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State and Federal Pharmacy Laws & Rules
2008 Rule Changes
Oregon Laws & Rules
Federal Regulations
2008 Rule Changes
FEBRUARY 2008
The following rule filing amends rules regarding nonprescription drug outlets, repeals DMSO rules, as well asadopts new rules, and renumber and amend existing rules regarding pharmacists and compounding of drugs.
 
Permanent Rules Certificate - Effective 2/20/08
 
 

JANUARY 2008
On August 17, 2007, the US Department of Health and Human Services, Center for Medicaid and State Operations issued a letter of guidance to State Medicaid agencies on section 7002(b) of the U.S. Troop Readiness, Veterans’ Care, Katrina Recovery, and Iraq Accountability Appropriations Act of 2007, regarding the use of tamper-resistant prescription pads, which was signed into law May 25, 2007.
 
This section amends the Social Security Act that effects payment reimbursements on Medicaid prescriptions that do not meet the new federal requirement for tamper-resistant prescriptions.
 
On Wednesday January 30, 2008, during a public meeting, the Oregon Board of Pharmacy adopted a permanent rule establishing definitions for “electronically transmitted prescription” and “tamper-resistant prescription”.  These definitions had previously been discussed with Department of Human Services and have been in place as a Temporary Rule since August 2007.
 
Permanent Rules Certificate - Effective 2/5/08
 

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 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 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: September 25, 2008

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