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State and Federal Pharmacy Laws & Rules

RECENT RULE CHANGES

April 2015
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.
December 2015
On December 17, 2015 the Board amended or adopted rules in Division 006, 019, 025, 043, 062 and repealed rules in Division 090. The Division 006 Definition rules establish definitions for clinical pharmacy agreements and the practice of clinical pharmacy. Amendments also clarify compounding under a shared pharmacy service agreement is only allowed by a pharmacy located in Oregon for a practitioner or dispenser located in Oregon for outlets and practitioners located in Oregon. Amendments are primarily related to Oregon 2015 House Bill 2028.
Division 019 Pharmacist rules establish definitions for clinical pharmacy agreements and practice of clinical pharmacy. Amendments also define the type of activities that require the professional judgment of a pharmacist. Other amendments allow a pharmacist to authorize an intern to perform the duties of a pharmacist under their direction and supervision, after the intern successfully completes his or her first academic year and only after successful completion of coursework corresponding to the specific duties. An intern may not perform final verification. State Drug Therapy Management Protocol rules are also adopted. Rules adopted or amended in this Division are primarily related to Oregon 2015 House Bill 2028.
Other amendments in the Division 019 Pharmacist rules allow a pharmacist to administer vaccines to persons who are at least seven years of age. Amendments also allow a pharmacist to prescribe immunizations, including oral vaccines, as established by written protocols approved by the Oregon Health Authority. These amendments are related to Oregon 2015 Senate Bill 520.
Amendments in the Division 025 Certified Oregon Pharmacy Technician rules clarify in rule that newly licensed Certified Oregon Pharmacy Technicians do not need to complete the annual continuing education requirements prior to their first renewal. The Certificate and Order for Filing makes the current temporary rule permanent.
Amendments in the Division 043 Practitioner Dispensing rules establish a waiver clause in the Drug Delivery and Control rules. The waiver clause allows for requests for exemption of certain requirements if the waived requirements will further public health and safety. The Certificate and Order for Filing makes the current temporary rule permanent.
Amendments in the Division 062 Drug Distribution Agent rules update record keeping requirements. They also identify the information that a Drug Distribution Agent who distributes product to a Wholesaler or Pharmacy must contain in their records. Amendments also reflect that a pedigree must be maintained if a Drug Distribution Agent distributes product to another Drug Distribution Agent. The Certificate and Order for Filing makes the current temporary rule permanent.
Division 090 Aerosol Sprays rules are repealed. This is because all fluorocarbon aerosol sprays which contain a medication are no longer manufactured in the United States. The rules were established in 1977 as an exception to the banned use of fluorocarbon aerosol sprays which delivered medication.
  • Div 006  Definitions
  • Div 019  Definitions, Vaccines and Immunizations
  • Div 025  Certified Oregon Pharmacy Technicians
  • Div 043  Practitioner Dispensing
  • Div 062  Drug Distribution Agents
  • Div 090  Aerosol Sprays

On December 17, 2015 the Board extended the effective date for the Division 041 Auto Refill rules in OAR 855-041-1120(5)-(8) to July 1, 2016 to allow more time for implementation. The Board expects full compliance with this part of the rule by July 1, 2016.

Certificate and Order for Permanent Administrative Rules - Effective 07/01/16

 November 2015
2015 HB 2879 requires the Board to adopt rules (OAR 855-019-0400 through 855-019-0435) to implement new laws that become operative on January 1, 2016.
These Temporary Rules allow Oregon pharmacists to prescribe and dispense hormonal contraceptive patches and self administered oral hormonal contraceptives under certain circumstances.
At the Board's 11/4/15 meeting, they adopted the Temporary Rules to allow pharmacies time to evaluate and prepare policies and procedures for the January 1, 2016 operative date and for pharmacists to complete the required training that was also approved. The Board consulted with legislatively identified parties to advise the Board in creation of the standard procedures for pharmacist prescribing of hormonal contraceptives. Pharmacists who prescribe must also complete an ACPE and Board approved training program. The legislative intent is to remove barriers and provide timely access to care. The Board will pursue permanent rulemaking in early 2016 that will allow for public input.
Certificate and Order for Temporary Rules - Effective 11/6/15 - Operative 1/1/2016

 

 

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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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