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Controlled Substances Oregon Board of Pharmacy BOARD MEETING AGENDA Meeting Location: Portland State Office Building 800 NE Oregon Street, Portland, OR 97232 April 3-4, 2019 The mission of the Oregon State Board of Pharmacy is to promote, preserve and protect the public health, safety and welfare by ensuring high standards in the practice of pharmacy and by regulating the quality, manufacture, sale and distribution of drugs. Wednesday, April 3, 2019 @ 8:30AM – Conference Room 1A Thursday, April 4, 2019 @ 8:30AM – Conference Room 1A ≈ If special accommodations are needed for you to attend or participate in this Board Meeting, please contact Loretta Glenn at: (971) 673-0001. ≈ WEDNESDAY, APRIL 3, 2019 I. 8:30AM OPEN SESSION, Rachael DeBarmore, R.Ph, Presiding A. Roll Call B. Agenda Review and Approval Action Necessary II. Contested Case Deliberation pursuant to ORS 192.690(1) - Not Open to the Public III. EXECUTIVE SESSION – NOT OPEN TO THE PUBLIC, pursuant to ORS 676.175, ORS 192.660 (1) (2) (f) (k). A. Items for Consideration and Discussion: 1. Deliberation on Disciplinary Cases and Investigations 2. Personal Appearances 3. Deficiency Notifications 4. Case Review IV. OPEN SESSION - PUBLIC MAY ATTEND - At the conclusion of Executive Session, the Board may convene Open Session to begin some of the following scheduled agenda items - time permitting at approximately 3:30PM. THURSDAY, APRIL 4, 2019 8:30AM V. OPEN SESSION, Rachael DeBarmore, R.Ph, Presiding A. Roll Call B. Motions for Contested Cases & Disciplinary Action – Efremoff Action Necessary VI. GENERAL ADMINISTRATION A. Rules *First Look ** Second Look *** Third Look 1. Review Rulemaking Hearing Report & Comments – none Agenda – April 3-4, 2019 NOTE: The Board may rearrange its agenda to accommodate the Board or members of the public. Page 1 of 4 2. Consider Adoption of Rules – none 3. Consider Adoption of Temporary Rules – none 4. Rules Update - none 5. Consider rules and send to Rulemaking Hearing • Div 110 – Fees - #A MacLean Action Necessary 6. Policy Issues for Discussion / Updates: • Div 045 Compounding – RAC update - MacLean B. Public Health and Pharmacy Formulary Advisory Committee Karbowicz/MacLean/Efremoff 1. Committee Meeting and Recommendation update 2. Consider rules & send to Rulemaking Hearing – none C. Discussion Items: 1. Waiver Requests: none 2. TCVP: none 3. Other: a. R.Ph. Renewal and CE requirements update #B1 - Hennigan b. Cannabidiol sales – #B Efremoff/Gin Action Necessary c. Strategic Planning update – Schnabel/MacLean d. Annual elections in June – process reminder – DeBarmore/MacLean D. Annual Business Meeting - MacLean (In the interest of time, the Board will consider a few items at this meeting to allow more time for other discussion at the June meeting) 1) Approval of ACPE Accredited Schools & Colleges of Pharmacy and Approval of ACPE Continuing Education Process # Action Necessary 2) Approve current list of Fed. List of Controlled Substances #C2 Action Necessary 3) Schedule of Administrative Fees # Action Necessary 4) Attorney General’s Model Rules of Procedure #C4 Action Necessary 5) Review and affirm Board Per Diem Policy #C5 Action Necessary Lunch – estimated time depending on the length of discussions VIII. ISSUES/ACTIVITIES A. Board Meeting Dates • June 5-6, 2019 Portland • August 7-9, 2019* Portland (*3 day meeting) • October 2-3, 2019 Portland • November 6-7, 2019 Portland (Strategic Planning – subject to change) • December 11-12, 2019 Portland • February 5-7, 2020* Portland (*3 day meeting) • April 15-16, 2020 Portland • June 17-18, 2020 Portland • August 12-14, 2020* Portland (*3 day meeting) Agenda – April 3-4, 2019 NOTE: The Board may rearrange its agenda to accommodate the Board or members of the public. Page 2 of 4 • October 14-15, 2020 Portland • November 18-19, 2020 TBA (Strategic Planning – subject to change) • December 16-17, 2020 Portland B. Rulemaking Hearing Dates (The following dates are reserved for potential rulemaking hearings and identified only for planning purposes and approved by the Board. Actual Rulemaking Activities will be noticed as required by law and may deviate from this schedule as needed.) • May 22, 2019 • July 23, 2019 (possible) • September 24, 2019 (possible) • November 26, 2019 C. Committees/Meetings 1. OSPA Lane Co. Mid-Winter CE Seminar, Eugene – 2/16-17/2019 – Karbowicz/Logan/Efremoff 2. OSHP Spring Meeting – Sunriver - 4/26-28/2019 – Schnabel/Efremoff 3. Linn-Benton Pharmacist Association 4/16/19 - Baldwin/Linares 4. NABP 2019 Annual meeting – Minneapolis, MN - May 16-18, 2019 a. Resolution review and input #D CONFIDENTIAL Action Necessary 5. NABP District VI-VIII Mtg. Boise, ID, 10/6-9/2019 D. Board Member/Staff Presentations – DeBarmore • Pharmacy Coalition – 2/12/19, 3/12/19 • Professional Practice Roundtable – none E. Financial/Budget Report – #E Schnabel/MacLean F. Legislative update – Schnabel/Karbowicz/MacLean G. Reports: 1. Board President/Members 2. Executive Director 3. Board Counsel 4. Compliance Director 5. Pharmacist Consultant 6. Administrative Director 7. Licensing Program Supervisor VIII. Approve Consent Agenda* Action Necessary *Items listed under the consent agenda are considered to be routine agency matters and will be approved by a single motion of the Board without separate discussion. If separate discussion is desired, that item will be removed from the consent agenda and placed on the regular business agenda. 1. NAPLEX Scores – 9/1/18 – 12/31/18 # CONSENT -1 CONFIDENTIAL 2. MPJE Scores – 9/1/18 – 12/31/18 # CONSENT -1 CONFIDENTIAL 3. License/Registration Ratification – January 23, 2019 – March 25, 2019 # CONSENT – 2 4. Pharmacy Technician Extensions – none 5. Board Minutes – February 6-7, 2019 # CONSENT – Agenda – April 3-4, 2019 NOTE: The Board may rearrange its agenda to accommodate the Board or members of the public. Page 3 of 4 IX. OPEN FORUM – At the completion of regular Board business, the Board provides an opportunity to make comments or present issues of general interest. The Board will not deliberate any issues or requests during Open Forum. Therefore, Open Forum should not be used to make formal requests to the Board, nor to address issues currently under investigation or requests pending before the Board. If you wish to be called upon, please sign up on the sheet at the podium in advance for inclusion. Adjourn Agenda – April 3-4, 2019 NOTE: The Board may rearrange its agenda to accommodate the Board or members of the public. Page 4 of 4 2019 APRIL / #A Oregon Board of Pharmacy 800 NE Oregon Street, Suite 150 Portland, OR 97232 Phone: 971 / 673-0001 Fax: 971 / 673-0002 E-mail: [email protected] Web: www.pharmacy.state.or.us November 13, 2018 NOTICE TO LICENSEES – PROPOSED FEE INCREASES The Oregon Board of Pharmacy has prepared its 2019-2021 Agency Budget Request for the Governor and Legislative approval during the 2019 Legislative Session. This is available on the Board’s “About Us” web page. Proposed fee increases are necessary to allow the Board to continue current and anticipated operations to carry out the Board’s mission. The agency operates solely on licensing and miscellaneous fees. The Board takes raising fees very seriously and we do all we can to minimize expenses. The last meaningful fee increase was in 2001. In 2011, the Board increased a number of fees, however most were reverted back to the 2001 fees in 2013 due to an unexpected surplus of funds. The Board’s proposed fee increases must be approved by the Governor and Legislature. If authorized, the Board plans to adopt all updated fees by rule. The Board proposes the following fee increases to be effective July 1, 2019 for all new applicants and renewing licensees / registrants. Please see the chart on the next page. OBOP 2019-21 Proposed Fee Increases Page 1 of 2 2019 APRIL / #A 2017-19 2019-21 2001 Current Proposed LICENSE CATEGORY Fees Fees Fees ANIMAL EUTHANASIA $25 $50 $75 CERTIFIED PHARMACY TECHNICIAN - *2 yr license $35 $50 $100 CHARITABLE PHARMACY $75 $75 $75 COMMUNITY HEALTH CLINIC (previously known as County Health and Family Planning Clinics) $75 $75 $100 CONSULTING / DRUGLESS PHARMACY $175 $175 $225 $25 or CONTROLLED SUBSTANCE 50 $50 $100 DISPENSING PRACTITIONER DRUG OUTLET $100 $100 DRUG DISTRIBUTION AGENT $400 $400 DRUG ROOM & CORRECTIONAL FACILITIES $75 $75 $100 GASES-MEDICAL CLASS C $50 $50 $75 INSTITUTIONAL PHARMACY $175 $175 $225 INTERN LICENSE - 2 yr license $30 $50 $100 MANUFACTURER $400 $400 $525 NONPRESCRIPTION A $50 $50 $75 NONPRESCRIPTION B $25 $50 $75 NONPRESCRIPTION D $100 $100 $100 PHARMACIST LICENSE - *2 yr license $120 $120 $250 PRECURSOR $25 $50 $75 PROPHYLACTIC CONTRACEPTIVE MGF $50 $50 $50 REMOTE DISPENSING/DISTRIBUTION $100 $120 RETAIL PHARMACY, includes HOME DIALYSIS $175 $175 $225 SUPERVISING PHYSICIAN DISPENSING OUTLET $175 $175 PHARMACY TECHNICIAN - *up to 2 yr license $35 $50 $100 WHOLESALER I, II, III $400 $400 $525 *Additional background information for items marked with an asterisk for Pharmacists, Certified Oregon Pharmacy Technicians and Pharmacy Technicians were converted to a two-year biennial license between 2015 and 2016 without a fee increase; in other words, licensees received a two-year license for the price of a one-year license. The noted increases update the annual fee to a biennial fee (ORS 183.705). OBOP 2019-21 Proposed Fee Increases Page 2 of 2 2019 APRIL / B SBAR: Retail Sales of Cannabidiol (CBD) Products and Pharmacies Situation: Compliance staff are receiving questions about CBD sales, such as: S • Are pharmacies permitted to sell CBD products at the retail (front-end) of the store and if so does this require registration with a regulatory body? • Who regulates these products and verifies that the amount of THC is within legal concentrations, per 2018 Farm Bill THC level < 0.3%? • Are there any restrictions to sale; age restriction, limit in quantity, delivery mechanism? • Can CBD products be sold at the pharmacy register? • Who may answer questions about CBD? • May CBD be sold as a dietary supplement? Background: • 2018 Farm Bill legalized industrial hemp (THC <0.3%).
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