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State and Federal Pharmacy Laws & Rules
2010 Rule Changes
2009 Rule Changes
Oregon Laws & Rules
Federal Regulations
2010 Rule Changes
January 2010
 
On January 27, 2010 the Board adoped and amended permanent rules that provide regulatory framework to permit prescribing and dispensing of drugs for Expedited Partner Therapy (EPT).
 
These amendments and new rules will permit pharmacists, nurse practitioners, Clinical Nurse Specialists and other practitioners regulated by rules in Division 41 and 43 to prescribe and dispense, within their scope of practice, specified drugs for an unnamed patient when the prescription is identified as “for EPT Therapy”. The rules provide a labeling protocol when the patient’s name is unknown. There are also minor rule amendments in Division 43 to incorporate changes necessitated by recent legislation.
 
Rule Filing Certificate - Effective 2/8/10 


January 2010 Rulemaking Hearing
 
On Wednesday, January 20, 2010, at 9:00AM, Room 1B, 800 NE Oregon St., Portland, the Oregon Board of Pharmacy will conduct a rulemaking hearing on the following topics:
 
Division 041, 043 – Provides regulatory framework to permit prescribing and dispensing of drugs for Expedited Partner Therapy (EPT).
 
Notice of Rulemaking Hearing & Statement of Need 

  • 855-041 - EPT - Note: 855-041-8000 and 8005 has been corrected to read 4000 and 4005 - 1/13/10 
  • 855-043 - EPT

2009 Rule Changes
December 2009
 
On December 15, 2009, the Board adopted and amended permanent registration rules for drug distribution agents and wholesalers, and amend fee schedules.
 
The new rules in Division 62, and the amended rules in Division 65 define which entities must register as drug distribution agents and as drug wholesalers. The new category of Drug Distribution Agent is created in Division 62 to accommodate entities that are involved in the drug manufacturing and distribution industry but that do not ever take ownership or possession of actual product and are not licensed with the FDA as manufacturers. Division 65 is further amended to eliminate confusion over the status of repackagers and brokers, to eliminate the requirement for a surety bond for a wholesale drug outlet that is accredited by the National Association of Boards of Pharmacy's Verified Accredited Wholesale Distributor (VAWD) program, and to classify certain entities as Class 2 Wholesalers. The fee schedule in Division 110 is amended to include the new category of Drug Distribution Agent. Division 110 is also amended to add the $25 Electronic Prescription Monitoring Fund Fee mandated by SB 355 (Oregon Laws 2009, Chapter 799), to the pharmacist license fee.
 
Rule Filing Certificate - Effective 12/24/09
  • 855-062 - Drug Distribution Agent  (Click here to view changes) 
  • 855-065 - Wholesalers (Click here to view changes)
  • 855-110 - Fees (Click here to view changes)
 
 
On December 15, 2009, the Board amended the criteria for implementation of rules for a Public Health Emergency.
 
Rule Filing Certificate - Effective 12/24/09

  • 855-007 - Public Health Emergency (Click here to view changes) 
 

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 19 Licensing of 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 Nonpharmacy Dispensing Outlets
 
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 (April 2004) 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

 
Page updated: February 08, 2010

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