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Rule Changes

2013 RULE CHANGES

December 20, 2013
On Wednesday December 18, 2013 the Board adopted a temporary rule to correct a filing error in Division 080 of the Schedule I rules. This temporary rule reestablishes other cannabinoid receptor agonists and an exception clause.
 
 
 
November 21, 2013
On Thursday November 21, 2013 at 9:30 AM, the Oregon Board of Pharmacy will conduct a rulemaking hearing on the following topics in Room 1A of the Portland State Office Building, 800 NE Oregon St., Portland, OR 97232
 
  • Div 007 - Public Health Emergencies
  • Div 011 - Health Professionals Service Program
  • Div 019 - Duty to Report
  • Div 019 - Administration of Vaccines by Pharmacists  
  • Div 041 - Definitions and Prescriptions
  • Div 041 - Reporting Drug Loss
  • Div 041 - Distribution of Emergency Medication
  • Div 041 - Remote Dispensing Facility
  • Div 110 - Fees
 
November 6, 2013
On August 14, 2013 the Board amended its Consulting Pharmacist Practice rules in Division 019 and adopted new drug outlet retail and/or institutional models  in Division 041 for Central Fill, Remote Processing, and Consulting or Drugless Pharmacies. The Central Fill, Remote Processing, and Consulting or Drugless Pharmacy rules provide minimum requirements of operation for these new drug outlet models and accommodate modern practices and new technologies while promoting patient safety.
  • 855-019 - Consulting Pharmacist Practice - Effective November 6, 2013
  • 855-041 - Central Fill Drug Outlets, Remote Processing Drug Outlets, and Consulting  or Drugless Pharmacies - Effective November 6, 2013      
  • 855-041 - Central Fill Drug Outlets - Effective November 6, 2013
  • 855-041 - Remote Processing Drug Outlets  - Effective November 6, 2013
  • 855-041 - Consulting or Drugless Pharmacies  - Effective November 6, 2013
 
 
October 2013
 
On October 28, 2013 the Board amended its schedule I controlled substances rules to incorporate certain synthetic cannabinoids subject to abuse.
 
 
September 2013
On August 14, 2013 the Board amended its customized patient medication packages rules to incorporate a waiver clause. The amendment allows the Board to waive any of the requirements of the customized patient medication packages rules if a waiver will further public health or safety or the health and safety of a patient.
 
  •  855-041 - Customized Patient Medication Packages
 
 
On August 14, 2013 the Board adopted temporary rules to define the procedures for disributing naloxone to certain authorized individuals in opiate overdose circumstances. Administration of naloxone may only take place by those who have successfully completed training from the Oregon Health Authority, Public Health Division or who have been identified in Oregon Laws 2013, Chapter 340.
 
 
On September 19, 2013 the Board adopted permanent rules to amend its fees. These amendments implement revenue surplus reductions pursuant to ORS 291.055(3) for certain licensing fees as approved by the Board's 2013-15 Legislatively Approved Budget.  
 
August 2013
On August 14, 2013 the Board amended its manufacturer rules. The permanent rules clarify that any compounded non-patient specific drug from an out-of-state drug outlet may only be distributed into the state by an Oregon registered manufacturer.
 
 
July 2013
On June 12, 2013 the Board amended the following fees: Reciprocity, County Health Clinics, Family Planning Clinics, Hospital Drug Rooms, Correctional Facilities, Prophylactic/Contraceptive Outlets, Retail and Institutional Drug Outlets, Home Dialysis Drug Outlets and all Controlled Substance registration fees.
The Board implemented a temporary fee reduction for these fees as allowed by ORS 291.055(3) due to an unexpected surplus in revenue. These fee reductions are in addition to the temporary pharmacist licensure fee reduction that went into effect on April 5, 2013.
 
 
Notice of Rulemaking or Rulemaking Hearings
 
Notice of Proposed Rulemaking
The Board is proposing permanent rules for adoption that will implement revenue surplus reductions pursuant to ORS 291.055(3) for certain licensing fees as approved by the Board's 2013-15 Legislatively Approved Budget. Public comment will be accepted through August 30, 2013.
 
 
June 27, 2013 Rulemaking Hearing
On Thursday, June 27, 2013 at 9:30AM, the Oregon Board of Pharmacy will conduct a rulemaking hearing on the following topics in Room 1A of the Portland State Office Building, 800 NE Oregon St., Portland, OR 97232. 
  • Div 019 - Consulting Pharmacist Practice
  • Div 041 - Preamble for Central Fill, Remote Processing and Consulting or Drugless Pharmacies
  • Div 041 - Central Fill
  • Div 041 - Remote Processing
  • Div 041 - Consulting or Drugless Pharmacies
  • Div 041 - Customized Patient Medication Packages
  • Div 060 - Manufacturers
  • Div 080 - Controlled Substances
Remote Processing Drug Outlet rules provide minimum requirements of operation for centralized prescription processing by a pharmacy that processes drug orders on behalf of an Oregon pharmacy.
Central Fill Drug Outlet rules provide minimum requirements of operation for centralized prescription drug filling by a pharmacy that fills drug orders on behalf of an Oregon pharmacy.
Consulting or Drugless Pharmacy rules are intended to ensure that a consulting pharmacist may safely store records and protected health information in an Oregon licensed drugless pharmacy when engaged in Independent Pharmacy Practice.
 
Consulting Pharmacist Practice rules are amended to establish registration requirements for a consulting pharmacist that stores health protected records outside an Oregon licensed pharmacy.
Customized Patient Medication Packages rules are amended to include a waiver clause.
 
Manufacturer rules are amended to clarify that any compounded non-patient specific drug from an
out-of-state drug outlet may only be distributed into the state by an Oregon registered manufacturer.
 
Controlled Substance rules are amended to include certain synthetic cannabinoids and cathinone-type derivatives that are subject to abuse, and have no legitimate medical purpose.
 
 April 2013
On April 4, 2013 the Board amended Pharmacist Licensure Fees.
The Board has implemented a temporary fee reduction for pharmacist licensure as allowed by ORS 291.055(3) due to an unexpected surplus in revenue. The license fee will be reduced from $200 to $120.
 
February 2013
On February 14, 2013 The Board amended rules relating to Manufacturers.
This temporary rule clarifies that any out-of-state outlet that compounds a drug that is distributed into Oregon and is based on a non-patient specific order must register as a Manufacturer.
 
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2012 RULE CHANGES

December 2012 
On December 12, 2012 The Board amended rules relating to Wholesaler and Fee rules.

Division 065 rules amend the definition of Class II Wholesaler to include Oxygen USP and medical gases.   Division 110 rules implement a licensing and delinquent fee for the registration and renewal of Supervising Dispensing Outles as required by 2012 Senate Bill 1565. 

Certificate of Permanent Rulemaking - Effective 12/15/12

On December 12, 2012, The Board also reorganized, renumbered, amended and repealed rules within Division 041 in an effort to update the Division in its entirety and provide greater clarity for licensees. In addition rules relating to correctional facilities have been renumbered to Division 043 for organizational purposes. The Board will further review Division 041 in its entirety in 2013 after the reorganization occurs to ensure that rules within the Division accurately reflect current pharmacy practice standards and accommodate new business models.  

The Board also amended emergency department distribution rules that update labeling and records requirements. The amendments also contain a waiver clause and establishes requirements for Automated Dispensing Machines (ADM) within the Emergency Department. 


Certificate of Permanent Rulemaking
- Effective 12/21/12

  • 855-041 - Emergency Department Distribution

 

 June 2012

 

On June 6, 2012 The Board amended the Wholesaler Class II definition to include Oxygen USP.  

Notice of Temporary Rulemaking and Statement of Need - Effective 6/19/12 

• 855-065 – Wholesaler
 

On May 24, 2012 The Board adopted and amended rules related to Definitions, Practitioner Dispensing Outlets and Animal Euthanasia.

Division 006 rules are amended to define “Board” and add “dispense” to existing definitions. Division 043 Practitioner Dispensing Outlet rules implement 2012 Oregon Laws Chapter 34. These rules define “Supervising Physician Dispensing Outlet” and identify which entities must register as well as their requirements. Division 080 Animal Euthanasia rules are amended to correct an outdated fee reference.

Certificate of Permanent Rulemaking - Effective 6/19/2012 
• 855-006 - Definitions
• 855-043 - Practitioner Dispensing Outlets
• 855-080 – Animal Euthanasia
 
The Board also amended rules which add fees for the registration and renewal of Supervising Physician Dispensing Outlets.
 

• 855-110 - Fees


On May 24, 2012 The Board adopted new Drug Outlet conduct rules.
 
Division 041 Drug Outlet conduct rules define the grounds for discipline for outlets that fail to provide a working environment that protects the health, safety and welfare of patients.  
 

Certificate of Permanent Rulemaking - Effective 6/12/12

• 855-041- Drug Outlet Conduct

 

May 2012

On April 11, 2012 The Board adopted and amended rules related to Pharmacy Depots, Technician Checking Validation Programs and Residential Drug Outlets.

The Div. 041 Pharmacy Depot Rules previously amended in December 2011 are amended to further clarify where a patient may designate delivery of a prescription. The Div. 041 Residential Drug Outlet rules are renumbered, amended and repealed to update rules that have not been updated since 1990. The Div. 041 Technician Checking Validation Program (TCVP) rules will allow hospitals to implement TCVP's to allow the redirection of a pharmacist from a distributive role to a patient oriented role

Certificate of Permanent Rulemaking - Effective 5/1/12 

  • 855-041 - Technician Checking Validation Program (TCVP)
  • 855-041 - Pharmacy Depots 
  • 855-041 - Residential Drug Outlets

 

January 2012

On December 14, 2011 The Board adopted and amended rules regarding new Collaborative Therapy, Immunization, Intern, Pharmacy Depots and Manufacturer rules.

Division 019 rules are amended to clarify requirements for Therapeutic Substitution and the Administration of Vaccines. Division 031 Intern rules are amended for clarification. Division 041 Pharmacy Depot rules are amended to allow for exceptions. Division 060 updates the Manufacturer rules to more clearly identify which entities must register as Manufacturers.

Certificate of Permanent Rulemaking - Effective 1/1/12

 

 

 

 

Rulemaking Hearings 

 

On Thursday, November 29, 2012 at 9:00AM, the Oregon Board of Pharmacy conducted a rulemaking hearing on the following topics in Room 1A of the Portland State Office Building, 800 NE Oregon St., Portland, OR 97232

 

 

The Division 041 Emergency Department Dispensing amendments are needed to update labeling and record requirements. These rules also propose to establish requirements for Automated Dispensing Machines (ADM) within the Emergency Department.

The Board is in the process of reorganizing and renumbering Division 041 to provide greater clarity, order and consistency with Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) regulations. For those rules that only required renumbering, they have been filed and updated with the Secretary of State. This filing includes rules that have been both renumbered and amended. Also
reflected are rules that are proposed to be repealed because they are outdated. The Board intends to develop new rules to accommodate new business models and will review the Division in its entirety to ensure that the rules accurately reflect current pharmacy practice standards.

The proposed amendments in Division 065 permanently amend the definition of Class II Wholesaler to include Oxygen USP and medical gases which is currently a Temporary Rule. The Temporary Rule will expire on December 16, 2012.

The proposed amendments in Division 110 establish a permanent licensing and delinquent fee for the registration and renewal of Supervising Physician Dispensing Outlets as required by 2012 Senate Bill 1565. This rule is currently a Temporary Rule and will expire on December 16, 2012.
 
 

On May 24, 2012 the Oregon Board of Pharmacy conducted rulemaking hearing to amend or adopt new Definitions, Practitioner Dispensing Outlet, Controlled Substance, Outlet Conduct and Fee rules.

Notice of Rulemaking Hearing and Statement of Need

* At the April 11, 2012 Board meeting, the Board discussed the March 22nd Rulemaking Hearing Report and corresponding written testimony.  The Board has revised the initial proposal and is required to re-notice this version for reconsideration.  We welcome your public comment and written testimony on the revised proposed rule as noticed. 

Division 006 rules are needed to amend rules to define "Board" and add "dispense" to existing definitions. The Division 041 Drug Outlet conduct rules are being reconsidered and define the Grounds for Discipline for outlets that fail to provide a working environment that protects the health, safety and welfare of patients. Division 043 Practitioner Dispensing Outlet rules are needed to implement 2012 SB 1565. These rules define "Supervising Physician Dispensing Outlet" and identify which entities must register as well as their requirements. Division 080 controlled Substance Identification rules establish requirements for the dispensing of a controlled substance directly to a patient or patient's representative. Division 080 Animal Euthanasia rules correct an outdated fee reference. Division 110 Fee rules are needed to establish a fee for Supervising Physician Dispensing Outlets.

Submit written comments to Karen MacLean, Rules Coordinator at the Board office (800 NE Oregon St., Suite 150, Portland, OR 97232) or email Karen.S.MacLean@state.or.us. Comments must be received by 4:30pm on Monday, May 21, 2012 for consideration. 

 

On March 22, 2012 the Oregon Board of Pharmacy conducted a rulemaking hearing to
adopt and/or amend rules related to Drug Outlet conduct, Pharmacy Depots, Technician Checking Validation Programs etc.

Notice of Rulemaking Hearing and Statement of Need

 
The Div. 41 Pharmacy Depot Rules previously amended in December 2011 are amended to further clarify where a patient may designate delivery of a prescription. The Div. 041 Residential Drug Outlet rules are renumbered, amended and repealed to update rules that have not been updated since 1990. The Div. 041 Drug Outlet conduct rules are new rules that define the Grounds for Discipline for outlets that fail to provide a working environment that protects the health, safety and welfare of patients. The Div. 041 Technician Checking Validation Program (TCVP) rules will allow hospitals to implement TCVP's to allow the redirection of a pharmacist from a distributive task to a cognitive task.

 

 

 

 

 

 

 

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2011 RULE CHANGES

December 2011
 
On December 14, 2011, the Board amended Controlled Substance Rules relating to animal euthanasia.
 
Changes to OAR 855-080-0100 through 855-080-0103 are required to accommodate revisions that were made to the Veterinary Medical Examining Board’s rules relating to the registration of Certified Euthanasia Technicians that expired on October 31, 2011.
 
December 9, 2011, the Veterinary Medical Examining Board adopted temporary rules to reinstate licensure requirements for Certified Euthanasia Technicians that were previously removed.  Without the Board of Pharmacy temporary rule, new Animal Euthanasia Drug Outlet registrations cannot be issued and existing registered Animal Euthanasia Drug Outlets will not be able to renew.  Animal Euthanasia Drug Registrations with the Oregon Board of Pharmacy expire December 31, 2011.
 
Notice of Temporary Rulemaking and Statement of Need - Effective 12/15/11

 
 
On December 14, 2011, The Board amended 855-080-0100 to incorporate a reference to Division 110 where 2011 legislatively approved fee increase which were adopted by Temporary Rule in June and effective July 1, 2011 were implemented.  The Board suspends temporary rules
855-080-0100(T) and  855-080-0103(T).
 
Certificate of Permanent Rulemaking - Effective 12/15/11



October 2011
 
On October 12, 2011 The Board amended rules to accommodate revisions that were made to the Veterinary Medical Examining Board's rules relating to the registration of Certified Euthanasia Technicians that expires on October 31, 2011.
 
Without this temporary rule, new Animal Euthanasia Drug Outlet registrations cannot be issued and existing registered Animal Euthanasia Drug Outlets will not be able to renew an Animal Euthanasia Drug Outlet Registration with the Oregon Board of Pharmacy which expires December 31, 2011.  The Board eliminates the requirement for Certified Euthanasia Technicians and establishes new training requirements for those who possess/administer sodium pentobarbital for euthanizing injured, sick, homeless or unwanted domestic pets and other animals.
 
Notice of Temporary Rulemaking and Statement of Need - Effective 10/31/11

 

June 2011
 
On June 23, 2011 The Board adopted rules to amend licensing fees for registration and renewal of individuals and certain drug outlets. The Board’s 2011-2013 Legislatively Adopted Budget is dependent on the implementation of fee increases effective 7/1/11. These rules amend licensing fees for the registration and renewal for individuals and certain drug outlets.
 
Notice of Temporary Rulemaking and Statement of Need - Effective 7/1/11

 
The Board also adopted permanent rules for criminal background checks on employees and potential employees, and amended pharmacist licensing rules. These rules provide the authority and process for the Board to conduct fingerprint-based nationwide criminal background checks, through the Oregon State Police and FBI, on employees, potential employees and applicants for volunteer positions with the Board. This includes a process for final determination of fitness and an appeals procedure. These rules replace temporary rules adopted in January 2011.
 
The amendment to 855-019-0120 provides a one-year waiting period for applicants for licensure as a pharmacist who have failed the MPJE or NAPLEX three times.
 
Certificate of Permanent Rulemaking - Effective 7/1/11

  • 855-010 - Criminal Background Checks for Potential Board Employees
  • 855-019 - Pharmacist Licensure Exam Limits
 

April 2011
 
On April 6, 2011 The Board adopted and amended rules regarding administration of drugs, remote dispensing and compounding of drugs.
 
Certificate of Permanent Rulemaking - Effective 4/18/11 

 
 
On April 6, 2011 The Board adopted rules to amend Controlled Substances Schedule I with addition of certain synthetic cannabinoids and other dangerous chemicals. 

Certificate of Permanent Rulemaking - Effective 4/11/11
 

February 2011
 
Need for the Temporary Rule:
 
These rules provide the authority and process for the Board to conduct fingerprint-based nationwide criminal background checks, through the Oregon State Police and FBI, on employees, potential employees and applicants for volunteer positions with the Board. This includes a process for final determination of fitness and an appeals procedure.
 
Notice of Temporary Rulemaking & Statement of Need  - Effective 2/8/11

  • 855-010 - Fingerprinting for Employment Applicants

Rulemaking Hearings
 
On November 22, 2011 the Oregon Board of Pharmacy conducted a rulemaking hearing to amend or adopt new Collaborative Therapy, Immunization, Intern, Pharmacy Depots, Manufacturer, Controlled Substance and Fee Rules.  
 
Notice of Proposed Rulemaking & Statement of Need

 
On March 23, 2011, the Oregon Board of Pharmacy conducted a rulemaking hearing to adopt and amend rules regarding administration of drugs, remote dispensing, compounding, and controlled substances schedule.
 
Notice of Rulemaking Hearing and Statement of Need
 

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2010 RULE CHANGES

December 2010
 
On December 14, 2010 the Board adopted rules for the Heath Professional’s Service Program rules, and to clarify rule on electronic prescribing, and amend continuing education requirements.
 
Certificate of Permanent Rulemaking - Effective 12/23/10

 
 
Notice of Proposed Rulemaking & Statement of Need
 
Adopt Heath Professionals Service Program rules, clarify rule on electronic prescribing, amend continuing education requirements.
 
1. The Health Professional’s Service Program is the impaired health professionals program established by the Oregon Health Authority pursuant to ORS 676.190. These rules provide a framework for the Board of Pharmacy’s participation in the Program and establish a procedure for the Board to refer licensees to the program. The rules also specify a process for the Board to approve an independent evaluator and set requirements that must be met by participants. The rules replace the Temporary Rules effective from June 29, 2010.
 
2.  The amendment to the Continuing Education rule deletes the requirement that 11 hours need to be in "therapeutics". The Board proposes adding a requirement that one hour be in the topic of Patient Safety or Medication Error Reduction.
 
3.ORS 689.515 was revised in 2009 to permit "no substitution" instructions to be electronic or in writing. This amendment to OAR 855-041-0065 brings regulations in line with statute.  

October 2010
 
On October 13, 2010 the Board amended rules for administration of vaccines by pharmacists.
 
Certificate of Permanent Rulemaking 

 
 
 
On October 13, 2010 the Board also adopted temporary rules that list certain synthetic cannabinoids as Schedule 1 controlled substances.
 
Press Release - 10/15/10  

Need for the Temporary Rule(s):
By adding the synthetic cannabinoid chemicals to Schedule 1 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.
 
 
Notice of Temporary Rulemaking & Statement of Need  - Effective 10/15/10



August 2010
 
Notice of Rulemaking Hearing & Statement of Need 

These amendments implement legislation passed in 2009 (Ch 250, OL 2009) and permit a qualified pharmacist to administer a vaccine to a person who is at least 11 years of age. Amendments also change the reporting requirements in accordance with protocols written and approved by the Oregon Health Authority.


June 2010
 
On June 16, 2010 the Board adopted permanent rules that amend definitions, fees, and rules for pharmacists and pharmacy technicians and adopted new rules for Charitable Pharmacies.   
 
Permanent Rule Filing Certificate - Effective 6/29/10
 
 
In addition, the Board adopted permanent rules that reschedule methamphetamine into Controlled Substance Schedule 1 and marijuana into Controlled Substance Schedule II.
 
Permanent Rule Filing Certificate - Effective 6/29/10
 
 
 
The Board also adopted temporary rules for agency participation in the Impaired Health Professional Program established by the Oregon Health Authority and establishes application procedures for remotely supervised pharmacy facilities. 
 
Temporary Rule Filing Certificate and Statement of Need - Effective 6/29/10
 
Temporary Rule Filing Certificate and Statement of Need - Effective 7/8/10  

April 2010
 
On April 7, 2010 the Board amended permanent rules that amend rules for pharmacy interns and pharmacist licensure requirements, and adopted new rules for hospital pharmacies.
 
Permanent Rule Filing Certificate - Effective 4/30/10
 
Div 031 & 019 - Interns - The rule changes for Interns bring the requirements for experiential education in line with current standards and practices for the Doctor of Pharmacy (Pharm. D.) programs. Schools and colleges of pharmacy now have a greater responsibility for managing the students’ “intern hours” and the Board will not duplicate their record keeping. In order to monitor licensees more effectively, the Intern license will now be renewable every two years rather than a four year license.  Changes to rules for out-of-state Pharmacists seeking Oregon licensure reflect changes to national standards.
 
Interns
 
 
Div 041 - Hospital Pharmacies - The rules required updating to accommodate modern practices and new technologies, and to provide a structure for drug management and control in hospitals. This action repeals and totally replaces the existing hospital rules.  See below for a complete summary of the new Division 041 Hospital rules section by section. 
 
Hospital Pharmacies


January 2010
 
On January 27, 2010 the Board adoped and amended permanent rules that provide regulatory framework to permit prescribing and dispensing of drugs for Expedited Partner Therapy (EPT).
 
These amendments and new rules will permit pharmacists, nurse practitioners, Clinical Nurse Specialists and other practitioners regulated by rules in Division 41 and 43 to prescribe and dispense, within their scope of practice, specified drugs for an unnamed patient when the prescription is identified as “for EPT Therapy”. The rules provide a labeling protocol when the patient’s name is unknown. There are also minor rule amendments in Division 43 to incorporate changes necessitated by recent legislation.
 
Permanent Rule Filing Certificate - Effective 2/8/10 


 
 
On January 27, 2010 the Board also amended permanent rules that revise and update certain fees and establishes conditions for waiver of fees. It also establishes criteria and charges for special inspections of drug outlets and establishes a fee schedule for administrative fees which the Board approved.  The current fee schedule can be found below:
 
Rule Filing Certificate 


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