Amicus Curiae Brief — Wells Pharma of Houston, L.L.C., Petitioner v. Zyla Life Sciences, L.L.C.

No. 25-257

In The

Supreme Court of the United States

______________

WELLS PHARMA OF HOUSTON, LLC,

Petitioner,

v.

ZYLA LIFE SCIENCES, LLC,

Respondent.

_______________

ON PETITION FOR A WRIT OF CERTIORARI TO

THE UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

_______________

BRIEF OF AMICUS CURIAE AMERICANS FOR

ACCESS TO COMPOUNDED MEDICATION IN

SUPPORT OF PETITIONER

MARK D. BOESEN

Counsel of Record

8501 E. Princess Road, Suite 220

Scottsdale, AZ 85298

(602) 900-8562

mboesen@bslawusa.com

i

TABLE OF CONTENTS

TABLE OF CONTENTS ............................................. i

TABLE OF AUTHORITIES ...................................... ii

INTEREST OF AMICUS CURIAE ........................... 1

SUMMARY OF ARGUMENTS ................................. 4

ARGUMENTS ............................................................ 5

I. The Decision Below Deepens a Circuit Split ...... 7

II. The Decision Is Inconsistent with a

Comprehensive Federal Framework to Govern

Compounding .......................................................... 7

III. The Fifth Circuit’s Decision in Zyla Creates a

Direct Conflict With This Court’s Preemption

Jurisprudence ......................................................... 9

IV. The Circuit Split Will Produce a Patchwork of

Regulatory Outcomes............................................ 10

V. The Decision Threatens Immediate and Severe

Disruption to Patient Care ................................... 11

VI. This Court’s Review Is Necessary to Prevent

Fractured National Drug Policy ........................... 12

VII. This Case Is an Ideal Vehicle ....................... 13

ii

TABLE OF AUTHORITIES

Cases

Bartlett, 570 U.S. at 486–90 ...................................... 9

Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S.

341 (2001)…………………………...….4, 5, 6, 8, 9, 13

Mut. Pharm. Co. v. Bartlett, 570 U.S. 472 ,(2013) 3, 5

Nexus Pharmaceuticals, Inc. v. Central Admixture

Pharmacy Services, Inc., 48 F.4th 1040, 1041 (9th

Cir. 2022) ................................................................. 7

Patel v. Merck & Co., Inc., 485 F. App’x 894 (6th Cir.

2012) .................................................................... 5, 9

Perez v. Nidek Co., 711 F.3d 1109 (9th Cir. 2013) ... 7

PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir.

2010) .......................................................... 5, 7, 9, 10

PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) ... 3, 5, 9

U.S. Const. art. VI, cl. 2 (Supremacy Clause) . 3, 6, 10

Wyeth v. Levine, 555 U.S. 555 (2009) ....................... 3

Zyla Life Sciences., L.L.C. v. Wells Pharma of

Houston, L.L.C., No. 23-20533 ........................... 4, 5

Statutes

21 U.S.C. § 337(a).................................................. 4, 7

21 U.S.C. §§ 353a–353b (FDCA §§ 503A–503B)1, 8, 9

Other Authorities

Drug Quality and Security Act of 2013 (“DQSA”) 2, 7

Food and Drug Administration Modernization Act of

1997 (“FDAMA”) ................................................ 2, 8

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INTEREST OF AMICUS CURIAE 1

The Americans for Access to Compounded Medication (“AACM”) is a national coalition of pharmacists, physicians, physician assistants, nurse practitioners, patients, businesses, and other medication

compounding stakeholders. Compounded medications, prepared under the authority granted by 21

U.S.C. §§ 353a–353b (FDCA §§ 503A–503B), serve as

a critical safety net for patients in circumstances

where no FDA-approved therapy is available and during periods of drug shortages. Congress has long recognized that individualized compounding is an essential component of pharmacy and physician practice

and an integral safeguard for patient care. Unlike

mass-manufactured drugs, compounded medications

allow prescribers to tailor therapies to meet unique

patient needs to avoid allergens, create dosage forms

for children or the elderly who otherwise would not be

able to consume the medication, or create formulations when commercially available products are unavailable or inadequate.

The legislative history of the FDCA Sections

503A and 503B reflects Congress’s intent to preserve

and regulate this practice nationally, not to eliminate

it or to rely on the states and territories to create 56

1 No

counsel for any party authored this brief in whole or in

Party, and no person or entity other than amicus curiae, its

members, or its counsel made a monetary contribution intended

to fund the preparation or submission of this brief. Additionally,

notice of this brief was provided to counsel for the parties on September 22, 2025.

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different regulatory schemes to regulate the practice

of compounding. When Congress enacted the Food

and Drug Administration Modernization Act of 1997

(“FDAMA”), it codified Section 503A specifically to

protect traditional pharmacy compounding while

providing a framework to prevent its abuse. In response to the 2012 New England Compounding Center tragedy, which revealed dangerous gaps in oversight of large-scale operations masquerading as traditional pharmacies, Congress passed the Drug Quality

and Security Act of 2013 (“DQSA”). That law reaffirmed the need for the FDCA’s Section 503A for patient-specific compounding and created Section 503B,

which established FDA-supervised outsourcing facilities permitted to produce compounded medications in

large quantities under current good manufacturing

practices (cGMP) for health care providers and 503A

pharmacies when needed for large populations of patients, particularly during times of national drug

shortages. Together, these provisions struck a deliberate balance: ensuring stronger federal oversight

where warranted, while preserving access to the individualized therapies that patients and clinicians depend upon.

This statutory framework demonstrates Congress’s clear policy judgment—that compounding is

not a loophole or workaround to FDA approval, but a

vital, necessary, and authorized practice that complements the commercial drug supply chain. By embedding compounding within the FDCA, Congress

acknowledged that the health care system cannot

function without a lawful and reliable mechanism to

meet patient needs in the management of rare

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diseases, drug allergy avoidance, pediatric dosing,

palliative care, and emergencies such as national

drug shortages. Far from being an afterthought, compounded medications are a congressionally protected

component of American pharmacy practice, designed

to promote both patient safety and continued access

to life-saving care.

While states and territories retain the authority to regulate the practice of pharmacy through licensure and permitting of individuals and businesses

within their borders, Congress recognized that compounding services implicate a national interest that

cannot be left to a patchwork of inconsistent local regimes. By embedding compounding authority within

the FDCA, Congress established a uniform framework that necessarily preempts state efforts to unduly restrict or prohibit compounding services. This

reflects a compelling governmental interest: ensuring

that patients in every state and territory have reliable

access to compounded therapies when commercial

drugs are unavailable or unsuitable. Congress understood that barriers at the state level would undermine

this federal objective and thus enacted §§ 503A and

503B as a cohesive, nationwide scheme to safeguard

patient access while preserving safety through FDA

oversight. See U.S. Const. art. VI, cl. 2 (Supremacy

Clause); Wyeth v. Levine, 555 U.S. 555 (2009) (recognizing federal law may preempt conflicting state requirements under the FDCA); Mut. Pharm. Co. v.

Bartlett, 570 U.S. 472 ,(2013) (holding state law

claims preempted where compliance with both federal

and state law is impossible); PLIVA, Inc. v. Mensing,

564 U.S. 604 (2011). Recent federal courts have

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likewise applied these principles to hold that FDCA

enforcement lies exclusively with the federal government, preempting state efforts to regulate matters reserved to FDA jurisdiction.

The decision below threatens uniformity in

this carefully balanced framework of centralized governance with federalism by allowing states and private litigants to second-guess FDA authority. Americans for Access to Compounded Medication files to

urge review and correction. See Sup. Ct. R. 37.1.

SUMMARY OF ARGUMENTS

The Fifth Circuit permitted state unfair-competition statutes in California, Colorado, Connecticut,

Tennessee, South Carolina, and Florida to be used as

private enforcement tools against FDA-permitted

compounding activities by pharmacists and physicians. Zyla Life Sciences., L.L.C. v. Wells Pharma of

Houston, L.L.C., No. 23-20533 (5th Cir. Apr. 10,

2025). That holding conflicts with this Court’s

preemption jurisprudence, particularly Buckman Co.

v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001), and

circuit decisions holding that state-law claims are

preempted when they intrude into FDA’s exclusive

domain. The decision threatens immediate disruption

to patient care. Compounding pharmacies supply critical medications during shortages, including epinephrine, sterile water for injection, IV solutions after

Hurricane Helene, and GLP-1 medications. Allowing

private competitors to weaponize state statutes undermines Congress’s intent in the Drug Quality and

5

Security Act of 2013 and fractures national drug policy.

ARGUMENTS

The Fifth Circuit’s decision in Zyla Life Sciences, L.L.C. v. Wells Pharma of Houston, L.L.C., No.

23-20533 (5th Cir. Apr. 10, 2025), creates a direct and

untenable split with this Court’s precedent and the

holdings of other circuits. By permitting private competitors to invoke state unfair-competition statutes in

California, Colorado, Connecticut, Tennessee, South

Carolina, and Florida against pharmacies and physicians engaged in FDA-permitted compounding activities, the Fifth Circuit effectively sanctioned state-law

private enforcement of the FDCA. That result cannot

be reconciled with Buckman Co. v. Plaintiffs’ Legal

Comm., 531 U.S. 341 (2001), which held that claims

premised on FDCA violations are impliedly

preempted because Congress entrusted the FDA

alone with policing compliance. Nor can it be squared

with this Court’s impossibility-preemption cases,

which emphasize that states may not impose requirements “in addition to, or different from” federal law

when compliance with both is impossible. See PLIVA,

Inc. v. Mensing, 564 U.S. 604 (2011); Mut. Pharm. Co.

v. Bartlett, 570 U.S. 472, 486–90 (2013).

Other circuits have faithfully applied these

principles, holding that state-law claims are

preempted where they intrude into the FDA’s exclusive regulatory domain. See, e.g., Patel v. Merck &

Co., Inc., 485 F. App’x 894 (6th Cir. 2012) (rejecting

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private state-law enforcement of FDCA standards);

PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir.

2010) (holding that Lanham Act claims premised on

FDCA violations were preempted because the FDA

has exclusive enforcement authority). The Fifth Circuit’s contrary approach opens the door to a patchwork of state enforcement schemes, where the legality

of federally authorized compounding depends not on

FDA policy, but on the vagaries of state unfair-competition laws. This Court’s intervention is essential to

prevent precisely the type of fractured regulatory

landscape the Supremacy Clause was designed to

avoid. U.S. Const. art. VI, cl. 2.

The consequences are not academic. Compounding pharmacies serve as a vital backstop during

drug shortages and emergencies, producing medications such as epinephrine, sterile water for injection,

IV solutions after Hurricane Helene, and GLP-1 therapies during ongoing shortages. Allowing private

competitors to weaponize state statutes against these

federally authorized activities undermines Congress’s

carefully calibrated scheme in the Drug Quality and

Security Act of 2013 (“DQSA”), Pub. L. No. 113-54,

127 Stat. 587, and threatens to fracture national drug

policy at the precise moment when coordinated, nationwide access to compounded medicines is most critical. Without this Court’s review, the Fifth Circuit’s

holding will invite further state-law incursions into

FDA’s exclusive authority, producing immediate disruption to patient care and an inconsistent national

framework for access to compounded therapies.

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I. The Decision Below Deepens a Circuit Split

Section 337(a) of the FDCA bars private enforcement. This Court confirmed in Buckman that

claims existing solely by virtue of the FDCA are

preempted. Buckman 531 U.S. at 353. Yet the Fifth

Circuit allowed mirror statutes to survive preemption. By contrast, the Ninth Circuit has held that such

claims are preempted when they intrude into FDA’s

exclusive enforcement. The Court of Appeals held

that FDCA’s prohibition on private enforcement

barred action by a manufacturer of Food and Drug

Administration (FDA) approved ready-to-use ephedrine sulfate product when it brought action against

operator of network of compounding pharmacies alleging that their sale of ephedrine sulfate preloaded

into ready-to-use syringes violated state laws prohibiting sale of drugs not approved by FDA, which is the

precise question in this case. Nexus Pharmaceuticals,

Inc. v. Central Admixture Pharmacy Services, Inc., 48

F.4th 1040, 1041 (9th Cir. 2022). See also, e.g. PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010);

Perez v. Nidek Co., 711 F.3d 1109 (9th Cir. 2013).

II. The Decision Is Inconsistent with a Comprehensive Federal Framework to Govern Compounding

Congress has long recognized the indispensable role of pharmacy compounding in patient care, but

it also understood that compounding implicates national interests too important to leave to a patchwork

of state regulation. In the Food and Drug Administration Modernization Act of 1997 (“FDAMA”), Congress

codified Section 503A of the FDCA to preserve

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traditional, patient-specific compounding as part of

pharmacy and physician practice. 21 U.S.C. § 353a.

Section 503A struck a deliberate balance: it exempted

compounded medications from certain federal approval and labeling requirements while making clear

that the practice remained subject to FDA oversight.

Congress reaffirmed and strengthened this

judgment in the wake of the 2012 New England Compounding Center tragedy. The DQSA was a direct response to the dangers of large-scale operations operating outside any clear regulatory structure. In it,

Congress reaffirmed the authority of Section 503A

and created Section 503B, establishing FDA-supervised outsourcing facilities permitted to manufacture

compounded drugs in bulk under current good manufacturing practices (“cGMP”). 21 U.S.C. § 353b. By doing so, Congress addressed the need for scalable compounded medications during shortages, while ensuring such operations were firmly subject to national

oversight. The DQSA reflects Congress’s clear intent

to prevent inconsistent state-by-state rules that

would undermine patient access and fracture national drug policy.

This framework leaves no doubt that Congress

entrusted the FDA—not private litigants or state

courts—with the exclusive responsibility of enforcing

the FDCA’s requirements for compounded drugs. See

Buckman, 531 U.S. at 348. While states retain the

traditional authority to license pharmacists and pharmacies, that authority does not extend to secondguessing FDA determinations about permissible compounding. To allow otherwise is to substitute fifty

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different regulatory schemes for the uniform system

Congress carefully designed.

III. The Fifth Circuit’s Decision in Zyla Creates a Direct Conflict With This Court’s Preemption Jurisprudence

The Fifth Circuit’s ruling authorizes precisely

what Congress sought to prevent: the use of state law

as a vehicle for private enforcement of the FDCA. By

permitting plaintiffs to invoke state unfair-competition statutes in jurisdictions such as California, Colorado, Connecticut, Tennessee, South Carolina, and

Florida, the decision transforms local business-tort

statutes into tools to challenge compounding practices

the FDA has authorized under Sections 503A and

503B. This result undermines the federal framework

and invites litigation designed to chill lawful compounding activity rather than protect public health.

That outcome cannot be squared with this

Court’s precedent. In Buckman, the Court held that

claims premised on FDCA violations are impliedly

preempted because Congress entrusted enforcement

exclusively to the FDA. Likewise, in its impossibilitypreemption cases, the Court has made clear that

states may not impose obligations “in addition to, or

different from” federal requirements where compliance with both is impossible. See Mensing, 564 U.S.

at 617-18; Bartlett, 570 U.S. at 486–90. The Fifth Circuit departs sharply from these principles by allowing

private litigants to leverage state law to dictate

whether pharmacies may engage in compounding

practices federal law expressly permits.

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Other circuits have rejected this approach. The

Ninth Circuit in PhotoMedex, 601 F.3d at 924–28,

and the Sixth Circuit in Patel, 485 F. App’x at 898–

99, recognized that courts cannot entertain claims requiring them to determine whether conduct violates

the FDCA, because that determination belongs solely

to the FDA. The Fifth Circuit’s ruling thus places it in

direct conflict not only with this Court’s preemption

jurisprudence but also with its sister circuits’ recognition of the FDA’s exclusive enforcement authority.

IV. The Circuit Split Will Produce a Patchwork of

Regulatory Outcomes

The Fifth Circuit’s ruling threatens to create

precisely the fractured regulatory environment Congress and this Court have long sought to prevent. By

allowing private parties to invoke state unfair-competition statutes, the court invited state-law enforcement of federal standards in areas Congress reserved

exclusively to the FDA. Pharmacies now face litigation not because the FDA has found them noncompliant, but because private competitors seek to weaponize local statutes as proxy enforcement mechanisms.

This outcome stands in stark contrast to the

approach taken in other circuits. Both the Ninth Circuit (PhotoMedex) and the Sixth Circuit (Patel) rejected attempts to recast FDCA violations as statelaw claims, recognizing that if state law may serve as

a vehicle for FDCA enforcement, the result will be

conflicting judgments and obligations—exactly what

Congress avoided in enacting the DQSA.

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The Supremacy Clause makes clear that federal law prevails over conflicting state regimes. U.S.

Const. art. VI, cl. 2. Allowing states to impose additional or inconsistent obligations on compounding

providers would erode FDA’s authority and frustrate

Congress’s express intent to ensure reliable access nationwide. Without this Court’s intervention, pharmacies in one state may be free to engage in FDA-authorized compounding, while those in a neighboring state

may be barred under state-law theories—an intolerable disparity in a field where uniform national standards are indispensable.

V. The Decision Threatens Immediate and Severe

Disruption to Patient Care

The stakes of the Fifth Circuit’s ruling extend

far beyond statutory interpretation—they reach directly into hospitals, clinics, and pharmacies where

patients rely on compounded medicines. Compounding pharmacies supply critical therapies when FDAapproved options are unavailable, unsuitable, or in

short supply. For example, compounded epinephrine

has served as an indispensable emergency therapy

when commercial products were scarce. After Hurricane Helene, when supply chains for sterile injectables collapsed, compounding pharmacies produced

sterile water and IV solutions to sustain patient care.

More recently, national shortages of GLP-1 medications have forced prescribers to rely on compounded

formulations to manage diabetes and weight-related

conditions for patients who would otherwise be left

without treatment.

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Permitting private competitors to weaponize

state unfair-competition statutes undermines the reliability of this safety net. Instead of focusing on FDA

oversight, providers may now be forced to defend

against duplicative state-law claims. This litigation

risk will chill lawful compounding, discourage providers from stepping in during emergencies, and ultimately reduce the availability of life-saving medications when patients need them most.

The inevitable result is unequal access. Patients in states where unfair-competition statutes

may be invoked will face diminished access to compounded therapies, while those in other jurisdictions

will continue to benefit from the uniform federal system Congress designed. Such disparities are untenable in practice and contrary to Congress’s express intent.

VI. This Court’s Review Is Necessary to Prevent

Fractured National Drug Policy

The Supremacy Clause requires that federal

law govern where Congress has enacted a comprehensive framework to address a matter of national importance. Through the FDCA and specifically Sections 503A and 503B, Congress created such a framework for compounding, assigning exclusive enforcement authority to the FDA. The Fifth Circuit’s decision disregards that mandate by allowing private litigants to use state unfair-competition statutes as de

facto enforcement tools. This invites states to intrude

into the FDA’s domain, producing precisely the

13

regulatory disarray Congress sought to prevent when

it enacted the DQSA.

If left unreviewed, the decision will fracture national drug policy along state lines. Pharmacies and

prescribers will face different legal standards depending not on federal law, but on local statutes and lawsuits. Patients in one jurisdiction may lose access to

compounded therapies available across state borders,

creating the very patchwork Congress deliberately

avoided. Only this Court can restore the uniformity

the Supremacy Clause demands and prevent further

disruption to patient care.

The Fifth Circuit’s reasoning turns entirely on

whether mirror statutes escape preemption. The issue is clean, outcome-determinative, and nationally

significant. Review is warranted.

VII. This Case Is an Ideal Vehicle

This case presents the Court with a clean, outcome-determinative question of national significance:

whether state statutes that mirror or overlap with the

FDCA can be used as private enforcement mechanisms without violating federal preemption principles. The Fifth Circuit held that they can. That reasoning conflicts directly with this Court’s precedents,

including Buckman, and with other circuits that have

barred such claims.

No threshold issues obscure the path to review.

The question presented was squarely addressed below, the record is fully developed, and the decision’s

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consequences are immediate and sweeping—placing

access to critical compounded medications at risk nationwide. This Court’s intervention is therefore imperative to restore uniformity in federal drug policy,

protect Congress’s carefully crafted scheme, and ensure that patients across the country continue to receive the therapies they need.

The Fifth Circuit’s reasoning turns entirely on

whether mirror statutes escape preemption. The issue is clean, outcome-determinative, and nationally

significant. Review is warranted.

Because the decision below squarely conflicts

with this Court’s precedent and threatens to fracture

national drug policy, review is essential. And this case

provides the ideal vehicle for resolving the conflict

once and for all.

Finally, there is a further concern that counsels

strongly in favor of review. The decision below arises

from an unremarkable dispute over a very old medication technology that was invented more than 55

years ago. That product, indomethacin, especially in

its suppository dosage form, is unlikely to garner national media attention or prompt robust public scrutiny. The amicus curiae does not see any one of the

Sunday morning television Supreme Court analysts

putting together a segment on the nuanced legal analysis regarding how something as innocuous as a holding regarding states’ rights regarding compounded indomethacin suppositories out of the Fifth Circuit now

affects more profound issues such as Americans’

rights to bear arms, reproductive healthcare, or a

15

state’s role in the enforcement of immigration policies. This amicus makes no judgement on the importance of these issues or the profound role the

states can and should play in their implementation

and enforcement. A case this low-salience and lightly

scrutinized should not be the occasion for precedent

based on questionable reasoning that will harden into

doctrine and drive substantial constitutional outcomes in future, higher-stakes disputes.

In the end, if left undisturbed, Zyla becomes a

one-way ratchet: litigants can cite it to justify broad

state-law incursions into FDA-reserved terrain well

beyond indomethacin or even traditional compounded

products. The immediate effect will be felt by pharmacies and prescribers chilled from providing FDA-permitted compounded therapies; the longer-term effect

will be a patchwork of state-law “mirror” regimes that

displace the very national uniformity Congress enacted in the FDCA and DQSA. This Court has cautioned against precisely this sort of end-run around

federal allocation of authority: doctrines forged in

easy cases that silently reshape the law for hard ones.

Review is warranted to prevent that hydraulic

pressure from building around a weak vehicle. There

will be future cases that squarely present the alleged

state interests, the federal interests, and a full record

on actual risk and patient impact. This is not one of

them. The Court should grant review to ensure that

any doctrinal shift with nationwide consequences occurs—if at all—in a case that places those consequences in clear view and within the proper federal

framework.

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CONCLUSION

The decision below deepens a square circuit

conflict, departs from this Court’s preemption jurisprudence, and invites state-by-state private enforcement of the FDCA in an area Congress reserved to

FDA. Left in place, it will fracture national drug policy, chill FDA-permitted compounding precisely when

patients most need it and undermine the uniform

framework Congress enacted in FDAMA and the

DQSA.

This is an ideal vehicle to resolve the question

presented: whether “mirror” state statutes may be

used as de facto private FDCA enforcement. The issue

is clean, outcome-determinative, and nationally significant. It should not be allowed to harden into precedent through a low-salience dispute over indomethacin suppositories—an unremarkable context that

masks the decision’s far-reaching structural consequences.

For these reasons, the Court should grant the

petition for a writ of certiorari. If the Court grants review, it should reverse the judgment of the Fifth Circuit (or, at minimum, vacate and remand) and reaffirm that the FDCA and DQSA preempt private efforts to police FDCA compliance through state unfaircompetition law, thereby restoring the uniform federal scheme and protecting patient access to compounded medicines nationwide.

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Respectfully submitted,

MARK D. BOESEN

Counsel of Record

Counsel for Amicus Curiae

8501 E Princess Drive, Suite 220

Scottsdale, AZ 85255

(602) 900-8562

mboesen@bslawusa.com