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State and Federal Pharmacy Laws & Rules

RECENT RULE CHANGES

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.

Certificate and Order for Permanent Administrative Rules - Effective 07/01/15

Certificate and Order for Permanent Administrative Rules - Effective 01/01/16

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.

Certificate and Order for Temporary Rules - Effective 07/01/15

  • 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.

Certificate and Order for Temporary Rules - Effective 07/01/15

  • 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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RULE CHANGES 2010-2014

 Please click here.

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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 download a copy of the Oregon Board of Pharmacy Laws & Rules, click here. Filed through 4/15/15
To order a CD or paper copy of the Oregon Board of Pharmacy Laws & Rules, click here
 
Note: Regarding the electronic prescribing of controlled substances,  ORS 475.185 was clarified during the 2014 Legislative session. Please see: https://www.oregonlegislature.gov/bills_laws/lawsstatutes/2014R1orLaw0055ss.pdf


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 11 Health Professional's Service Program 

Division 19 Pharmacists      -    Frequently Asked Questions for Division 19 
 
Division 21 Pharmacist Continuing Education
 
Division 25 Certified Oregon 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 *
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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 (2010) 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.
 
Pursuant to ORS 689.522(3) the Board of Pharmacy shall link a list of biosimilar products determined by the FDA to be interchangeable.
 
 
FOOD AND DRUG ADMINISTRATION
 
DRUG ENFORCEMENT ADMINISTRATION
 
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