Or. Admin. Code § 333-333-8200

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

Section 333-333-8200 - [Effective until 1/1/2025] Product Tracking - General Requirements

(1) A service center, manufacturer or laboratory licensee must use the product tracking system as an inventory and recordkeeping system.

(2) Each individual service center, manufacturer and laboratory licensee will have access to the product tracking system. A licensee may authorize additional licensee representatives to use the product tracking system for their licensed premises.

(3) Each service center, manufacturer and laboratory licensee must:

(a) Maintain an accurate and complete list of all product tracking system users for each licensed premises and must update the list when a new product tracking system user is added.

(b) Train and authorize any new product tracking system users before those users are permitted to access the product tracking system or input, modify, or delete any information in the product tracking system.

(c) Remove access for any product tracking system user from an associated product tracking system account if that individual is no longer a licensee representative.

(d) Correct any data that is entered into the product tracking system in error.

(4) Each service center, manufacturer and laboratory licensee is responsible for all actions licensee representatives take while logged into the product tracking system or while otherwise conducting inventory tracking activities.

(5) Nothing in this rule prohibits a service center, manufacturer or laboratory licensee from using secondary separate software applications to collect information to be used in its operation including secondary inventory tracking or point of sale systems.

(6) If at any point a service center, manufacturer or laboratory licensee loses access to the product tracking system for any reason, the licensee must keep and maintain comprehensive records detailing all tracking inventory activities that were conducted during the loss of access.

(a) Once access is restored, all inventory tracking activities that occurred during the loss of access must be entered into the product tracking system.

(b) A licensee must document when access to the system was lost and when it was restored.

(c) A licensee may not transport any psilocybin product to another licensed premises until such time as access is restored and all information is recorded into the product tracking system unless the Oregon Health Authority (Authority) has provided written authorization to do so.

(7) The Authority may issue a temporary waiver of any requirements of these rules if the product tracking system is unable to perform required functions. Any temporary waiver issued under this section will be published on the Authority's website and will identify the specific rule sections affected and the duration of the waiver.

Or. Admin. Code § 333-333-8200

PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022; PH 58-2023, amend filed 12/21/2023, effective 1/1/2024

Statutory/Other Authority: ORS 475A.235 & ORS 475A.400

Statutes/Other Implemented: ORS 475A.235 & ORS 475A.400