Or. Admin. Code § 333-333-2410

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

Section 333-333-2410 - Product Information Document

(1) Manufacturers must provide a product information document with all products transferred to a service center that lists the following information in English on a printed or electronic document in 12-point font or larger.

(a) The manufacturer's business or trade name and license number.

(b) The business or trade name of the manufacturer that packaged the product, if different from the original manufacturer.

(c) One of the following product type names: whole fungi, homogenized fungi, psilocybin extract, or edible psilocybin product.

(d) Net quantity of contents using the metric system of measurement and expressed in terms of fluid measure if the item is liquid, or in terms of weight if the item is solid, semi-solid, or viscous.

(e) Results of all laboratory tests required by OAR 333-333-7040.

(f) Species of fungi.

(g) Harvest date for whole fungi.

(h) Date of manufacture for all products other than whole fungi.

(i) Unique identification number as defined in OAR 333-333-1010.

(j) List of all active and inactive ingredients in descending order of predominance by weight or volume.

(k) List of potential major food allergens by:

(A) Listing the name of the food source of any major food allergen at the end of or immediately adjacent to the ingredient list; or

(B) Placing the term for the appropriate major food allergen in parenthesis within the ingredient list after the common or usual name of the ingredient derived from that major food allergen.

(l) "Best by" date indicating the time that the manufacturer has determined that their product will retain its original quality.

(m) If the psilocybin product is perishable, a statement that the product must be refrigerated or kept frozen.

(2) A facilitator must make reasonable efforts to provide a product information document for psilocybin products that may be consumed during an administration session during a client's preparation session and provide the client an opportunity to discuss the document. If a client does not receive a product information document during their preparation session, a facilitator must provide the client a product information document for psilocybin products that may be consumed during an administration session and provide the client an opportunity to discuss the document at another time prior to beginning their administration session.

(3) A service center must make reasonable efforts to translate the product information document to languages other than English and otherwise provide the product information document in an accessible format upon the client's request.

Or. Admin. Code § 333-333-2410

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

Statutes/Other Implemented: ORS 475A.235