June 27, 2013 Rulemaking Hearing
On Thursday, June 27, 2013 at 9:30AM, the Oregon Board of Pharmacy will conduct a rulemaking hearing on the following topics in Room 1A of the Portland State Office Building, 800 NE Oregon St., Portland, OR 97232.
Notice of Rulemaking Hearing and Statement of Need
- Consulting Pharmacist Practice
- Preamble for Central Fill, Remote Processing and Consulting or Drugless Pharmacies
- Remote Processing
- Consulting or Drugless Pharmacies
- Customized Patient Medication Packages
- Controlled Substances
Remote Processing Drug Outlet rules provide minimum requirements of operation for centralized prescription processing by a pharmacy that processes drug orders on behalf of an Oregon pharmacy.
Central Fill Drug Outlet rules provide minimum requirements of operation for centralized prescription drug filling by a pharmacy that fills drug orders on behalf of an Oregon pharmacy.
Consulting or Drugless Pharmacy rules are intended to ensure that a consulting pharmacist may safely store records and protected health information in an Oregon licensed drugless pharmacy when engaged in Independent Pharmacy Practice.
Consulting Pharmacist Practice rules are amended to establish registration requirements for a consulting pharmacist that stores health protected records outside an Oregon licensed pharmacy.
Customized Patient Medication Packages rules are amended to include a waiver clause.
Manufacturer rules are amended to clarify that any compounded non-patient specific drug from an
out-of-state drug outlet may only be distributed into the state by an Oregon registered manufacturer.
Controlled Substance rules are amended to include certain synthetic cannabinoids and cathinone-type derivatives that are subject to abuse, and have no legitimate medical purpose.
On April 4, 2013 The Board amended Pharmacist Licensure Fees.
The Board has implemented a temporary fee reduction for pharmacist licensure as allowed by ORS 291.055(3) due to an unexpected surplus in revenue. The license fee will be reduced from $200 to $120.
Notice of Temporary Rulemaking and Statement of Need - Effective 4/5/13
On February 14, 2013 The Board amended rules relating to Manufacturers.
This temporary rule clarifies that any out-of-state outlet that compounds a drug that is distributed into Oregon and is based on a non-patient specific order must register as a Manufacturer.
Notice of Temporary Rulemaking and Statement of Need - Effective 3/7/13
On December 12, 2012 The Board amended rules relating to Wholesaler and Fee rules.
Division 065 rules amend the definition of Class II Wholesaler to include Oxygen USP and medical gases. Division 110 rules implement a licensing and delinquent fee for the registration and renewal of Supervising Dispensing Outlets as required by 2012 Senate Bill 1565.
Certificate of Permanent Rulemaking - Effective 12/15/12
On December 12, 2012, The Board also reorganized, renumbered, amended and repealed rules within Division 041 in an effort to update the Division in its entirety and provide greater clarity for licensees. In addition rules relating to correctional facilities have been renumbered to Division 043 for organizational purposes. The Board will further review Division 041 in its entirety in 2013 after the reorganization occurs to ensure that rules within the Division accurately reflect current pharmacy practice standards and accommodate new business models.
The Board also amended emergency department distribution rules that update labeling and records requirements. The amendments also contain a waiver clause and establishes requirements for Automated Dispensing Machines (ADM) within the Emergency Department.
Certificate of Permanent Rulemaking - Effective 12/21/12
855-041 - Emergency Department Distribution
Recent Rulemaking Hearings
On Thursday, November 29, 2012 at 9:00AM, the Oregon Board of Pharmacy conducted a rulemaking hearing on the following topics in Room 1A of the Portland State Office Building, 800 NE Oregon St., Portland, OR 97232
The Division 041 Emergency Department Dispensing amendments are needed to update labeling and record requirements. These rules also propose to establish requirements for Automated Dispensing Machines (ADM) within the Emergency Department.
The Board is in the process of reorganizing and renumbering Division 041 to provide greater clarity, order and consistency with Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) regulations. For those rules that only required renumbering, they have been filed and updated with the Secretary of State. This filing includes rules that have been both renumbered and amended. Also
reflected are rules that are proposed to be repealed because they are outdated. The Board intends to develop new rules to accommodate new business models and will review the Division in its entirety to ensure that the rules accurately reflect current pharmacy practice standards.
The proposed amendments in Division 065 permanently amend the definition of Class II Wholesaler to include Oxygen USP and medical gases which is currently a Temporary Rule. The Temporary Rule will expire on December 16, 2012.
The proposed amendments in Division 110 establish a permanent licensing and delinquent fee for the registration and renewal of Supervising Physician Dispensing Outlets as required by 2012 Senate Bill 1565. This rule is currently a Temporary Rule and will expire on December 16, 2012.