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State and Federal Pharmacy Laws & Rules
2012 RULE CHANGES

 

May 2012

On April 11, 2012 The Board adopted and amended rules related to Pharmacy Depots, Technician Checking Validation Programs and Residential Drug Outlets.

The Div. 041 Pharmacy Depot Rules previously amended in December 2011 are amended to further clarify where a patient may designate delivery of a prescription. The Div. 041 Residential Drug Outlet rules are renumbered, amended and repealed to update rules that have not been updated since 1990. The Div. 041 Technician Checking Validation Program (TCVP) rules will allow hospitals to implement TCVP's to allow the redirection of a pharmacist from a distributive role to a patient oriented role

Certificate of Permanent Rulemaking - Effective 5/1/12 

  • 855-041 - Technician Checking Validation Program (TCVP)
  • 855-041 - Pharmacy Depots 
  • 855-041 - Residential Drug Outlets

 

Rulemaking Hearings 

 

On May 24, 2012 the Oregon Board of Pharmacy will be conducting a rulemaking hearing to amend or adopt new Definitions, Practitioner Dispensing Outlet, Controlled Substance, Outlet Conduct and Fee rules.

Notice of Rulemaking Hearing and Statement of Need

* At the April 11, 2012 Board meeting, the Board discussed the March 22nd Rulemaking Hearing Report and corresponding written testimony.  The Board has revised the initial proposal and is required to re-notice this version for reconsideration.  We welcome your public comment and written testimony on the revised proposed rule as noticed. 

Division 006 rules are needed to amend rules to define "Board" and add "dispense" to existing definitions. The Division 041 Drug Outlet conduct rules are being reconsidered and define the Grounds for Discipline for outlets that fail to provide a working environment that protects the health, safety and welfare of patients. Division 043 Practitioner Dispensing Outlet rules are needed to implement 2012 SB 1565. These rules define "Supervising Physician Dispensing Outlet" and identify which entities must register as well as their requirements. Division 080 controlled Substance Identification rules establish requirements for the dispensing of a controlled substance directly to a patient or patient's representative. Division 080 Animal Euthanasia rules correct an outdated fee reference. Division 110 Fee rules are needed to establish a fee for Supervising Physician Dispensing Outlets.

Submit written comments to Karen MacLean, Rules Coordinator at the Board office (800 NE Oregon St., Suite 150, Portland, OR 97232) or email Karen.S.MacLean@state.or.us. Comments must be received by 4:30pm on Monday, May 21, 2012 for consideration. 

 

March 2012

On March 22, 2012 the Oregon Board of Pharmacy conducted a rulemaking hearing to
adopt and/or amend rules related to Drug Outlet conduct, Pharmacy Depots, Technician Checking Validation Programs etc.
 
Notice of Rulemaking Hearing and Statement of Need 

 

The Div. 41 Pharmacy Depot Rules previously amended in December 2011 are amended to further clarify where a patient may designate delivery of a prescription. The Div. 041 Residential Drug Outlet rules are renumbered, amended and repealed to update rules that have not been updated since 1990. The Div. 041 Drug Outlet conduct rules are new rules that define the Grounds for Discipline for outlets that fail to provide a working environment that protects the health, safety and welfare of patients. The Div. 041 Technician Checking Validation Program (TCVP) rules will allow hospitals to implement TCVP's to allow the redirection of a pharmacist from a distributive task to a cognitive task. 


January 2012 
 
On December 14, 2011 The Board adopted and amended rules regarding new Collaborative Therapy, Immunization, Intern, Pharmacy Depots and Manufacturer rules. 
 
Division 019 rules are amended to clarify requirements for Therapeutic Substitution and  the Administration of Vaccines.  Division 031 Intern rules are amended for clarification.  Division 041 Pharmacy Depot rules are amended to allow for exceptions.  Division 060 updates the Manufacturer rules to more clearly identify which entities must register as Manufacturers. 
 
Certificate of Permanent Rulemaking - Effective 1/1/12 

 
2011 RULE CHANGES
December 2011
 
On December 14, 2011, the Board amended Controlled Substance Rules relating to animal euthanasia.
 
Changes to OAR 855-080-0100 through 855-080-0103 are required to accommodate revisions that were made to the Veterinary Medical Examining Board’s rules relating to the registration of Certified Euthanasia Technicians that expired on October 31, 2011.
 
December 9, 2011, the Veterinary Medical Examining Board adopted temporary rules to reinstate licensure requirements for Certified Euthanasia Technicians that were previously removed.  Without the Board of Pharmacy temporary rule, new Animal Euthanasia Drug Outlet registrations cannot be issued and existing registered Animal Euthanasia Drug Outlets will not be able to renew.  Animal Euthanasia Drug Registrations with the Oregon Board of Pharmacy expire December 31, 2011.
 
 
 
On December 14, 2011, The Board amended 855-080-0100 to incorporate a reference to Division 110 where 2011 legislatively approved fee increase which were adopted by Temporary Rule in June and effective July 1, 2011 were implemented.  The Board suspends temporary rules
855-080-0100(T) and  855-080-0103(T).
 
 
 
October 2011
 
On October 12, 2011 The Board amended rules to accommodate revisions that were made to the Veterinary Medical Examining Board's rules relating to the registration of Certified Euthanasia Technicians that expires on October 31, 2011.
 
Without this temporary rule, new Animal Euthanasia Drug Outlet registrations cannot be issued and existing registered Animal Euthanasia Drug Outlets will not be able to renew an Animal Euthanasia Drug Outlet Registration with the Oregon Board of Pharmacy which expires December 31, 2011.  The Board eliminates the requirement for Certified Euthanasia Technicians and establishes new training requirements for those who possess/administer sodium pentobarbital for euthanizing injured, sick, homeless or unwanted domestic pets and other animals.
 
 
 

Rulemaking Hearings 

 
On November 22, 2011 the Oregon Board of Pharmacy conducted a rulemaking hearing to amend or adopt new Collaborative Therapy, Immunization, Intern, Pharmacy Depots, Manufacturer, Controlled Substance and Fee Rules.  
 
 
On March 23, 2011, the Oregon Board of Pharmacy conducted a rulemaking hearing to adopt and amend rules regarding administration of drugs, remote dispensing, compounding, and controlled substances schedule.
 
 
 
 
 
RULE CHANGES 2010-2011
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 order a CD containing 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