- New Rule - December 30, 2020
- Permanent Rulemaking Hearing on January 21, 2021
- Guidance for Cold Storage, Record Keeping
- Advisory Committee Members Wanted
- New Rules for Pharmacy Licensees
- Sunset Review
- Pharmacy Technician Q&A
- Revised Opioid Guidelines Adopted
New Rule - December 30, 2020
A new rule for the State Board of Pharmacy went into effect on December 30, 2020. The new rule was adopted to comply with Colorado Senate Bill 20-102: Concerning required disclosures to patients regarding formal actions based on sexual misconduct.
To view the details of this rulemaking project and track all rule changes, follow Tracking Number 2020-00821. The Board encourages all licensees and stakeholders to read the final, published New Rule. Please direct any questions to firstname.lastname@example.org.
Permanent Rulemaking Hearing on January 21, 2021
The State Board of Pharmacy will hold a virtual Permanent Rulemaking Hearing to consider adopting revisions to Rule 5.01.31, to amend the refrigerator and freezer storage requirements; Rule 17.00.00, as required by the Office of Legislative Legal Services (OLLS); and Rule 19.00.00, to align with recent federal guidance allowing Pharmacy technicians to administer immunizations, and simplify the record keeping requirements for pharmacists and pharmacies when administering vaccines.
Thursday, January 21, 2021, at 8:45 A.M. (MDT)
Guidance for Cold Storage, Record Keeping
The State Board of Pharmacy is in the process of adopting rule revisions around temperature requirements related to cold storage of medications (Board Rule 5.01.21) and simplification of record keeping (19.01.40).
In lieu of emergency rulemaking, the Board is providing the following guidance to aid licensees with pending vaccinations related to the treatment of the Novel Coronavirus (COVID-19).
When storing products associated with the COVID-19 vaccine, registrants and licensees should adhere to the drug manufacturer’s temperature storage requirements. Similarly, the name and address of the patient’s primary healthcare provider as identified by the patient will not be necessary outside of Colorado Immunization Information System upload requirements during the interim period prior to rule adoption.
Amended rules repealing language currently in Board Rule 19.01.40.a.5 and adding language to 5.01.21 on adhering to manufacturer’s cold-storage requirements are expected to be addressed within the next several months.
Input on these proposed changes will be accepted at the Board’s Dec. 11 stakeholder meeting (meeting notice here). The Board will consider permanent adoption of these rules, among others, at its January 21, 2021 Permanent Rulemaking Hearing. Please visit the Board’s website under the “Public Notices” tab for the most current information regarding rulemaking and stakeholder meetings.
Questions or concerns may be submitted to DORA_dpo_rulemaking@state.co.us.
Advisory Committee Members Wanted
The Division of Professions and Occupations is seeking qualified candidates to serve on the Naturopathic Medical Advisory Committee ("Committee") The Committee is appointed by the Director of Professions and Occupations, under the Department of Regulatory Agencies (DORA) umbrella. The Committee consists of nine members, including three naturopathic doctors, three doctors of medicine or osteopathy, one pharmacist and two public members.
Recent legislative changes require that of the doctors of medicine or osteopathy who serve on the Committee, one must be a pediatrician and one must be a member of a statewide multi-specialty medical society.
The Committee will meet at least annually and will advise the Director regarding administration and enforcement of laws and rules governing naturopathic doctor practice, discuss issues of importance to naturopathic doctors and their patients, and make recommendations for additions to the naturopathic formulary.
Members are appointed to serve four year terms and may be appointed to serve a second term. Members are not compensated but are reimbursed for expenses incurred in performing their duties.
If you would like to be considered for this opportunity, please submit an application to: email@example.com
New Rules for Pharmacy Licensees
On November 14, 2020, the following new State Board of Pharmacy rules went into effect.
- 2.01.20 (Receipt of Order, additional information)
- 3.01.22 and 3.00.81 (Filling of Automated Cassettes)
- 5.00.40 and 5.00.50 (Transfer of Ownership and Relocation)
- 7.00.30 and 11.08.00 (Compliance of Outlet [related to List of Employees])
- 10.00.60 (Emergency Kits Inspection)
- 14.00.40 (Application Procedure)
- 15.01.11, 15.01.14, and 15.01.17 (Requirements for Licensure)
- 14.05.11 and 14.05.20 - Implementation of HB 20-1050 Expansion of Casual Sales.
- 17.00.50(c) and Appendix C - Implementation of HB20-1061 Human Immunodeficiency Virus Infection Prevention Medications
- 14.00.05 - Implementation of SB20-136 - Recommendations of the Statutory Revision Committee Related to the Committee’s Statutory Charge
- 24.00.50 - Implementation of SB20-007 - Consistency to Language Regarding Substance Use Disorder.
Sunset Review Underway
The Colorado Office of Policy, Research, and Regulatory Reform conducted a sunset review of the State Board of Pharmacy and the Prescription Drug Monitoring Program. Analysis of a sunset review was performed to determine whether the regulatory program is necessary and should be continued, modified or eliminated. This review produced a report with recommendations to the Colorado General Assembly and will result in subsequent legislation based on the recommendations in the report. Your input is an important component of a successful sunset review. If you would like to submit comments online, please visit COPRRR's website.
Revised Opioid Guidelines Adopted
On March 14, 2019, the revised Guidelines for Prescribing and Dispensing Opioidswere adopted by all six of Colorado's prescribing and dispensing Boards: the Colorado Dental Board, the Colorado Medical Board, theState Board of Nursing, the State Board of Optometry, the Colorado Podiatry Board, and the State Board of Pharmacy, and endorsed by the State Board of Veterinary Medicine.