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State and Federal Pharmacy Laws & Rules

2018 PROPOSED & ADOPTED RULES

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 the 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  • Division 045 - Compounding proposed rules repeals outdated Compounding rules and proposes replacement rules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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RULE CHANGES 2010-2017

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 23 divisions which are categorized by subject.  Division 41  is by far the largest and most pertinent to the practice of pharmacy. 

OREGON STATE PHARMACY STATUTES

 

OREGON STATE PHARMACY RULES  

(Click the link above to navigate to the Oregon Administrative Rules by Division)
 
To download a PDF copy of the Oregon Board of Pharmacy Laws & Rules, click here.  
(Filed through 1/15/18)
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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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