WA Pharmacy Commission - Public Meeting
(April 23, 2021)

Here are some observations from the Friday April 23rd Washington State Pharmacy Quality Assurance Commission (WA Pharmacy Commission) public meeting.

My top 3 takeaways:

• The commission was asked by WSLCB cannabis regulators to clarify their interpretation of part of the definition of tetrahydrocannabinols (THC) in current law prior to issuing a directly related policy statement.
  • The Washington State Liquor and Cannabis Board (WSLCB) began evaluating delta-8-tetrahydrocannabinol (delta-8-THC) last year following questions raised about the delta-9-THC isomer. Agency officials reviewed the definition of THC in RCW 69.50.204(c)(30)(i) and their authority to regulate cannabinoids beyond delta-9-THC. By November, WSLCB staff started finalizing a draft policy statement focused on delta-8-THC, later deciding to expand the statement scope to include compounds other than delta-9-THC.
  • WSLCB staff sought input from sister agencies including:
    • The Washington State Department of Agriculture (WSDA), which runs the State hemp program and works with WSLCB in regulating cannabis edibles.
    • The Washington State Department of Health (DOH), which regulates medical cannabis while operating prevention and education programs. 
    • The Washington State Board of Health (SBOH), which permanently banned vitamin E acetate in cannabis and nicotine vapor products in October 2020 and was tasked with helping develop public health rules.
    • And the WA Pharmacy Commission, which has a mission “to promote public health and safety by establishing the highest standards in the practice of pharmacy and to advocate for patient safety through effective communication with the public, profession, Department of Health, governor and the legislature.” The commission has rulemaking powers over controlled substances, including “Whether the substance is an immediate precursor of a substance already controlled under the Uniform Controlled Substances Act.”
  • WA Pharmacy Commission Chair Tim Lynch told commissioners that “Clarification of Tetrahydrocannabinol (THC) Compounds other than Delta-9 under Chapter 69.50 RCW” had been added to the agenda at the request of WSLCB staff. Lauren Lyles-Stolz, the commission’s Executive Director, said the commission was contacted “about two weeks ago to ask for clarification on the commission’s current interpretation of RCW 69.50.204(c)(30)(i) which defines THC under the listings of schedule one drug[s].” She stated that agency officials were “noticing a rise in chemically or genetically altered THC compounds of delta-8, delta-9, and other compounds” and had become “concerned about public health implications of these alter[ed] and potentially psychoactive compounds in the marketplace.” Lyles-Stolz added WSLCB staff “wanted to make sure...that they were in alignment with the commission’s interpretation of the statute” (audio - 2m).
  • WA Pharmacy Commission Rules and Legislative Consultant Lindsay Trant provided background on the topic, describing how hemp was “removed from the definition of marijuana” in the 2018 Farm Bill and federal law considered cannabis with “not more than .3% delta-9-THC on a dry weight basis” a distinctly different, legal agricultural commodity “depending on certain restrictions and individual state laws.” It had since “been brought to our attention” by WSLCB staff “that producers are chemically or genetically [altering] hemp into compounds including, but not limited to, delta-8-THC,” she said, indicating compounds like delta-10-THC “and several others” had also been made from hemp crops. Trant said the topic had been raised within and outside of Washington “because in many states the language in the uniform controlled substances act doesn’t provide the clarity on these other compounds.” Delta-8-THC “has been sold around Washington state but the process to produce genetic or chemically modified products and the product itself have both been unregulated, posing a public health risk,” she explained. The commission had been asked to review the statutory definition and “opine on the scope of the provision as, as it is written, as to whether the language broadly extends to all extracts, synthetic substances, derivatives, and isomers of the cannabis plant” (audio - 2m).
  • RCW 69.50.204(c)(30)(i) states: “Tetrahydrocannabinols, meaning tetrahydrocannabinols naturally contained in a plant of the genera Cannabis, as well as synthetic equivalents of the substances contained in the plant, or in the resinous extractives of the genera Cannabis, and/or synthetic substances, derivatives, and their isomers with similar chemical structure and pharmacological activity such as the following:
    • (A) 1 - cis - or trans tetrahydrocannabinol, and their optical isomers, excluding tetrahydrocannabinol in sesame oil and encapsulated in a soft gelatin capsule in a drug product approved by the United States Food and Drug Administration;
    • (B) 6 - cis - or trans tetrahydrocannabinol, and their optical isomers;
    • (C) 3,4 - cis - or trans tetrahydrocannabinol, and its optical isomers; or
    • (D) That is chemically synthesized and either:
      • (I) Has been demonstrated to have binding activity at one or more cannabinoid receptors; or
      • (II) Is a chemical analog or isomer of a compound that has been demonstrated to have binding activity at one or more cannabinoid receptors; (Since nomenclature of these substances is not internationally standardized, compounds of these structures, regardless of numerical designation of atomic positions covered.)”
  • Washington State Office of the Attorney General (WA OAG) Assistant Attorney General (AAG) Christopher Gerard, the AAG assigned to the commission, remarked that “while the Farm Bill did amend” federal law, state lawmakers legalized hemp production in February 2019 creating “equivalent state statute” that placed hemp control “under the Department of Agriculture” (audio - 1m). 
    • A recently approved law establishing a voluntary hemp processor registration program also provided WSLCB additional statutory authority over licensees “engaged in producing or processing hemp at the same location for which they are licensed to produce or process marijuana” to “test samples represented as hemp that are obtained from a location licensed for marijuana production or marijuana processing for the sole purpose of validating THC content of products represented as hemp.” 

• The commissioners, staff, and their assigned assistant attorney general discussed how best to word a motion from the body responding to the WSLCB request.
  • Lynch brought forward the question the commission faced of whether the “interpretation of this [statute] is that it includes all of those substances” (audio - <1m). 
  • Commissioner Craig Ritchie commented that was “exactly what the statute says when it uses the term…’such as the following,’ it doesn’t say ‘limited to the following.’” As the law was written to be “broad” his immediate reaction was that the compounds in question would be included. “That’s how I read it as well,” Lynch seconded (audio - 1m). 
  • Gerard suggested there could be value for WSLCB if the commission could “also make it clear that they consider all THC synthesized from hemp-derived [cannabidiol] CBD to be a schedule one controlled substance,” adding what he understood to be “the immediate concern here.” Lyles-Stolz felt it was “pretty clear in front of us that it would include those isomers...but I understand what you’re asking.” Ritchie said the motion should be “telling the cannabis board ‘yes,’ it does include all those.” Lyles-Stolz suggested two motions, one about the interpretation of existing law by WSLCB, and another for “the second piece about that, any of those synthetic THC isomers that are derived from hemp would also...fall under this interpretation.” Gerard advised a single motion to “encapsulate everything...and so maybe it would be helpful” to recess for staff to draft a response “taking a position that seems to be reflective of the discussion” (audio - 3m).
  • After returning from a short break, Gerard provided motion language that both “mirrored the statutory language” of what compounds were covered but also added “this includes, but is not limited to, THC synthesized from hemp-derived CBD.” He hoped this phrasing of the motion would “try and capture the kind of specific situation that they’re handling.” Lyles-Stolz voiced her gratitude for Gerard’s help to “reconfirm, I think, the kind of standing interpretation” of the commission (audio - 2m).
  • Ritchie brought up whether the second part of the motion should instead say "are contained in or synthesized from hemp-derived CBD." Lynch pointed out that the immediately following statute, RCW 69.50.204(c)(30)(ii), stated “Hemp and industrial hemp, as defined in RCW 15.140.020, are excepted from the categories of controlled substances identified under this section,” and asked if Ritchie’s edit conformed with that (audio - 10m) .
    • Gerard said “this covers a situation where hemp is taken and then chemically synthesized or goes through some kind of process, basically I’m gonna, I’m not going to get the right words here, then get converted into a THC, and my understanding has been that that’s the delta-8-THC situation where you originally start with hemp. It then goes through some kind of process and it’s synthesized into delta-8-THC.” Gerard argued an individual would have “started with a hemp product, which is excluded, but then you make a product that now falls under, that’s now a synthetic THC. You’ve taken that hemp” and made it into delta-8-THC. Gerard preferred only adding the term “‘synthesized,’ rather than ‘contained’” since otherwise “there’s an argument there that it would fall under the definition” of hemp.
      • Synthetic cannabinoids have an existing definition in state law inclusive of substances “identified in RCW 69.50.204(c)(30) or by the pharmacy quality assurance commission under RCW 69.50.201” and are unlawful in Washington state.
    • Lynch wanted to be certain the commission’s choice was “not creating challenges with some of the other” decisions made by the group on products with “hemp-derived CBD infused in them,” referencing the scheduling of Epidiolex. Gerard responded that the second sentence in the proposed motion was unnecessary and the motion would still support “a plain reading” of the law, which Lyles-Stolz also believed would allow staff sufficient leeway to speak to the specific cannabinoids at issue for the agency. Trant also agreed that the first sentence “captures” the inquiry put to the commission by WSLCB.
    • Ritchie then mentioned citing THC in the first sentence to express concurrence with the statute, leading to some debate over whether and how to include the term. Gerard said, “I don’t really know how someone could make the argument that if you take hemp and make it into a THC that it’s not a synthetic equivalent,” suggesting that the motion be reworded as “the commission adopts plain reading of the statutory provision and agrees and answers affirmatively to the question posed by LCB.”

• Before voting to adopt a motion affirming the commissioner’s shared interpretation of the THC statute, several interested parties were granted an opportunity to offer public comment on the law and action.
  • Lynch moved that “the commission agrees with the plain language reading of the statute and responds in the affirmative of the LCB’s policy statement.” Lyles-Stolz suggested referring to the WSLCB staff “inquiry” instead. Lynch brought up the policy statement on delta-8-THC that WSLCB was drafting before accepting “it’s LCB’s inquiry” instead. The motion was seconded by commission member Kenneth Kenyon and Lynch invited discussion on the proposed action inclusive of public and stakeholder input (audio - 1m).
  • John Worthington (audio - 4m).
    • Worthington said, “the presence of THC does not guarantee it's a psychoactive substance,” arguing that the levels of THC in hemp as defined in law meant there was “an offset that just doesn’t seem to come up because you haven’t been given proper binding and medical and scientific studies.” He believed better data would show low levels of THC would be “offset by the amount of other compounds.”
    • Worthington believed the WSLCB inquiry was tantamount to “trying to reel in this activity so they can continue to regulate and pick winners and losers.” In Worthington’s view, WSLCB Director Rick Garza "has combined the lobbyist community with the regulation community. And they’re the ones that are seeking this. When you see ‘the public this, or the public that,’ it’s actually the lobbyists that want Mr. Garza to bring this underneath the realm of the cannabis board.”
      • On April 14th, WSLCB’s board heard from cannabis producers and other stakeholders opposed to delta-8-THC derived from hemp in legal cannabis products. 
    • Worthington argued the commission was “rewriting this to basically sneak in the THC part, which doesn’t necessarily mean that it’s going to be psychoactive.” This presumption was part of the “underlying theme of the treaty, and what they basically adopted at the uniform law commission, which got handed down to you guys,” he said, leaving him with “severe concerns about the purpose of this.”
      • According to the Governor, the law commission “Drafts and recommends uniform laws on subjects in which uniformity of legislation in the various states is desirable. The Commission was formed for the promotion of uniformity of legislation in the United States.” Learn more about the national Uniform Law Commission (ULC), their information on controlled substances law, or the commission's unique role in federalism.
    • Worthington believed the topic was more related to “revenue and control and being able to hand the industry over to the big boys” rather than a “public health or public concern issue.” He urged caution about “just using the word THC and wait until you guys actually acknowledge that there’s an offset from the other components” and stated that “I don’t think [WSLCB] motives are pure in requesting this from you.”
    • Lynch said the motion at issue was that WA Pharmacy Commission “agrees with the plain language interpretation of the RCW and not necessarily saying THC or any of that.”
  • Steve Sarich, CannaBiogen Research Founder (audio - 14m) 
    • Sarich stated that he’d “Worked with Rep[resentative] Matt Shea on HB 2064 which removed hemp from [RCW] 69.50” in 2017 and claimed “hemp is no longer controlled by this section and the reason tetrahydrocannabinols and all these other components are covered” in law was because “the whole marijuana plant is covered under schedule one.” He said, “whether it’s THC or CBD or anything else...when you start trying to split hairs on things like whether or not this is now a synthetic,” it wouldn’t be appropriate without the group learning “a bit more about this stuff.”
    • Sarich opined that “Mr. Garza believes that the marijuana industry there should be selling delta-8, it is not looking to ban delta-8,” and instead wants “it included as a controlled substance so that industry can sell it as opposed to hemp farmers.” He added that this was what Worthington had meant in saying “they’re trying to pick winners and losers.”
    • Lynch asked to look at RCW 69.50.204(c)(30)(ii), which said “Hemp and industrial hemp, as defined in RCW 15.140.020, are excepted from the categories of controlled substances identified under this section.” He said the commission was only “agreeing with the plain reading of the statute” and Sarich took that agreement to mean hemp’s mention exempted it from the controlled substances law. Lynch told him the commission was focused on the cannabis plant in the law, with Sarich replying the statute was about “delta-8 from marijuana, and just from a scientific standpoint...delta-8 can be naturally occurring, it can be made from CBD using a carbon-swapping, but it can also be made from delta-9.” He said the situation was “not as simple as what you’re trying to consider right now” and that there was “no study whatsoever showing that delta-8 is harmful in any way.” He understood that “the only way you can put it in the controlled substances act without determining whether or not it’s harmful or not is if it’s contained in marijuana, and this is not contained in marijuana, it’s contained in hemp...so you’re making a decision on hemp products that aren’t in this law.” Lynch understood him to mean “anything synthesized from hemp cannot be subject to this RCW,” and Sarich agreed, saying the mention of “synthetic equivalents” in the legal definition was only intended to apply to plants with over .3% THC.
    • Gerard commented that the commission was only agreeing with what was written, not “disagreeing that hemp and industrial hemp as defined in  15.140.020 RCW are not exempted from” the controlled substances act. He advised that THC “naturally contained in the plant, genera Cannabis, as well as synthetic equivalents...that have been derived are schedule one controlled substances.” Sarich disagreed, but Gerard noted “marijuana is listed in this section separately,” in RCW 69.50.204(c)(22), and “subsection 30, which you’re considering, is not marijuana, it’s tetrahydrocannabinol, which is distinct from marijuana.” Lyles-Stolz asked whether the reference in law was to THC “in the genera Cannabis, which includes hemp, right, isn’t that the whole broad group of plants?” Gerard answered that “hemp is excluded down from there,” but interpreted “the question that LCB is posturing is if someone takes hemp and chemically synthesizes it to make THC, does that bring it under the scope of this subsection 30?” He continued, saying “under a plain meaning of the statute where it talks about synthetic equivalents contained in the plant, it appears that the answer to that, whether it is chemical synthesis or some kind of synthetic equivalent, that it would be” covered as he understood the wording and the WSLCB inquiry. Sarich disagreed, calling “CBD that is synthesized and is synthesized from hemp, however, is a completely legal product that you can buy in your local drugstore.” He said the legality hinged on “where it comes from...it’s stupid, I understand, but I didn’t make up the law.”
    • Sarich was the Manager and Spokesman for the NO on I-502 campaign.
  • Crystal Oliver, Washington SunGrowers Industry Association (WSIA) Executive Director (audio - 2m) 
    • Oliver believed the issue was that ”when you take hemp-derived CBD and you use a process to synthesize that” that any “resulting tetrahydrocannabinol is a synthetic.” She wanted more clarity from regulators, but “it is my belief that when you take CBD and you convert it” using a “synthetic drug development technique to create a tetrahydrocannabinol” the resulting compound was “a synthetic under the statute that you’re looking at.” Oliver said the resulting material shouldn’t “be allowed for sale in the Washington market” because “synthetic tetrahydrocannabinols were not legalized via the Farm Bill.”
  • Micah Sherman, Raven Co-Owner  (audio - 2m) 
    • Echoing Oliver’s points, Sherman said the compounds were “distinct from isolation, which is how you would theoretically get a THC product out of a hemp plant” and his interest was getting WSLCB to “clarify this issue of synthesis and our, our position is that when you turn one molecule into another you’ve gone through a process of synthesis.” Sherman was less concerned “that it came from hemp, but that it was synthesized.”
  • Justin Nordhorn, WSLCB Policy and External Affairs Director (audio - 1m)
    • Nordhorn acknowledged that the agency had been developing a policy statement on the topic and that he was there to “field questions that you may have pertaining to the interest points of the LCB.”
    • Lynch restated the confusion over separate statutes where “one deals directly with marijuana and the other deals with THC products” and that section 30 was “broader than marijuana, but specifically excludes hemp.” He said the motion at issue was “the plain interpretation of (30)(i) is that includes exactly what it stated” understanding it as “a very broad statement in terms of THC products, or synthesized THC products, or their derivatives.” Lynch then asked for confirmation from Nordhorn that WSLCB authority over “items that were derived from hemp that convert to THC would be covered under their, their interpretation.”
    • Nordhorn responded that the agency was “exploring kind of the role that we should have in this particular area and we’ve had questions come in from multiple stakeholders.” He said the “other side of...the issue is...just in THC in general” and the various isomers ”that are out there.” He said WSLCB staff had “seen literature where under the schedule one controlled substances act of the DEA[, the U.S. Drug Enforcement Administration], delta-8 is also called out in there as a schedule one.” Nordhorn said agency leaders were trying to figure out when it comes to “these other isomers of THC out of the cannabis plant”---whether it was a hemp or marijuana plant---“should the LCB be engaged in those types of oversight issues when we’re talking about the intoxicating substances not the other generalized areas.” He added that agency officials concluded “and some of the research shows that it does fall under the federal controlled substances act and/or the controlled substance analog” act. Nordhorn said WSLCB was working “with our partner agencies out there to help clarify where these roles and where that lives” to assist with “consistency” in regulation among agencies. There was “another, kind of, issue that’s out there around synthetics” which he called “similar in nature” to natural compounds. He reiterated that WSLCB was focusing on “intoxicating compounds” and said there was dissent around the position that the federal Farm Bill “was saying that anything coming out of hemp is automatically legal” (audio - 6m).
  • The commission took a vote resulting in unanimous agreement “that the commission agrees with the plain language interpretation of (30)(i)...as it’s written” (audio - 1m).
    • The next week on April 28th, WSLCB announced their policy statement on delta-8-THC and other cannabinoids before sending out a clarifying bulletin about the policy statement on May 3rd which stated the initial policy statement amounted to “notifying the public and stakeholders that the agency will be addressing the issue...Current interpretive and policy statements are advisory only. To better inform the public, agencies are encouraged to also convert long-standing interpretive and policy statements into rules.” 
    • On May 4th, WSLCB Policy and Rules Manager Kathy Hoffman assured the WSLCB board that she’d seek to initiate rulemaking at their next board meeting on May 12th “that contemplates rule development that would allow you, the board, to evaluate additives, solvents, ingredients, and compounds used in the production and processing of marijuana products to determine whether such products pose a risk to public health or youth access.”