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State and Federal Pharmacy Laws & Rules
RECENT RULE CHANGES

 

August 2014 

The Board is proposing permanent adoption of this temporary rule which allows pharmacy residents who have been accepted into a program the ability to reciprocate sooner in order to satisfy residency requirements. This is applicable to nonresident pharmacists who have obtained licensure in another state, but have less that one full year of pharmacist licensure to reciprocate. Public comment will be accepted through October 13, 2014.

Notice of Proposed Rulemaking and Statement of Need

  • Div 019 - Licensure by Reciprocity

 

June 2014 

On Wednesday June 11, 2014 the Board amended rules in Division 019 and Division 080. The Division 019 Foreign Pharmacy Graduate rules remove the minimum score requirements for the Test of English as a Foreign Language (TOEFL) and Internet Based Test (iBT). The amendment require Foreign Pharmacy Graduates applying for licensure in Oregon to provide the original Foreign Pharmacy Graduate Equivalency Certificate (FPGEC) issued by the National Association of Boards of Pharmacy, Foreign Pharmacy Examination Committee. The Division 080 Schedule I rules reestablish as Schedule I items gamma-butyrolactone and other cannabinoid receptor agonists that are not listed in OARs 855-080-0022 through 0026 (Schedule II through V) or that are not an FDA approved drug. In addition, certain exceptions are reestablished as well as Schedule I compounds in structural classes 2a-2k and their salts. These Schedule I items have been reestablished as a result of administrative errors.

Certificate and Order for Permanent Administrative Rules - Effective 6/18/14

 

April 2014

On Wednesday April 9, 2014, the Board sent rules in Division 019 and Division 080 to a Rulemaking Hearing scheduled at 9:30 a.m. on May 22, 2014 in Room 1A of the Portland State Office Building, 800 NE Oregon St. Portland, OR 97232. The Division 019 Foreign Pharmacy Graduate rules propose to remove the minimum score requirements for the Test of English as a Foreign Language (TOEFL) and Internet Based Test (iBT). Foreign Pharmacy Graduates must  provide the Board with the original certificate issued by the National Association of Board's of Pharmacy (NABP) Foreign Pharmacy Graduate Examination Committee as one of the conditions for applying for licensure in Oregon. The Division 080 Schedule I rules propose to reestablish other cannabinoid receptor agonists, gamma butyrolactone, an exception clause and other  and other compounds in structural classes 2a-2k.

Notice of Proposed Rulemaking and Statement of Need

April 9, 2014

On Wednesday April 9, 2014 the Board amended by temporary rule its Division 019 Pharmacist Licensure by Reciprocity rules to allow pharmacy residents who have been accepted into a program the ability to reciprocate sooner in order to satisfy residency requirements. This is applicable to nonresident pharmacists who have obtained licensure in another state, but have less than one full year of pharmacist licensure to reciprocate.

Division 019 Certificate and Order for Temporary Rules - Effective 4/25/14

  •  Div 019 - Licensure by Reciprocity

April 15, 2014

Division 080 rules were amended to include Schedule I compound structural classes 2a-2k and their salts.

Division 080 Certificate and Order for Temporary Rules -Effective 04/15/14

 

February 2014
On Wednesday February 5, 2014 the Board amended by temporary rule its Division 080 Schedule I rules to include gamma-butyrolactone. Other rules amended by temporary rule include the Board's Division 019 Foreign Pharmacy Graduate rules. These rules were amended to eliminate reference to minimal acceptable scores to obtain FPGEC Certification.
 
  • Div 019 - Foreign Pharmacy Graduates

Division 080 Certificate and Order for Temporary Rules - Effective 02/28/14

 
 
January 24, 2014
On Wednesday December 19, 2013 the Board adopted or amended rules relating to public health emergencies, the Health Professional's Service Program (HPSP), biosimilars and naloxone as required by the 2013 Oregon Legislature. Additionally, rules for the distribution of epinephrine in emergency health circumstances were adopted. Other rules in Division 019 and 041 were adopted and amended to require a pharmacist and outlet to notify the Board within one (1) business day in the even of significant drug losses or violations related to drug theft.  
  • Div 007 - Public Health Emergencies
  • Div 011 - Health Professionals Service Program
  • Div 019 - Administration of Vaccines by Pharmacists
  • Div 019 - Duty to Report
  • Div 041 - Definitions
  • Div 041 - Distribution of Emergency Medication
  • Div 041 - Prescriptions
  • Div 041 - Reporting Drug Loss
 
 
January 3, 2014
On Wednesday December 18, 2013 the Board amended its Division 041 rules to change the name of Remote Dispensing Facility to Remote Distribution Facility for clarification purposes from other similar named rules. In addition the Board amended its Division 110 Fee rules to implement revenue surplus reductions pursuant to ORS 291.055(3) for Pharmacist Score Transfer and Supervising Physician Dispensing Outlet fees.
 
 
 
 
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.
 
 
 
 
RULE CHANGES 2010-2013
Please click here.

 
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 copy of the Oregon Board of Pharmacy Laws & Rules, click here. Filed through 7/2014

To order a CD or paper copy of the Oregon Board of Pharmacy Laws & Rules, click here



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      -    Frequently Asked Questions for Division 19 
 
Division 21 Continuing Pharmacy Education
 
Division 25 Certified 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 *

Division 42 Nuclear Pharmacies and Pharmacists
 
Division 43 Practitioner Dispensing
 
Division 44 Charitable Pharmacies
 
Division 45 Sterile and Non-sterile Compounding - Frequently Asked Questions for Division 45
 
Division 50 Restriction on Retail Sales
 
Division 60 Pharmaceutical Manufacturers
 
Division 62 Drug Distribution Agent 

Division 65 Wholesale Drug Outlets
 
Division 70 Prophylactics and Contraceptives
 
Division 80 Schedule of Controlled Substances
 
Division 90 Aerosol Sprays
 
Division 110 Fees
 

 

 
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.


FOOD AND DRUG ADMINISTRATION
Laws Enforced by the FDA
Food Drug and Cosmetic Act
Search FDA Rules under the FD & C Act: 21 CFR Parts 1-1499
Dietary Supplement Health and Education Act of 1994

DRUG ENFORCEMENT ADMINISTRATION
Controlled Substances Act
Title 21 - Food and Drugs, Part 1300 to END

 
Div 041 Reporting Drug Loss.pdf