Chapter 333-333

333-333-6160 Investigations (1) For purposes of this rule and OAR 333-333-6040, “evidence” includes but is not limited to, physical objects, documents, records, video recordings and interviews with an Oregon Health Authority (Authority) authorized representative. (2) An applicant…

333-333-6200 Suspension, Cancellation, Civil Penalties, Sanction Schedule (1) The Oregon Health Authority (Authority) may suspend or revoke: (a) A license issued under ORS chapter 475A for violation of a provision of ORS chapter 475A or these rules, in accordance with section (4)…

333-333-6210 Licensee Responsibility (1) A licensee is responsible for: (a) The violation of any of these rules and any provision of ORS 475A.210 to 475A.722. (b) Any act or omission of a licensee representative in violation of these rules or of ORS 475A.210 to 475A.722. (2) If a…

333-333-6220 Suspended Licenses: Posting of Suspension Notice Sign, Activities Allowed During Suspension (1) Before 6:00 AM on the date a license suspension goes into effect, and until the suspension is completed, Authority staff must ensure that a suspension notice sign is poste…

333-333-7010 Psilocybin Testing: Purpose (1) The purpose of OAR 333-333-7010 to OAR 333-333-7150 is to establish minimum compliance testing standards for psilocybin products. (2) A person licensed under ORS 475A.290 or 475A.305may not transfer, accept or provide a psilocybin prod…

333-333-7020 Ordering Tests (1) A manufacturer must provide to a laboratory, prior to the laboratory taking samples, the following information: (a) The manufacturer’s license number and endorsement type; (b) The manufacturer’s name, address and contact information; (c) Type of ps…

333-333-7030 Speciation Testing (1) A manufacturer must order a test for a batch taken from the first harvest lot recorded in a calendar year to ensure that the lot contains Psilocybe cubensis. This test must be performed prior to transferring the harvest lot to another licensee …

333-333-7040 Potency Testing (1) A manufacturer must order tests for every batch of finished psilocybin product from a harvest lot or process lot to determine the concentration (potency) of psilocybin and psilocin in the product. (2) A process lot of homogenized fungi, psilocybin…

333-333-7050 Solvent Testing (1) If methanol or acetic acid are used to manufacture psilocybin extract, a manufacturer must order tests for methanol or acetic acid for every process lot of psilocybin extract prior to selling or transferring the psilocybin extract or converting to…

333-333-7060 Pesticide Testing (1) A licensee must submit one or more batches from a harvest lot or process lot for pesticide testing upon written request by the Oregon Health Authority. (2) A batch fails pesticide testing if the test detects the presence of a pesticide above act…

333-333-7070 Contaminant Testing (1) A licensee must submit one or more batches from a harvest lot or process lot for contaminant testing upon written request by the Oregon Health Authority. (2) A psilocybin product required to be tested for contaminants under these rules must be…

333-333-7080 Heavy Metals Testing (1) A licensee must submit one or more batches from a harvest lot or process lot for heavy metal testing upon written request by the Oregon Health Authority. (2) A harvest lot or process lot required to be tested for heavy metals may be tested fo…

333-333-7090 Psilocybin Batch Requirements (1) A manufacturer must separate each harvest lot of dried whole fungi into batches no larger than one kilogram. (2) A process lot for psilocybin extracts, homogenized fungi or edible psilocybin products is considered a batch. (3) A manu…

333-333-7100 Psilocybin Product Sampling Requirements (1) Whole fungi. (a) Whole fungi may only be sampled after it is dried, regardless of whether the whole fungi will be processed into another product type. (b) Sufficient sample increments must be taken to perform required test…

333-333-7110 Requirements for Pre-Tested Psilocybin Products (1) Following samples being taken from a harvest or process lot a manufacturer must: (a) Label the batch with the following information: (A) The harvest or process lot unique identification number; (B) The name of the l…

333-333-7120 Failed Test Samples (1) If a sample or a field duplicate sample (collectively referred to as "sample" for purposes of this rule) fails any initial test, the laboratory that did the testing may reanalyze the sample. The laboratory that did the initial test may not sub…

333-333-7150 Quality Control Testing (1) A manufacturer may request that a laboratory conduct testing for the purpose of assuring quality control for psilocybin products that are manufactured in compliance with these rules, except as provided in section (2) of this rule. (2) A ma…

333-333-8000 Waste Management (1) A manufacturer, service center or laboratory licensee must store, manage and dispose of solid and liquid wastes generated during production and processing of psilocybin products in accordance with applicable state and local laws and regulations w…

333-333-8100 Product Transportation (1) Psilocybin products transferred by licensees. (a) Psilocybin products transferred between licensed premises may only be transported by a licensee or licensee representative of the originating or receiving licensee. (b) Samples of psilocybin…

333-333-8200 Product Tracking — General Requirements (1) A service center, manufacturer or laboratory licensee must use the product tracking system as an inventory and recordkeeping system to record and maintain an accurate inventory of psilocybin products as specified in OAR 333…

333-333-8210 Product Tracking - Reconciliation of Inventory (1) Each service center, manufacturer and laboratory licensee must: (a) Use the product tracking system for all inventory tracking activities, as required by these rules. (b) By 11:59 AM local time of the next calendar d…

333-333-8220 Product Tracking - Unique Identification Numbers (1) A service center, manufacturer or laboratory licensee must use unique identification numbers generated by the product tracking system for inventory tracking activities required by these rules. (2) A manufacturer li…

333-333-8230 Product Tracking — Cultivation Batches (1) Within 72 hours of beginning a production process, a manufacturer must create a cultivation batch that will contain all fruiting bodies and mycelium produced by that production process. (2) A manufacturer must create a batch…

333-333-8240 Product Tracking — Inventory Audits (1) The Oregon Health Authority may perform a physical audit of the inventory of any service center, manufacturer or laboratory licensee at the agency’s discretion and with reasonable notice to the licensee. (2) A variance between …

333-333-8250 Product Tracking - User Requirements (1) A service center, manufacturer or laboratory licensee and any product tracking system user shall enter data into the product tracking system that fully and transparently accounts for all inventory tracking activities. (2) A se…