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[159.112.244.41]) by mx.google.com with UTF8SMTPS id 6a1803df08f44-8b53854e2besi11505986d6.72.2026.04.30.19.34.59 for (version=TLS1_2 cipher=ECDHE-ECDSA-AES128-GCM-SHA256 bits=128/128); Thu, 30 Apr 2026 19:34:59 -0700 (PDT) Received-SPF: pass (google.com: domain of bounce+30b528.39b08c6-tjphuhs=gmail.com@mg-d1.substack.com designates 159.112.244.41 as permitted sender) client-ip=159.112.244.41; Authentication-Results: mx.google.com; dkim=pass header.i=@mg-d1.substack.com header.s=k1 header.b=ltx5BkEE; dkim=pass header.i=@mailgun.org header.s=mg header.b="rdLSu/Gy"; spf=pass (google.com: domain of bounce+30b528.39b08c6-tjphuhs=gmail.com@mg-d1.substack.com designates 159.112.244.41 as permitted sender) smtp.mailfrom="bounce+30b528.39b08c6-tjphuhs=gmail.com@mg-d1.substack.com"; dmarc=pass (p=REJECT sp=REJECT dis=NONE) header.from=substack.com DKIM-Signature: a=rsa-sha256; v=1; c=relaxed/relaxed; d=mg-d1.substack.com; q=dns/txt; s=k1; t=1777602899; x=1777610099; h=List-Unsubscribe-Post: List-Unsubscribe: List-Post: List-Id: List-Archive: List-Owner: Reply-To: In-Reply-To: References: Sender: Sender: Date: Message-Id: To: To: From: From: Subject: Subject: Content-Type: Mime-Version: X-Feedback-Id; bh=w/6+SOp3vvp7fAQX4OEnX9Cj/Su2Y+zLffuX+65wbOE=; b=ltx5BkEEC7pBv+POIIdOABCu7DK+8yXt5QSz+MgZHgl00fG0/ogOt2y9kt2PWIjxn0sIOFBffIbILSPY/IyIRcLXmUofp+i+0FDmPMeshaojCyFA9ejp/iRWFIgSQkfG+xiMlcLoEHYVcleG6cjuZNTfj2gRFsq66xPpuCKisJ4= DKIM-Signature: a=rsa-sha256; v=1; c=relaxed/relaxed; d=mailgun.org; q=dns/txt; s=mg; t=1777602899; x=1777610099; h=List-Unsubscribe-Post: List-Unsubscribe: List-Post: List-Id: List-Archive: List-Owner: Reply-To: In-Reply-To: References: Sender: Sender: Date: Message-Id: To: To: From: From: Subject: Subject: Content-Type: Mime-Version: X-Feedback-Id; bh=w/6+SOp3vvp7fAQX4OEnX9Cj/Su2Y+zLffuX+65wbOE=; b=rdLSu/GyI1+etBUdNslT1GRejY5dQRieFhQ6wR54msET10NaszrACPKaM4tlQfJVSohKsO6/wO+PGN4AbdU6h41HOpazbldr1JrtW4/rkfVauteCHqcATXFLj6v3Jftbi0S12khDfxnYOdtTqhZ6O5J+PTOyfFeXkPtylbK8nng= X-Mailgun-Sid: WyIxMWU0ZSIsInRqcGh1aHNAZ21haWwuY29tIiwiMzliMDhjNiJd X-Feedback-Id: postmaster@mg-d1.substack.com:post:614a1297c57bbbe25fa40e08:mailgun Received: by 4cbff49b92ef431708fa33a48a662b1525c180f391f27a3171f8ef05c506db48 with HTTP id 69f41153067e0fa45bb204f5; Fri, 01 May 2026 02:34:59 GMT X-Mailgun-Sending-Ip: 159.112.244.41 Mime-Version: 1.0 Content-Type: multipart/alternative; boundary="0d6ba4a1e511d45a4a8557e64ee4c553b775fe2685790675a6b05e8e59ed" Subject: BREAKING: Two Stories That Impact Compounded GLP-1 From: Dave Knapp from On The Pen To: tjphuhs@gmail.com X-Mailgun-Tag: post X-Mailgun-Track-Clicks: false Message-Id: <20260501023222.3.fa0c13c660bcfb4b@mg-d1.substack.com> Date: Fri, 1 May 2026 02:32:22 +0000 Feedback-Id: post-196062491:cat-post:pub-4808993:substack Sender: Dave Knapp from On The Pen References: In-Reply-To: Reply-To: Dave Knapp from On The Pen List-Owner: List-Url: List-Archive: List-Id: List-Post: List-Unsubscribe: List-Unsubscribe-Post: List-Unsubscribe=One-Click X-Mailgun-Variables: {"category": "post", "email_generated_at": "1777602899582", "is_freemail": "true", "post_audience": "everyone", "post_id": "196062491", "post_type": "newsletter", "pub_community_enabled": "true", "publication_id": "4808993", "subdomain": "onthepen", "user_id": "273622398"} --0d6ba4a1e511d45a4a8557e64ee4c553b775fe2685790675a6b05e8e59ed Content-Type: text/plain; charset="utf-8" Content-Transfer-Encoding: quoted-printable View this post on the web at https://onthepen.substack.com/p/breaking-two-s= tories-that-impact A federal judge just handed Eli Lilly a mixed ruling in its lawsuit against= Empower Pharmacy. At almost the same time, the FDA quietly proposed someth= ing that could matter even more long term: formally declaring that there is= no =E2=80=9Cclinical need=E2=80=9D to compound semaglutide, tirzepatide, o= r liraglutide at scale. Two separate developments. Two separate processes. = But they are pointing in the same direction, and patients who have been rid= ing the compounded GLP-1 wave need to understand what that direction looks = like. The Court Ruling: What Was Dismissed, and What Was Not The Empower ruling dismissed Lilly=E2=80=99s Lanham Act claim, which was th= e company=E2=80=99s attempt to frame Empower=E2=80=99s marketing as unlawfu= l false advertising. The reason was procedural, not philosophical. Lilly co= uld not demonstrate a direct enough link between Empower=E2=80=99s advertis= ing and measurable harm. The court was not willing to accept the narrative = without proof. Courts are not simply handing Lilly or Novo whatever they as= k for in their respective lawsuits. Interestingly, the court allowed Lilly=E2=80=99s state-level claims to move= forward, and those claims hinge on something much more fundamental than ma= rketing. They hinge on whether compounded tirzepatide products can be sold = at all under state laws governing unapproved drugs. The fight is no longer = about how these products are advertised. It is about whether they have a le= gal right to exist in the first place, something courts thus far have prefe= rred to default back to the FDA. In Lilly=E2=80=99s separate case against Mochi Health [ https://substack.co= m/redirect/d7581340-3911-4a99-bc7a-8aafb52e104e?j=3DeyJ1IjoiNGl3b2U2In0.sVD= xRtmZ85v8kfdamY0krRXGMy3p768BWtuZifRB-Zs ], a judge who had previously sign= aled skepticism recently acknowledged that Lilly may have a plausible path = forward tied to reputational harm and lost sales. Different case, different= defendant, same structural outcome: federal claims narrowed, but the core = challenge to the compounding model still standing and moving forward. Lilly= is building a consistent playbook across multiple courtrooms, and so far t= he courts seem to be willing to entertain at least some of their claims. The FDA Proposal: Affordability Is Not a Clinical Need While that legal fight unfolds, the FDA has continued to signal a serious c= rackdown on compounded GLP-1=E2=80=99s, this week proposing not to include = semaglutide, tirzepatide, or liraglutide on the 503B Bulks List. That is th= e list that determines which substances outsourcing facilities can compound= from at scale. The agency was explicit about its reasoning. It stated that= there is no clinical need for outsourcing facilities to compound these dru= gs from bulk substances. It stated that cost, access, and convenience do no= t qualify as clinical need. It stated that the existence of FDA-approved pr= oducts undermines the justification for compounded alternatives. The agency also drew a hard line around shortage justifications. Shortages = can justify compounding while they exist. Once resolved, that pathway narro= ws. That is the framework the FDA has laid out, and it does not leave much = room for interpretation. At this point, given the complex legal battles tha= t have ensued over branded GLP-1 shortages and compounding, one must wonder= if the FDA is conceiving other ways to handle potential future shortages. Through today=E2=80=99s (and other recent actions [ https://substack.com/re= direct/d6c19076-cd5c-4beb-a6b3-5b3ebd1049f3?j=3DeyJ1IjoiNGl3b2U2In0.sVDxRtm= Z85v8kfdamY0krRXGMy3p768BWtuZifRB-Zs ]), what the FDA is saying, plainly, i= s this: if a GLP-1 drug is approved and available, it does not believe it s= hould be mass compounded, regardless of whether patients can afford it. Why These Two Things Together Matter Patients who have been on compounded GLP-1s have lived through cycles that = would exhaust anyone. The excitement of finally finding something that work= ed. The scramble during shortages. The relief when compounding filled the g= ap. The uncertainty every time a new enforcement action dropped. The questi= ons about what comes next. This community has been through a lot. What is happening right now is not a single dramatic moment. It is the slow= erosion of the conditions that made compounded GLP-1s possible in the firs= t place. The legal system is allowing challenges that test whether these pr= oducts can exist under state frameworks. The regulatory system is tightenin= g the federal criteria that allowed them to flourish. Neither of those thin= gs, on its own, ends compounding. But together, they reduce the number of a= vailable pathways, and the people walking those pathways are the ones who f= eel each narrowing most directly. The Reality for Patients Patients did not turn to compounded GLP-1s because they wanted a workaround= =2E They turned to them because the bra= nded medications were out of stock, ou= t of reach, imprecisely dosed, or excluded by their insurance. Compounding = was not a loophole. For hundreds of thousands of people, it was the only pa= th forward. The FDA=E2=80=99s position is now clear. Affordability is not a clinical ne= ed. The courts have not yet ruled on the core question, but they are allowi= ng it to be tested. If these trends continue, the likely outcome is not an = overnight shutdown. It is something slower and, in some ways, harder. Fewer= pharmacies willing to accept the legal exposure. Tighter regulatory interp= retations. A gradual contraction of supply that happens without a headline = moment to point to.=20 Patients deserve to know that is what is being built, one ruling and one pr= oposal at a time. Safety matters. But access matters too. And any framework= that treats affordability as irrelevant has not actually solved the proble= m. It has simply decided that the people who cannot afford branded medicati= on are not its problem to solve. Unsubscribe https://substack.com/redirect/2/eyJlIjoiaHR0cHM6Ly9vbnRoZXBlbi5= zdWJzdGFjay5jb20vYWN0aW9uL2Rpc2FibGVfZW1haWw_dG9rZW49ZXlKMWMyVnlYMmxrSWpveU= 56TTJNakl6T1Rnc0luQnZjM1JmYVdRaU9qRTVOakEyTWpRNU1Td2lhV0YwSWpveE56YzNOakF5T= 0RrNUxDSmxlSEFpT2pFNE1Ea3hNemc0T1Rrc0ltbHpjeUk2SW5CMVlpMDBPREE0T1Rreklpd2lj= M1ZpSWpvaVpHbHpZV0pzWlY5bGJXRnBiQ0o5Lk1CNWN1Nm53WFFqS0pUc1ZMbVdQRjVNZWR0WjF= SdEZyWE1jeDdIMzZMZW8iLCJwIjoxOTYwNjI0OTEsInMiOjQ4MDg5OTMsImYiOnRydWUsInUiOj= I3MzYyMjM5OCwiaWF0IjoxNzc3NjAyODk5LCJleHAiOjIwOTMxNzg4OTksImlzcyI6InB1Yi0wI= iwic3ViIjoibGluay1yZWRpcmVjdCJ9.PNHHhkf8sl2aqpzoENOD8EKoDu65LOnuvAaYqw6XRv0= ? --0d6ba4a1e511d45a4a8557e64ee4c553b775fe2685790675a6b05e8e59ed Content-Type: text/html; charset="utf-8" Content-Transfer-Encoding: quoted-printable = BREAKING: Two Stories That Impact Compounded GLP-1=3D""
The FDA Proposes leaving GLP-1 off bulks list,= judge allows Lilly's case agains Empower to proceed....
͏   = 199; ­͏     ­͏     ­͏ &= nbsp;   ­͏     ­͏     ­= ;͏     ­͏     ­͏   Q= 99; ­͏     ­͏     ­͏ &n= bsp;   ­͏     ­͏     ­= ͏     ­͏     ­͏   ̳= 9; ­͏     ­͏     ­͏ &nb= sp;   ­͏     ­͏     ­&= #847;     ­͏     ­͏    = ; ­͏     ­͏     ­͏ &nbs= p;   ­͏     ­͏     ­&#= 847;     ­͏     ­͏    = ­͏     ­͏     ­͏  = ;   ­͏     ­͏     ­= 47;     ­͏     ­͏     = ­͏     ­͏     ­͏  =   ­͏     ­͏     ­T= 7;     ­͏     ­͏     &= #173;͏     ­͏     ­͏   =   ­͏     ­͏     ­͏= ;     ­͏     ­͏     &#= 173;͏     ­͏     ­͏   &= #8199; ­͏     ­͏     ­͏=     ­͏     ­͏     = 73;͏     ­͏     ­͏   &#= 8199; ­͏     ­͏     ­͏ =     ­͏     ­͏     = 3;͏     ­͏     ­͏   = 199; ­͏     ­͏     ­͏ &= nbsp;   ­͏     ­͏     ­= ;͏     ­͏     ­͏   Q= 99; ­͏     ­͏     ­͏ &n= bsp;   ­͏     ­͏     ­= ͏     ­͏     ­͏   ̳= 9; ­͏     ­͏     ­͏ &nb= sp;   ­͏     ­͏     ­&= #847;     ­͏     ­͏    = ; ­͏     ­͏     ­͏ &nbs= p;   ­͏     ­͏     ­&#= 847;     ­͏     ­͏    = ­͏     ­͏     ­͏  = ;   ­͏     ­͏     ­= 47;     ­͏     ­͏     = ­͏     ­͏     ­͏  =   ­͏     ­͏     ­T= 7;     ­͏     ­͏     &= #173;͏     ­͏     ­͏   =   ­͏     ­͏     ­͏= ;     ­͏     ­͏     &#= 173;͏     ­͏     ­͏   &= #8199; ­͏     ­͏     ­͏=     ­͏     ­͏     = 73;͏     ­͏     ­͏   &#= 8199; ­͏     ­͏     ­͏ =     ­͏     ­͏     = 3;͏     ­͏     ­͏   = 199; ­͏     ­͏     ­͏ &= nbsp;   ­͏     ­͏     ­= ;͏     ­͏     ­͏   Q= 99; ­͏     ­͏     ­͏ &n= bsp;   ­͏     ­͏     ­= ͏     ­͏     ­͏   ̳= 9; ­͏     ­͏     ­͏ &nb= sp;   ­͏     ­͏     ­&= #847;     ­͏     ­͏    = ; ­͏     ­͏     ­͏ &nbs= p;   ­͏     ­͏     ­&#= 847;     ­͏     ­͏    = ­͏     ­͏     ­͏  = ;   ­͏     ­͏     ­= 47;     ­͏     ­͏     = ­͏     ­͏     ­͏  =   ­͏     ­͏     ­T= 7;     ­͏     ­͏     &= #173;͏     ­
<= td>
Forwa= rded this email? Subscribe here for mor= e

BREAKING: Two Stories That Impact Compounded GLP-1

The FDA Propo= ses leaving GLP-1 off bulks list, judge allows Lilly's case agains Empower = to proceed....

= =
On The Pen GLP-1 News
=
 
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3D""=
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READ IN APP3D""
 

A federal judge just handed Eli Lilly a mixed ruling in= its lawsuit against Empower Pharmacy. At almost the same time, the FDA qui= etly proposed something that could matter even more long term: formally dec= laring that there is no “clinical need” to compound semaglutide= , tirzepatide, or liraglutide at scale. Two separate developments. Two sepa= rate processes. But they are pointing in the same direction, and patients w= ho have been riding the compounded GLP-1 wave need to understand what that = direction looks like.

<= /table>
3D"X
On The Pen™= ;
@ManOnThePen
This would put the burden of mee= ting compounded GLP-1 demand on 503A pharmacies, who are not permitted to c= ompound in bulk. I expect we will also see FDA action against those who do.= So where does that demand go? Mostly to the unregulated grey market. Great= =2E Super. All the docs
= =
U.S. FDA @US_FDA
FDA proposes to exclude semaglutide, tirzepatide, and liraglutide on= the 503B bulks list. After careful review, we did not identify sufficient = clinical need for outsourcing facilities to compound these drugs from bulk = substances. Public comment period now open. Learn more:
4:18 PM · Apr 30, 2026 · 1.04K Views
2 = Replies · = 1 Repost · 12 Likes

The Cour= t Ruling: What Was Dismissed, and What Was Not

The= Empower ruling dismissed Lilly’s Lanham Act claim, which was the com= pany’s attempt to frame Empower’s marketing as unlawful false a= dvertising. The reason was procedural, not philosophical. Lilly could not d= emonstrate a direct enough link between Empower’s advertising and mea= surable harm. The court was not willing to accept the narrative without pro= of. Courts are not simply handing Lilly or Novo whatever they ask for in th= eir respective lawsuits.

Interestingly, the court allowed L= illy’s state-level claims to move forward, and those claims hinge on = something much more fundamental than marketing. They hinge on whether compo= unded tirzepatide products can be sold at all under state laws governing un= approved drugs. The fight is no longer about how these products are adverti= sed. It is about whether they have a legal right to exist in the first plac= e, something courts thus far have preferred to default back to the FDA.

=

In Lilly’s separate case against Mochi Health,= a judge who had previously signaled skepticism recently acknowledged that = Lilly may have a plausible path forward tied to reputational harm and lost = sales. Different case, different defendant, same structural outcome: federa= l claims narrowed, but the core challenge to the compounding model still st= anding and moving forward. Lilly is building a consistent playbook across m= ultiple courtrooms, and so far the courts seem to be willing to entertain a= t least some of their claims.

The FDA Propos= al: Affordability Is Not a Clinical Need

While tha= t legal fight unfolds, the FDA has continued to signal a serious crackdown = on compounded GLP-1’s, this week proposing not to include semaglutide= , tirzepatide, or liraglutide on the 503B Bulks List. That is the list that= determines which substances outsourcing facilities can compound from at sc= ale. The agency was explicit about its reasoning. It stated that there is n= o clinical need for outsourcing facilities to compound these drugs from bul= k substances. It stated that cost, access, and convenience do not qualify a= s clinical need. It stated that the existence of FDA-approved products unde= rmines the justification for compounded alternatives.

The a= gency also drew a hard line around shortage justifications. Shortages can j= ustify compounding while they exist. Once resolved, that pathway narrows. T= hat is the framework the FDA has laid out, and it does not leave much room = for interpretation. At this point, given the complex legal battles that hav= e ensued over branded GLP-1 shortages and compounding, one must wonder if t= he FDA is conceiving other ways to handle potential future shortages.

Through today’s (and other recent actions), what the FDA is sayin= g, plainly, is this: if a GLP-1 drug is approved and available, it does not= believe it should be mass compounded, regardless of whether patients can a= fford it.

Why These Two Things Together Matt= er

Patients who have been on compounded GLP-1s hav= e lived through cycles that would exhaust anyone. The excitement of finally= finding something that worked. The scramble during shortages. The relief w= hen compounding filled the gap. The uncertainty every time a new enforcemen= t action dropped. The questions about what comes next. This community has b= een through a lot.

What is happening right now is not a sin= gle dramatic moment. It is the slow erosion of the conditions that made com= pounded GLP-1s possible in the first place. The legal system is allowing ch= allenges that test whether these products can exist under state frameworks.= The regulatory system is tightening the federal criteria that allowed them= to flourish. Neither of those things, on its own, ends compounding. But to= gether, they reduce the number of available pathways, and the people walkin= g those pathways are the ones who feel each narrowing most directly.

The Reality for Patients

Patient= s did not turn to compounded GLP-1s because they wanted a workaround. They = turned to them because the branded medications were out of stock, out of re= ach, imprecisely dosed, or excluded by their insurance. Compounding was not= a loophole. For hundreds of thousands of people, it was the only path forw= ard.

=
In= stagram
View on Instagram

The FDAR= 17;s position is now clear. Affordability is not a clinical need. The court= s have not yet ruled on the core question, but they are allowing it to be t= ested. If these trends continue, the likely outcome is not an overnight shu= tdown. It is something slower and, in some ways, harder. Fewer pharmacies w= illing to accept the legal exposure. Tighter regulatory interpretations. A = gradual contraction of supply that happens without a headline moment to poi= nt to.

Patients deserve to know that is what is being buil= t, one ruling and one proposal at a time. Safety matters. But access matter= s too. And any framework that treats affordability as irrelevant has not ac= tually solved the problem. It has simply decided that the people who cannot= afford branded medication are not its problem to solve.

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