OHA Division 7 Amended Rules / Labeling, Concentration and Testing

ohalg500_18
Please note, this document does not contain all rules found in division 7 and 8. It only
contains the rules which were added or amended during the rule making process.

OREGON ADMINISTRATIVE RULES

OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION

CHAPTER 333

DIVISION 7 – Amended

MARIJUANA LABELING, CONCENTRATION LIMITS, AND TESTING

Permanent rules effective November 28, 2016
_________________________________________________________________
333-007-0010      333-007-0090      333-007-0100      333-007-0200 
333-007-0210      333-007-0220     333-007-0300
___________________________________________________________________________
333-007-0010
Labeling: Purpose, Scope and Effective Date
(1) The purpose of OAR 333-007-0010 through 333-007-0100 is to set the minimum standards
for the labeling of marijuana items that are sold to a consumer, patient or designated primary
caregiver. These minimum standards are applicable to:
(a) A Commission licensee as that is defined in OAR 845-025-1015; and
(b) A person registered with the Authority under ORS 475B.400 to 475B.525 who is not exempt
from the labeling requirements as described in section (2) of this rule.
(2) The labeling requirements in these rules do not apply to:
(a) A grower if the grower is transferring usable marijuana or an immature marijuana plant to:
(A) A patient who designated the grower to grow marijuana for the patient; or
(B) A designated primary caregiver of the patient who designated the grower to grow marijuana
for the patient.
(b) A designated primary caregiver of a patient if the caregiver is transferring a marijuana item to
a patient of the designated primary caregiver.
(3) Nothing in these rules prohibits the Commission or the Authority from:
(a) Imposing additional labeling requirements in their respective rules governing licensees and
registrants as long as those additional labeling requirements are not inconsistent with these rules;
or
(b) Requiring licensees or registrants to provide informational material to a consumer, patient or
designated primary caregiver at the point of sale.
(4) A person licensed by the Commission must comply with these rules at all times
333-007-0090
General Label Requirements; Prohibitions; Exceptions
(1) Principal Display Panel.
(a) Every container that contains a marijuana item for sale or transfer to a consumer, patient or
designated primary caregiver must have a principal display panel, as that term is defined in OAR
333-007-0020.
(b) If a container is placed within packaging for purposes of displaying the marijuana item for
sale or transfer to a consumer, patient or designated primary caregiver, the packaging must have
a principal display panel as that term is defined in OAR 333-007-0020.
(c) The principal display panel must contain the product identity, net weight, and universal
symbol, if applicable.
(d) If the product is a medical grade cannabinoid product, concentrate or extract processed by a
licensee the principal display panel must include the medical grade symbol.
(2) A label required by these rules must:
(a) Be placed on the container and on any packaging that is used to display the marijuana item
for sale or transfer to a consumer, patient or designated primary caregiver.
(b) Comply with the National Institute of Standards and Technology (NIST) Handbook 130
(2016), Uniform Packaging and Labeling Regulation, incorporated by reference.
(c) Be in no smaller than 8 point Times New Roman, Helvetica or Arial font;
(d) Be in English, though it can be in other languages; and
(e) Be unobstructed and conspicuous.
(3) A marijuana item may have one or more labels affixed to the container or packaging.
(4) A marijuana item that is in a container that because of its size does not have sufficient space
for a label that contains all the information required for compliance with these rules:
(a) May have a label on the container that contains a marijuana item and on any packaging that is
used to display the marijuana item for sale or transfer to a consumer, patient or designated
primary caregiver that includes at least the following:
(A) Information required on a principal display panel, if applicable for the type of marijuana
item;
(B) Licensee or registrant business or trade name and licensee or registrant number;
(C) For licensees, package unique identification number and for registrants, batch or process lot
number;
(D) Concentration of THC and CBD; and
(E) Required warnings; and
(b) Must include all other required label information not listed in subsection (4)(a) of this rule on
an outer container or package, or on a leaflet that accompanies the marijuana item; and
(c) May:
(A) Use a peel-back or accordion label with the information required in subsection (4)(b) of this
rule, if the peel-back or accordion label can be easily identified by a patient or consumer as
containing important information.
(B) Use 6 point font for the information listed in paragraph (4)(a)(A) to (D) of this rule.
(5) A marijuana item in a container that is placed in packaging that is used to display the
marijuana item for sale or transfer to a consumer, patient, or designated primary caregiver must
comply with the labeling requirements in these rules, even if the container qualifies for the
exception under section (4) of this rule.
(6) The universal symbol:
(a) Must be at least 0.48 inches wide by 0.35 inches high.
(b) May only be used by licensees or registrants.
(c) May be downloaded at www.healthoregon.org/marijuana.
(7) Medical grade symbol. The medical grade symbol must be at least 0.35 inches in diameter.
(8) A label may not:
(a) Contain any untruthful or misleading statements including, but not limited to, a health claim
that is not supported by the totality of publicly available scientific evidence (including evidence
from well-designed studies conducted in a manner which is consistent with generally recognized
scientific procedures and principles), and for which there is significant scientific agreement,
among experts qualified by scientific training and experience to evaluate such claims; or
(b) Be attractive to minors, as that is defined in OAR 845-025-7000
(9) A marijuana item that falls within more than one category, for example a product that is both
a cannabinoid concentrate and cannabinoid edible, must comply with the labeling requirements
that apply to both categories, with the exception of the “DO NOT EAT” warning if the product is
intended for human consumption or the “BE CAUTIOUS” warning if the effects of the product
are customarily felt immediately.
(10) The THC and CBD amount required to be on a label must be the value calculated by the
laboratory that did the testing in accordance with OAR 333-064-0100.
(11) If a marijuana item has more than one test batch number, laboratory, or test analysis date
associated with the marijuana item that is being sold or transferred, each test batch number,
laboratory and test analysis date must be included on a label.
(12) If a marijuana item is placed in a package that is being re-used, the old label or labels must
be removed and it must have a new label or labels.
(13) A licensee or registrant must have documentation that demonstrates the validity of the
calculation of the amount of sodium, sugar, carbohydrates and total fat in a cannabinoid edible
and must make that documentation available to the Commission or the Authority upon request.
(14) Exit packaging must contain a label that reads: “Keep out of the reach of children.”
(15) A cartridge containing a cannabinoid concentrate, extract or product intended for use with
an inhalant delivery system as that is defined in ORS 431.840 is not required to be labeled in
accordance with these rules except that the cartridge must have a label with the universal symbol.
All the remaining label requirements must be included on the packaging that is used to display
the cartridge for sale or transfer
333-007-0100
Pre-Approval of Labels
(1) A registrant must submit labels for pre-approval in accordance with OAR 845-025-7060 and
must keep all records related to the pre-approval process and provide those records at the request
of the Authority.
(2) A registrant may not transfer a marijuana item unless the label has been pre-approved in
accordance with OAR 845-025-7060
333-007-0200
Concentration and Serving Size Limits: Definitions, Purpose, Scope and Effective Date
(1) In accordance with ORS 475B.625, the Authority must establish, for marijuana items sold or
transferred to a consumer, patient or designated primary caregiver through a Commission
licensed marijuana retailer or medical marijuana dispensary:
(a) The maximum concentration of THC permitted in a single serving of a cannabinoid product
or cannabinoid concentrate or extract; and
(b) The number of servings permitted in a cannabinoid product container or cannabinoid
concentrate or extract container.
(2) OAR 333-007-0200 through 333-007-0220 apply to:
(a) A Commission licensee as that is defined in OAR 845-025-1015; and
(b) A person registered with the Authority under ORS 475B.400 to 475B.525 who is not exempt
under ORS 475B.630.
(3) The concentration of THC permitted under OAR 333-007-0210 through 333-007-0220 must
take into account both the amount of Delta-9 THC in the cannabinoid product or cannabinoid
concentrate or extract and the amount of tetrahydrocannabinolic acid (THCA) in the cannabinoid
product or cannabinoid concentrate or extract that if heated would convert THCA to THC. A
cannabinoid product or cannabinoid concentrate or extract that contains a high amount of THCA
must meet the concentration limits established in OAR 333-007-0200 through 333-007-0220
even if heated.
(4) The amounts of THC listed on a label are based on an average from samples taken from a
harvest or process lot and may not represent the exact amount of THC in a marijuana item
purchased by a consumer, patient or designated primary caregiver.
(5) A marijuana item received or transferred by a dispensary must meet the concentration and
serving size limits in OAR 333-007-0220 and until January 1, 2017, OAR 333-008-1500.
(6) For purposes of OAR 333-007-0200 through 333-007-0220:
(a) The definitions in OAR 333-007-0020 apply unless otherwise specified.
(b) “Cannabinoid capsule” means a small soluble container, usually made of gelatin, that
encloses a dose of a cannabinoid product, concentrate or extract intended for human ingestion.
(c) “Cannabinoid edible” means a food or potable liquid into which a cannabinoid concentrate or
extract or the dried leaves or flowers of marijuana have been incorporated.
(d) “Cannabinoid suppository” means a small soluble container designed to melt at body
temperature within a body cavity other than the mouth, especially the rectum or vagina
containing a cannabinoid product, concentrate or extract.
(e) “Cannabinoid transdermal patch” means an adhesive substance applied to human skin that
contains a cannabinoid product, concentrate or extract for absorption into the bloodstream.
(f) “Medical marijuana item” is a marijuana item for sale or transfer to a patient or designated
primary caregiver and includes medical grade cannabinoid products, cannabinoid concentrates
and cannabinoid extracts.
(g) “Retail adult use marijuana item” is a marijuana item for sale to a consumer.
(h) “Scored” means to physically demark a cannabinoid edible in a way that enables a reasonable
person to:
(A) Intuitively determine how much of the product constitutes a single serving; and
(B) Easily physically separate the edible into single servings either by hand or with a common
utensil, such as a knife
333-007-0210
Retail Marijuana Item Concentration and Serving Size Limits
(1) The maximum concentration or amount of THC permitted in a container and the maximum
concentration or amount of THC permitted in a serving of a retail adult use marijuana item is
listed in Table 1.
(2) A cannabinoid edible must be scored unless it is not capable of being scored in which case
the cannabinoid edible must be:
(a) Sold and packaged with a measuring device that measures single servings; or
(b) Placed in packaging that clearly enables a consumer to determine when a single serving has
been consumed.
(3) Serving size is as determined by the processor.
(4) A retail adult use marijuana item that does not fall within a category in Table 1 such as
cannabinoid suppositories and transdermal patches must meet the concentration and serving size
limits applicable to a cannabinoid edible in Table 1.
333-007-0220
Medical Marijuana Item Concentration Limits
(1) The maximum concentration or amount of THC permitted in a container and the maximum
concentration or amount of THC permitted in a serving of a medical marijuana item is listed in
Table 2. [Table not included. See ED. NOTE.]
(2) A cannabinoid edible must be scored unless it is not capable of being scored in which case
the cannabinoid edible must be:
(a) Sold and packaged with a measuring device that measures single servings; or
(b) Placed in packaging that clearly enables a patient to determine when a single serving has
been consumed, as that serving size is determined by the processor.
(3) Serving size is as determined by the processor.
(4) A medical marijuana item that does not fall within a category in Table 2 must meet the
concentration and serving size limits applicable to a cannabinoid edible in Table 2
333-007-0300
Marijuana Testing: Purpose and Effective Date
(1) The purpose of these rules is to establish the minimum testing standards for marijuana items.
These rules are applicable to:
(a) A licensee; and
(b) A registrant who is not exempt from the testing requirements.
(2) The testing requirements do not apply to:
(a) A grower if the person is transferring usable marijuana or an immature marijuana plant to:
(A) A patient who designated the grower to grow marijuana for the patient; or
(B) A designated primary caregiver of the patient who designated the grower to grow marijuana
for the patient; or
(b) A designated primary caregiver of a patient if the caregiver is transferring a marijuana item to
a patient of the designated primary caregiver.
(c) Immature plants or seeds.
(3) A person registered with the Authority under ORS 475B.400 to 475B.525 who is subject to
these rules may not:
(a) Transfer a marijuana item that is not sampled and tested in accordance with these rules; or
(b) Accept the transfer of a marijuana item that is not sampled and tested in accordance with
these rules.
(4) A person licensed by the Commission must comply with these rules at all times.
(5) Notwithstanding section (3)(a) of this rule, until January 1, 2017, a dispensary may transfer a
marijuana item to a patient or caregiver that was transferred to the dispensary before October 1,
2016, and that was not sampled and tested in accordance with these rules if the item contains a
label placed on the package where it can easily be seen by the patient or caregiver that reads
“DOES NOT MEET NEW TESTING REQUIREMENTS” in 12 point font, and in bold, capital
letters

Leave a Reply

Be the First to Comment!

Notify of
wpDiscuz