Or. Admin. Code § 855-139-0145

Current through Register Vol. 63, No. 11, November 1, 2024

Section 855-139-0145 - Outlet: Closure- Temporary, Permanent and Emergency

(1) Temporary Closing. Unless subject to an exemption in OAR 855-139-0145(3), when a RDSP is temporarily closed to the public the RDSP must:

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

(A) Estimated period of time the RDSP 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 RDSP 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 RDSP 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 RDSP is permanently closing to the public, the RDSP must:

(a) Prior to closing, the RDSP 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 RDSP will be open;

(ii) Name, address and telephone number of the pharmacy to which pharmacy records will be transferred or the Oregon licensed Pharmacist 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 notification with each prescription dispensed;

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

(iii) Posting a closing notice at each building and each RDSP 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 RDSP may also provide notification via email or text.

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

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

(ii) Name, address and telephone number of the pharmacy to which pharmacy records will be transferred or the Oregon licensed Pharmacist 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.

(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 RDSP 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 RDSP operating status with each electronic prescribing vendor; and

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

(c) After closing. Within 30 calendar days after the closing of the RDSP, 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 RDSP 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 RDSP were transferred or disposed;

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

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

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

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

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

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

(D) Once the RDSP has notified the board that the RDSP is permanently closed, the license may not be renewed. The RDSP may apply for a new license as specified in OAR 855-139-0015.

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

Or. Admin. Code § 855-139-0145

BP 10-2022, temporary adopt filed 02/16/2022, effective 2/16/2022through 6/7/2022; 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 46-2022, minor correction filed 11/17/2022, effective 11/17/2022; 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 475.035, ORS 689.205 & ORS 689.700

Statutes/Other Implemented: ORS 689.155 & ORS 689.700