On September 2, 2016 the Board voted to temporarily adopted rules in Division 019 & Division 041. These rule incorporate new statutory language put forth by 2016 House Bill 4124, which is intended to improve access to naloxone.
2016 HB 4124 permits pharmacists to prescribe and distribute unit-of-use packages of naloxone to individuals who conduct or complete Oregon Health Authority (OHA) approved training. This new legislation builds on the original 2013 legislation (ORS 689.681) that allows a trainer to possess and distribute naloxone to trainees, and allows trainees to possess and administer naloxone to an individual experiencingan opiate overdose.
The rules give the purpose; specifies the qualifications of participating pharmacists and mandatory counseling; and outlines the delivery of care expectations for the pharmacist and pharmacy, including documentation and recordkeeping.
These rules clarify and incorporate a 2013 statute implemented in ORS 433.825 that specifically allows an entity to acquire epinephrine with a valid prescription when they employ someone who has completed an Oregon Health Authority approved training program for the treatment of allergic emergencies.
On August 11, 2016 the Board voted to temporarily adopt amended rules in Division 080. The action came after initial research by the Board's staff and OSP to report that use of such substances and overdose deaths associated with their use are on the rise in Oregon. By adding the illicit synthetic opioids and fentanyl analogue chemicals to Schedule I of the Oregon list of controlled substances (pursuant to ORS 475.035), the Board gives law enforcement the authority needed to prosecute the sale and possession of these substances under the Oregon Uniform Controlled Substances Act. This will have positive effect on public safety by limiting distribution and access to potentially deadly substances. Permanent rulemaking to follow this Fall.
On June 9, 2016 the Board voted to permanently amend, adopt or repeal rules in Divisions 006, 025, 041, 043 and 110.
Amendments in Division 006 add a definition for "Quality Assurance Plan" and establish a new rule number for "Unprofessional Conduct".
Amendments in Division 025 change the annual Certified Oregon Pharmacy Technician license to a biennial license that expires June 30th in even numbered years. Other changes are primarily housekeeping related matters or changes that correspond with biennial licensure. Changes also clarify and update the Pharmacy Technician rules.
Amendments in Division 041 are minor housekeeping changes which include an updated rule reference related to Remote Distribution Facilities.
Rules in Division 043 Practitioner Dispensing rules repeal the existing County Health Clinic and Family Planning Clinic Drug Outlet rules and establish a new section of rules to combine these two licenses into one category that will be called a Community Health Clinic Drug Outlet. A facility must register when medication dispensing is performed by a Registered Nurse (RN). The new rules provide minimum requirements of operation and define requirements for personnel, policies, and procedures, security, drug acquisition, storage of drugs, labeling, dispensing and drug delivery, disposal of drugs and recordkeeping. The new rules go into effect 7/1/16; however, facilities currently registered with the Board under the former license categories will be issued a new Community Health Clinic Drug Outlet registration upon renewal in 2017.
Amendments in Division 110 correspond with the transition to biennial licensure for Certified Oregon Pharmacy Technicians and make other minor corrections as a result of changes to various rules.
• Div 006
• Div 025
Certified Pharmacy Technicians and Pharmacy Technicians (implements biennial licensure)
• Div 041
Remote Distribution Facilities
• Div 043
Community Health Clinic Drug Outlets (replaces Family Planning Clinics and County Health Clinics)
• Div 110
On June 9, 2016, the Board sent the following rule to Proposed Rulemaking. The Epinephrine rules were previously noticed in May 2016 and are being re-noticed due to changes recommended by the Oregon Health Authority and needed clarifications identified. The deadline to make comments on this rule is: 4:30 p.m. 7/25/16.
After a public comment period and
hearing in March, the Board adopted Permanent Rules in OAR 855-019-0400 through
855-019-0435 at their 4/7/16 meeting.
The rules allow Oregon pharmacists to prescribe and dispense hormonal
contraceptive patches and self administered oral hormonal contraceptives to
eligible patients. under certain circumstances. These rules also provide
direction to pharmacies for policies and procedures. The rules replace the Temporary Rules that
went into effect 11/6/15. 2015 HB 2879 is
now fully implemented. Please see http://www.oregon.gov/pharmacy/Pages/ContraceptivePrescribing.aspx for a Tool-kit of
resources, training and required updated documents and other information
regarding the legislation and implementation.
The legislative intent is to remove barriers and provide timely access
May 24, 2016 Rulemaking Hearing
On April 7, 2016, the Board sent the following rules to a Rulemaking Hearing that is scheduled for 9:30a.m. on Tuesday, May 24, 2016 in Conference Room 1A of the Portland State Office Building, 800 NE Oregon St. Portland, OR 97232. For more information, please review the Notice of Proposed Rulemaking Hearing and Statement of Need and Fiscal Impact, as well as the draft proposed rules linked below. The deadline to make comments on these rules is 4:30 p.m. 5/24/16.
Amendments to Division 006 - Definitions rules add a definition for Quality Assurance Plan and move the definition of Unprofessional Conduct to its own rule number for agency recordkeeping purposes.
Amendments to Division 025 - Pharmacy Technicians rules are updated bring additional clarification and update requirements. The rules also propose that a Certified Oregon Pharmacy Technician (CPT) license will be valid for up to two years and will be renewed biennially; rules also reflect a change in the date of expiration to June 30th in even numbered years. Amendments require CPTs to complete 20 continuing education (CE) hours during the period from July 1 through June 30 of each biennial license renewal cycle as defined. This means that upon renewal in 2016, a CPT licensed before 7/1/16 will renew, complete CE and the license will expire June 30, 2018 in order to make this shift to biennial licensure. All CPT licenses issued beginning on 7/1/16 will expire 6/30/18. Rules also update requirements for CPT reinstatement.
- Pharmacy Technicians and Certifed Oregon Pharmacy Technicians
Amendments to Division 041 - Operation of Pharmacies update rules related to the distribution of emergency medication to allow an entity to acquire and possess epinephrine; and housekeeping corrections to the Remote Distribution Facilities rules.
Amendments to Division 043 - Practitioner Dispensing repeal the existing County Health Clinic and Family Planning Clinic rules and establish a new section of rules to combine these two licenses into one category that will be called a Community Health Clinic Drug Outlet. A facility must register when medication dispensing is performed by a Registered Nurse (RN). The new rules provide minimum requirements of operation and define requirements for personnel, policies and procedures, security, drug acquisition, storage of drugs, labeling, dispensing and drug delivery, disposal of drugs and recordkeeping.
Amendments to Division 110 - Fee rules reflect the fee structure for Certified Oregon Pharmacy Technician licensure; note that the current fee of $50.00 remains the same. The CPT license will be valid for up to two years. A reduction in fees is also included for initial CPT licenses issued within 180 days of expiration. The Workforce Data Collection fee has been reduced for pharmacists and CPTs. The name has been changed to reflect the new Community Health Clinic license. The name of the Remote Distribution Facility fee in rule -0010 was corrected.
The intention is for all of the proposed rules to be effective on July 1, 2016.
March 23, 2016 Rulemaking Hearing
On February 12, 2016, the Board sent Prescriptive Authority rules in OAR 855-019-0400 through 855-019-0435 to a Rulemaking Hearing scheduled at 9:30a.m. on Wednesday, March 23, 2016 in Conference Room 1A of the Portland State Office Building, 800 NE Oregon St. Portland, OR 97232. These rules are currently temporary rules. 2015 HB 2879 (ORS 689.683) allows Oregon pharmacists to prescribe and dispense hormonal contraceptive patches and self administered oral hormonal contraceptives under certain circumstances. Pharmacies that choose to provide this service are required to prepare policies and procedures. Pharmacists who choose to prescribe must complete an ACPE and Board approved training program. The legislative intent is to remove barriers and provide timely access to care. For more information, please review the Notice of Proposed Rulemaking Hearing and Statement of Need and Fiscal Impact, as well as the draft proposed rules linked below. The deadline to make comments on these rules is 4:30 p.m. 3/23/16.