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State and Federal Pharmacy Laws & Rules

RECENT RULE CHANGES

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.

  • Division 065 – Wholesaler reporting of 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
 
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.
December 2016
 
The Board permanently adopted the following rules at its December 7, 2016 Board meeting:
 
Changes to Division 019 - Reduce the number of days before eligibility to retake the NAPLEX.  Limits the number of retakes on the NAPLEX and MPJE exams to no more than three times in one year for a lifetime maximum of five attempts. This change is consistent with the National Association of Boards of Pharmacy (NABP) new policy that changed on 11/1/16.
 
Changes to Divisions 019 & 041 - Permanently incorporates new statutory language put forth by House Bill 4124 (2016) related to Naloxone. The bill permits pharmacists to prescribe and distribute unit-of-dose packages of naloxone to individuals who conduct or complete OHA approved training.  It allows a trainer to possess and distribute naloxone to trainees, and allows trainees to possess and administer naloxone to an individual experiencing an opiate overdose. The rule (1) gives the purpose; (2) specifies the qualifications of participating pharmacists and individuals; and (3) outlines the delivery of care expectations for the pharmacist and pharmacy, including documentation and recordkeeping.
Changes for Division 080 - Permanently add illicit synthetic opioids/fentanyl derivatives (known as U-47700 and W-18) to Oregon Schedule CI drugs. Schedule I also includes any substituted derivatives of fentanyl that are not specifically listed, or are not FDA approved. 
 
 
November 22, 2016 Rulemaking Hearing
On October 6, 2016, the Board sent the following rules to a Rulemaking Hearing that is scheduled for 9:30a.m. on Tuesday, November 22, 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. 11/22/16.
Notice of Proposed Rulemaking Hearing and Statement of Need and Fiscal Impact

Amendments to Division 007 & 041 - The proposed rule amendments update rules related to the registration and regulation of Drug Rooms.
Amendments to Division 019 - The proposed rule amendments reduce the number of days before eligibility to retake the NAPLEX exam and number of retakes.
Amendments to Division 019 - The proposed rules add a no cost legislatively approved registration for liability limitations for pharmacist volunteers. 
Amendments for Divisions 019 & 041 - The proposed rule amendments permanently incorporate new statutory language put forth by House Bill 4124 (2016) related to Naloxone.  (Currently Temp. Rules)
Amendments for Division 041 - The proposed rule amendments add a requirement for outlets to notify the Board within 10 days of a Board licensee’s termination or resignation in lieu of termination.
Amendments for Division 041 - The proposed rule amendments put forth the requirements for a pharmacy to lawfully participate in Drug Take Back initiatives.
Amendments for Division 041 - The proposed rule amends the Remote Dispensing Machine (RDM) rules to allow use of new technology in licensed residential facilities.
Amendments for Division 043 - These rules are intended to distinguish between traditional and non-traditional dispensing of drugs by a health care practitioner who has been granted dispensing privileges from their licensing board and dispenses from their practice location.
Amendments for Division 044 - The proposed rule amendments incorporate new statutory language put forth by Senate Bill 1514 (2016) related to Charitable Pharmacies.
Amendments for Division 080 - The proposed rule amendments permanently add synthetic opioids/fentanyl derivatives (known as U-47700 and W-18) to Oregon Schedule CI drugs. (Currently Temp. Rules)

September 2016
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.
 
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RULE CHANGES 2010-2016

 Please click here.

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OREGON LAWS & RULES

State laws regulating the practice of pharmacy in Oregon fall into two categories: statutes and rules.


STATUTES are laws which have been enacted by a vote of the legislature.  Any modifications made to a statute also requires the approval of the legislature. The Oregon Board of Pharmacy has the responsibility for implementing and regulating Chapters 475 and 689 of the Oregon Statutes.

RULES, on the other hand, are written by the Board of Pharmacy. Rules are required to be supported by a statute. Rules typically are less general and more specific to a particular situation. All Oregon pharmacy rules are found in Chapter 855. Chapter 855 is subdivided into 18 divisions which are categorized by subject. Below is a list of each division by title, which can be accessed by double clicking on the name. Division 41  is by far the largest and most pertinent to the practice of pharmacy. 
To download a searchable copy of the Oregon Board of Pharmacy Laws & Rules, click here. Filed through 1/15/17
 
 
Note: Regarding the electronic prescribing of controlled substances,  ORS 475.185 was clarified during the 2014 Legislative session. Please see: https://www.oregonlegislature.gov/bills_laws/lawsstatutes/2014R1orLaw0055ss.pdf


OREGON STATE PHARMACY STATUTES 
  
 
Chapter 475: Controlled Substances; Illegal Drug Cleanup; Paraphenalia; Precursors 
 
Chapter 689: Pharmacists, Outlets, Sale 
 

OREGON STATE PHARMACY RULES 
  
 
OAR 855 - Table of Contents 
 
Division 1 Procedural Rules 
 
Division 6 Definitions
 
Division 7 Public Health Emergency 
 
Division 10 Board Administration and Policies 
 
Division 11 Health Professional's Service Program 

Division 19 Pharmacists          
 
Division 21 Pharmacist Continuing Education
 
Division 25 Certified Oregon Pharmacy Technicians and Pharmacy Technicians 
 
Division 31 Internship Regulations
 
Division 35 Operation of Nonprescription and Medicinal Gas Outlets
 
Division 41 Operation of Pharmacies (Retail and Institutional Drug Outlets)  Consulting Pharmacists and Operation of Drug Rooms *
 
Resources for Drug Storage Rules (OAR 855-041-1036)
 
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FEDERAL REGULATIONS

In addition to Oregon statutes and rules, federal laws regulate the practice of pharmacy with respect to controlled substances. These laws can be found in Title 21 - Food and Drugs, Part 1300 to END of the Code of Federal Regulations. Part 1300 to END, includes Chapter II - Drug Enforcement Administration, Department of Justice and Chapter III - Office of National Drug Control Policy.  The Pharmacist´s Manual published by the DEA (2010) is a condensed version of the laws found in Title 21. For the PDF version of the Pharmacist's Manual please click here.  For HIPAA Information, please click here.
 
Pursuant to ORS 689.522(3) the Board of Pharmacy shall link a list of biosimilar products determined by the FDA to be interchangeable.
 
 
FOOD AND DRUG ADMINISTRATION
 
DRUG ENFORCEMENT ADMINISTRATION
 
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