OAR 333-008-5000: Product Recall

(1) The Oregon Health Authority (Authority) may request or require a patient, caregiver, person responsible for a marijuana grow site (PRMG), dispensary, or processing site to recall any marijuana item that they have sold or transferred that does not meet the requirements in OAR chapter 333, division 8 or the minimum standards established by OAR chapter 333, division 7 when testing a marijuana item is required including but not limited to when there is evidence that: (a) Pesticides were used in the production of marijuana in violation of ORS chapter 634 or OAR chapter 603, division 57 or pesticides not on the Department of Agriculture’s guideline or approved by the U.S. Environmental Protection Agency (EPA) were used in the production of marijuana; (b) A marijuana item is adulterated, contaminated, may pose a risk to public health and safety, or is otherwise unfit for human use, consumption, or application; (c) Marijuana was not produced by a PRMG; (d) A marijuana item was not processed by a processing site, was processed using marijuana that was not produced by a PRMG, or was processed using a marijuana item not processed by a processing site, except as explicitly allowed under OAR chapter 333, division 8; or (e) A marijuana item is labeled or packaged in a manner that poses a risk to public health and safety. (2) If a product is being recalled, the Authority: (a) May notify, or require the patient, caregiver, PRMG, dispensary, or processing site to notify, anyone that received the product of the recall; (b) May require the dispensary or processing site to notify anyone to whom a marijuana item was sold; and (c) May require that the patient, caregiver, PRMG, dispensary, or processing site destroy the recalled product. (3) If the Authority requests or requires the patient, caregiver, PRMG, dispensary, or processing site to initiate a recall pursuant to this rule, the Authority must provide the reason for the recall and any other information necessary for the recall to be initiated. (4) A patient, caregiver, PRMG, dispensary, or processing site conducting a voluntary or required recall must: (a) Have a product removal strategy appropriate to the threat and location of the recalled product. (b) Identify the scope of impacted product and establish a process for identifying affected product subject to a recall, which must include the following: (A) Distribution list. When identifying products subject to a recall, the patient, caregiver, PRMG, dispensary, or processing site must create a distribution list that includes the following information: (i) The name, registration number, and address of the dispensary or processing site, and anyone that received the product subject to the recall; (ii) Manifest or transfer date for each product subject to the recall; and (iii) Contact information for each person that received product subject to the recall, including names and telephone numbers. (B) Product information. When identifying each product subject to a recall, the patient, caregiver, PRMG, dispensary, or processing site must document the following product information: (i) Product description; (ii) If applicable, a photograph of the principle display panel; (iii) If applicable, the label identification number required by OAR 333-008-0600, OAR 333-008-1200, or OAR 333-008-1740; (iv) If applicable, the name and Oregon Medical Marijuana Program (OMMP) identification card number of the PRMG that produced the marijuana; (v) If applicable, the registration number of the processing site that manufactured the product subject to the recall; and (vi) Date or date range of the manufacture or harvest of the product subject to the recall. (c) Provide notification to the following: (A) The Authority, within 24 hours of initiating the recall. (B) Each patient, caregiver, PRMG, dispensary and processing site identified on the distribution list under paragraph (4)(b)(A) of this rule that includes the following information: (i) Product description for the product subject to the recall; (ii) The reason for recall and related hazards, if any. If the product is being removed for quality rather than public health and safety reasons, the notice may state that the product does not meet internal specifications and is being removed from distribution; (iii) The name and OMMP identification card number of the PRMG that produced the marijuana subject to the recall; (iv) The registration number, name, and trade name of the processing site that manufactured the product subject to the recall; (v) Expiration date(s) for the product subject to the recall, if applicable; (vi) Date or date range of the manufacture or harvest of the product subject to the recall; and (vii) Instructions regarding the disposition of the affected product subject to the recall. (C) No later than 48 hours from issuing a recall notice under paragraph (B) of this subsection, notify patients and caregivers of the recall using the most effective method available, which may include any of the following methods or combination of methods: (i) An electronic mail to those affected. (ii) An alert on the dispensary’s or processing site’s website. (iii) A warning that is clearly and visibly posted on the premises of a dispensary. (iv) A press release to notify patients and caregivers. (d) Make all reasonable efforts to remove the affected products from circulation. Affected products that are either still in control of a patient, caregiver, PRMG, dispensary, or processing site must be secured, segregated, clearly labeled not for sale or distribution, and separated from any other non-affected products. (e) Complete recall effectiveness checks to verify that all dispensaries or processing sites have been notified and have taken the appropriate action, including: (A) Confirming having received the recall notification; (B) Determining whether the recalled marijuana item was handled as instructed in the recall notification; and (C) If the product was further transferred by a receiving dispensary or processing site before receipt of the recall notification, and if so, were they notified. (5) Prior to the recall being initiated, the Authority may require the patient, caregiver, PRMG, dispensary, or processing site to submit any information required by this rule. (6) If the Authority issues a Notice of Intent to Recall the patient, caregiver, PRMG, dispensary, or processing site is entitled to a contested case hearing as provided under ORS chapter 183.