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The Oregon Administrative Rules contain OARs filed through August 15, 2014
 
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BOARD OF PHARMACY

 

DIVISION 7

PUBLIC HEALTH EMERGENCY

 

855-007-0010

Declaration of Emergency

(1) With the exception of OAR 855-007-0060(2)(a) and (b), 855-007-0080(2), 855-007-0080(8)(a) and (b), and 855-007-0120 that are always in effect, the rules in this Division are only effective when:

(a) A State of Emergency or a Public Health Emergency has been declared by the Governor of Oregon under ORS 401.055 or 433.441 through 433.452;

(b) The provisions of any relevant rules in chapter 855 Oregon Administrative Rules have been suspended by the Governor under the authority of ORS 401.065(2);

(c) A signatory to the Pacific Northwest Emergency Management Arrangement (the states of Alaska, Idaho, Oregon, Washington, the Province of British Columbia, and Yukon) has requested assistance during a civil emergency as authorized in Chapter 25 Oregon Laws 2008;

(d) A signatory to the Emergency Management Assistance Compact has requested assistance during a civil emergency as authorized in ORS 401.043;

(e) The President of the United States or another federal official has declared a public health emergency; or

(f) The Governor has authorized the Public Health Director to take the actions described in ORS 431.264.

(2) When these rules are authorized by any one of the actions listed in (1)(a)–(f) they are in effect to the extent necessitated by the scope of the declaration, and control to the extent that they are in conflict with other Divisions of OAR Chapter 855.

Stat. Auth.: ORS 401.043, 401.065, 433.441 & 689.205
Stats. Implemented: 2008 OL Ch. 25, ORS 401.055 & 689.155
Hist.: BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09; BP 1-2009, f. & cert. ef. 6-22-09; BP 3-2009(Temp), f. & cert. ef. 8-19-09 thru 2-15-10; BP 4-2009, f. & cert. ef. 12-24-09

855-007-0020

Applicability

(1) These rules apply to all persons licensed or registered with the Board under OAR chapter 855 and to any persons acting under the authority of Oregon State Public Health Division or any other state agency, or any local or county health department or emergency manager, during a Declared Emergency or a Public Health Emergency, or to any such person acting in preparation for a Public Health Emergency.

(2) These rules may apply to the whole state of Oregon or only to a county or area included in the declared emergency. They also apply to the activities of any licensee or registrant who is working during a declared emergency in the state or territory of any of the signatories of Pacific Northwest Emergency Management Arrangement or the Emergency Management Assistance Compact.

(3) These rules apply to the dispensing and administration of drugs and vaccines to any person within an area subject to an emergency declaration or to any person who has been displaced from their place of residence even if the place to which they have been displaced has not been included in the emergency declaration.

(4) Insofar as neither the Governor of Oregon nor the Board has the authority to waive any provisions of Federal Law, nothing in these rules that conflicts with the Federal Controlled Substances Act (CSA) or the implementing regulations in 21 CFR, shall apply to federal controlled substances as listed in Division 80 of this chapter of rules, unless an agency of the US Government has waived the appropriate section of the CSA or the implementing regulations in 21 CFR.

Stat. Auth.: ORS 401.065, 433.441 & 689.205
Stats. Implemented: 2008 OL Ch. 25 & ORS 689.155
Hist.: BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09; BP 1-2009, f. & cert. ef. 6-22-09; BP 4-2009, f. & cert. ef. 12-24-09

855-007-0030

Definitions

(1) “Administer” has the meaning given that term in ORS 689.005.

(2) “Community Partner” has the meaning given that term in OAR 855-007-0080.

(3) “Dispense” has the meaning given that term in ORS 689.005.

(4) “Distribute” has the meaning given that term in ORS 689.005.

(5) “Drug” in this division of rules, the term “drug” means a drug or vaccine or medical device, or any combination of these terms.

(6) “Emergency” has the meaning given that term in ORS 401.025.

(7) “Emergency Management Assistance Compact” (EMAC) means the compact for mutual assistance that was ratified by Congress and signed by all states, and is codified in ORS 401.043.

(8) “Emergency Prescription” means a record that is created in a pharmacy that records the dispensing of a refill of a drug, or a new or modified drug therapy to a patient in the absence of a valid prescription.

(9) “Health-care provider” means an individual licensed, certified or otherwise authorized or permitted by the laws of this state or another state to administer health-care services within their scope of practice.

(10) “Mobile Pharmacy” means a pharmacy that is located in a vehicle or a trailer.

(11) “Oregon State Public Health Division” (OSPHD) means that division of the Oregon Department of Human Services (DHS) that is responsible for planning for and responding to a public health emergency.

(12) “Pacific Northwest Emergency Management Arrangement” (PNEMA) means the compact, ratified in Chapter 25 Oregon Laws 2008, between the states of Alaska, Idaho, Oregon and Washington, and the Province of British Columbia, and Yukon, to provide mutual assistance in an emergency or public health emergency.

(13) “Public Health Emergency” has the meaning given that term in ORS 433.442.

(14) “Strategic National Stockpile” (SNS) means the US Government stockpile of antiviral drugs and other drugs and medical supplies that can be made available to a state in an emergency.

(15) “Temporary Pharmacy” means a facility established under these rules to temporarily provide pharmacy services within or adjacent to an area subject to a State of Emergency.

Stat. Auth.: ORS 401.065, 433.441 & 689.205
Stats. Implemented: 2008 OL Ch. 25 & ORS 689.155
Hist.: BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09; BP 1-2009, f. & cert. ef. 6-22-09; BP 4-2009, f. & cert. ef. 12-24-09

855-007-0040

Delegation of Authority

When these rules are in effect, any authority vested in the Board may be exercised by the Executive Director (ED), any person acting as Executive Director in the ED’s absence or incapacity, or any person the ED designates to make such decisions on the ED’s behalf.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.165
Hist.: BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09; BP 1-2009, f. & cert. ef. 6-22-09; BP 4-2009, f. & cert. ef. 12-24-09

855-007-0050

Emergency Licensure

(1) Article V of ORS 401.043 (EMAC) and Article V of Annex B of PNEMA provide that whenever a person holds a license, certificate or other permit issued by a signatory to the compact evidencing the meeting of qualifications for professional, mechanical or other skills, and when such assistance is requested by the receiving signatory, the person is deemed to be licensed, certified or permitted by the signatory requesting assistance to render aid involving the skill to meet an emergency or disaster, to the extent allowed by law and subject to limitations and conditions as the requesting signatory prescribes by executive order or otherwise.

(2) When an emergency has been declared, a drug outlet may employ a pharmacist, intern or pharmacy technician who does not hold a license issued by the Board, provided that the individual provides evidence that they hold a comparable license issued by any other state or signatory to PNEMA or EMAC.

(3) In an emergency, the Board may grant an emergency temporary license to a licensee of the board of pharmacy of any state, province, foreign state or political sub-division that is not a signatory to PNEMA or EMAC as follows:

(a) A pharmacist, intern, pharmacy technician or certified pharmacy technician who holds an active license in another state, province, foreign state or political sub-division that is not suspended or restricted for any reason and who is sponsored by a pharmacy that has an active registration from the Board may be granted an emergency temporary license subject to approval by the Board of an application that contains:

(A) The name, permanent address and phone number of the applicant;

(B) The license number and state, province or political sub-division of permanent licensure;

(C) The name and license number of the sponsoring Oregon pharmacy; and

(D) Any other information requested by the Board.

(b) The emergency temporary license issued under these rules shall be valid for a period determined by the Board, but not exceeding six months. If the emergency still exists after six months, the Board may renew any emergency temporary license for an additional six months.

(c) The Board shall notify the sponsoring pharmacy of the approval of each emergency temporary license.

(d) A licensee granted an emergency temporary license under this rule may only practice in the sponsoring pharmacy or a pharmacy under common ownership with the sponsoring pharmacy, except that the licensee may transfer to another pharmacy that is not under common ownership with the sponsoring pharmacy, provided that the licensee notifies the Board within three days.

(4) Inactive License Reactivation: In an emergency, the Board may allow a pharmacist whose license has been inactive for no more than two years to reactivate their license without completing any required continuing education or MPJE. The license will revert to an inactive status at the end of six months unless all required continuing education has been completed.

Stat. Auth.: ORS 401.065, 433.441 & 689.205
Stats. Implemented: 2008 OL Ch. 25, ORS 689.151 & 689.155
Hist.: BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09; BP 1-2009, f. & cert. ef. 6-22-09; BP 4-2009, f. & cert. ef. 12-24-09

855-007-0060

SNS and State Stockpile Emergency Drugs

(1) General: When drugs from the Strategic National Stockpile (SNS) are delivered to the state, the drugs may be delivered to a state Receipt, Staging and Storage center (RSS) for further distribution to Points of Dispensing (PODs) selected by OSPHD. State drugs (state stockpile) may also be delivered to the RSS.

(2) Storage of drugs from SNS or state stockpile:

(a) The RSS, PODs and local health departments (LHD) are authorized to store any drugs from the SNS or state stockpile prior to and during an emergency without any registration from the Board.

(b) All such drugs must be stored in accordance with manufacturers’ guidelines.

(c) This authority to possess drugs shall extend beyond the declared emergency until procedures issued by OSPHD for the return or destruction of unused drugs have been completed.

(3) Repackaging: If it is necessary to repackage drugs into unit-of-use regimen packages, this will be done at RSS under Centers for Disease Control (CDC) protocols as follows:

(a) Repackaging equipment will be provided by SNS or OSPHD;

(b) Staff from the CDC Technical Advisory Response Unit (TARU) will train the repackaging team members on the use of the equipment and will provide team leadership.

(c) OSPHD will provide repackaging procedures and team members.

(d) For SNS drugs, unit-of-use regimens shall be labeled in accordance with SNS protocols as follows:

(A) Official health agency name, city and state;

(B) Prescriber’s name — when using State protocols prescriber’s name will be “State Protocol”;

(C) Date repackaged;

(D) Quantity of drugs in the regimen;

(E) Prescription number, name, strength, expiration date and lot number of the drug;

(F) Number for 24-hour telephone line;

(G) Patients name left blank — to be filled in at time of dispensing.

(4) Distribution: The RSS, POD or LHD may distribute or dispense SNS or state stockpile drugs in accordance with the distribution and dispensing procedures provided by OSPHD.

(5) Administration and dispensing: A health-care provider designated by OSPHD or a LHD to supervise the administration and dispensing of SNS or state stockpile drugs shall follow protocols approved by OSPHD, a local health officer or CDC.

(6) An Intake Form that shall serve as a valid prescription is to be filled out for each person receiving a drug at a POD. The intake form is to be retained as specified in OAR 855-007-0110.

(7) Returns: At the conclusion of the emergency, all such drugs are to be returned to the RSS or other designated location under instructions issued by OSPHD.

Stat. Auth.: ORS 401.065, 433.441 & 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09; BP 1-2009, f. & cert. ef. 6-22-09; BP 4-2009, f. & cert. ef. 12-24-09

855-007-0080

Emergency Immunization and Drug Distribution

When a public health emergency has been declared, the following principles and procedures shall apply to the distribution, dispensing and administration of vaccines or drugs:

(1) The distribution of vaccines and drugs is to be in accordance with instructions provided by OSPHD.

(2) LHDs are authorized to distribute SNS or state stockpile drugs to designated Treatment Centers (TC) or health-care providers designated by the State Public Health Director or a local health administrator.

(3) A TC may include but is not limited to:

(a) A LHD;

(b) A clinician;

(c) A community health clinic;

(d) An independent or chain pharmacy;

(e) A hospital or other health-care facility;

(f) A temporary pharmacy;

(g) A mobile pharmacy; or

(h) A tribal health-care facility.

(4) A TC may possess, distribute, dispense and administer vaccines and drugs if these rules are in effect.

(5) A health-care provider, designated by the local health administrator, at a TC shall be responsible for administration, distribution and tracking of vaccines and drugs in accordance with procedures established by OSPHD.

(6) A health-care provider may, if permitted under that provider’s scope of practice and these rules, distribute, dispense and administer vaccines and drugs.

(7) An Individual Data Collection Form (IDCF) shall be filled out for each person receiving a vaccine or drug at a TC or from a health-care provider, and this IDCF shall be treated as a valid prescription and retained as follows:

(a) An IDCF initiated at a pharmacy or other licensed health-care facility shall be filed and retained for three years;

(b) An IDCF initiated at a facility that is not a licensed health-care facility or at a temporary or mobile pharmacy shall be sent to OSPHD at the end of the state of emergency except that where the temporary or mobile facility has been established under the authority of OAR 855-007-0100 all records shall be filed and retained in accordance with 855-007-0110.

(8) Community Partner: A Community Partner means any entity that is authorized by OSPHD or OBOP to:

(a) Purchase and store vaccines or drugs prior to a pandemic event;

(b) Store vaccines or drugs in a Board registered facility or at a tribal site;

(c) Take possession of the vaccines or drugs and distribute to critical infrastructure and key resources when so directed by OSPHD in accordance with OSPHD protocols and procedures.

(d) A Community Partner shall:

(A) Distribute all drugs within 72 hours of removal from the storage site;

(B) Store all drugs in accordance with manufacture’s guidelines;

(C) Record all distributions on a Distribution Log that shall include:

(i) The name and age of the person receiving the drugs;

(ii) The name, strength and quantity of the drugs;

(iii) The date and the time of the distribution.

(e) The Distribution Log shall be treated as a valid prescription and stored or otherwise disposed of as specified in 855-007-0110;

(9) This authority for LHDs, TCs, health-care providers and Community Partners to possess drugs shall extend beyond the declared emergency until procedures issued by OSPHD for the return or destruction of unused drugs have been completed.

(10) A pharmacist may administer a vaccine to a person who is at least three years of age or older.

Stat. Auth.: ORS 401.065, 433.441, 689.205 & 2013 OL Ch 332
Stats. Implemented: 689.155 & 2013 OL Ch 332
Hist.: BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09; BP 1-2009, f. & cert. ef. 6-22-09; BP 4-2009, f. & cert. ef. 12-24-09; BP 2-2014, f. & cert. ef. 1-24-14

855-007-0090

Emergency Pharmacy Rules

(1) Refills: A pharmacist in the area covered by a declared emergency or in an area engaged in disaster assistance may dispense a refill of a prescription drug without a valid prescription provided that:

(a) In the pharmacist’s professional judgment, the drug is essential to the maintenance of the patient’s health or the continuation of therapy; and

(b) The pharmacist provides no more than a 30-day supply; and

(c) The pharmacist records all relevant information and indicates that it is an Emergency Prescription; and

(d) The pharmacist informs the patient or the patient’s agent that the drug is being provided without a prescriber’s authorization and that a prescriber authorization is required for any additional refill.

(e) If the refill is for a controlled substance, permission has been granted by the DEA for this type of refill, either by waiver of appropriate controlled substance regulations or by notification to the Board.

(2) New and modified drug therapy: A pharmacist in the area covered by a declared emergency or in an area engaged in disaster assistance may, after consultation with any authorized prescriber, initiate or modify any drug therapy, and dispense an amount of the drug to meet the patient’s health needs until that patient can be seen by a health-care practitioner, provided that:

(a) The pharmacist acts in accordance with currently accepted standards of care; and

(b) In the pharmacist’s professional judgment, the drug is essential to the maintenance of the patient’s health or to the continuation of therapy; and

(c) The pharmacist records all relevant information to a form and indicates that a drug therapy has been initiated or modified and that this is an Emergency Prescription; and

(d) The pharmacist informs the patient or the patient’s agent at the time of dispensing that the drug is being provided in the absence of a valid patient — prescriber relationship but that a prescriber was consulted regarding the appropriateness of the drug therapy; and

(e) The pharmacist informs the patient or the patient’s agent that a prescriber authorization is required for any refill.

Stat. Auth.: ORS 401.065, 433.441 & 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09; BP 1-2009, f. & cert. ef. 6-22-09; BP 4-2009, f. & cert. ef. 12-24-09

855-007-0100

Temporary Pharmacies

(1) When these rules are in effect, the Board may issue a Temporary Pharmacy Registration to any facility or mobile facility.

(2) A facility, including a mobile pharmacy, holding a Temporary Pharmacy Registration may store and dispense drugs in accordance with the requirements of OAR 855-041 and these rules. The supervising pharmacist of a mobile pharmacy shall notify the Board of the pharmacy location within three working days of commencing business, and within three working days of any change in location.

(3) A Temporary Pharmacy Registration automatically expires when the state of emergency ends unless specifically extended by the Board.

(4) Within 30 days of the end of the declared emergency, the holder of a Temporary Pharmacy Registration shall notify the Board as to the disposition of its drug inventory and records.

(5) A temporary or mobile pharmacy that is established for the sole purpose of expediting distribution of emergency immunizations, antibiotics or antiviral drugs under OAR 855-007-0080, is located adjacent to an existing pharmacy registered with the Board and is under the supervision of the PIC of the existing pharmacy, does not need to be registered as a temporary pharmacy.

Stat. Auth.: ORS 401.065, 433.441 & 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09; BP 1-2009, f. & cert. ef. 6-22-09; BP 4-2009, f. & cert. ef. 12-24-09

855-007-0110

Emergency Recordkeeping

All records initiated during a state of emergency shall be disposed of as follows:

(1) POD intake forms and Individual Data Collection Forms or electronic records shall be transferred to OSPHD at the end of the emergency;

(2) Community Partner’s Logs:

(a) Vaccines: Logs shall be transferred to OSPHD within 14 days of administration to be entered into the statewide immunization information system. If the Community Partner is a registered health-care facility or under the control of a licensed health-care provider, a copy of the log shall be made before submission and retained for three years.

(b) Antivirals and other drugs: Logs shall be transferred to OSPHD at the end of the emergency unless the Community Partner is a registered health-care facility or under the control of a licensed health-care provider in which case logs shall be stored securely by the Community Partner;

(3) Emergency Prescriptions and Individual Data Collection Forms for drugs dispensed from a pharmacy that is not a Temporary or Mobile Pharmacy shall be stored at the pharmacy.

(4) Emergency Prescriptions and Individual Data Collection Forms for drugs dispensed from a Temporary or Mobile Pharmacy shall be stored at whichever of the following locations is most appropriate:

(a) At the parent pharmacy that provided the majority of the drugs to the Temporary or Mobile Pharmacy; or

(b) At the pharmacy that employs the supervising pharmacist of the Temporary or Mobile Pharmacy; or

(c) At the pharmacy that receives the unused drugs from the Temporary or Mobile Pharmacy at the end of the emergency.

(5) Unless otherwise specified, all records are to be retained for three years and must be made available to the Board upon request.

Stat. Auth.: ORS 401.065, 433.441 & 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09; BP 1-2009, f. & cert. ef. 6-22-09; BP 4-2009, f. & cert. ef. 12-24-09

855-007-0120

Damage to a Pharmacy and Drug Integrity

(1) If a pharmacy prescription department sustains damage, whether by flood or otherwise, the entire drug inventory, including any prescriptions that are awaiting pickup, is unfit for dispensing, shall be classified as adulterated and must be destroyed unless, in the pharmacist’s professional judgment, any items are deemed safe for dispensing. Any incident of this nature must be reported to the Board within three working days.

(2) If a pharmacy loses power that affects temperature or humidity controls such that USP standards for proper storage of drugs have been violated, such drugs shall be classified as adulterated and may not be dispensed.

NOTE: for those drugs labeled for storage at “controlled room temperature,” the acceptable range of temperature is 68° to 77°F with allowances for brief deviations between 59° to 86°F.

(3) Controlled substances damaged, lost or stolen shall be documented and reported to the DEA and the Board on DEA Form 41 or DEA Form 106 as appropriate.

(4) A pharmacy that is required to temporarily close or relocate due to an emergency must report this event to the Board within three working days.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09; BP 1-2009, f. & cert. ef. 6-22-09; BP 4-2009, f. & cert. ef. 12-24-09

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