Arizona's HB 4036 Puts Patients At Risk

Op-Ed by Dr. Justin Brock, Arizona Pharmacist

Proposed legislation will make patient care harder — not safer
By Justin Brock, Pharm D, Arizona pharmacist

As a practicing pharmacist in Arizona, my job is simple: make sure patients get
medications that are appropriate for their individual needs. My wife and I opened our first
pharmacy location in 2014 with the goal of supporting the communities where we grew up
and helping our patients achieve the best possible outcomes by working closely with their
physicians. The mission we started with remains true today. Every day, I work with
physicians and patients who rely on compounded medications because commercially
available, one-size-fits-all products don’t work for them.

That’s why I’m concerned about HB4036, a bill moving through the Arizona Legislature that
would impose sweeping new restrictions on pharmacy compounding. While supporters
frame it as a safety measure, the reality is that it risks limiting access to care without
meaningfully improving patient protection.

Compounding is not some loophole or shortcut. It’s a long-standing, carefully regulated
practice that allows pharmacists to tailor medications when patients can’t use massmanufactured
drugs. In the last year alone, I have had countless face-to-face interactions
with patients—from high schoolers to retired veterans—who heave a sigh of relief in my
pharmacy when we dispense custom medications without certain dyes or preservatives
that they are allergic to. Many of my patients need their medication in doses that simply
aren’t manufactured. Pediatric and geriatric patients often require customized
formulations that allow them to swallow pills larger than the size of a raisin. We give them
the medicine they need. For them, compounding is not optional — it’s essential.
In addition, we work with veterinarians to develop compounded medications at our Tucson
location for pets that oVer a number of benefits ranging from customization through ease
of administration.

Arizona already regulates compounding pharmacies through the State Board of Pharmacy,
and pharmacists operate under strict professional standards. We are trained to verify
ingredient quality, maintain sterile environments when required, and document our
processes. We take our responsibility seriously.

HB4036 would layer on additional requirements that, while sounding technical and
prudent, create rigid barriers that don’t reflect how pharmacy practice or supply chains
actually work. The bill would make it unlawful to compound certain medications unless
pharmacies meet a long list of criteria related to bulk ingredients, documentation, supplier
inspections and testing protocols.

On paper, that may sound like a reasonable tightening of standards. In practice, it risks
cutting oV access to medications because of bureaucratic hurdles beyond a pharmacist’s
control. For example, pharmacies could be required to verify that ingredient suppliers were
inspected by the FDA within a specific timeframe — something pharmacies cannot dictate
or schedule. If an inspection is delayed, even when the supplier remains compliant and
safe, patients could lose access to their medication.

When compliance becomes too complex and resource-intensive there is a very real risk
that smaller pharmacies could step away from compounding altogether, and if that
happens patients lose options.

When access shrinks, patients don’t just face inconvenience. They face treatment
interruptions. They face higher costs. They face delays while searching for alternatives that
may not meet their medical needs.

Good policy should target actual risks, not create broad restrictions that treat responsible,
licensed professionals as though they are operating outside the system. We already work
within a framework of state oversight, federal standards and professional accountability.
There is also a larger principle at stake. Health care decisions should be made by patients,
their physicians and the licensed professionals entrusted with their care — not dictated
through rigid statutory checklists that cannot adapt to clinical realities. Legislating new
restrictions into state law may sound decisive, but it leaves little room for flexibility when
circumstances change.

If lawmakers believe improvements are needed, pharmacists should be at the table. We
support thoughtful policies that strengthen safety without undermining access. But
HB4036, as written, tilts the balance to big global drug manufacturers and away from
patients and those who directly provide care.

Arizona patients deserve both safety and access. We can have both — but only if we avoid
policies that make it harder for trusted health professionals to meet individualized medical
needs.

For the sake of the patients I serve every day, I urge lawmakers to reconsider HB4036.

Legal Analysis

Mark Boesen, Pharm.D., J.D. is an Arizona licensed pharmacist and Arizona licensed attorney. He is a founder of AACM. Mark is a University of Arizona College of Pharmacy Graduate (1995).

Arizona’s HB 4036 (2026) aims to increase oversight of compounded GLP-1 medications (like semaglutide and tirzepatide) by placing stringent sourcing and testing requirements on pharmacies. While designed to protect patients from "unscrupulous actors" and "inferior ingredients," the bill’s language creates several significant unintended consequences that could disrupt the pharmacy landscape in Arizona.

1. Regulatory "Blind Spots" and Transparency Issues

The bill requires pharmacies to obtain proof that a manufacturer has undergone an FDA inspection within the last two years (Section A, Paragraph 7b).

a The Problem: FDA Establishment Inspection Reports (EIRs) are not public documents. While the FDA provides a "Data Dashboard," it is months or years behind and may not specify if an inspection occurred within a precise two-year window.

b. Unintended Consequence: Legitimate pharmacies may be forced into technical non-compliance because they cannot "prove" a federal agency’s internal schedule, even if the manufacturer is fully compliant and registered.

2. Impossible Burden on the State Board

The legislation grants the Arizona State Board of Pharmacy the authority to inspect not only compounding pharmacies but also their domestic suppliers, wholesalers, and repackagers (Section D).

a. The Problem: All of these FDA-Registered bulk drug substance manufacturers and wholesalers are located outside of Arizona (many in New Jersey, California, or overseas).

b. Unintended Consequence: The Arizona Board lacks the budget, jurisdiction, and manpower to conduct out-of-state or international inspections. This creates an "unfunded mandate" where the Board is legally responsible for oversight it physically cannot perform, potentially leading to a backlog that freezes the supply chain for these medications.

3. Barrier to Patient Access

By requiring pharmacies to conduct and document independent quality control testing for every batch that include identifying every impurity above 0.1% (Section A, Paragraph 5 & 6); the bill moves far beyond typical 503A(traditional) compounding requirements.

a. The Problem: These tests require expensive equipment (like HPLC or Mass Spectrometry) that no Arizona community pharmacy owns. Sending samples to third-party labs adds weeks to the lead time and hundreds of dollars to the cost per prescription. Further, Arizona and federal law already put this burden on the manufacturers. Arizona pharmacies must receive a Certificate of Analysis with every bulk substance before compounding. Another test is unnecessary and a waste of money that will only drive up the cost of compounded medications.

b. Unintended Consequence: Smaller, independent pharmacies may stop offering these medications entirely. Patients who cannot afford the compounded medication will lose access to their treatment.

4. Redundant Federal Conflict

The bill essentially codifies parts of the federal Section 503Awhile adding state-specific layers that may conflict with how the FDA manages "Bulk Drug Substance" lists.

a. The Problem: If the FDA updates its "interim list" of substances allowed for compounding, but the Arizona statute is not updated at the same pace, Arizona pharmacies could find themselves in a position where a substance is legal federally but "unlawful" under HB 4036.

b. Unintended Consequence: This creates a "chilled" regulatory environment where pharmacists may refuse to fill valid prescriptions out of fear of the$1,000-per-dose civil penalty (Section F).

5. Misleading Advertising Traps

The bill mandates that any advertisement for a compounded GLP-1 must include a summary of all risk information from the FDA-approved version of the drug (Section E, Paragraph 2).

a. The Problem: Compounded drugs are, by definition, not the same as the FDA-approved brand-name drugs. Requiring a pharmacy to use the "Summary of Risk" for a product they did not manufacture could be viewed as practicing medicine or providing medical advice. This is the circularity of the language. Federal law already PROHIBITS false or misleading advertising of compounded medications (see, Thompson v. Western States Medical Center (2002 US Supreme Court); see also the federal Lanham Act). To propose that pharmacies include a summary of all risks associated with a compound that is NOT the same as the FDA-approved version would be by definition, providing false information.

b. Unintended Consequence: This could lead to legal liability for pharmacies if they are forced to provide warnings for a brand-name product that may not apply to their specific compounded formulation (e.g., different active, inactive ingredients, and dosage forms (delivery methods)).