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Rule Changes

2015 RULE CHANGES​

December 2015
On December 17, 2015 the Board amended or adopted rules in Division 006, 019, 025, 043, 062 and repealed rules in Division 090. The Division 006 Definition rules establish definitions for clinical pharmacy agreements and the practice of clinical pharmacy. Amendments also clarify compounding under a shared pharmacy service agreement is only allowed by a pharmacy located in Oregon for a practitioner or dispenser located in Oregon for outlets and practitioners located in Oregon. Amendments are primarily related to Oregon 2015 House Bill 2028.
Division 019 Pharmacist rules establish definitions for clinical pharmacy agreements and practice of clinical pharmacy. Amendments also define the type of activities that require the professional judgment of a pharmacist. Other amendments allow a pharmacist to authorize an intern to perform the duties of a pharmacist under their direction and supervision, after the intern successfully completes his or her first academic year and only after successful completion of coursework corresponding to the specific duties. An intern may not perform final verification. State Drug Therapy Management Protocol rules are also adopted. Rules adopted or amended in this Division are primarily related to Oregon 2015 House Bill 2028.
Other amendments in the Division 019 Pharmacist rules allow a pharmacist to administer vaccines to persons who are at least seven years of age. Amendments also allow a pharmacist to prescribe immunizations, including oral vaccines, as established by written protocols approved by the Oregon Health Authority. These amendments are related to Oregon 2015 Senate Bill 520.
Amendments in the Division 025 Certified Oregon Pharmacy Technician rules clarify in rule that newly licensed Certified Oregon Pharmacy Technicians do not need to complete the annual continuing education requirements prior to their first renewal. The Certificate and Order for Filing makes the current temporary rule permanent.
Amendments in the Division 043 Practitioner Dispensing rules establish a waiver clause in the Drug Delivery and Control rules. The waiver clause allows for requests for exemption of certain requirements if the waived requirements will further public health and safety. The Certificate and Order for Filing makes the current temporary rule permanent.
Amendments in the Division 062 Drug Distribution Agent rules update record keeping requirements. They also identify the information that a Drug Distribution Agent who distributes product to a Wholesaler or Pharmacy must contain in their records. Amendments also reflect that a pedigree must be maintained if a Drug Distribution Agent distributes product to another Drug Distribution Agent. The Certificate and Order for Filing makes the current temporary rule permanent.
Division 090 Aerosol Sprays rules are repealed. This is because all fluorocarbon aerosol sprays which contain a medication are no longer manufactured in the United States. The rules were established in 1977 as an exception to the banned use of fluorocarbon aerosol sprays which delivered medication.
  • Div 006  Definitions
  • Div 019  Definitions, Vaccines and Immunizations
  • Div 025  Certified Oregon Pharmacy Technicians
  • Div 043  Practitioner Dispensing
  • Div 062  Drug Distribution Agents
  • Div 090  Aerosol Sprays
On December 17, 2015 the Board extended the effective date for the Division 041 Auto Refill rules in OAR 855-041-1120(5)-(8) to July 1, 2016 to allow more time for implementation. The Board expects full compliance with this part of the rule by July 1, 2016.
 November 2015
2015 HB 2879 requires the Board to adopt rules (OAR 855-019-0400 through 855-019-0435) to implement new laws that become operative on January 1, 2016.
These Temporary Rules allow Oregon pharmacists to prescribe and dispense hormonal contraceptive patches and self administered oral hormonal contraceptives under certain circumstances.
At the Board's 11/4/15 meeting, they adopted the Temporary Rules to allow pharmacies time to evaluate and prepare policies and procedures for the January 1, 2016 operative date and for pharmacists to complete the required training that was also approved. The Board consulted with legislatively identified parties to advise the Board in creation of the standard procedures for pharmacist prescribing of hormonal contraceptives. Pharmacists who prescribe must also complete an ACPE and Board approved training program. The legislative intent is to remove barriers and provide timely access to care. The Board will pursue permanent rulemaking in early 2016 that will allow for public input.
Certificate and Order for Temporary Rules - Effective 11/6/15 - Operative 1/1/2016
 
 
October 2015
 
On October 8, 2015, the Board sent rules in Divisions 006, 019, 025, 041, 043, 062, 090 to a Rulemaking Hearing scheduled at 9:30 a.m. on Tuesday, November 24, 2015 in Conference Room 1A of the Portland State Office Building, 800 NE Oregon St. Portland, OR 97232. 
Various rules proposed for adoption or amendments are related to recent 2015 legislation.   For more information, please review the Notice of Proposed Rulemaking Hearing and Statement of Need and Fiscal Impact, as well as the draft proposed rules linked below.   The deadline to make comments on these rules is 4:30 p.m. 11/24/15.
Division 006 and 019 definition rules are needed as a result of 2015 House Bill 2028 which newly defines clinical pharmacy agreements, the practice of clinical pharmacy and state drug therapy management protocols. The Div. 006 rules also clarify the conditions for compounding under a shared pharmacy service agreement. The compounding shared pharmacy agreement amendments coincide with other definitions of compounding under a shared pharmacy service agreements throughout the Board's existing rules.  Div. 019 rules also clarify activities that require professional judgment and when an intern pay perform certain duties.   Div. 019 rules are needed as a result of 2015 Senate Bill 520 which lowers the age for pharmacists to administer vaccines and allows pharmacists to prescribe immunizations under OHA protocols.
Division 025 rules are currently temporary rules that need to be made permanent rules for clarification relating to Certified Oregon Pharmacy Technicians continuing education reporting.
Division 041 rules are needed to extend the effective date of the Auto Refill rules from 1/1/2016 to 7/1/2016 due to the number of extension request the Board received.
Division 043 rules are currently temporary rules that need to be made permanent to allow for waiver requests associated with this rule.
Division 062 rules are currently temporary rules that need to be made permanent to update record keeping requirements associated with Drug Distribution Agents. 
Division 090 rules are required to repeal out of date rules.
  • Div 006 Definitions - new statutory definitions for clinical practice and other clarifications
  • Div 019 Definitions – new statutory definitions for clinical practice and other clarifications
  • Div 019 Vaccines / Immunizations
  • Div 025 Certified Oregon Pharmacy Technician CE Requirement waived for first renewal
  • Div 041 Auto-Refill Program – extends effective date to 7/1/2016
  • Div 043 Practitioner Dispensing Rules – adds waiver clause in the Drug Delivery and Control rules
  • Div 062 Drug Distribution Agents - updates recordkeeping requirements
  • Div 090 Aerosol Sprays – repeals rules
August 2015
On Thursday August 13, 2015 the Board amended rules in Division 025 Renewal of Licensure as a Certified Pharmacy Technician. These amendments clarify in rule that Certified Oregon Pharmacy Technicians whose license has been issued beginning in October 2014 to date, are not required to complete the annual continuing education requirements prior to their first renewal. Rule revisions previously adopted in Division 025 increased the amount of continuing education hours due upon renewal for Certified Oregon Pharmacy Technicians. Prior reporting requirements for continuing education hours within the first year of licensure was managed by agency policy up until this time and due to the number of calls that we have received during this renewal cycle, the Board determined this needed to be addressed in the rules.
  • Division 025 - Renewal of Licensure as a Certified Pharmacy Technician
July 2015
On Thursday June 11, 2015 the Board amended or adopted rules in Division 025 Licensure as a Pharmacy Technician, Division 031 School and Preceptor Registration Responsibilities, Division 041 Non Resident Pharmacies, Division 041 Drug Storage 060 Pharmaceutical Manufacturers, 062 Drug Distribution Agents, Division 065 Wholesale Drug Outlets and Division 110 Fees.
Amendments in Division 025 make the Pharmacy Technician license expire the second June 30 from the date of issue, which is not to exceed more than two years.
Amendments in Division 031 make the Preceptor license a biennial license which expires on June 30 in odd numbered years. This corresponds with the Pharmacist biennial expiration date and renewal cycle.
Amendments in Division 041 Non-Resident Pharmacy rules establish requirement for when there is a change in Pharmacist-in-Charge (PIC) in a non-resident pharmacy. It also requires pharmacies to notify the Board of a change in PIC within 10 business days and identify a Pharmacist employed at the location to serve as the Board contact person until a PIC is designated. An Oregon licensed PIC must be employed within 90 days.
New Division 041 Drug Storage rules establish new requirements for the proper storage of drugs, cold storage monitoring and vaccine drug storage. Note that the Drug Storage rules are not effective until January 1, 2016.
New rules and amendments in Division 060 establish new definitions in the Pharmaceutical Manufacturer rules. Amendments also incorporate outsourcing facilities as one of the Food and Drug Administration (FDA) registration types that must be registered with the Board as a Manufacturer. Third-Party Logistics Providers are directed to register as a Drug Distribution Agent.
Amendments in Division 062 require Third-Party Logistics Providers to register as a Drug Distribution Agent. Amendments also establish new definitions, update minimum requirements for record keeping and inventory management, and update prohibited practices.
Amendments in Division 110 update the Fee rules to reflect that a Pharmacy Technician license issued prior to January 1, 2015 to a person under 18 years of age expires June 30 in odd numbered years. Other updates include listing the three classifications of Manufacturers and the three classification of Wholesalers identified in Division 060 and 065.
  • Div 025 - Licensure as a Pharmacy Technician
  • Div 031 - School and Preceptor Registration Responsibilities
  • Div 041 - Non-Resident Pharmacies
  • Div 060 - Pharmaceutical Manufacturers
  • Div 062 - Drug Distribution Agents
  • Div 065 - Wholesale Drug Outlets
  • Div 110 - Fees
  • Div 041- Drug Storage
On Thursday June 11, 2015 the Board amended by temporary rule, Division 043 Drug Delivery and Control rules. The amendment establishes a waiver clause that will allow requests for exemption of certain requirements if the waived requirements will further public health and safety.
  • Div 043 - Drug Delivery and Control 
On Thursday June 11, 2015 the Board amended by temporary rule, Division 062 Drug Distribution Agent rules. The amendments update record keeping requirements and identify the information that a Drug Distribution Agent who distributes product to a Wholesaler or Pharmacy must contain in their records. Amendments also reflect that a pedigree must be maintained if a Drug Distribution Agent distributes product to another Drug Distribution Agent.
  • Div 062 - Drug Distribution Agents
 
April 2015
On Thursday April 9, 2015 the Board sent rules in Division 019, 025, 031, 041, 060, 062, 065 and 110 to a Rulemaking Hearing scheduled at 9:30 a.m. on May 28, 2015 in Conference Room 1A of the Portland State Office Building, 800 NE Oregon St. Portland, OR 97232. The proposed rules in Division 019 establish minimum requirements for a Pharmacist-in-Charge (PIC) to be practicing onsite at a pharmacy.
 
Amendments also establish requirements for a Pharmacist to be designated as the PIC of more than one pharmacy. Amendments in Division 025 make the Pharmacy Technician license expire the second June 30 from the date of issuance, which is not to exceed more than two years.
 
Amendments in Division 031 make the Preceptor license a biennial license which expires on June 30 in odd numbered years.
 
Amendments in Division 041 establish requirements for when there is a change in Pharmacist-in-Charge (PIC) in a non-resident or resident pharmacy. It also requires pharmacies to notify the Board of a change in PIC within five business days and identify a Pharmacist employed at the location to serve as the Board contact person until a PIC is designated. Resident pharmacies are required to designate an Oregon licensed PIC within 60 days when there is a change. Non-resident pharmacies are required to designate an Oregon licensed PIC within 90 days when there is a change.
 
Rules proposed for adoption in Division 041 establish new requirements for the proper storage of drugs, cold storage and monitoring, and vaccine drug storage.
 
Amendments in Division 060 establish new definitions in the Pharmaceutical Manufacturer rules.  Amendments also incorporate outsourcing facilities as one of the Food and Drug Administration (FDA) registration types that must register with the Board as a Manufacturer.
 
Amendments in Division 062 Drug Distribution Agent rules require a third-party logistics provider to register as a Drug Distribution Agent. In addition, new definitions are incorporated into these rules.
 
Amendments in Division 065 Wholesaler rules direct third-party logistics providers to register as a Drug Distribution Agent. Amendments also establish new definitions, updates minimum requirements for record keeping and inventory management, and updates prohibited practices.
 
Amendments in Division 110 update the Fee rules to reflect that a Pharmacy Technician license issued prior to January 1, 2015 to a person under 18 years of age expires June 30 in odd numbered years.
 
Other updates include listing the three classifications of Manufacturers and the three classifications of Wholesalers identified in Divisions 060 and 065.
 
On Thursday April 9, 2015 the Board amended by temporary rule, Division 031 School and Preceptor Registration and Responsibilities and Eligibility for Exams and Pharmacist Licensure rules. The amendments change the Preceptor license from an annual license to a biennial license. This corresponds with the new Pharmacist biennial expiration date of June 30 in odd numbered years.
 
  • Div 031 - School and Preceptor Registration and Responsibilities and Eligibility for Exams and Pharmacist Licensure
December 2014
 
On Wednesday December 3, 2014 the Board amended, repealed or adopted rules in Division 001 Model Rules of Procedure, Division 019 Licensing of Pharmacists, Division 025 Certified Oregon Pharmacy Technicians and Pharmacy Technicians, and Division 080 Controlled Substances. Division 001 rule amendments reflect the most current version of the Attorney General's Uniform and Model Rules of Procedure under the Administrative Procedures Act. Division 019 rule amendments make the Pharmacist license valid for two years and renewable on a biennial basis. The Pharmacists license will expire on June 30 in odd numbered years. Other rule amendments require Pharmacists to provide a valid e-mail address and notify the Board in writing if they have had a change in their e-mail address. Rules for the petition for reinstatement of Pharmacist licenses have been repealed and a new section of rules are permanently adopted for the reinstatement of a revoked or surrendered license. Division 025 rule amendments require a Certified Oregon Pharmacy Technician or Pharmacy Technician to be at least 18 years of age and hold either a high school diploma or GED. The age requirement does not apply to persons currently under the age of 18 licensed by the Board as a Pharmacy Technician prior to January 1, 2015. Other amendments include making the Pharmacy Technician license valid for only one year except by petition to the Board or it may be reinstated if lapsed for more than five years. Certified Oregon Pharmacy Technicians are required to hold a national certification for initial licensure. However, effective January 1, 2015 it is no longer a requirement for renewals going forward. Certified Oregon Pharmacy Technicians are required to complete 10 continuing pharmacy education hours from September 1 through August 31 of each renewal cycle. Reinstatement rules have been permanently amended to provide applications with a process more aligned with Pharmacist reinstatement requirements. Division 080 rules are amended to add delta-9-tetrahydrocannabinol (THC) to Schedule II substances for clarification. The rules are effective January 1, 2015.
  • Div 001 - Model Rules of Procedure
  • Div 019 - Licensing of Pharmacists
  • Div 025 - Certified Oregon Pharmacy Technicians and Pharmacy Technicians
  • Div 080 - Controlled Substances
On Wednesday December 3, 2014 the Board amended Division 110 Fee rules. The amendments reflect the fee structure for Pharmacist biennial licensure. The current fee of $120.00 will remain the same for the fist biennial renewal cycle. However, the license will be valid for a period of two years, to further reduce the agency's ending balance. Other amendments include the biennial fee for the electronic prescription monitoring fund as well as a fee reduction for Pharmacists whose initial application for licensure is received or the mailing date of the application is within 180 days of expiration. These rules are effective April 1, 2015 to coincide with the transition to Pharmacist biennial licensure.  
  • Div 110 - Fees
On Wednesday December 3, 2014 the Board amended Division 021 Pharmacist Continuing Education rules. These rules require Pharmacists to complete three continuing pharmacy education units from July 1 through June 30 of each biennial license renewal cycle in approved continuing pharmacy education programs. These rules are effective July 1, 2015.
  •  Div 021 - Pharmacist Continuing Education
On Wednesday December 3, 2014 the Board amended Division 041 Prescription Refill rules. These rules establish requirements for the use of auto-refill programs, reminders, and pick-up notifications for retail pharmacies. These rules are effective January 1, 2016 in order to provide retail pharmacies time to modify their automated systems and notify patients as appropriate.
  • Div 041 - Prescription Refills
On Wednesday December 3, 2014 the Board amended Charitable Pharmacy rules in Division 044 to establish a waiver clause in the records section.
  • Div 044 - Records
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2014 RULE CHANGES

 

December 2014
On Wednesday December 3, 2014 the Board amended, repealed or adopted rules in Division 001 Model Rules of Procedure, Division 019 Licensing of Pharmacists, Division 025 Certified Oregon Pharmacy Technicians and Pharmacy Technicians, and Division 080 Controlled Substances. Division 001 rule amendments reflect the most current version of the Attorney General's Uniform and Model Rules of Procedure under the Administrative Procedures Act. Division 019 rule amendments make the Pharmacist license valid for two years and renewable on a biennial basis. The Pharmacists license will expire on June 30 in odd numbered years. Other rule amendments require Pharmacists to provide a valid e-mail address and notify the Board in writing if they have had a change in their e-mail address. Rules for the petition for reinstatement of Pharmacist licenses have been repealed and a new section of rules are permanently adopted for the reinstatement of a revoked or surrendered license. Division 025 rule amendments require a Certified Oregon Pharmacy Technician or Pharmacy Technician to be at least 18 years of age and hold either a high school diploma or GED. The age requirement does not apply to persons currently under the age of 18 licensed by the Board as a Pharmacy Technician prior to January 1, 2015. Other amendments include making the Pharmacy Technician license valid for only one year except by petition to the Board or it may be reinstated if lapsed for more than five years. Certified Oregon Pharmacy Technicians are required to hold a national certification for initial licensure. However, effective January 1, 2015 it is no longer a requirement for renewals going forward. Certified Oregon Pharmacy Technicians are required to complete 10 continuing pharmacy education hours from September 1 through August 31 of each renewal cycle. Reinstatement rules have been permanently amended to provide applications with a process more aligned with Pharmacist reinstatement requirements. Division 080 rules are amended to add delta-9-tetrahydrocannabinol (THC) to Schedule II substances for clarification. The rules are effective January 1, 2015.
 
  • Div 001 - Model Rules of Procedure
  • Div 019 - Licensing of Pharmacists
  • Div 025 - Certified Oregon Pharmacy Technicians and Pharmacy Technicians
  • Div 080 - Controlled Substances
On Wednesday December 3, 2014 the Board amended Division 110 Fee rules. The amendments reflect the fee structure for Pharmacist biennial licensure. The current fee of $120.00 will remain the same for the fist biennial renewal cycle. However, the license will be valid for a period of two years, to further reduce the agency's ending balance. Other amendments include the biennial fee for the electronic prescription monitoring fund as well as a fee reduction for Pharmacists whose initial application for licensure is received or the mailing date of the application is within 180 days of expiration. These rules are effective April 1, 2015 to coincide with the transition to Pharmacist biennial licensure.  
On Wednesday December 3, 2014 the Board amended Division 021 Pharmacist Continuing Education rules. These rules require Pharmacists to complete three continuing pharmacy education units from July 1 through June 30 of each biennial license renewal cycle in approved continuing pharmacy education programs. These rules are effective July 1, 2015.
  •  Div 021 - Pharmacist Continuing Education
On Wednesday December 3, 2014 the Board amended Division 041 Prescription Refill rules. These rules establish requirements for the use of auto-refill programs, reminders, and pick-up notifications for retail pharmacies. These rules are effective January 1, 2016 in order to provide retail pharmacies time to modify their automated systems and notify patients as appropriate.
On Wednesday December 3, 2014 the Board amended Charitable Pharmacy rules in Division 044 to establish a waiver clause in the records section.
 
October 2014
On Friday October 17, 2014 the Board amended rules in Division 019 to allow pharmacy residents who have been accepted into a program the ability to reciprocate sooner in order to satisfy residency requirements. This rule is applicable to nonresident pharmacists who have obtained licensure in another state, but have less that one full year of pharmacist licensure to reciprocate.
On Wednesday October 8, 2014, the Board sent rules in Division 001, Division 019, Division 021, Division 025, Division 041, Division 044, Division 080, and Division 110 to a Rulemaking Hearing scheduled at 9:30 a.m. on November 25, 2014 in Conference Room 1A of the Portland State Office Building, 800 NE Oregon St. Portland, OR 97232. The proposed rules in Division 001 reflect the most current Attorney General's Uniform and Model Rules of Procedures used by the Board. The proposed rules in Division 019 incorporate amendments to implement biennial licensure for Pharmacists to begin during the 2015 renewal cycle. Other proposed changes in Division 019 include requiring Pharmacists to provide the Board with a valid e-mail address and to notify the Board in writing if they have had a change of e-mail address. The proposed rules also repeal the existing rules for the petition for reinstatement of pharmacist licenses and create a new section of rules for the reinstatement of a suspended, revoked, or surrendered license. The proposed rules in Division 021 implement continuing education biennial requirements for Pharmacists that would become effective July 1, 2015. The proposed rules in Division 021 amend continuing education requirements to require Pharmacists to complete three continuing pharmacy education units in an approved continuing pharmacy education program over the course of two years. Other proposed changes in this Division include allowing a Pharmacist that reciprocates his or her license to Oregon to not be required to submit proof of continuing education during their initial renewal cycle. The proposed rules in Division 041 apply to retail pharmacies and establish requirements for the use of auto-refill programs, reminders, and pick-up notifications. The proposed rules in Division 044 establish a waiver clause in the records section of the Charitable Pharmacy rules. The proposed rules in Division 080 are amended to add delta-9-tetrahydrocannabinol (THC) to Schedule II controlled substances for clarification. The proposed rules in Division 110 reflect the fee structure for Pharmacist biennial licensure. Note that the current fee of $120.00 will remain the same. However, the first biennial Pharmacist license will be valid for two years at this rate. Also reflected is a biennial fee for the electronic prescription monitoring fund fee. A fee adjustment is proposed for initial Pharmacist licenses issued within 13 months of expiration. These rules are proposed to be effective April 1, 2015.
 
August 2014 
The Board is proposing permanent adoption of this temporary rule which allows pharmacy residents who have been accepted into a program the ability to reciprocate sooner in order to satisfy residency requirements. This is applicable to nonresident pharmacists who have obtained licensure in another state, but have less that one full year of pharmacist licensure to reciprocate. Public comment will be accepted through October 13, 2014.
  • Div 019 - Licensure by Reciprocity
 
June 2014 
On Wednesday June 11, 2014 the Board amended rules in Division 019 and Division 080. The Division 019 Foreign Pharmacy Graduate rules remove the minimum score requirements for the Test of English as a Foreign Language (TOEFL) and Internet Based Test (iBT). The amendment require Foreign Pharmacy Graduates applying for licensure in Oregon to provide the original Foreign Pharmacy Graduate Equivalency Certificate (FPGEC) issued by the National Association of Boards of Pharmacy, Foreign Pharmacy Examination Committee. The Division 080 Schedule I rules reestablish as Schedule I items gamma-butyrolactone and other cannabinoid receptor agonists that are not listed in OARs 855-080-0022 through 0026 (Schedule II through V) or that are not an FDA approved drug. In addition, certain exceptions are reestablished as well as Schedule I compounds in structural classes 2a-2k and their salts. These Schedule I items have been reestablished as a result of administrative errors.
 
April 2014
On Wednesday April 9, 2014, the Board sent rules in Division 019 and Division 080 to a Rulemaking Hearing scheduled at 9:30 a.m. on May 22, 2014 in Room 1A of the Portland State Office Building, 800 NE Oregon St. Portland, OR 97232. The Division 019 Foreign Pharmacy Graduate rules propose to remove the minimum score requirements for the Test of English as a Foreign Language (TOEFL) and Internet Based Test (iBT). Foreign Pharmacy Graduates must  provide the Board with the original certificate issued by the National Association of Board's of Pharmacy (NABP) Foreign Pharmacy Graduate Examination Committee as one of the conditions for applying for licensure in Oregon. The Division 080 Schedule I rules propose to reestablish other cannabinoid receptor agonists, gamma butyrolactone, an exception clause and other  and other compounds in structural classes 2a-2k.
April 9, 2014
On Wednesday April 9, 2014 the Board amended by temporary rule its Division 019 Pharmacist Licensure by Reciprocity rules to allow pharmacy residents who have been accepted into a program the ability to reciprocate sooner in order to satisfy residency requirements. This is applicable to nonresident pharmacists who have obtained licensure in another state, but have less than one full year of pharmacist licensure to reciprocate.
  •  Div 019 - Licensure by Reciprocity
April 15, 2014
Division 080 rules were amended to include Schedule I compound structural classes 2a-2k and their salts.
February 2014
On Wednesday February 5, 2014 the Board amended by temporary rule its Division 080 Schedule I rules to include gamma-butyrolactone. Other rules amended by temporary rule include the Board's Division 019 Foreign Pharmacy Graduate rules. These rules were amended to eliminate reference to minimal acceptable scores to obtain FPGEC Certification.
 
  • Div 019 - Foreign Pharmacy Graduates
 
January 24, 2014
On Wednesday December 19, 2013 the Board adopted or amended rules relating to public health emergencies, the Health Professional's Service Program (HPSP), biosimilars and naloxone as required by the 2013 Oregon Legislature. Additionally, rules for the distribution of epinephrine in emergency health circumstances were adopted. Other rules in Division 019 and 041 were adopted and amended to require a pharmacist and outlet to notify the Board within one (1) business day in the even of significant drug losses or violations related to drug theft.  
  • Div 007 - Public Health Emergencies
  • Div 011 - Health Professionals Service Program
  • Div 019 - Administration of Vaccines by Pharmacists
  • Div 019 - Duty to Report
  • Div 041 - Definitions
  • Div 041 - Distribution of Emergency Medication
  • Div 041 - Prescriptions
  • Div 041 - Reporting Drug Loss
 
January 3, 2014
On Wednesday December 18, 2013 the Board amended its Division 041 rules to change the name of Remote Dispensing Facility to Remote Distribution Facility for clarification purposes from other similar named rules. In addition the Board amended its Division 110 Fee rules to implement revenue surplus reductions pursuant to ORS 291.055(3) for Pharmacist Score Transfer and Supervising Physician Dispensing Outlet fees.
 
 
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2013 RULE CHANGES

December 20, 2013
On Wednesday December 18, 2013 the Board adopted a temporary rule to correct a filing error in Division 080 of the Schedule I rules. This temporary rule reestablishes other cannabinoid receptor agonists and an exception clause.
 
 
 
November 21, 2013
On Thursday November 21, 2013 at 9:30 AM, 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
 
  • Div 007 - Public Health Emergencies
  • Div 011 - Health Professionals Service Program
  • Div 019 - Duty to Report
  • Div 019 - Administration of Vaccines by Pharmacists  
  • Div 041 - Definitions and Prescriptions
  • Div 041 - Reporting Drug Loss
  • Div 041 - Distribution of Emergency Medication
  • Div 041 - Remote Dispensing Facility
  • Div 110 - Fees
 
November 6, 2013
On August 14, 2013 the Board amended its Consulting Pharmacist Practice rules in Division 019 and adopted new drug outlet retail and/or institutional models  in Division 041 for Central Fill, Remote Processing, and Consulting or Drugless Pharmacies. The Central Fill, Remote Processing, and Consulting or Drugless Pharmacy rules provide minimum requirements of operation for these new drug outlet models and accommodate modern practices and new technologies while promoting patient safety.
  • 855-019 - Consulting Pharmacist Practice - Effective November 6, 2013
  • 855-041 - Central Fill Drug Outlets, Remote Processing Drug Outlets, and Consulting  or Drugless Pharmacies - Effective November 6, 2013      
  • 855-041 - Central Fill Drug Outlets - Effective November 6, 2013
  • 855-041 - Remote Processing Drug Outlets  - Effective November 6, 2013
  • 855-041 - Consulting or Drugless Pharmacies  - Effective November 6, 2013
 
 
October 2013
 
On October 28, 2013 the Board amended its schedule I controlled substances rules to incorporate certain synthetic cannabinoids subject to abuse.
 
 
September 2013
On August 14, 2013 the Board amended its customized patient medication packages rules to incorporate a waiver clause. The amendment allows the Board to waive any of the requirements of the customized patient medication packages rules if a waiver will further public health or safety or the health and safety of a patient.
 
  •  855-041 - Customized Patient Medication Packages
 
 
On August 14, 2013 the Board adopted temporary rules to define the procedures for disributing naloxone to certain authorized individuals in opiate overdose circumstances. Administration of naloxone may only take place by those who have successfully completed training from the Oregon Health Authority, Public Health Division or who have been identified in Oregon Laws 2013, Chapter 340.
 
 
On September 19, 2013 the Board adopted permanent rules to amend its fees. These amendments implement revenue surplus reductions pursuant to ORS 291.055(3) for certain licensing fees as approved by the Board's 2013-15 Legislatively Approved Budget.  
 
August 2013
On August 14, 2013 the Board amended its manufacturer rules. The permanent rules 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.
 
 
July 2013
On June 12, 2013 the Board amended the following fees: Reciprocity, County Health Clinics, Family Planning Clinics, Hospital Drug Rooms, Correctional Facilities, Prophylactic/Contraceptive Outlets, Retail and Institutional Drug Outlets, Home Dialysis Drug Outlets and all Controlled Substance registration fees.
The Board implemented a temporary fee reduction for these fees as allowed by ORS 291.055(3) due to an unexpected surplus in revenue. These fee reductions are in addition to the temporary pharmacist licensure fee reduction that went into effect on April 5, 2013.
 
 
Notice of Rulemaking or Rulemaking Hearings
 
Notice of Proposed Rulemaking
The Board is proposing permanent rules for adoption that will implement revenue surplus reductions pursuant to ORS 291.055(3) for certain licensing fees as approved by the Board's 2013-15 Legislatively Approved Budget. Public comment will be accepted through August 30, 2013.
 
 
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. 
  • Div 019 - Consulting Pharmacist Practice
  • Div 041 - Preamble for Central Fill, Remote Processing and Consulting or Drugless Pharmacies
  • Div 041 - Central Fill
  • Div 041 - Remote Processing
  • Div 041 - Consulting or Drugless Pharmacies
  • Div 041 - Customized Patient Medication Packages
  • Div 060 - Manufacturers
  • Div 080 - 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.
 
 April 2013
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.
 
February 2013
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.
 
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2012 RULE CHANGES

December 2012 
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 Outles 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

 

 June 2012

 

On June 6, 2012 The Board amended the Wholesaler Class II definition to include Oxygen USP.  

Notice of Temporary Rulemaking and Statement of Need - Effective 6/19/12 

• 855-065 – Wholesaler
 

On May 24, 2012 The Board adopted and amended rules related to Definitions, Practitioner Dispensing Outlets and Animal Euthanasia.

Division 006 rules are amended to define “Board” and add “dispense” to existing definitions. Division 043 Practitioner Dispensing Outlet rules implement 2012 Oregon Laws Chapter 34. These rules define “Supervising Physician Dispensing Outlet” and identify which entities must register as well as their requirements. Division 080 Animal Euthanasia rules are amended to correct an outdated fee reference.

Certificate of Permanent Rulemaking - Effective 6/19/2012 
• 855-006 - Definitions
• 855-043 - Practitioner Dispensing Outlets
• 855-080 – Animal Euthanasia
 
The Board also amended rules which add fees for the registration and renewal of Supervising Physician Dispensing Outlets.
 

• 855-110 - Fees


On May 24, 2012 The Board adopted new Drug Outlet conduct rules.
 
Division 041 Drug Outlet conduct rules define the grounds for discipline for outlets that fail to provide a working environment that protects the health, safety and welfare of patients.  
 

Certificate of Permanent Rulemaking - Effective 6/12/12

• 855-041- Drug Outlet Conduct

 

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

 

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

 

 

 

 

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.
 
 

On May 24, 2012 the Oregon Board of Pharmacy conducted 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. 

 

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.

 

 

 

 

 

 

 

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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.
 
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

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.
 
Press Release - 10/15/10  

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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