Or. Admin. Code § 855-041-1092

Current through Register Vol. 63, No. 12, December 1, 2024

Section 855-041-1092 - Retail Drug Outlet Pharmacy Closures: Temporary, Permanent or Emergency

(1) Temporary Closing. Unless subject to an exemption in OAR 855-041-1092(3), when a Retail Drug Outlet pharmacy is temporarily closed to the public the pharmacy must:

(a) Post notification of closure on each pharmacy entrance as soon as the need to deviate from the posted hours is known by the pharmacy, but no later than 2 hours after the temporary closure begins. The posting must include:

(A) Estimated period of time the pharmacy will be closed; and

(B) Options for prescription pick-up (e.g. another local pharmacy, contact prescriber for new prescription, reverse processed prescriptions).

(b) Post notification of closure on each telephone greeting and pharmacy operated internet (e.g. website, social media, mobile applications) as soon as possible. The posting must include:

(A) Estimated period of time the pharmacy will be closed; and

(B) Options for prescription pick-up (e.g. another local pharmacy, contact prescriber for new prescription, reverse processed prescriptions).

(c) If the pharmacy is temporarily closed greater than 2 consecutive business days, notify the board office as soon as possible but no later than 72 hours after the temporary closure begins with the date and time the closure began, anticipated date and time of re-opening, and the reason for the temporary closure.

(d) Federal and state holidays are exempt from the requirements of (1).

(2) Permanent Closing. If a Retail Drug Outlet pharmacy is permanently closing to the public, the pharmacy must:

(a) Prior to closing, the pharmacy must comply with the following:

(A) Provide notification to each patient who has filled a prescription within the previous 12 months. This notification must be made a minimum of 15 calendar days prior to closing and must include:

(i) The last day the pharmacy will be open;

(ii) Name, address and telephone number of the pharmacy that will take possession of the pharmacy records or the person who will serve as the custodian of records;

(iii) Instructions on how patients can arrange for transfer of their pharmacy records to a pharmacy of their choice; and

(iv) The last day a transfer may be initiated.

(B) The notification must be made via:

(i) Distribution by direct mail or written notice with each prescription dispensed;

(ii) Public notice in a newspaper of general circulation, if available, in the area served by the pharmacy; and

(iii) Posting a closing notice on each pharmacy entrance, on each telephone greeting, and pharmacy-operated internet (e.g. website, social media, mobile applications).

(iv) In addition to (i), (ii) and (iii), the pharmacy may also provide notification via email or text.

(C) Provide any new patients filling prescriptions during the 15 calendar day period prior to the pharmacy closing with written notification that includes:

(i) The last day the pharmacy will be open;

(ii) Name, address and telephone number of the pharmacy to which pharmacy records will be transferred or the person who will serve as the custodian of pharmacy records;

(iii) Instructions on how patients can arrange for transfer of their pharmacy records to a pharmacy of their choice; and

(iv) The last day a transfer may be initiated.

(D) Notify DEA of any controlled substances being transferred to another registrant as specified in 21 CFR 1301.52 (04/01/2023).

(b) On the date of closing or up to 24 hours after the permanent closure begins, the Pharmacist-in-charge must comply with the following:

(A) Complete and document an inventory of all controlled substances.

(B) If the pharmacy dispenses prescriptions:

(i) Transfer the prescription drug order files, including refill information, and patient medication records to a licensed pharmacy or to an Oregon licensed Pharmacist who will serve as the custodian of records;

(ii) Update the pharmacy operating status with each electronic prescribing vendor; and

(iii) Remove all signs and symbols indicating the presence of the pharmacy including pharmacy-operated internet (e.g. website, social media, mobile applications).

(c) After closing. Within 30 calendar days after the closing of the pharmacy, the Pharmacist-in-charge must:

(A) Complete and document an inventory of all non-controlled drugs and devices.

(B) Remove all prescription and non-prescription drugs, devices, and related supplies from the pharmacy by one or a combination of the following methods:

(i) Return to manufacturer or supplier (credit or disposal);

(ii) Transfer (sell or give away) to a licensed healthcare professional or outlet who is legally authorized to possess drugs; or

(iii) Destroy and document the destruction by two board licensees. For controlled substances, the registrant must comply with 21 CFR 1304.21 (04/01/2023), 21 CFR 1304.22 (04/01/2023), 21 CFR 1317.05 (04/01/2023), 21 CFR 1317.90 (04/01/2023) and 21 CFR 1317.95 (04/01/2023).

(C) Provide the board a written notice of the closing on a board prescribed form which includes the following information:

(i) Date of closing to the public and discontinuance of the business;

(ii) Date and time the inventory of all prescription drugs and devices was conducted;

(iii) Name, address, phone number and applicable registration number where all legend and controlled substances possessed by the pharmacy were transferred or disposed;

(iv) If drugs were destroyed, name and license numbers of individuals that who witnessed the destruction;

(v) If the pharmacy is registered to possess controlled substances, confirmation that the pharmacy complied with all applicable federal requirements in 21 CFR 1301.52 (04/01/2023) for discontinuing operation as a pharmacy that dispenses controlled substances.

(vi) The name, address and phone number of the pharmacy that took possession of the pharmacy records or the Oregon licensed Pharmacist who is serve as the custodian of pharmacy records which must be maintained according to OAR 855-041-1160;

(vii) Confirmation all pharmacy labels and blank prescriptions were destroyed;

(viii) Confirmation all signs and symbols indicating the presence of the pharmacy including pharmacy-operated internet (e.g. website, social media, mobile applications) have been removed; and

(ix) Confirmation that each registration certificate issued to the pharmacy by the board has been mailed to the board office.

(D) Once the pharmacy has notified the board that the pharmacy is permanently closed, the license may not be renewed. The pharmacy may apply for a new license as specified in OAR 855-041-1080.

(E) Unless a registration has expired, the registration will remain active until the board has notified the registrant that the notice of permanent closure has been received and the registration has been lapsed.

(3) Emergency closing. If a Retail Drug Outlet pharmacy is closed suddenly due to fire, destruction, natural disaster, death, property seizure, eviction, bankruptcy, inclement weather, or other emergency circumstances and the Pharmacist-in-charge cannot provide notification as required in (1), the Pharmacist-in-charge must comply with the provisions of (1) as far in advance or as soon after the closing as allowed by the circumstances.

(4) Non-resident Retail Drug Outlet pharmacies are exempt from (1)-(3) and must follow laws and rules in the pharmacy's state of residence pertaining to temporary, permanent and emergency closures. The non-resident pharmacy must provide the board a written notice of the closing within 30 calendar days on a form prescribed by the board which includes the following information:

(a) Date of closing to the public and discontinuance of the business;

(b) If the pharmacy dispenses prescriptions, the name, address and phone number of the pharmacy or Oregon licensed Pharmacist who will serve as the custodian of records for Oregon patients to which the prescriptions, including refill information, and patient medication records were transferred; and

(c) Confirmation that each registration certificate issued to the pharmacy by the board has been mailed to the board office.

(5) The board may conduct an inspection to verify all requirements in subsection (1), (2), (3) and (4) of this section have been completed.

Or. Admin. Code § 855-041-1092

BP 33-2021, temporary adopt filed 12/10/2021, effective 12/10/2021 through 06/07/2022; BP 10-2022, temporary adopt filed 02/16/2022, effective 02/16/2022 through 06/07/2022; BP 19-2022, adopt filed 04/20/2022, effective 4/20/2022; BP 32-2022, amend filed 06/15/2022, effective 6/16/2022; BP 10-2023, amend filed 06/13/2023, effective 6/13/2023; BP 57-2024, amend filed 06/18/2024, effective 6/20/2024

Publications: Publications referenced are available for review at the agency.

Statutory/Other Authority: ORS 689.205 & ORS 475.035

Statutes/Other Implemented: ORS 689.205