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Rule Changes

2018 RULE CHANGES

October 2018
 
The Board permanently adopted the following rules at its October 4,2018 Board meeting:

September 27, 2018 Rulemaking Hearing
The following rules have been noticed for this hearing, please see the attached for complete information:
 
The Board is very interested in your comments on the above rules.  Please attend the hearing on Thursday, September 27, 2018 at 9:30AM to provide testimony or submit written comments to pharmacy.rulemaking@oregon.gov by the comment period deadline on September 27, 2018 at 4:30PM.
 
August 2018
On August 23, 2018 the PIC/Community Pharmacy Personnel and Compliance Rules Advisory Committee (RAC) met (Minutes​) for its 2nd and final meeting, at this time.

 
July 2018
The Board adopted a temporary rule to correct the Auto Refill rule previously adopted and filed in June 2017. 

 June 2018

- On June 29, 2018 the PIC/Community Pharmacy Personnel and Compliance Rules Advisory Committee (RAC) met (Minutes). The 2nd meeting is scheduled for August 23, 2018 (Agenda​​).
- The Board permanently adopted the following rules at its June 7, 2018 Board meeting:      
 
  • Public Health and Pharmacy Formulary Advisory Committee makeup and procedures – Effective 6/19/2018
May 23, 2018 Rulemaking Hearing
The following rules have been noticed at this hearing, please see the attached for complete information.
  • Division 019 – Naloxone proposed rules make the current Temporary Rule into a Permanent Rule
  • Division 020 – This new Division is related to Pharmacist Prescriptive Authority, proposed rules establish the 2017 HB 2397 created Public Health and Pharmacy Formulary Advisory Committee and function in rule
  • Division 045 - Compounding proposed rules repeals outdated Compounding rules and proposes replacement rules
The Board is very interested in your comments on the above rules.   Please attend the hearing on May 23, 2018 at 9:30 to provide testimony or submit written comments to pharmacy.rulemaking@oregon.gov by the comment period deadline on May 23, 2018 at 4:30.
 
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2017 RULE CHANGES​

December 2017

The Board permanently adopted the following rules at its December 14, 2017 Board meeting:

November 29, 2017 Rulemaking Hearing
On October 12, 2017, the Board sent the following rule to a Rulemaking Hearing scheduled for 9:30a.m. Wednesday, November 29, 2017 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 that include the draft proposed rules linked below.  The deadline to make comments on these rules is 4:30 p.m. November 29, 2017.
 
To submit written comments on Proposed Rules email Pharmacy.Rulemaking@state.or.us ​
 
 

  ​August 2017

 
July 27, 2017 Rulemaking Hearing
 
On June 8, 2017, the Board sent the following rule to a Rulemaking Hearing scheduled for 9:30a.m. Thursday, July 27, 2017 in Conference Room 1E 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. 07/27/17.
To submit written comments on Proposed Rules, email to:Pharmacy.Rulemaking@state.or.us 

 

The Board permanently adopted the following rules at its August 10, 2017 Board meeting:

 
June 2017
The Board permanently adopted the following rules at its June 8, 2017 Board meeting:
 
May 25, 2017 Rulemaking Hearing
On April 6, 2017, the Board sent the following rules to a Rulemaking Hearing scheduled for 9:30a.m. on Thursday, May 25, 2017 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. 05/25/17.
Amendments to Div 041 - Prescription Refills related to the auto-refilling of prescriptions by pharmacy outlets.
Amendments to Division 065 - Wholesaler rules to reflect changes in DEA law for reporting suspicious orders.
 
February 2017

The Board permanently adopted the following rules at its January 9, 2017 Board meeting:

Division 007 and Division 041 - The rules relate to the registration and regulation of Drug Rooms. The rules (1) describe oversight of long-term storage of state and federal emergency medications in a Drug Room (2) clarify that secondary storage areas related to Retail Pharmacies that can register as a Drug Room; and (3) allow a Drug Room to be affiliated with an Institutional Pharmacy.

Division 019 - The rules add a no cost legislatively approved registration for liability limitations for pharmacist volunteers.  A pharmacist who is registered and who provides health care services without compensation is not liable for any injury, death, or other loss arising out of the provision of those services, unless the injury, death or other loss results from the gross negligence of the pharmacist.

Division 041-1010 - The rules add a requirement for outlets to notify the Board within 10 days of a Board licensees termination or resignation in lieu of termination.

Division 041 - The rules put forth the requirements for a pharmacy to lawfully participate in Drug Take Back initiatives. 

Division 041 - The rules for a Remote Dispensing Machine (RDM) now allow use of new technology in licensed residential facilities with approval from the Board for certain individuals.

Division 044 - The rules incorporate new statutory language put forth by Senate Bill 1514 (2016). The rules (1) clarify that this is an Oregon specific program that allows donations and distribution of donated drugs within Oregon; and (2) prohibits a Charitable Pharmacy from accepting an FDA REMS drugs.

Certificate and Order for Permanent Rules -  Effective February 23, 2017

• Division 007 & Div 041 - Drug Rooms
 Division 019 - Registration for Limited Liability for Volunteers
• Division 041 - Outlet Notification Requirements
• Division 041 & Division 080  - Drug Take Back
 Division 041- Remote Dispensing Machines
• Division 044 - Charitable Pharmacy Donations/Distribution
 
January 2017
 
*The Board reviewed the comments from the 3/7/17 Rulemaking Hearing and decided to conduct some additional review.  The Board expects to review updated draft rules in June for a July 2017 Rulemaking Hearing and public comment.*
 
On January 9, 2017, the Board sent the Dispensing Practitioner Drug Outlets revised Division 043 rules to a Rulemaking Hearing for consideration a second time after incorporating various edits made to address comments and input received during the public comment period in November 2016, with the goal to register the large volume Dispensing Practitioner Drug Outlets (DPDO). 
 
The Rulemaking Hearing is scheduled for 9:30a.m. on Tuesday, March 7, 2017 in Conference Room 1E of the Portland State Office Building, 800 NE Oregon St. Portland, OR 97232.  The deadline to make comments on these rules is 4:30 p.m. 3/7/17.
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