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Drug compounding advocate talks Alabama regulations, GLP-1 “frenzy”

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, explained how compounders filled gaps during drug shortages and provided custom formulations.

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With a nationwide increase in compounded drug usage sparking backlash from some drug manufacturers, Alabama native and CEO of the Alliance for Pharmacy Compounding Scott Brunner has been a leading spokesperson for licensed compounding pharmacies.

APC is an industry trade association that represents over 600 compounding pharmacies across the U.S. 

Brunner, who grew up in Bessemer and is a graduate of the University of Montevallo, has held leadership positions in numerous trade associations over the last 35 years, working for the Alabama, Mississippi and Virginia Associations of Realtors, National Association for Plastic Container Recovery, the Georgia Pharmacy Association and National Community Pharmacists Association before his time at APC.

Brunner took on his position as CEO of APC, at that time named the International Academy of Compounding Pharmacists, in 2019.

“I was brought in as I guess you would call it a turnaround artist, and so we have worked to rebuild this organization,” Brunner said. “We’ve rebranded the organization. We now have a different name, a broader tent, and it’s been a wonderful ride.”

Brunner described FDA approved drugs as “the gold standard” of pharmaceutical treatments, emphasizing that although compounded drugs are often inaccurately portrayed as inferior to FDA medications, they are in fact either direct chemical copies of the drugs or custom formulations made to better fit patients’ needs.

“[FDA approved drugs] have been rigorously tested, and those drugs work for most Americans,” Brunner said. “Compounding exists when FDA approved drugs are in shortage or a prescriber for an individual patient needs a custom formulation of a drug—needs it in a dosage form, or a dosage strength, or a combination that is not commercially available, not FDA approved.”

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Brunner said that APC is “at heart an advocacy organization.”

“Compounding is an essential therapy in the American health care system. It is often misunderstood. It often gets maligned by drug makers and others,” he said.

“There are millions of Americans whose lives are made better, whose lives are extended because they are taking a compounded therapy,” Brunner added. “We advocate for those patients. We advocate for their ability to access compounded drugs when their prescriber says they need them. We advocate for the pharmacies themselves and their ability to provide this therapy.”

Brunner also emphasized that compounded drugs are not intended “in law or practice” to serve as competition for FDA approved medications, but rather to fill coverage gaps left when a drug company is not producing enough of a medication to fill demand or doesn’t produce certain dosages or formulations of a drug due to a lack of financial incentive.

Brunner spoke before the Alabama Pharmacy Association at its annual conference this June and has made multiple trips to compounding pharmacies across the state in recent years as part of his work with APC.

When asked if Alabama compounding pharmacists had expressed any concerns with how state regulatory bodies such as the Alabama Board of Pharmacy govern their operation, Brunner emphasized, because of the rigorous nature of Alabama’s pharmacy regulations and individual judgements of compliance inspectors, some state pharmacy owners have emphasized the difficulty adhering to ALBOP guidelines.

“Alabama, in terms of regulatory rigor, is in probably the top five state boards of pharmacy,” Brunner said. “Alabama is a tough state, and I would put it right up there with California and New York and Florida and some others—Massachusetts—as being a particularly difficult state for compounding pharmacies, only because you end up with sometimes subjective judgments on the part of inspectors.”

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“You know, one inspector comes in and says, ‘everything’s fine,’ and six months later, another inspector comes in and you get written up and cited and fined for things that were just the same six months ago,” Brunner said. “And so, what’s the standard? And that would—that would be my only argument with Alabama, is consistency of enforcement so that the compounding pharmacies know what the compliance standard looks like and can manage to that standard.”

When asked to comment on the “Community Pharmacy Relief Act,” a law enacted during Alabama’s 2025 legislative session which imposed further regulations on pharmacy benefit managers, Brunner expressed support for lawmakers attempting to reform PBM practices.

PBMs act as middlemen between pharmacies, drug manufacturers and insurance companies, setting reimbursement rates for pharmacies obtaining FDA approved drugs from manufacturers and managing prescription drug benefits.

The law prohibits PBMs from issuing reimbursements to independent pharmacies at rates lower than those paid by the Alabama Medicaid Agency, as well as charging pharmacies certain fees and blocking pharmacists from telling patients about lower-cost treatment alternatives. It also requires PBMs to pass all drug manufacturer rebates to health plans.

Brunner emphasized that although compounding pharmacies don’t do business through PBMs, APC members who run hybrid pharmacies—pharmacies that dispense FDA approved drugs and compound medications—have seen their businesses put at risk by inadequate reimbursements from PBMs.

“For those members, yeah, the tyranny of the PBMs, is certainly an issue. I talked to pharmacists all the time who run hybrid pharmacies, and they tell me the compounding business is carrying the traditional retail dispensing business,” Brunner said.

Brunner said many members have told him the cost of obtaining FDA approved drugs is often not reimbursed fully by PBMs.

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“I think PBMs need to be reformed. They are middlemen who have carved out such a vast area of influence, and they are taking from the transaction in a way that increases the cost of the drug, but they’re also not adding value commensurate with the money that they’re pulling out,” he said. “They’re undercutting traditional retail dispensing pharmacies, and those pharmacies are going out of business as a result. And then you end up with rural areas of Alabama and other states that don’t have a local pharmacy.”

Brunner said he believed further regulatory legislation aimed at curbing the influence of PBMs could be merited, when asked what pharmaceutical issues the Alabama legislature should focus on during their 2026 legislative session.

He also urged lawmakers to keep an open dialogue with APC and the Alabama Pharmacy Association to ensure information they’re given regarding compounding by pharmaceutical lobbyists is accurate.

“Drug maker lobbyists are doing what I would say is a masterful, although insidious job of misrepresenting what state licensed compounding pharmacies do,” Brunner said. “Before anybody in the legislature wants to introduce a bill that has to do with compounding. I would hope they would reach out to the Alabama Pharmacy Association and to the Alliance for Pharmacy Compounding, for input.”

Describing instances he felt showed the importance of compounding in correcting drug shortages, Brunner pointed to a shortage of acetaminophen, ibuprofen and amoxicillin suspensions, commonly used for child patients, that took place during the winter of 2022 and 2023.

“We had prescribers writing for amoxicillin suspension for the patient, and the parents are frantic because they can’t find a pharmacy that has this drug,” he said. “Compounding pharmacies stepped in and prepared copies of those suspensions, those drugs, and I have no doubt, children’s lives were saved because of it.”

He also highlighted how compounded suspensions of hydroxyurea, the only FDA approved drug for treating Sickle Cell Anemia, have improved care for children with the disease.

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“Hydroxyurea therapy is a big old pill, and these hospitals have pediatric sickle cell patients, five-year-olds with sickle cell,” Brunner said.

He explained that suspensions of the drug both “alleviates the suffering” of child patients by being easier to tolerate and allow for better dosing, saying there is no FDA approved version of the drug with a dosage strength designed for a five-year-old.

Brunner went on to describe compounding’s growing prevalence and controversy in light of the emergence of GLP-1 drugs, originally indicated for weight loss and diabetes and sold under brands such as Ozempic, Wegovy and Mounjaro.  

“We have been for the past three years in a frenzy of GLP-1 weight loss drugs,” Brunner said. “Almost monthly they’re coming out with new indications that these drugs, either semaglutide or tirzepatide, are appropriate for—from Parkinson’s to cardiovascular disease, even addiction.”

“The drug makers themselves hyped them in television commercials and more. I bet most Americans can hum the ‘oh, oh, Ozempic’ commercial, and the drug went into shortage,” he continued.

The FDA declared an end to the shortage of tirzepatide, branded as Mounjaro and Zepbound, in 2024, as well as semaglutide, sold as Wegovy and Ozempic, earlier this year.

“We have asserted all along that the that FDA was premature in ending the shortage, because even though the drug came off the shortage list and compounders could no longer prepare it, patients could not get the FDA approved drug,” Brunner said.

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Brunner emphasized that compounded drugs are typically not covered by insurance because of their lack of FDA approval, and therefore oftentimes more expensive than FDA approved medications.

However, he cited that compounded GLP-1 medications are “significantly cheaper” than drugs currently being offered by pharmaceutical companies.

When asked if there were any ways he felt compounded therapies could be used to improve rural or low-income healthcare access in states such as Alabama, Brunner said APC has considered ways a collaborative pilot program between Medicaid and drug compounders could utilize compounded GLP-1 therapies to save health insurers money and improve access to care.

“Diabetes is a big issue in Alabama with a lot of folks. You get wounds on your feet, et cetera. There are compounding therapies, that we believe can get patient outcomes faster and cheaper than traditional therapies, and we would love to be able to try that,” Brunner remarked.

“There are other ways that compounded drugs, I think can, can be helpful,” Brunner continued. “But until insurance companies begin to cover them, or hospitals are willing to try via some sort of pilot project to see if we can do cost containment for them, I think we’re going to sort of be stuck where we are, which is compounded therapies are right for patients who can afford them, but they are not as widely used as they might be.”

While direct copies of GLP-1 drugs can no longer be compounded on account of the FDA declaring an end to the shortage, compounding pharmacies can still produce and dispense custom formulations of the drug if prescribed by a doctor.

Brunner explained that prescribers often add additional drugs to semaglutide or the tirzepatide to alleviate patient nausea or otherwise help them tolerate the treatment better.

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“FDA guidance allows for that based on the judgment of the prescriber. The drug companies don’t like that,” he said.

“I have great respect for drug companies and how FDA approved drugs have made America really just the model for the world in terms of the rigor with which and safety with which those drugs are prepared,” Brunner continued. “I think the drug makers and with the makers of these GLP-1 drugs have felt threatened by compounding in this moment when they couldn’t meet demand for the drug, and so they’ve pulled out every, every trick in the book.”

Brunner cited that pharmaceutical companies behind popular GLP-1 brands have filed numerous nuisance complaints with state boards of pharmacy regarding compounded GLP-1 treatments.

“And so, we find now that we’re sort of playing a little bit of Whack-a-Mole. The drug makers have more money than God. They have a lot of law for firms on retainer,” Brunner said.

“We look at the agendas of every meeting of state boards of pharmacy. We look at the communication that is released publicly between the boards of pharmacy and their stakeholders,” he explained. “And if there is an issue that arises, we will weigh in. The drug makers lately have been using that avenue a great a great bit.”

Brunner also pointed to lawsuits brought by drug companies against telehealth providers, compounding pharmacies and med spas who provide compounded versions of GLP-1 drugs.

“There have been plenty of lawsuits against med spas for making inappropriate claims about the compounded drugs that they were dispensing, and if the med spa was indeed doing that, then they’ve had to settle with the drug maker,” Brunner continued.

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He explained that many other lawsuits filed by drug makers have failed because courts “again and again” have ruled against the private right of action to enforce the “Food, Drug and Cosmetic Act,” the enabling statute for drug compounding.

“With every new sort of tranche of lawsuits that these drug makers file, they try to more elaborate claims,” Brunner said, explaining that, while drug companies lost their first round of lawsuits filed against compounding pharmacies under state laws, they have since progressed to prosecuting pharmacies under the Lanham Act—a federal law regarding trademarking and deceptive practices.

“Those lawsuits are still in process, and we’re concerned. The court so far seem to know which end is up and are largely getting this right, but one errant court decision will help will, hurt patients in that it may serve to be an impediment for them to be able to get a compounded drug therapy that ensures their survival,” he added, emphasizing that a ruling against compounding GLP-1 drugs could potentially put the availability of other compounded therapies at risk.

“They sort of veil this through, they enunciate it through the lens of, ‘oh, we’re protecting patients, and we’re keeping patients safer,’ and yet, this is really about protecting their profits and many of their arguments are fairly specious,” Brunner alleged.

Wesley Walter is a reporter. You can reach him at [email protected].

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