The Oregon Health Authority revised regulations under OAR 333-047 and -049 regarding requirements for health care persons, entities and other enrolled providers that receive, store, administer or transfer coronavirus (COVID-19) vaccines, including reporting the amounts of doses administered and that are in inventory to the immunization registry, also known as the immunization information system. The rule was effective July 12, 2021.

The Oregon Health Authority, Public Health Division, temporarily adopted regulations under OAR 333-047 to prohibit health care providers and vaccine sites from requiring parental consent for coronavirus (COVID-19) vaccination for minors age 15 to 17 years, and from asking for a Social Security number. The temporary rule also requires persons or entities administering state-supplied COVID-19 vaccines to have a designated site coordinator, post signs with the site coordinator’s contact information, provide information about when and where to get a second dose and provide a vaccine card as proof of vaccination. The rule, which replaces an earlier temporary rule on the same topic, is effective July 9, 2021, and expires November 22, 2021. 

For more information, contact NACDS’ Sandra Guckian at 703-774-4801.

Effective June 15, 2021, the Board of Pharmacy amended the following regulations: 

• OAR 855-007 to allow pharmacists at immunizing clinics to supervise as many state-licensed immunizing interns as they determine will maintain public health and safety during a declared public health emergency. The rule is response to the coronavirus (COVID-19) pandemic.  
• OAR 855-041 to remove the limit on epinephrine dispensed to an entity to allow maintenance of epinephrine at coronavirus (COVID-19) vaccination locations.  
• OAR 855-019, -021, -025 and -031 to incorporate cultural competency continuing education requirements for pharmacists, pharmacy technicians and pharmacy interns.  
• OAR 855-020 to update the statewide drug therapy management protocols in the formulary and protocol compendia.  

• OAR 855-001 and -041 to revise requirements for inspection of drug outlets, including performance by the Compliance Officer, and for pharmacy records.  
• OAR 855-110 to revise the late fee expiration dates for licensees and registrants.  
• OAR 855-080 to ensure clarity, transparency and promote patient safety related to controlled substances. 
• OAR 855-006 and repeals regulations under OAR 855-050 to remove outdated restrictions on retail drug sales and make a confirming change to incorporate the definition of “prescription drug.”  
• OAR 855-041 to clarify requirements for pharmacies related to Drug Take Back Programs.  

Also in Oregon, on June 15, 2021, Gov. Kate Brown (D) signed HB 2648, removing the existing prescription only requirement for purchases of pseudoephedrine (PSE) containing medications and instituting the National Precursor Log Exchange (NPLEx) in its place. As a result of this newly enacted law, Oregon becomes the 37th state to mandate the use of NPLEx, and no state will require a prescription for the purchase of a Food and Drug Administration (FDA) approved over-the-counter product containing PSE. NACDS acknowledges the efforts of CHPA to support this repeal over the last several years. 

For more information, contact NACDS’ Sandra Guckian at 703-774-4801.

HB 2648, related to pseudoephedrine (PSE), was passed by the Senate Committee on Health Care and transmitted to the Senate floor for consideration. The bill would remove the existing prescription only requirement and require an electronic system to track all over-the-counter sales of PSE in the state.

Also in Oregon, the agenda for the next Board of Pharmacy meeting being held June 9-10, 2021, has been posted.

Laslty in Oregon, the Health Authority adopted temporary regulations under OAR 333-003-5000 to prohibit health care providers and vaccine sites from requiring parental consent for coronavirus (COVID-19) vaccination for minors age 15 to 17 who are exercising their right to consent under state law. The rule also establishes civil penalties of up to $500 per day per violation. In addition, the temporary regulations (OAR 333-047-2000) require persons or entities receiving state-supplied COVID-19 vaccines to comply with the OHA’s COVID-19 Vaccine Administration Site and Provider Guidance. The rules are effective May 27, 2021, and expire November 22, 2021.

For more information, contact NACDS’ Sandra Guckian at 703-774-4801.

The Board of Pharmacy published the following proposed rules with a deadline for comments on May 26, 2021.  Also, hearings are scheduled for May 26, 2021, via teleconference.

• Proposed rule amends regulations under OAR 855-007 to allow pharmacists at immunizing clinics to supervise as many state-licensed immunizing interns as they determine will maintain public health and safety during a declared public health emergency. The proposal, which is the response to the COVID-19 pandemic, currently is in effect as a temporary rule, expiring June 18, 2021.   
• Proposed rule amends and adopts regulations under OAR 855-019, -021, -025, and -031 to incorporate cultural competency continuing education requirements for pharmacists, pharmacy technicians, and pharmacy interns.   
• Proposed rule amends, adopts, and repeals regulations under OAR 855-080 to update the incorporation by reference to the federal controlled substance schedules and prescription requirements. The rule also would add provisions on persons who are exempt from controlled substances registration requirements and remove outdated provisions on verification of research registration and drug disposal.   
• Proposed rule amends regulations under OAR 855-041 to remove the limit on epinephrine dispensed to an entity to allow maintenance of epinephrine at coronavirus (COVID-19) vaccination locations. The proposal currently is in effect as a temporary rule, expiring Sept. 19, 2021.   
• Proposed rule amends regulations under OAR 855-041 to revise provisions on returned drugs and devices and on secure and responsible drug disposal to implement requirements for drug take-back programs. Note: Requirements for pharmacies that operate collections sites would be updated to include notifying the Board if they initiate or cease to operate such a program.
• Proposed rule amends regulations under OAR 855-001 and -041 to revise requirements for inspection of drug outlets and pharmacy records. The rule would require records to be stored on-site for 12 months, require records to be provided to the board upon request, and allow for off-site storage after 12 months.   
• Proposed rule amends regulations under OAR 855-110 to revise the late fee expiration dates for licensees and registrants.   
• Proposed rule amends regulations under OAR 855-006 and repeals regulations under OAR 855-050 to remove outdated restrictions on retail drug sales and make a confirming change to incorporate the definition of “prescription drug.”   
• Proposed rule amends regulations under OAR 855-041, -043, and -044 to add requirements on information inserts for prescription drugs dispensed to limited English proficiency patients.   

For more information, contact NACDS’ Sandra Guckian at 703-774-4801.

The May 20, 2021, Continuing Education Rules Advisory Committee meeting agenda is now available.

For more information, contact NACDS’ Sandra Guckian at 703-774-4801.

The Oregon Health Authority issued the following:

• Temporary rule amending regulations under OAR 410-121 to revise the practitioner-managed prescription drug plan to update the preferred drug list. The rule is effective April 1, 2021, and expires June 29, 2021.
• Proposed rule amending regulations under OAR 410-121 to revise the practitioner-managed prescription drug plan to update the preferred drug list, beginning April 1, 2021. The rule currently is in effect as a temporary rule, expiring June 29, 2021. Comments are due April 21, 2021.

For more information, contact NACDS’ Leigh Knotts at 803-243-7207.

Effective March 23, the Health Authority adopted a final rule amending regulations as follows:

• Repeals Temporary 333-018-0005 from PH 3-2021 & Amends 333-018-0005: Requires reporting of out-of-state (non-Oregon) cases of COVID-19 to the jurisdictional public health authority of the patient’s residence, rather than to OHA. Housekeeping changes remove outdated reporting language.
• Amends OAR 333-018-0015: Housekeeping changes clarify in all relevant places that “intoxications” are among the illnesses to be reported and removes outdated reporting language, which is no longer applicable.
• Amends OAR 333-018-0016: Requires reporting of positive and negative COVID-19 laboratory reports of tests “waived” in accordance with the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA), whether or not the tests were performed in a laboratory accredited for higher complexity testing.

Also in Oregon, Via a temporary rule effective March 24 and expiring September 19, 2021, the Board of Pharmacy amends regulations under OAR 855-041 to remove the limit of the number of epinephrine devices that may be dispensed to an entity. For COVID-19 vaccines, appropriate medical treatment for severe allergic reactions must be immediately available if an acute anaphylactic reaction occurs following administration of a COVID-19 vaccine.

For more information, contact NACDS’ Sandra Guckian at 703-774-4801.