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State and Federal Pharmacy Laws & Rules

RECENT RULE CHANGES

April 2016
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 to care.
 
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.

  • Division 025 - 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.

 

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RULE CHANGES 2010-2015

 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 1/15/16
 
 
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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