’s responsibility to provide timely and complete evidence for review and consideration. Satisfactory evidence of such education, training, or service will be assessed on a case by case basis. 4.00.40 Requirements for License Transfer or Endorsement are as follows: a. Submission of a completed application and fee to the Board designated clearinghouse for license transfer. b. Submission of a completed application form provided by the Division of Professions and Occupations with the appropriate fee. c. Successful passage of the Board-approved jurisprudence examination. The passing score is set by the examining entity. d. Applicants for license transfer must have been licensed as a pharmacist for at least one year in another state or have served an Internship meeting the Colorado requirements at the time of original licensure. e. A person duly licensed, certified, registered, or enrolled through the federal government under the conditions set forth in section 12-20-202, CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 35 C.R.S., to practice pharmacy or who possesses the education, training, or service gained in military services pursuant to section 12-20-202, C.R.S., is upon application to the Board, eligible for licensure. f. An applicant for license transfer shall apply for license transfer using a license issued by examination in another state. Such license shall be active, current, and in good standing. If the applicant holds pharmacist licenses in multiple states, all licenses must be in good standing. For the purposes of these Rules, “good standing” means that the applicant is not currently subject to active disciplinary actions in any state. 4.03.00 Reinstatement or Reactivation of Pharmacist License. a. If the license has been inactive or expired for over twenty-four months, a person wishing to reinstate or reactivate such license shall do the following: all licenses must be in good standing. For the purposes of these Rules, “good standing” means that the applicant is not currently subject to active disciplinary actions in any state. 4.03.00 Reinstatement or Reactivation of Pharmacist License. a. If the license has been inactive or expired for over twenty-four months, a person wishing to reinstate or reactivate such license shall do the following: (1) Submit the appropriate application with the required fee; (2) Submit one hour of continuing education for each month such license was inactive or expired. Twenty-four of these hours shall have been completed in the twenty-four months prior to application for reinstatement or reactivation; and (3) Take and pass the approved jurisprudence examination. The passing score shall be set by the examining entity. b. If the license has been expired or inactive for less than twenty-four months, a person wishing to reinstate or reactivate such license shall do the following: (1) Submit the appropriate application with the required fee; and (2) Submit twenty-four hours of continuing education completed within the twenty-four months prior to application. 4.05.00 License Changes. a. Name change. A licensee shall report a name change and provide appropriate supporting documentation within thirty days of such change. If the licensee wishes to obtain a new wall license with the new name, the licensee shall pay the requisite fee. b. Change of residential and electronic mail address. All pharmacists and interns shall notify the Board in writing within thirty days of any change of residential or electronic mail address. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy n thirty days of such change. If the licensee wishes to obtain a new wall license with the new name, the licensee shall pay the requisite fee. b. Change of residential and electronic mail address. All pharmacists and interns shall notify the Board in writing within thirty days of any change of residential or electronic mail address. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 36 c. Change of manager. A pharmacist shall immediately notify the Board in writing of the date he ceases to be the pharmacist manager of a prescription drug outlet. 4.06.00 Identification of Licensee. A pharmacist, pharmacy intern, pharmacy technician, pharmacy clerk, store manager, or assistant store manager shall at all times while on duty within a prescription drug outlet wear a badge which is visible to the patient and which shall state at least the title accurately reflecting a person’s role in the outlet such as Pharmacist, Pharmacy Intern, Pharmacy Technician, Pharmacy Clerk, Store Manager, or Assistant Store Manager. 5.00.00 OUTLETS. 5.00.01 Definitions. The following words and terms shall have the following meanings, unless the context clearly indicates otherwise. a. Compounding / Dispensing Area: means any area in a prescription drug outlet where “compounding / dispensing” is performed. b. In-State Prescription Drug Outlet: means any prescription drug outlet located within Colorado that is registered pursuant to Title 12, Article 280, C.R.S., where prescriptions are compounded and dispensed. c. Non-Resident 503 Outsourcing Facility: means a facility that is registered by the Federal Food and Drug Administration, that is located outside the state, and that distributes compounded drugs into the state without a prescription order. d. Non-Resident Prescription Drug Outlet: means any pharmacy outlet located outside this state that is registered pursuant to Title 12, Article 280, C.R.S., which ships, mails, or delivers, in any manner, drugs or devices into this state pursuant to a prescription order. e tration, that is located outside the state, and that distributes compounded drugs into the state without a prescription order. d. Non-Resident Prescription Drug Outlet: means any pharmacy outlet located outside this state that is registered pursuant to Title 12, Article 280, C.R.S., which ships, mails, or delivers, in any manner, drugs or devices into this state pursuant to a prescription order. e. Risk-Base Assessment: means, pursuant to section 12-280-108(1)(a)(II), C.R.S., to inspect a non-resident prescription drug outlet, a non-resident 503B outsourcing facility, or an out-of-state prescription drug wholesaler when the Board determines, based on a complaint, that there may be an imminent threat to the health, safety and welfare of Colorado consumers and that such an inspection is imperatively necessary to preserve health, safety and welfare of Colorado consumers. f. Third-Party Logistics Provider: means a person that contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of a manufacturer but does not take title to a prescription drug or have general responsibility to direct the prescription drug’s sale or distribution. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 37 g. “Automated Pharmacy Dispensing System” or “System” means a mechanical system that dispenses prescription drugs to a person interacting with a remote pharmacist and maintains related transaction information. (1) An “Automated Pharmacy Dispensing System” may only be operated under a Pharmacy Drug Outlet license type. tribution. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 37 g. “Automated Pharmacy Dispensing System” or “System” means a mechanical system that dispenses prescription drugs to a person interacting with a remote pharmacist and maintains related transaction information. (1) An “Automated Pharmacy Dispensing System” may only be operated under a Pharmacy Drug Outlet license type. (2) Automated pharmacy dispensing systems may be stocked or loaded by a pharmacist, or a pharmacy technician (provisional and non-provisional) or intern under the supervision of a pharmacist. 5.00.10 Registration. The applicant for registration shall obtain the appropriate form as approved by the Board to register an outlet. In the case of an application for a new in-state or non-resident prescription drug outlet or non-resident 503B outsourcing facility or third-party logistics provider, for a transfer of ownership of an in-state or non-resident prescription drug outlet or non-resident 503B outsourcing facility or third-party logistics provider, or for the relocation of an in- state or non-resident prescription drug outlet or non-resident 503B outsourcing facility or third-party logistics provider, the applicant shall submit such additional documentation as the Board may require. 5.00.15 Registration for nonresident prescription drug outlets. An applicant for a new nonresident prescription drug outlet registration shall submit the following: a. The current application with required fee; b. A verification of the current pharmacy license or registration issued by the applicant’s resident state board of pharmacy; c. A copy of the most recent report detailing an inspection of the nonresident prescription drug outlet by either its resident state board of pharmacy or the National Association of Boards of Pharmacy’s Verified Pharmacy Program dated within the previous two years of submission of the application; and d nt pharmacy license or registration issued by the applicant’s resident state board of pharmacy; c. A copy of the most recent report detailing an inspection of the nonresident prescription drug outlet by either its resident state board of pharmacy or the National Association of Boards of Pharmacy’s Verified Pharmacy Program dated within the previous two years of submission of the application; and d. An affidavit attesting that the nonresident prescription drug outlet shall not ship compounded or other prescription drugs into the State of Colorado without a prescription order for a specific patient, except as provided pursuant to Rule 21.00.20. 5.00.17 Non-Resident 503B Outsourcing Facility. A nonresident 503B outsourcing facility shall submit the following to the Board with the application: a. Proof that the facility is actively registered with the Federal Food and Drug Administration as a 503B outsourcing facility and is actively licensed, permitted, or registered in the state in which it is a resident; CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 38 b. The location, names, and titles of all principle entity officers and the name of the pharmacist in charge of the operations of the facility; c. Verification that the facility complies with all lawful directions and requests for information from the Federal Food and Drug Administration and from the regulatory or licensing agency of the state in which it is licensed, permitted, or registered, as well as all requests for information made by the Board pursuant to this section; and d. A copy of the most recent inspection report resulting from an inspection by the Federal Food and Drug Administration. 5.00.19 Third-Party Logistics Provider. A third-party logistics provider shall submit the following to the Board with the application: a. Proof, if available, that the facility is actively registered with the Federal Food and Drug Administration as third-party logistics provider; b A copy of the most recent inspection report resulting from an inspection by the Federal Food and Drug Administration. 5.00.19 Third-Party Logistics Provider. A third-party logistics provider shall submit the following to the Board with the application: a. Proof, if available, that the facility is actively registered with the Federal Food and Drug Administration as third-party logistics provider; b. The location, names, and titles of all principle entity officers; and c. Verification that the facility complies with all lawful directions and requests for information from the Federal Food and Drug Administration as well as all requests for information made by the Board pursuant to this section. 5.00.20 Applications. The Board, or its agent, may require any applicant or pharmacist manager of an outlet to meet with the Board, or its agent, before the Board takes action on any registration. 5.00.21 Automated Pharmacy Dispensing System. Requirements for Registration. Eligibility requirements for an Automated Pharmacy Dispensing System application include the following: a. Automated Pharmacy Dispensing Systems do not include those that do not involve direct patient interaction and are for internal operations use only. b. A current Board issued registration of the managing prescription drug outlet that engages in the compounding, dispensing, and delivery of drugs, or provision of pharmaceutical care to patients receiving prescriptions from the Automated Pharmacy Dispensing System; c. The submission of a separate application by the managing prescription drug outlet on behalf of the Automated Pharmacy Dispensing System for an Automated Pharmacy Dispensing System registration, on a form provided by the Division of Professions and Occupations. The managing prescription drug outlet shall submit an application for each individual Automated Pharmacy Dispensing System to which the managing prescription drug outlet will provide stock drugs; CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy ensing System for an Automated Pharmacy Dispensing System registration, on a form provided by the Division of Professions and Occupations. The managing prescription drug outlet shall submit an application for each individual Automated Pharmacy Dispensing System to which the managing prescription drug outlet will provide stock drugs; CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 39 d. A Drug Enforcement Administration registration specifically assigned to the Automated Pharmacy Dispensing System if the managing prescription drug outlet provides stock controlled substances to the Automated Pharmacy Dispensing System; e. A pharmacist manager who, in addition to being responsible for the operations of the managing prescription drug outlet in compliance with all state and federal laws and rules, is responsible for the operations of the Automated Pharmacy Dispensing System; and f. A secure Automated Pharmacy Dispensing System that prevents the diversion of drugs and that limits the access to drugs within the Automated Pharmacy Dispensing System only to those persons whom have been given permission to access the Automated Pharmacy Dispensing System; g. The necessary fee; h. The APDS shall be located in the state of Colorado and a pharmacist providing any clinical services, including initial and final interpretation, must be licensed in the state of Colorado. i. Automated pharmacy dispensing systems may be stocked or loaded by a pharmacist or a pharmacy technician (provisional and non-provisional) or intern under the supervision of a pharmacist. 5.00.30 No two registered in-state or non-resident prescription drug outlets may occupy the same physical space. If there are two (or more) registrants co-located within the same building or at the same address, each must have its own area, separated by floor to ceiling walls, and separate entrances. 5.00.40 Transfer of Ownership nd non-provisional) or intern under the supervision of a pharmacist. 5.00.30 No two registered in-state or non-resident prescription drug outlets may occupy the same physical space. If there are two (or more) registrants co-located within the same building or at the same address, each must have its own area, separated by floor to ceiling walls, and separate entrances. 5.00.40 Transfer of Ownership. Application to transfer registration of an in-state or non-resident prescription drug outlet or a non-resident 503B outsourcing facility or third-party logistics provider shall be submitted to the Board within thirty (30) days of the transfer of ownership. A transfer of ownership shall be deemed to have occurred: a. In the event the in-state or non-resident prescription drug outlet or a non- resident 503B outsourcing facility or third-party logistics provider 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. b. In the event the in-state or non-resident prescription drug outlet or a non- resident 503B outsourcing facility or third-party logistics provider is owned by a partnership, upon sale or transfer of twenty percent or more of any ownership interest. c. In the event the in-state or non-resident prescription drug outlet or a non- resident 503B outsourcing facility or third-party logistics provider is owned CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy non- resident 503B outsourcing facility or third-party logistics provider is owned by a partnership, upon sale or transfer of twenty percent or more of any ownership interest. c. In the event the in-state or non-resident prescription drug outlet or a non- resident 503B outsourcing facility or third-party logistics provider is owned CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 40 by a limited liability company (LLC), upon sale or transfer of twenty percent or more of the membership interests. d. Upon incorporation of an existing in-state or non-resident prescription drug outlet or non-resident 503B outsourcing facility or third-party logistics provider. 5.00.50 Relocation. a. In the event of a relocation of an in-state or non-resident prescription drug outlet or non-resident 503B outsourcing facility or third-party logistics provider, the outlet shall submit an application provided by the board along with the prescribed fee no more than thirty (30) days prior to the effective date of relocation. b. The registration of a non-resident prescription drug outlet or non-resident 503B outsourcing facility or third-party logistics provider shall become void and shall be cancelled if the non-resident prescription drug outlet or non- resident 503B outsourcing facility or third-party logistics provider relocates to a state other than that which appears on its registration. In the event the non-resident prescription drug outlet or non-resident 503B outsourcing facility or third-party logistics provider wishes to continue conducting business in Colorado, it must apply for and receive a new Colorado registration prior to conducting business in Colorado. 5.00.55 Reinstatement of an In-State or Non-Resident Prescription Drug Outlet Registration. a. In-state Prescription Drug Outlet. If a registration has expired, a facility seeking to reinstate such registration shall submit the following: (1) The current reinstatement application with the required fee; must apply for and receive a new Colorado registration prior to conducting business in Colorado. 5.00.55 Reinstatement of an In-State or Non-Resident Prescription Drug Outlet Registration. a. In-state Prescription Drug Outlet. If a registration has expired, a facility seeking to reinstate such registration shall submit the following: (1) The current reinstatement application with the required fee; (2) If the owner of the in-state prescription drug outlet is a corporation, submit either a copy of the articles of incorporation as they were filed with the Colorado Secretary of State or a Certificate of Good Standing issued by the Colorado Secretary of State; (3) A letter stating whether the corporation is public or private as follows: (A) If the corporation is a public corporation, submit a list of all stockholders owning five percent or more of the stock; or (B) If the corporation is a private corporation, submit a list of all stockholders; CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 41 (4) An accurate drawn-to-scale floor plan of the prescription drug outlet’s compounding / dispensing area detailing all counters, bays, sinks, refrigerators and, if applicable, sterile and non-sterile compounding hoods; and (5) A completed, dated and signed minimum equipment self-inspection form as provided with the reinstatement application. b. Non-resident Prescription Drug Outlet or non-resident 503B outsourcing facility or third-party logistics provider. If a registration has expired, a facility seeking to reinstate such registration shall submit the following: (1) The current reinstatement application with the required fee; (2) A verification of the current pharmacy license, registration, or permit issued by the resident state board of pharmacy for the non-resident pharmacy or 503B outsourcing facility, and a verification of the current license or registration issued by the Federal Food and Drug Administration for a non-resident 503B outsourcing facility or third- party logistics provider; tion with the required fee; (2) A verification of the current pharmacy license, registration, or permit issued by the resident state board of pharmacy for the non-resident pharmacy or 503B outsourcing facility, and a verification of the current license or registration issued by the Federal Food and Drug Administration for a non-resident 503B outsourcing facility or third- party logistics provider; (3) If the registration has expired for a non-resident pharmacy for more than two years, a copy of the most recent report detailing an inspection of the non-resident prescription drug outlet by its resident state board of pharmacy dated within five years of submission of the reinstatement application. 5.00.60 Closure. a. Closure shall mean the permanent cessation of the practice of pharmacy in any in state or non-resident prescription drug outlet or the permanent cessation of conducting business in Colorado for a non-resident 503B outsourcing facility or third-party logistics provider. For in-state prescription drug outlets, closure shall also be deemed to have occurred if the compounding/dispensing area is not open for business the minimum hours specified in Rule 5.01.40(a). b. Upon the closure of any in-state or non-resident prescription drug outlet, it shall be the responsibility of the last pharmacist manager of record to remove the prescriptions and/or chart orders to another prescription drug outlet where patrons and/or practitioners are afforded reasonable access to a pharmacist’s interpretation of such orders. Such relocation of records shall be made within seventy-two hours after closure. The pharmacist manager shall submit a notice, on a form and manner approved by the Board, detailing the closure of the prescription drug outlet or nonresident prescription drug outlet within seventy-two hours after closure. If the last pharmacist manager of record fails to relocate the records as required herein, the Board may direct the removal of the records to a suitable wo hours after closure. The pharmacist manager shall submit a notice, on a form and manner approved by the Board, detailing the closure of the prescription drug outlet or nonresident prescription drug outlet within seventy-two hours after closure. If the last pharmacist manager of record fails to relocate the records as required herein, the Board may direct the removal of the records to a suitable CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 42 location. The last pharmacist manager of record shall make a reasonable effort to inform patrons of the prescription drug outlet of the location of the records. A non-resident 503B outsourcing facility or third-party logistics provider shall inform the Board, in writing, within seventy-two hours after closure. c. The Board on request shall provide the owner of any prescription drug outlet an instruction sheet applicable to the transaction prior to closure, or conducting bankruptcy proceedings, or transferring or selling the prescription drug inventory. d. The preceding subsections under 5.00.60 shall not apply if a public health order is in effect and consequently and temporarily impacts operating hours. 5.00.70 Change in Pharmacist manager. a. An in-state and non-resident prescription drug outlet shall be under the direct charge of a pharmacist manager. A proprietor who is not a pharmacist shall comply with this requirement and shall provide a manager who is a pharmacist. b. The registration of any in-state and non-resident prescription drug outlet shall become void if the pharmacist manager in whose name the registration was issued ceases to be engaged as the manager, and the owner shall close the outlet unless such owner has employed a pharmacist manager and, within thirty days after termination of the former manager’s employ23ment, has made application to transfer the registration to the new pharmacist manager and has paid the transfer fee therefor. 5.00.80 Disclosure acist manager in whose name the registration was issued ceases to be engaged as the manager, and the owner shall close the outlet unless such owner has employed a pharmacist manager and, within thirty days after termination of the former manager’s employ23ment, has made application to transfer the registration to the new pharmacist manager and has paid the transfer fee therefor. 5.00.80 Disclosure. Any Board registered non-resident prescription drug outlet shall disclose to the Board, in writing, the location, names, and titles of all principal entity officers and all pharmacists who are dispensing drugs to residents of this state on an annual basis and within thirty days after any change of office, officer or pharmacist. 5.01.00 Prescription Drug Outlets (In-State). 5.01.10 Controlled Substance Inventory. a. Upon the change of pharmacist manager of a prescription drug outlet, an inventory of all controlled substances shall be taken within seventy-two hours, by the new pharmacist manager or the new pharmacist manager’s designee. The inventory shall be taken either as of the opening or as of the close of business activity on the inventory date and such time and date taken shall be entered on the inventory record. CODE OF COLORADO REGULATIONS 3 CCR 719-1 State Board of Pharmacy 43 b. Upon the transfer of ownership of a prescription drug outlet, an inventory of all controlled substances shall be taken by the pharmacist manager or the pharmacist manager’s designee. The inventory shall be taken either as of the opening or as of the close of business activity on the inventory date and such time and date taken shall be entered on the inventory record State Board of Pharmacy 43 b. Upon the transfer of ownership of a prescription drug outlet, an inventory of all controlled substances shall be taken by the pharmacist manager or the pharmacist manager’s designee. The inventory shall be taken either as of the opening or as of the close of business activity on the inventory date and such time and date taken shall be entered on the inventory record. 5.01.20 Compounding/Dispensing Area (In-State) 5.01.21 In the event a transfer of ownership of a prescription drug outlet occurs, and the principal compounding/dispensing area or any satellite compounding/dispensing area does not meet the physical requirements of this Rule, the transfer of the registration may be approved, provided that comp [Text truncated at 120,000 characters. The full text is on the page linked above.] ## Nearby sections - [3 CCR 719-1 STATE BOARD OF PHARMACY RULES AND REGULATIONS](https://www.frixlaw.com/law-library/statutes/STATE_CO_CCR_3_CCR_719_1.md) --- Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/STATE_CO_CCR_3_CCR_719_1. Check the current official text before relying on it. Not legal advice.