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5.01.31 Within every prescription drug outlet as defined in section 12-280-103(43), C.R.S., there shall be one area designated as the principal compounding/dispensing area. In addition to the principal compounding/dispensing area there may be satellite compounding/dispensing areas and drug storage areas ( "satellites" ) which are located at the same location as the principal compounding/dispensing area. The principal compounding/dispensing area and any satellite shall comply with the following conditions:
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j. If refrigerated drugs are stored in the principal compounding/dispensing area or in any satellite, there shall be a refrigerator, dedicated to storing only drugs, meeting the compendia requirements and with an accurate thermometer in the refrigerator. The temperature of which shall be maintained between two and eight degrees Celsius (2 and 8 degrees C.) or thirty-six and forty-six degrees Fahrenheit (36 and 46 degrees F.) or in accordance with the corresponding drug manufacturer's directions. The temperature shall be electronically monitored each calendar day. Records detailing instances in which temperatures fall outside the aforementioned range requirement, for any period of time, shall be maintained at the prescription drug outlet and shall be made readily available for inspection upon request by the Board or its representatives for a period of at least two years preceding the request. Such records shall include the duration of time the temperature fell outside the aforementioned range requirement, based on the best available data, and measures taken by the outlet as a result of the temperature falling outside the aforementioned range requirement.
k. If frozen drugs are stored in the principal compounding/dispensing area or in any satellite, there shall be a freezer, dedicated to storing only drugs, meeting the compendia requirements and with an accurate thermometer in the freezer. The temperature of which shall be maintained between twenty-five degrees below zero and ten degrees below zero Celsius ( - 25 and - 10 degrees C.) or thirteen degrees below zero and fourteen degrees Fahrenheit ( - 13 and 14 degrees F.) or in accordance with the corresponding drug manufacturer's directions. The temperature shall be electronically monitored each calendar day.
Records detailing instances in which temperatures fall outside the aforementioned range requirement, for any period of time, shall be maintained at the prescription drug outlet and shall be made readily available for inspection upon request by the Board or its representatives for a period of at least two years preceding the request. Such records shall include the duration of time the temperature fell outside the aforementioned range requirement, based on the best available data, and measures taken by the outlet as a result of the temperature falling outside the aforementioned range requirement.
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17.00.00 COLLABORATIVE PHARMACY PRACTICE.
17.00.10 Definitions.
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d. "Evidence-based healthcare service" means a healthcare service provided by a Colorado-licensed pharmacist pursuant to a collaborative practice agreement with a Colorado-licensed prescriber or prescribers which is guided by or based on current, objective, supportive scientific evidence as published in scientific literature as opposed to anecdotal observations. Evidence-based healthcare services may include:
1. Specific services as agreed upon and defined under Rule 17.00.70(c), including but not limited to:
a. chronic disease management and optimization of therapeutic outcomes using medication therapies based on published clinical guidelines;
b. preventative services;
c. medication management and monitoring; and
d. services intended to achieve outcomes related to the cure or prevention of a disease, elimination or reduction of patients' symptoms, or arresting or slowing of a disease process, and include efforts to prevent, detect, and resolve medication-related problems.
2. Prescribing and consultative services pursuant to statewide protocols as defined under Rule 17.00.50 and Appendices, including but not limited to:
a. Prescribing contraceptives;
b. Prescribing smoking cessation products; and
c. Prescribing human immunodeficiency virus infection prevention medications.
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19.00.00 ADMINISTRATION.
19.01.00 Vaccines and Immunizations.
19.01.10 Qualifications.
a. A pharmacist certified in immunization, pharmacy intern, or pharmacy technician under the supervision of a pharmacist certified in immunization, may administer vaccines and immunizations per authorization of a physician. A copy of the authorization shall be maintained at the prescription drug outlet. Routine childhood immunizations, as defined by the Colorado State Board of Health, shall comply with CDC guidelines.
The CDC guidelines pertaining to the immunization schedule, incorporated by reference, may be examined at the State Board of Pharmacy, 1560 Broadway, Suite 1350, Denver, Colorado 80202, during normal business hours, Monday through Friday, except when such days are state holidays. Certified copies of the incorporated guidelines shall be provided at cost upon request. The Program Director or the Program Director's designee will provide information regarding how the incorporated guideline may be examined at any state public depository library. The guideline is also available from the organization originally issuing the guideline as follows: Centers for Disease Control and Prevention (https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html (reviewed February 3, 2020)). This rule does not include any later amendments or editions of the guideline.
b. Pharmacy interns, as directly part of their normal schedule or college of pharmacy curriculum, who are trained to administer vaccines and immunizations under this Board Rule 19.01.10(c) may administer vaccines and immunizations under the direct supervision of another regulated individual as defined by Board Rule 4.00.10(l) authorized by law to administer vaccines and immunizations as part of their scope of practice.
c. Licensees shall be considered "trained" to administer vaccines and immunizations to a person only if:
(1) The pharmacist or pharmacy intern has completed a pharmacy-based immunization delivery course of at least twenty hours of training, including didactic and live hands-on training that is either accredited by the Accreditation Council for Pharmacy Education or provided by an ACPE accredited school or college of pharmacy as part of obtaining a pharmacy degree.
(2) The pharmacy technician has completed a pharmacy based immunization administration course of at least four hours of training including didactic and live hands-on training that is accredited by the Accreditation Counsel for Pharmacy Education. Proof of completion of this training shall be posted at the pharmacist 's, pharmacy intern' s, or pharmacy technician's main practice location(s) .
(3) The pharmacist, pharmacy intern, or pharmacy technician holds a current basic cardiopulmonary resuscitation (CPR) certification issued by the American Heart Association or the American Red Cross or a basic cardiac life support certification. If the CPR certification has no expiration date, current means the certification must have been issued within the last two years. Proof of certification shall be available at licensee's main practice location.
(4) The vaccines are administered in accordance with CDC guidelines. The CDC guidelines pertaining to vaccine administration, incorporated by reference, may be examined at the State Board of Pharmacy, 1560 Broadway, Suite 1350, Denver, Colorado 80202, during normal business hours, Monday through Friday, except when such days are state holidays. Certified copies of the incorporated guidelines shall be provided at cost upon request. The Program Director or the Program Director's designee will provide information regarding how the incorporated guideline may be examined at any state public depository library. The guideline is also available from the organization originally issuing the guideline as follows: Centers for Disease Control and Prevention (https://www.cdc.gov/vaccines/hcp/admin/admin-protocols.html (reviewed May 16, 2018)). This rule does not include any later amendments or editions of the guideline.
(d) The prescription drug outlet shall have a current version available, either in hard copy or electronically available, of the CDC reference "Epidemiology and Prevention of Vaccine-Preventable Diseases" . The CDC guideline referencing "Epidemiology and Prevention of Vaccine-Preventable Diseases," incorporated by reference, may be examined at the State Board of Pharmacy, 1560 Broadway, Suite 1350, Denver, Colorado 80202, during normal business hours, Monday through Friday, except when such days are state holidays. Certified copies of the incorporated guideline or reference shall be provided at cost upon request. The Program Director or the Program Director's designee will provide information regarding how the incorporated guideline or reference may be examined at any state public depository library. This guideline or reference is also available on the Centers for Disease Control and Prevention's website: https://www.cdc.gov/vaccines/pubs/pinkbook/ (13th Edition (2015). This rule does not include any later amendments or editions of the guideline or reference.
19.01.20 A trained pharmacist may delegate the administration of vaccines and immunizations only to a trained pharmacy intern or pharmacy technician.
19.01.30 Policies and Procedures
a. Prior to administering vaccines or immunizations, pharmacists, pharmacy interns, and pharmacy technicians must be trained in a pharmacy-based immunization course accredited as detailed in Rule 19.01.10(c).
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19.01.40 Recordkeeping.
a. The following information must be maintained by the prescription drug outlet for three years for each dose of vaccine or immunization administered:
(1) The name, address, and date of birth of the patient;
(2) Patient responses to screening questions for indications/contraindications to the immunization or vaccine being administered;
(3) The date of the administration and site of injection of the immunization or vaccine;
(4) The name, dose, manufacturer, lot number, and expiration date of the vaccine or immunization;
(5) The name or identifiable initials of the administering pharmacist. If the administration is by a pharmacy intern or pharmacy technician, the initials of both the intern or pharmacy technician and supervising pharmacist;
(6) The signed informed consent document for each administration;
(7) Which vaccine information statement (VIS) was provided;
(8) The date the VIS was provided; and
(9) The name and address of the facility at which the vaccine or immunization was administered, if administered off-site.
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19.01.50 Off-Site Administration of Immunizations and Vaccines
a. A prescription drug outlet may allow a licensed pharmacist to remove immunizations and vaccines from the prescription drug outlet, provided the following requirements are met:
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(3) The vaccines and immunizations shall be secured during transport and storage at the off-site location so as to allow only licensed pharmacists, pharmacy interns, and pharmacy technicians affiliated with the prescription drug outlet to have access to them.
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Editor's Notes
History
Rules 2.01.10; 2.01.30; 3.00.50; 3.00.70, 6.00.20; 6.00.30; 6.00.40; 8.00.10; 11.04.20; 14.03.10 eff. 07/30/2007.
Rules 8.00.10; 11.04.10; 20.00.00 eff. 09/30/2007.
Rule 4.00.00 eff. 11/30/2007.
Rules 3.01.20, 10.00.00 eff. 03/01/2008.
Rules 5.01.31; 15.01.11; 15.01.12; 15.09.11; 15.09.14; 22.00.00 eff. 05/30/2008.
Rules 4.02.00 (c), 21.00.00, 23.00.00 eff. 06/30/2008.
Rules 1.00.00, 2.00.00, 3.00.00, 5.00.00, 7.00.00, 11.00.00, 12.00.00, 14.00.00 eff. 11/30/2008.
Rule 15.09.11 eff. 01/31/2009.
Rules 6.00.30, 11.06.00, 22.00.00 eff. 03/02/2009.
Rule 9.00.00 eff. 04/30/2009.
Rules 5.00.55, 5.01.31(a), 6.00.20(f), 14.00.40, 15.01.17, 15.01.18, 15.08.19(f), 15.09.11(d), 15. 09.15, 15.09.19, 15.09.20(g-h), 15.09.23, 15.09.24, 15.10.10, 16.00.20(d), 19.01.10(b), 19.01.30(a) eff. 12/30/2009.
Rules 4.00, 18.00 eff. 03/17/2010.
Rules 3.00.80 - 3.00.90; 5.00.55; 15.01.12; 19.00.00 - 19.01.50. Rule 22.00.00 repealed eff. 07/15/2010.
Rules 1.00.21, 5.01.31(e), 5.01.50 eff. 08/30/2010.
Rules 5.00.55, 21.11.10 (a), 21.21.70 (a) eff. 11/14/2010.
Rules 1.00.18, 2.01.50 - 2.01.53, 3.00.50 - 3.00.51, 5.00.50, 5.00.60, 5.01.31.a, 11.04.10, 15.01.11, 15.09.11.e eff. 06/14/2011.
Rules 3.01.24, 4.00.00, 11.04.20, 11.04.30, 21.00.00 - 21.11.20, 23.00.00 eff. 04/14/2012.
Rule 14.00.10 eff. 05/15/2012.
Entire rule eff. 01/01/2013. Rule 17.00.00 repealed eff. 01/01/2013.
Rules 3.00.21 - 3.00.22, 3.00.55, 3.00.90.e.(4), 3.01.20.c, 3.01.30, 3.01.32, 3.01.34, 4.00.10.f, 4.00.20, 5.01.31.a.(1)(C), 15.10.14.a, 23.00.90 eff. 09/14/2013.
Rules 2.01.10, 3.00.25, 3.00.91, 5.00.15, 6.00.30, 10.00.00, 11.03.00, 11.07.10, 14.00.05.k-l, 14.00.80.e.(2), 14.00.80.j, 16.00.00, 18.00.00, 20.00.00, 21.00.20, 21.10.80, 21.11.00.a.(12), 21.11.10.c, 21.20.20, 21.20.30.b(14), 21.21.40.c, 21.21.70.c, 21.22.00.b(1), 23.00.30, 23.00.50, 23.00.65, 23.00.70, eff. 10/15/2014.
Rules 3.00.22, 3.00.81.l-o, 3.00.82-3.00.84, 3.00.85.a(3), 3.00.86, 3.00.88.a(2), 3.00.88.b(10), 4.06.00, 6.00.10-6.00.20, 6.00.40.a, 6.00.50, 6.00.60.a, 6.00.60.b.10, 6.00.70.a, 6.00.90.b, 6.01.10.a, 19.01.40.c, 21.00.10, 21.00.20.b, 21.10.60.b, 21.10.80.b(4), 21.11.10.a(5), 21.11.10.c(9), 21.20.10.d, 21.20.20.b(2)(a), 21.20.25.b, 21.20.70.f, 21.20.90.b-c, 21.21.10.b, 21.21.70.a(6), 21.21.70.c(10), 23.00.40.y-z, 23.00.70.h-j eff. 09/14/2015.
Rules 3.00.21, 3.00.27, 19.01.10(1), 21.00.20, 21.11.20.d, 21.20.16, 21.20.20.b.(2), 21.20.60.b, 21.20.60.e, 21.21.90.d eff. 03/16/2016.
Rules 3.00.20, 3.00.22 e, 3.00.81 g, 3.00.84, 3.01.10 d, 4.00.10, 4.00.25, 4.05.00, 5.00.15 d, 5.01.31, 6.00.20 e, 7.00.10, 8.00.10, 14.00.80 i-k, 19.01.10 b.(2), 20.00.80 a.1, 21.00.20, 21.00.30, 21.20.20 b, 27.00.00, 28.00.00 eff. 11/14/2016. Rule 10.00.51 repealed eff. 11/14/2016.
Rule 17 eff. 03/17/2017. Rule 18 repealed eff. 03/17/2017.
Rules 3.01.10 d, 7.00.30 b.4, 21.00.20, 21.00.30, 23.00.10, 23.00.70 eff. 11/14/2017. Rules 1.00.15, 5.00.55 a.(6) repealed eff. 11/14/2017.
Rules 3.05.00, 5.01.31 m, 5.01.31 r, 5.01.40 a, 5.01.50 a-f, 11.03.05, 11.04.10, 11.06.10 j, 14.02.30 d, 20.00.90 c, 20.01.00 a.2.iv, 21.00.20 d.ii, 21.20.70 g, 25.00.12 d-e, 25.00.14 c-d, 25.00.16 e eff. 09/17/2018.
Rules 1.00.24, 2.01.50, 2.01.52, 2.01.53, 2.01.56, 2.01.80, 3.00.23, 3.00.30, 3.05.10-3.05.30, 3.05.80, 7.00.30 c, 11.03.00 a, 11.07.10 a, 14.00.05 m, 14.00.40 f.1, 14.00.80 e, 15.01.11 a.(8)(i), 15.01.11 a.(9), 15.09.14 a, 19.01.10 b.-c, 23.00.10, 23.00.70, 29.00.00 eff. 11/30/2019.
Rule 30.00.00 emer. rule eff. 05/01/2020; expired 08/28/2020.
Rules 17.00.10, 17.00.30 a.7, 17.00.50 b.2, 17.00.70, 17.00.80, 17.01.00, 17.02.00 a, 17.03.00 b, 17.04.00 eff. 05/15/2020. Rule 6.00.00 repealed eff. 05/15/2020.
Rule 30.00.00 eff. 08/30/2020. Rule 3.04.00 repealed eff. 08/30/2020.
Rules 2.01.20, 3.00.81 a, 3.01.22 b, 5.00.40, 5.00.50 a, 7.00.30 b, 10.00.60, 11.08.00, 11.08.50, 14.00.05 b, 14.00.40 b-c, 14.05.11, 15.05.20, 15.01.11 b-d, 15.01.14 a-b, 15.01.17, 17.00.50 c, 24.00.50, Appendix C eff. 11/14/2020.