OAR 845-025-7160
Packaging and Labeling Pre-approval Process

(1) Prior to selling, offering for sale, or transferring a marijuana item or industrial hemp commodity or product that is for ultimate sale to a consumer, patient, or designated primary caregiver, a licensee, a license applicant or a registrant must submit both a package and a label application to and receive approval from the Commission.
(a) The initial submission shall be made electronically if required by the Commission. The licensee, license applicant or registrant must submit a physical prototype upon request by the Commission.
(b) If a license applicant submits packages and labels for pre-approval, final determination for packages and labels will not be made until the applicant has been issued a license.
(2) Except as provided in sections (5) to (7) of this rule, the packaging and label applications must be accompanied by the following:
(a) A fee as specified in OAR 845-025-1060 (Fees); and
(b) Information including but not limited to:
(A) Documentation that the package has been certified as child resistant as defined by 16 CFR 1700 by a qualified third party child-resistant package testing firm.
(B) A picture of and description of the item to be placed in the package.
(C) For label applications for inhalable cannabinoid products that contain non-cannabis additives:
(i) The non-cannabis additive’s list of ingredients as required by 845-025-3265 (Inhalable Cannabinoid Product Processor Requirements)(1); and
(ii) In a form and manner prescribed by the Commission, information regarding the manufacturer of the non-cannabis additive, the additive or additives being used by the licensee, and attestation by the licensee of the accuracy of the information submitted for label pre-approval.
(3) If a licensee submits a list of ingredients to the Commission in order to comply with (2)(b)(C) of these rules, and that the licensee believes the list of ingredients is a trade secret, the licensee must mark the information "confidential - trade secret.”
(a) If the Commission receives a public records request for information submitted by a licensee, it will review all documents submitted to determine whether the documents contain trade secrets that would be exempt from disclosure under Oregon’s Public Records Act, ORS 192.345 (Public records conditionally exempt from disclosure).
(b) For purposes of this rule “trade secret” has the meaning given that term in ORS 192.345 (Public records conditionally exempt from disclosure).
(4) The Commission will evaluate the packaging and label in order to determine whether:
(a) The packaging:
(A) Has been certified as child resistant by a qualified third party child-resistant package testing firm;
(B) Is attractive to minors or is marketed in a manner attractive to minors;
(C) Contains untruthful or misleading content; and
(D) Will contain a marijuana item or industrial hemp commodity or product that is not compliant with ORS 475B, OAR 333, Divisions 7 and 8, or OAR 845, Division 25.
(b) The label:
(A) Complies with the labeling rules, OAR 845-025-7000 (Packaging and Labeling — Definitions) to 845-025-7190 (Effective Date), or any additional labeling requirements in ORS 475B, OAR 333, Divisions 7 and 8 or OAR 845, Division 25.
(B) Contains any material that is attractive to minors; and
(C) Contains untruthful or misleading content.
(5) The Commission must review the packaging and labeling and notify the licensee, licensee applicant or registrant whether the packaging and labeling is approved, and if not approved, a description of the packaging or labeling deficiencies.
(6) If a licensee or registrant’s label or package is deficient, it must correct the deficiencies and resubmit the label or package for pre-approval, but the licensee or registrant is not required to submit an additional fee unless the label or package is found deficient for a second time in which case the application will be denied and the licensee or registrant must resubmit the packaging or labeling in accordance with section (1) of this rule.
(7) A licensee, applicant or registrant may submit packaging and labeling for approval on the same application for a product that may have different flavors, colors or sizes, if the product and packaging is otherwise identical. Applications for approval of packaging and labeling under this section are subject to a single application fee.
(8) Packages and labels that have been previously approved do not need to be resubmitted if the only changes to the packaging or label are:
(a) Changes in the:
(A) Harvest or processing date;
(B) Strain;
(C) Test results;
(D) Net weight or volume; or
(E) UID numbers.
(b) The deletion of any non-mandatory label information.
(c) The addition, deletion or change in the:
(A) UPC barcodes or 2D mobile barcodes (QR codes);
(B) Website address, phone number, fax number, or place of address of the licensee or registrant; or
(C) Instructions for opening or using child-resistant packages.
(d) The repositioning of any label information on the package, as long as the repositioning of label information is consistent with these rules.
(9) Prior to a licensee transferring a package or label approval from one licensee to another, the licensee requesting to transfer the label must submit a form prescribed by the Commission and pay the applicable fee as described in OAR 845-025-1060 (Fees).
(10) The Commission may publish a list of previously-approved, child-resistant, commercially available packaging. Packaging identified on this list as approved for certain product types does not need to be submitted for package approval if the packaging is identical to the previously-approved package.
(11) The Commission may publish a list of licensees and registrants who have approved label applications.

(12)

Labels for marijuana items or industrial hemp commodity or products do not require pre-approval if they are generic labels as defined in OAR 845-025-7000 (Packaging and Labeling — Definitions) and contain only the information required by these rules.

(13)

Packages that are not intended to be child resistant do not require pre-approval. Any package that has not been certified as child-resistant must contain the statement described in OAR 845-025-7030 (Labeling for Sale to Consumer)(20).

(14)

Notwithstanding any provisions of this rule, the Commission may permit or require electronic submission of labels and packaging for approval.

Source: Rule 845-025-7160 — Packaging and Labeling Pre-approval Process, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=845-025-7160.

845‑025‑1000
Applicability 845‑025‑1015
Definitions 845‑025‑1030
Application Process 845‑025‑1045
True Name on Application 845‑025‑1060
Fees 845‑025‑1070
Late Renewal Fees 845‑025‑1080
Criminal Background Checks 845‑025‑1090
Application Review 845‑025‑1100
Approval of Application and Issuance of License 845‑025‑1115
Denial of Application 845‑025‑1130
Withdrawal of Application 845‑025‑1131
Producer Application Submission Deadlines 845‑025‑1132
Prohibited Changes to License Applications 845‑025‑1135
Application Processing Deadlines 845‑025‑1145
Communication With Commission 845‑025‑1160
Notification of Changes 845‑025‑1175
Changing, Altering, or Modifying Licensed Premises 845‑025‑1190
License Renewal 845‑025‑1200
Financial and Business Records 845‑025‑1215
Standardized Scales 845‑025‑1230
Licensed Premises Restrictions and Requirements 845‑025‑1245
Signage 845‑025‑1260
Standards for Authority to Operate a Licensed Business as a Trustee, a Receiver, a Personal Representative or a Secured Party 845‑025‑1275
Closure of Business 845‑025‑1290
Licensee Responsibility 845‑025‑1295
Local Ordinances 845‑025‑1300
Licensee Prohibitions 845‑025‑1330
Trade Samples 845‑025‑1335
Marijuana Promotional Events 845‑025‑1360
Quality Control Samples 845‑025‑1400
Security Plans 845‑025‑1405
Security Waivers 845‑025‑1410
Security Requirements 845‑025‑1420
Alarm System 845‑025‑1430
Video Surveillance Equipment 845‑025‑1440
Required Camera Coverage and Camera Placement 845‑025‑1450
Video Recording Requirements for Licensed Facilities 845‑025‑1460
Location and Maintenance of Surveillance Equipment 845‑025‑1470
Producer Security Requirements 845‑025‑1600
State and Local Safety Inspections 845‑025‑1620
General Sanitary Requirements 845‑025‑2000
Canopy Definitions 845‑025‑2020
Producer Privileges 845‑025‑2025
Micro Tier Processing. Privileges 845‑025‑2030
Licensed Premises of Producer 845‑025‑2040
Production Size Limitations 845‑025‑2045
Propagation Endorsement 845‑025‑2050
Recreational Marijuana Producers — Operating Procedures 845‑025‑2060
Recreational Marijuana Producers — Start-up Inventory 845‑025‑2070
Pesticides, Fertilizers and Agricultural Chemicals 845‑025‑2080
Harvest Lot Segregation 845‑025‑2090
Harvest Notification 845‑025‑2100
Transfer of Medical Marijuana Grower Inventory 845‑025‑2110
Medical Marijuana Registrant CTS Registration 845‑025‑2120
Medical Registrant CTS Requirements 845‑025‑2130
Grow site Transfers to Processor or Wholesaler Licensees 845‑025‑2140
Registrant to Patient Transfers 845‑025‑2150
Medical Marijuana Inspections and Compliance 845‑025‑2500
Registration to Produce Usable Marijuana for Patients 845‑025‑2550
Requirements for Producing and Providing Marijuana for Patients 845‑025‑2560
Cancellation of Registration 845‑025‑2700
Industrial Hemp Grower Certificate Application 845‑025‑2705
Industrial Hemp Handler Certificate Application 845‑025‑2750
Industrial Hemp Grower Certificate Privileges 845‑025‑2755
Industrial Hemp Handler Certificate Privileges 845‑025‑2760
THC Concentration Limits for Industrial Hemp and Hemp Items 845‑025‑2775
CTS Requirements for Industrial Hemp and Hemp Items 845‑025‑2785
Licensee Industrial Hemp Privileges 845‑025‑2800
Retailer Privileges 845‑025‑2820
Retailer Operational Requirements 845‑025‑2840
Retailer Premises 845‑025‑2860
Marijuana Retailers — Consumer Health and Safety Information 845‑025‑2880
Delivery of Marijuana Items by Retailer 845‑025‑2885
On-Site Delivery of Marijuana by Retailer 845‑025‑2890
Marijuana Retailers — Collection of Taxes 845‑025‑2900
Retail Sale of Marijuana for Medical Purposes 845‑025‑2910
Transfer of Medical Marijuana Dispensary Inventory 845‑025‑3200
Marijuana Processors — Definitions 845‑025‑3210
Marijuana Processors — Endorsements 845‑025‑3215
Processor Privileges 845‑025‑3220
General Processor Requirements 845‑025‑3230
Processor Policies and Procedures 845‑025‑3240
Processor Training Requirements 845‑025‑3250
Cannabinoid Edible Processor Requirements 845‑025‑3255
Alternating Proprietors 845‑025‑3260
Cannabinoid Concentrate and Extract Processor Requirements 845‑025‑3265
Inhalable Cannabinoid Product Processor Requirements 845‑025‑3270
CTS Requirements for Inhalable Cannabinoid Products with Non-Cannabis Additives 845‑025‑3280
Cannabinoid Topical Processor 845‑025‑3290
Processors Recordkeeping 845‑025‑3300
Processing Marijuana for Medical Purposes 845‑025‑3305
Processing for Cardholders 845‑025‑3310
Transfer of Medical Marijuana Processing Site Inventory 845‑025‑3500
Wholesale License Privileges 845‑025‑3505
Wholesaler For-Hire Trimming Privilege 845‑025‑3510
Micro-Wholesaler License Privileges 845‑025‑3600
Wholesaling Marijuana for Medical Purposes 845‑025‑5000
Laboratory License Privileges 845‑025‑5030
Laboratory Licensing Requirements 845‑025‑5045
Laboratory Tracking and Reporting 845‑025‑5060
Laboratory Transportation and Waste Disposal 845‑025‑5075
Laboratory Licensee Prohibited Conduct 845‑025‑5300
Application for Marijuana Research Certificate 845‑025‑5350
Marijuana Research Certificate Privileges 845‑025‑5500
Marijuana Worker Permit 845‑025‑5520
Marijuana Worker Permit Applications 845‑025‑5540
Marijuana Worker Permit Denial Criteria 845‑025‑5560
Marijuana Worker Examination Requirements 845‑025‑5580
Marijuana Worker Renewal Requirements 845‑025‑5590
Suspension or Revocation 845‑025‑5700
Licensee Testing Requirements 845‑025‑5720
Labeling, Storage, and Security of Pre-Tested Marijuana Items 845‑025‑5730
Wholesaler Coordination of Sampling and Testing 845‑025‑5740
Failed Test Samples 845‑025‑5760
Audit, Compliance, and Random Testing 845‑025‑5790
Marijuana Item Recalls 845‑025‑7000
Packaging and Labeling — Definitions 845‑025‑7010
Purpose, Scope and Effective Date 845‑025‑7020
Packaging for Sale to Consumer 845‑025‑7030
Labeling for Sale to Consumer 845‑025‑7045
Marijuana Plant Labeling Requirements 845‑025‑7050
Marijuana Seed Labeling Requirements 845‑025‑7070
Usable Marijuana Labeling Requirements 845‑025‑7080
Cannabinoid Topical Labeling Requirements 845‑025‑7090
Cannabinoid Edible Labeling Requirements 845‑025‑7100
Cannabinoid Concentrate and Extract Labeling Requirements 845‑025‑7110
Cannabinoid Tincture and Capsule Labeling Requirements 845‑025‑7120
Cannabinoid Products Other than Cannabinoid Edibles, Topicals, Tinctures or Capsules. 845‑025‑7130
Labeling Requirements for Medical Registrants Registered with the Oregon Health Authority 845‑025‑7140
Labeling Requirements for Industrial Hemp Commodities or Products Intended for Human Consumption or Use 845‑025‑7150
Wholesaler and Retailer Packaging and Labeling Compliance Requirements 845‑025‑7160
Packaging and Labeling Pre-approval Process 845‑025‑7170
Packaging and Labeling Prohibited Conduct 845‑025‑7180
Approval Withdrawal 845‑025‑7190
Effective Date 845‑025‑7500
Seed-To-Sale Tracking — CTS Requirements 845‑025‑7520
Unique Identification (UID) Tags 845‑025‑7540
Seed-To-Sale Tracking — CTS User Requirements 845‑025‑7560
Seed-To-Sale Tracking — System Notifications 845‑025‑7570
Seed-To-Sale Tracking — Cultivation Batches 845‑025‑7580
Reconciliation with Inventory 845‑025‑7590
Seed-To-Sale Tracking — Inventory Audits 845‑025‑7700
Transportation and Delivery of Marijuana Items 845‑025‑7750
Waste Management 845‑025‑8000
Advertising — Purpose and Application of Rules 845‑025‑8020
Advertising — Definitions 845‑025‑8040
Advertising Restrictions 845‑025‑8060
Advertising Media, Coupons, and Promotions 845‑025‑8080
Removal of Objectionable and Non-Conforming Advertising 845‑025‑8500
Responsibility of Licensee, Responsibility for Conduct of Others 845‑025‑8520
Prohibited Conduct 845‑025‑8540
Dishonest Conduct 845‑025‑8560
Inspections 845‑025‑8570
Uniform Standards for Minor Decoy Operations 845‑025‑8575
Restricting License Privileges and Conduct of Operations 845‑025‑8580
Suspended Licenses: Posting of Suspension Notice Sign, Activities Allowed During Suspension 845‑025‑8590
Suspension, Cancellation, Civil Penalties, Sanction Schedule 845‑025‑8700
Prohibited Interests in the Marijuana Industry 845‑025‑8750
License Surrender
Last Updated

Jun. 8, 2021

Rule 845-025-7160’s source at or​.us