| State and Federal Pharmacy Laws & Rules |
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| 2012 RULE CHANGES |
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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
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| 2011 RULE CHANGES |
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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.
Notice of Temporary Rulemaking and Statement of Need - Effective 12/15/11
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).
Certificate of Permanent Rulemaking - Effective 12/15/11
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.
Notice of Temporary Rulemaking and Statement of Need - Effective 10/31/11
June 2011
On June 23, 2011 The Board adopted rules to amend licensing fees for registration and renewal of individuals and certain drug outlets. The Board’s 2011-2013 Legislatively Adopted Budget is dependent on the implementation of fee increases effective 7/1/11. These rules amend licensing fees for the registration and renewal for individuals and certain drug outlets.
Notice of Temporary Rulemaking and Statement of Need - Effective 7/1/11
The Board also adopted permanent rules for criminal background checks on employees and potential employees, and amended pharmacist licensing rules. These rules provide the authority and process for the Board to conduct fingerprint-based nationwide criminal background checks, through the Oregon State Police and FBI, on employees, potential employees and applicants for volunteer positions with the Board. This includes a process for final determination of fitness and an appeals procedure. These rules replace temporary rules adopted in January 2011.
The amendment to 855-019-0120 provides a one-year waiting period for applicants for licensure as a pharmacist who have failed the MPJE or NAPLEX three times.
Certificate of Permanent Rulemaking - Effective 7/1/11
- 855-010 - Criminal Background Checks for Potential Board Employees
- 855-019 - Pharmacist Licensure Exam Limits
April 2011
On April 6, 2011 The Board adopted and amended rules regarding administration of drugs, remote dispensing and compounding of drugs.
Certificate of Permanent Rulemaking - Effective 4/18/11
On April 6, 2011 The Board adopted rules to amend Controlled Substances Schedule I with addition of certain synthetic cannabinoids and other dangerous chemicals.
Certificate of Permanent Rulemaking - Effective 4/11/11
February 2011
Need for the Temporary Rule:
These rules provide the authority and process for the Board to conduct fingerprint-based nationwide criminal background checks, through the Oregon State Police and FBI, on employees, potential employees and applicants for volunteer positions with the Board. This includes a process for final determination of fitness and an appeals procedure.
Notice of Temporary Rulemaking & Statement of Need - Effective 2/8/11
- 855-010 - Fingerprinting for Employment Applicants
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.
Notice of Proposed Rulemaking & Statement of Need
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.
Notice of Rulemaking Hearing and Statement of Need
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| 2010 RULE CHANGES |
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December 2010
On December 14, 2010 the Board adopted rules for the Heath Professional’s Service Program rules, and to clarify rule on electronic prescribing, and amend continuing education requirements.
Certificate of Permanent Rulemaking - Effective 12/23/10
Notice of Proposed Rulemaking & Statement of Need
Adopt Heath Professionals Service Program rules, clarify rule on electronic prescribing, amend continuing education requirements.
1. The Health Professional’s Service Program is the impaired health professionals program established by the Oregon Health Authority pursuant to ORS 676.190. These rules provide a framework for the Board of Pharmacy’s participation in the Program and establish a procedure for the Board to refer licensees to the program. The rules also specify a process for the Board to approve an independent evaluator and set requirements that must be met by participants. The rules replace the Temporary Rules effective from June 29, 2010.
2. The amendment to the Continuing Education rule deletes the requirement that 11 hours need to be in "therapeutics". The Board proposes adding a requirement that one hour be in the topic of Patient Safety or Medication Error Reduction.
3.ORS 689.515 was revised in 2009 to permit "no substitution" instructions to be electronic or in writing. This amendment to OAR 855-041-0065 brings regulations in line with statute.
October 2010
On October 13, 2010 the Board amended rules for administration of vaccines by pharmacists.
Certificate of Permanent Rulemaking
On October 13, 2010 the Board also adopted temporary rules that list certain synthetic cannabinoids as Schedule 1 controlled substances.
Need for the Temporary Rule(s):
By adding the synthetic cannabinoid chemicals to Schedule 1 of the Oregon list of controlled substances (pursuant to ORS 475.035), the board gives law enforcement the authority needed to prosecute the sale and possession of these substances under the Oregon Uniform Controlled Substances Act.
Notice of Temporary Rulemaking & Statement of Need - Effective 10/15/10
August 2010
Notice of Rulemaking Hearing & Statement of Need
These amendments implement legislation passed in 2009 (Ch 250, OL 2009) and permit a qualified pharmacist to administer a vaccine to a person who is at least 11 years of age. Amendments also change the reporting requirements in accordance with protocols written and approved by the Oregon Health Authority.
June 2010
On June 16, 2010 the Board adopted permanent rules that amend definitions, fees, and rules for pharmacists and pharmacy technicians and adopted new rules for Charitable Pharmacies.
Permanent Rule Filing Certificate - Effective 6/29/10
In addition, the Board adopted permanent rules that reschedule methamphetamine into Controlled Substance Schedule 1 and marijuana into Controlled Substance Schedule II.
Permanent Rule Filing Certificate - Effective 6/29/10
The Board also adopted temporary rules for agency participation in the Impaired Health Professional Program established by the Oregon Health Authority and establishes application procedures for remotely supervised pharmacy facilities.
Temporary Rule Filing Certificate and Statement of Need - Effective 6/29/10
Temporary Rule Filing Certificate and Statement of Need - Effective 7/8/10
April 2010
On April 7, 2010 the Board amended permanent rules that amend rules for pharmacy interns and pharmacist licensure requirements, and adopted new rules for hospital pharmacies.
Permanent Rule Filing Certificate - Effective 4/30/10
Div 031 & 019 - Interns - The rule changes for Interns bring the requirements for experiential education in line with current standards and practices for the Doctor of Pharmacy (Pharm. D.) programs. Schools and colleges of pharmacy now have a greater responsibility for managing the students’ “intern hours” and the Board will not duplicate their record keeping. In order to monitor licensees more effectively, the Intern license will now be renewable every two years rather than a four year license. Changes to rules for out-of-state Pharmacists seeking Oregon licensure reflect changes to national standards.
Interns
Div 041 - Hospital Pharmacies - The rules required updating to accommodate modern practices and new technologies, and to provide a structure for drug management and control in hospitals. This action repeals and totally replaces the existing hospital rules. See below for a complete summary of the new Division 041 Hospital rules section by section.
Hospital Pharmacies
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.
Permanent Rule Filing Certificate - Effective 2/8/10
On January 27, 2010 the Board also amended permanent rules that revise and update certain fees and establishes conditions for waiver of fees. It also establishes criteria and charges for special inspections of drug outlets and establishes a fee schedule for administrative fees which the Board approved. The current fee schedule can be found below:
Rule Filing Certificate
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