Or. Admin. R. 333-333-2050

Current through Register Vol. 63, No. 8, August 1, 2024

Section 333-333-2050 - Adulterants

(1) A licensee may not add to psilocybin products, substrates, growing medium or client packaging any chemical, drug, plant, or substance that has the effect of altering potency, intoxicating effect, duration of effect, toxicity or potential for excessive use, including but not limited to monoamine oxidase inhibitors (MAOI's), beverage alcohol or cannabis.

(2) A licensee may not produce, store or transfer adulterated psilocybin products.

(3) A psilocybin product that contains an adulterant is considered adulterated

(4) In addition to section (3) of this rule, a psilocybin product may be considered adulterated if:

(a) It bears or contains any poisonous or deleterious substance in a quantity rendering the psilocybin product a risk to human health;

(b) It bears or contains any added poisonous or deleterious substance exceeding a safe tolerance if such tolerance has been established;

(c) It consists in whole or in part of any unsanitary, putrid, or decomposed substance, or is otherwise unfit for human consumption;

(d) It is processed, prepared, packaged or held under improper time-temperature conditions or under conditions increasing the probability of contamination with excessive microorganisms or physical contaminants;

(e) It is processed, prepared, packaged, or held under unsanitary conditions increasing the probability of contamination or cross-contamination;

(f) It is held or packaged in containers composed, in whole or in part of any poisonous or deleterious substance rendering the contents potentially injurious to health;

(g) Any substance has been substituted wholly or in part;

(h) Damage or inferiority has been concealed in any manner; or

(i) Any substance has been added, mixed or packaged to make it appear better or of greater value than it is.

(5) Except for extraction allowed under these rules, a licensee may not utilize any manufacturing process that alters potency, intoxicating effect, duration of effect, toxicity or potential for excessive use.

(6) Psilocybin products that are intended for product development and will not be made available for consumption must be labeled in bold, capital letters, no smaller than 12-point font, "NOT FOR CONSUMPTION" and may be stored in states that are unfit for human consumption.

Or. Admin. R. 333-333-2050

PH 74-2022, adopt filed 05/19/2022, effective 5/20/2022; PH 58-2023, amend filed 12/21/2023, effective 1/1/2024

Statutory/Other Authority: ORS 475A.235

Statutes/Other Implemented: ORS 475A.235