THE PCCA BLOG

Chronic Pain, Hormones and Inflammation: Connecting the Dots at CONNEXT 2026

Thu, 05 Mar 2026 20:21:34 GMT

Featuring Sarah Zielsdorf, MD, MS, ABIM, IFMCP

Some patients don’t fit neatly into diagnostic categories. They’ve collected labels over time: fibromyalgia, endometriosis, mast cell activation, dysautonomia. Their labs fluctuate. Their symptoms overlap. They react to medications that are supposed to help. And too often, they leave appointments feeling unheard.

At CONNEXT 2026, Dr. Sarah Zielsdorf will address these complex intersections head-on — not as isolated conditions but as interconnected patterns across the endocrine, immune and inflammatory systems.

She’ll open the week alongside Sebastian Denison, RPh, in a live “Morning Warm-Up” session designed to answer unfiltered questions and fill education gaps for newer practitioners. It’s a practical starting point for a deeper conversation, grounded in real-world clinical uncertainty rather than textbook simplicity.

From there, Dr. Zielsdorf will move into one of the most challenging areas in modern medicine: chronic pain in women’s health. Conditions like adenomyosis, endometriosis and fibromyalgia are often treated as separate diagnoses. But she invites clinicians to look at what links them, including the spectrum of mast cell activation disorders, from MCAS to systemic mastocytosis, and their associations with dysautonomia and hypermobility spectrum disorders such as Ehlers-Danlos syndrome.

For many patients, these are not isolated problems but overlapping systems under stress. Supporting them requires compassion — and often compounded, individualized therapeutics due to sensitivities, allergies and trigger reactivity. Dr. Zielsdorf will discuss practical strategies, including low-dose naltrexone (LDN), bioidentical hormone therapy (bHRT), ketotifen and oral peptides — not as trends, but as tools that require thoughtful dosing, inclusion and exclusion criteria, and careful patient selection.

This theme will continue in her session on autoimmune and rheumatologic conditions, where inflammation is not simply a symptom but a driving force. She'll explore the expanding spectrum of autoinflammatory and autoimmune disorders and the mediators that fuel them: diet, trauma, microbial influences and environmental triggers. LDN’s mechanisms of action and clinical applications will be examined in detail, alongside safety profiles and practical implementation considerations.

Inflammation is also central to hormonal transitions. During perimenopause, menopause and andropause, Dr. Zielsdorf frames the conversation around inflammaging — the chronic, low-grade inflammation that accelerates age-related disease — and metaflammation, the metabolic inflammation tied to metabolic dysfunction. She'll explore the role of the gut microbiome, intestinal hyperpermeability, circadian rhythm disruption, HPA axis dysregulation, thyroid imbalance, mitochondrial dysfunction and weight gain — all through a systems-based lens.

The message is clear: Endocrine systems do not function in silos. As the science of bioidentical hormone replacement therapy continues to evolve, compounding pharmacies play a critical role in delivering precision therapeutics, especially for patients who cannot tolerate standard formulations or require individualized dosing strategies. Sebastian Denison’s complementary lectures will reinforce how these therapies translate into practical compounding solutions, bridging clinical insight with pharmacy application.

At its core, Dr. Zielsdorf’s presence at CONNEXT 2026 represents something bigger than a series of lectures: a shift toward integrative, systems-informed care that recognizes complexity rather than flattening it. If you treat patients navigating chronic pain, autoimmune disorders, inflammatory conditions or hormonal transitions, these sessions will provide both clarity and direction.

Join us at CONNEXT 2026 and be part of the conversations redefining individualized care.

The FDA Removes the Black Box Warning on Estrogen: What Pharmacists Need to Know (2025 Update)

Fri, 13 Feb 2026 16:24:46 GMT

On November 10, 2025, the U.S. Food and Drug Administration (FDA) announced a major update to menopausal hormone therapy labeling: the agency is removing the broad black box warning from estrogen-containing products used for menopause, with one important exception—systemic estrogen-alone products will retain the boxed warning for endometrial cancer risk in women with an intact uterus.¹

For pharmacists, this isn’t just a labeling change. It’s a clinical counseling opportunity to help patients understand who hormone replacement therapy (HRT) is appropriate for, when it is most beneficial, and which risks still require screening and monitoring.

How We Got Here: The Women’s Health Initiative (WHI) and the “HRT Fear” Era

The Women’s Health Initiative (WHI), launched in the 1990s and sponsored by the National Heart, Lung, and Blood Institute (NHLBI), enrolled more than 161,000 postmenopausal participants.² One key goal was to evaluate whether hormone therapy could prevent cardiovascular disease, fractures, and cancer.

Key WHI findings (as widely interpreted at the time):

Estrogen + progestin was associated with increased risk of coronary heart disease, stroke, venous thromboembolism (VTE), breast cancer, and dementia.
Estrogen alone (in women with prior hysterectomy) showed more favorable outcomes in younger subgroups and was associated with reduced coronary heart disease and all-cause mortality in some analyses. It also showed a statistically significant reduction in invasive breast cancer incidence overall.

The practical takeaway became blunt: HRT was seen as broadly dangerous, HRT prescribing dropped sharply, and many women stopped therapy or avoided it altogether.

What was often lost in translation: the average age in the WHI hormone trial was around 63—well beyond the typical menopause transition—and the regimen studied (oral conjugated equine estrogen plus medroxyprogesterone) does not represent the full range of current hormone therapy options. Risk estimates were frequently generalized to younger, newly menopausal patients, even though their benefit–risk profile can differ meaningfully.

What Exactly Is the FDA Changing in 2025?

In the November 2025 announcement, the FDA and HHS began removing broad boxed warnings that had linked systemic menopausal hormone therapy to cardiovascular disease, breast cancer, and probable dementia. The agencies explicitly described prior warnings as “misleading” when interpreted without clinical context and current evidence.¹

What remains: the FDA will retain the boxed warning for endometrial cancer on systemic estrogen-alone products, reinforcing the importance of appropriate progestogen use (or other uterine protection strategies) for patients with a uterus.

A centerpiece of the updated position is the FDA’s endorsement of the timing hypothesis: the benefit–risk balance of systemic HRT depends heavily on when therapy starts. The FDA cited randomized data suggesting that women who initiate systemic hormone therapy within 10 years of menopause onset or before age 60 may experience benefits such as fewer fractures and reduced all-cause mortality, along with favorable relative risk changes for certain cardiovascular outcomes.¹

What This Means for Pharmacists: Counseling That’s Accurate, Individualized, and Confidence-Building

For years, counseling often defaulted to: “Use the lowest dose for the shortest time—only if absolutely necessary.” The updated labeling supports a more nuanced approach.

As boxed warnings are removed, pharmacists play an even bigger role in helping patients understand why “estrogen” is not one uniform exposure.

And the “uterus rule” remains critical: unopposed systemic estrogen in a patient with an intact uterus increases risk of endometrial hyperplasia and endometrial cancer, and the boxed warning for this risk remains.¹

Age and timing now matter more in patient conversations
A healthy 52-year-old within a few years of her final menstrual period does not share the same baseline risk profile as a 68-year-old initiating hormone therapy for the first time. Pharmacists can help frame this distinction clearly and consistently.
Route, formulation, and regimen matter—and WHI isn’t the full story The WHI primarily studied a specific oral regimen. Today’s practice commonly involves:
- estradiol,
- micronized progesterone,
- lower doses, and
- individualized schedules.
Removing a black box warning is not the same as removing risk Pharmacists should still screen for contraindications and red flags—especially in patients with:
- history of estrogen-dependent cancer (including many breast cancers),
- active or high-risk VTE, known thrombophilia, or prior stroke,
- unexplained vaginal bleeding,
- severe liver disease,
- uncontrolled or significant cardiovascular disease (depending on route/regimen).
Expect fear, confusion, and skepticism—and be ready for it Many patients have internalized the message that “hormones cause cancer and heart attacks.” A helpful counseling approach:
- acknowledge why patients were warned for decades,
- explain what we’ve learned since WHI (especially the role of age, timing, and regimen),
- emphasize shared decision-making with the prescriber.

Bottom Line for Pharmacy Practice

The FDA’s removal of the broad black box warning on estrogen therapy for menopause is a course correction, not a claim that estrogen is risk-free.

For pharmacists, this moment means:

Updating how we explain HRT risk and benefit in plain language.
Shifting from “avoid at all costs” to patient-specific risk–benefit counseling.
Helping patients understand why labeling changed and how that supports informed decision-making.

Many women will spend a large portion of life in the postmenopausal phase, and symptom relief plus long-term health considerations are real quality-of-life issues. Pharmacists are uniquely positioned to translate this regulatory update into balanced, evidence-informed guidance.

References

U.S. Food and Drug Administration. HHS advances women’s health, removes misleading FDA warnings on hormone replacement therapy. FDA Newsroom. November 10, 2025. Accessed December 29, 2025. FDA Newsroom
National Heart, Lung, and Blood Institute. Women’s Health Initiative (WHI). NHLBI, National Institutes of Health. Accessed December 29, 2025. NHLBI WHI

Advancing Standardization with Sterile-to-Sterile Formulas

Fri, 05 Dec 2025 18:30:37 GMT

By Celeste Zizzamia, PharmD, BCSCP, PCCA Clinical Compounding Pharmacist

For years, sterile compounding formulas in the PCCA database were primarily built for nonsterile-to-sterile preparations, using bulk powder as the source of the active pharmaceutical ingredient (API). But as the needs of health system pharmacies have evolved, so has our approach. To better support hospital teams focused on medication safety and efficiency, PCCA has expanded our formulation database to include sterile-to-sterile formulas that use a Commercially Available Drug Product (CADP) as the API source.

This shift is more than a technical update. It represents a larger commitment to standardization — one that aligns with the American Society of Health-System Pharmacists (ASHP) Standardize 4 Safety (S4S) initiative and its goal of reducing IV medication errors nationwide.

How the new formulas came together

The PCCA Formulation Development Team and Clinical Compounding Pharmacists began by referencing ASHP’s S4S lists for both pediatric and adult continuous infusion standards. These lists identify standardized concentrations and dosing units for IV and oral medications — a framework first developed in 2008 to prevent patient harm and supported by an FDA grant beginning in 2015.

Using these lists, we evaluated which APIs and concentrations to include in our database. Each selection was guided by two questions: Is there clear, referenced data supporting this concentration? And will this formula help health systems adopt S4S standards more efficiently?

From there, our team compared the S4S information to each drug’s CADP package insert. If the insert already included directions for diluent type, resultant strength, container-closure system and storage time, pharmacists could follow those instructions directly — in which case the preparation would not be considered compounding.

However, when published research presented an alternative stability-indicating study that deviated from the package insert, that preparation became a Compounded Sterile Preparation (CSP) under USP <797> guidelines. Those instances required additional data review and verification to ensure compliance and clarity for users.

What each formula includes

Each sterile-to-sterile formula begins with the CADP information and integrates any relevant literature findings. The result is a practical, pharmacist-ready resource that outlines:

The recommended diluent (e.g., 0.9% Sodium Chloride Injection or 5% Dextrose Injection), with additional compatible options noted when supported by data.
Calculations showing how to determine the correct CADP volume based on the desired concentration.
Referenced stability data when available, prioritized from studies using stability-indicating assays.
Detailed notes covering concentration, diluent, container closure, storage temperature, light exposure and beyond-use dates (BUDs), as applicable.

This structure enables compounders to quickly assess whether a commercially available premade product is available at the same concentration before proceeding — and, when compounding is necessary, to do so with confidence in the data behind every step.

Why this matters for health systems

For hospital and health system pharmacies, sterile-to-sterile formulas can remove some of the most time-consuming barriers to standardization. Each formula in this growing library includes the research and references pharmacists need to make evidence-based decisions while staying focused on patient safety and workflow efficiency.

Every formulation includes literature citations that link directly to the studies informing our guidance. When no stability-indicating data is available, we provide a summary chart of USP <797> beyond-use-date limits by CSP category, giving pharmacists a clear framework to assign appropriate BUDs in line with regulatory expectations.

In practice, that means less time spent combing through primary literature or reconciling package inserts, and more time applying validated concentrations already aligned with S4S standards. It’s a small but significant way to help teams meet national benchmarks for medication safety without adding complexity to their compounding processes.

Continuing the work of standardization

The expansion of PCCA’s sterile-to-sterile database is an ongoing effort. As ASHP’s S4S lists evolve, so will our formulations. Upcoming additions will include ophthalmic preparations such as intravitreal, subconjunctival and topical dosage forms — areas where standardized concentrations can further improve safety and consistency.

Each update reflects the same guiding principle: that the right data, clearly presented, can help health systems strengthen both safety and efficiency. By combining referenced stability research with practical compounding guidance, we aim to make standardization not just an aspiration, but a daily reality for hospital pharmacies everywhere.

Profiles in Personalized Medicine: T.W. Taylor, RPh

Fri, 21 Nov 2025 15:45:47 GMT

Compounding has shaped not only my career, but the way I care for patients. From the beginning, I was drawn to the idea that medication shouldn’t be one‑size‑fits‑all. Compounding gives pharmacists the ability to tailor treatments to the very specific needs of individuals, and that ability to create something truly personalized is what pulled me into this profession and continues to inspire me today.

I found my way to PCCA because of their commitment to quality and innovation. Over time, they’ve become an essential partner in my work. Their education, resources and support help me provide solutions that standard medications simply can’t offer. Knowing I have access to their expertise allows me to continually grow as a compounder and better serve my patients.

If I had to choose one word — other than “personal” — to describe what compounding means to me, it would be “transformative.” Compounding transforms a traditional approach to health care into one that is precise, individualized and deeply impactful. I’ve seen this transformation in countless patients, and it’s one of the most rewarding parts of my work.

One patient who comes to mind is Susan, an elderly woman who struggled with swallowing pills and managing several medications at once. To make her treatments easier, I created a transdermal cream using PCCA’s Lipoderm® base, combining multiple medications into a single, easy‑to‑use formula. Her adherence improved significantly, and I collaborated closely with her primary care physician to make sure everything was dosed correctly. The improvement in her symptom relief — and her overall health — was unmistakable.

Today, I see compounders as an essential part of the healthcare landscape. We fill treatment gaps, improve patient compliance and offer solutions when commercial medications fall short. Every personalized preparation reinforces the importance of what we do.

The gratitude that patients express is one of the great joys of this work. I’ve received heartfelt letters, personal referrals and even handmade artwork from individuals who wanted to show their appreciation. Those moments remind me why I do what I do.

At Williamsburg Drug Company, we’re committed to making compounding accessible and understood within our community. We host seminars for healthcare providers, participate in health fairs, welcome legislators into the pharmacy and share patient stories whenever possible. We also have a pharmacist dedicated full‑time to marketing and speaking to organizations throughout the area, helping more people understand how compounding can change lives.

For pharmacists and technicians interested in entering the world of compounding, my advice is simple: stay curious and never stop learning. The field is constantly evolving, and success comes from embracing that growth. If you’re driven by problem‑solving and a desire to make a meaningful impact, you will find compounding incredibly fulfilling.

Profiles in Personalized Medicine Samantha Pitzarella, PharmD

Mon, 20 Oct 2025 22:44:56 GMT

I didn’t set out to be a pharmacist who compounds. In fact, my journey into compounding began in the most unexpected way — at my hometown pharmacy in Canonsburg, Pennsylvania, when I was a teenager. The owner, Jerry, did a little bit of compounding, and I started helping out after school — pouring suppositories, labeling, cleaning up. It wasn’t glamorous, but it was fascinating. I loved the hands-on aspect, the idea that we could make medicine specifically for someone who needed something different.

That experience set the course for my entire career. When I went to pharmacy school at the University of Pittsburgh, I was fortunate to receive a scholarship from that same hometown pharmacy — a full circle moment that shaped my path. Years later, I ended up working for Jerry again, and now, in an incredible twist of fate, our pharmacies have come back together to create ColtRx Pharmacy. It feels like my career has come home.

Compounding quickly became more than just part of my job — it became the reason I love pharmacy. In a world where most medications are mass-produced, compounding allows me to think creatively, to solve problems for real people. If it weren’t for compounding, I honestly don’t think I’d still be in pharmacy. It’s what keeps me inspired, challenged and deeply connected to my patients.

Over the years, I’ve learned that compounding can completely change a person’s quality of life. One of my most memorable patients has a rare mast cell disease that caused her to have severe allergic reactions multiple times a week. After hearing about new research at PCCA’s ThinkNext International Seminar, I had an idea — what if we tried low-dose naltrexone for her condition? It wasn’t something we’d used for mast cells before, but I reached out to her doctor and found one willing to give it a try. Months later, she went 75 days without a single episode of anaphylaxis. She even sent me a photo of herself driving a car again after years of being unable to. That one message — just a picture of freedom — reminded me exactly why I do what I do.

And that’s where PCCA comes in. I’ve been connected to PCCA since I was 18. They were my first call when I needed help troubleshooting a formula or validating a chemical. Compounding can be isolating — you’re solving unique problems that don’t have easy answers — but PCCA gives you an entire network of people who understand exactly what you’re doing and why it matters. Their quality standards allow me to sleep at night, knowing every ingredient is tested, verified and supported by data. Their innovation lets me focus on my patients, not on making bases from scratch. And their training programs — whether online webinars or in-person seminars — keep my team educated and confident. My technicians love those sessions; they make them feel like experts in their craft.

The truth is, compounding is both art and science. It takes creativity, precision and passion. But with PCCA behind us, it also comes with reassurance — the kind that enables me to stand behind what we do with qualification. Compounding isn’t just personal; it’s my purpose. And PCCA has been there every step of the way, helping me turn that purpose into something powerful for every patient we serve.

Profiles in Personalized Medicine: Tiffany Kofroth & Mindy Stephens, Live from the 2025 Tech Summit

Wed, 24 Sep 2025 17:25:00 GMT

At the 2025 PCCA Technician Summit, two pharmacy technicians shared their journeys from opposite ends of the compounding spectrum. Tiffany Kofroth, CSPT, CPhT-Adv, works in sterile compounding and education at MD Anderson Cancer Center. Mindy Stephens, CPhT, has built her career in nonsterile compounding at Magnolia Pharmacy in North Houston. Their experiences may differ, but their passion for personalized care is the same.

Two Beginnings, One Passion

Both Tiffany and Mindy began their pharmacy careers in 1998. For Tiffany, it started at a Rite Aid in Pennsylvania while she was still in high school. What was supposed to be a step toward nursing quickly became a lifelong commitment to pharmacy. Her career has taken her through retail, long-term care and hospital settings before leading her to MD Anderson, where she now serves as both an educator and active compounder.

Mindy got her start in retail pharmacy as well, and while her mother was a pharmacy technician, Mindy didn’t expect to follow in her footsteps. But after she joined Magnolia Pharmacy almost a decade later, owner Steve Hoffart, PharmD, asked her a simple question: Did she like to follow recipes? That question led her into compounding, and she’s been perfecting formulations for patients ever since.

Changing Lives Through Compounding

For both women, the reward is seeing how personalized medicine changes lives. Tiffany recalls watching children at MD Anderson ring the bell after completing treatment — a reminder of the very real stakes involved in sterile compounding. Mindy remembers helping compound for a little girl with anemia whose medication needs shifted from month to month. Today, that girl is thriving.

Whether it’s easing pain for a hospice patient, supporting fertility treatments or creating pet medications that extend an animal’s life, both Tiffany and Mindy carry with them the knowledge that behind every prescription is a person whose quality of life depends on what they make.

The Craft of Getting It Right

In sterile compounding, Tiffany focuses on rigorous quality checks, including barcode scanning, gravimetric verification and electronic documentation. At Magnolia Pharmacy, Mindy’s team uses multiple levels of pharmacist oversight and regular sync-ups to share new knowledge. Both emphasize that education never stops, whether it's through USP updates, PCCA training or peer-to-peer collaboration.

They’ve also seen the technician profession evolve dramatically since their early days. What was once a job that required little formal training is now a career with national certifications, specialized credentials and growing recognition. The pandemic underscored that shift, as many technicians stepped into expanded roles as essential healthcare providers.

The Future of Pharmacy Technicians

When asked what advice they’d share with future technicians, both point to shadowing as the best place to start. Seeing compounding up close reveals the creativity, precision and patient connection that make it so rewarding.

“Technicians aren’t just support staff,” Tiffany said. “We’re the backbone of the pharmacy.”

Mindy echoed the sentiment. “It’s incredibly rewarding to help people in your own way, every single day," she said.

Different settings, different specialties, but a shared mission. For Tiffany Kofroth and Mindy Stephens, compounding is where science and compassion meet to create something truly personal.

Know Pain, Know Gain

Wed, 03 Sep 2025 13:26:00 GMT

I’m honored to be speaking at ThinkNext 2025, where I’ll deliver a lecture on the Neuroscience of Pain. This presentation will explore how modern pain science is revolutionizing our understanding of pain and unlocking powerful, non-pharmacologic strategies to improve patient care.

The Pain Crisis: Time for a Paradigm Shift

The pain epidemic and its devastating link to the opioid crisis is well-documented. As a health care community, we must do better. Our patients deserve it. Fortunately, the last two to three decades have ushered in a “pain revolution,” dramatically expanding our understanding of the human pain experience. Gone are the days when pain was simply equated with tissue damage. The outdated formula of “injury = pain” no longer holds. We now recognize pain as a complex, multifactorial experience involving:

Sensitization of peripheral and central nervous systems
Functional and structural changes in the brain
Psychosocial influences
Neuroplasticity and bioplasticity
Immune system alterations
And much more

Part I: The Latest in Pain Neuroscience

At ThinkNext, I'll introduce an overview of cutting-edge pain neuroscience and its implications for clinical practice. We’ll explore pain phenotyping, outline a precision medicine approach and examine the mechanisms behind:

Nociceptive-driven pain
Peripheral neuropathic pain
Central sensitization (nociplastic pain)

This research will challenge outdated models and highlight how evolving science can reshape our response to pain and the opioid epidemic.

Part II: Translating Science into Non-Pharmacologic Care

In light of the opioid crisis and in alignment with global guidelines, pharmacologic interventions must no longer be the default approach to chronic pain. At ThinkNext, I’ll also delve into how advances in neuroscience now support a range of evidence-based, non-pharmacologic treatments that activate endogenous pain-relief mechanisms and reduce reliance on medication.

You’ll learn about the three key domains that we must address to truly transform lives affected by persistent pain:

Cognitive: Therapeutic cognitive strategies can reduce fear-avoidance, catastrophizing, depression and anxiety. Changing pain behavior begins with changing beliefs.
Movement: Once fear is addressed, movement becomes one of the most potent tools for pain relief, whether through aerobic exercise, resistance training or recreational activity.
Nervous System Down-Regulation: Persistent pain often stems from a hypervigilant nervous system. Calming it, preferably through non-pharmacologic means, is essential. Techniques include relaxation, sleep hygiene, nutrition, breathing exercises and more.

The Power of Words

Pain is a normal, necessary human experience. Chronic pain is not. Pain that is understood is pain that need not be feared. Every health care provider communicates with patients and as Rudyard Kipling once said in a 1923 address to the Royal College of Surgeons: “Words are, of course, the most powerful drug used by mankind.”

This October, join me as we journey from tissues through C-fibers, into the dorsal horn, second-order neurons and the brain’s distributed neuromatrix. Let’s deepen our understanding of pain and use this knowledge to engage meaningfully with every patient we meet, transforming their experience of pain and suffering.

Profiles in Personalized Medicine: Devesh Sheth, BPharm, MPS

Fri, 22 Aug 2025 00:25:31 GMT

Before I ever stepped behind the counter at Clinicare Compounding Pharmacy in Maylands, I knew I wanted a career where science and patient care met in a way you could see and feel. Compounding gave me that and more. It let me combine my love of chemistry with problem-solving and creativity, and it gave me the chance to work one-on-one with patients to make something just for them.

I wasn’t interested in simply handing over what came from a manufacturer’s box. I wanted to collaborate with prescribers, hear from patients about what wasn’t working and then create a solution that could. That’s what keeps me inspired: Compounding is science with a human touch.

Why I Joined PCCA — and Why I’ve Stayed

When I started, I needed more than formulas and ingredients. I needed education I could trust, a reliable source for quality materials and a community of people who understood the challenges of this work — the very definition of what PCCA offers. Their training keeps me sharp. Their bases and ingredients give me confidence that every prescription provides quality and safety for my patients. And their network of fellow compounders means I’m never on my own. That kind of support has shaped not only my skills but my practice.

If I had to describe compounding in one word, it'd be customized. Every patient is different — allergies, preferred dosage forms, even flavor preferences. We can meet those needs in ways no mass-produced medication ever could. I weave that philosophy into everything I do.

Changing Lives, One Solution at a Time

A middle-aged woman with fibromyalgia once came to me after struggling with oral pain medications. They upset her stomach and didn’t bring much relief. Working with her pain management specialist, we created a topical cream in a PCCA permeation-enhancing base. By bypassing her digestive system, we delivered targeted relief with fewer side effects. Her comfort improved, and so did her daily life.

Then there was a young child with autism spectrum disorder who needed antipsychotic medication but couldn’t swallow pills and refused anything with a strong taste or smell. We compounded a flavored liquid suspension in PCCA’s SuspendIt® base, masking the taste and making it easy for the child to take. Compliance improved overnight, reducing stress for the family and giving the treatment a real chance to work.

For topical formulations like that fibromyalgia cream, I often turn to PCCA Lipoderm®. It enhances absorption, it's easy to work with and patients like the smooth, non-greasy feel. I’ve used it in hormone therapy, pain relief and other applications where consistency and stability are as important as efficacy. It’s one of those behind-the-scenes tools that quietly make a huge difference.

Why Compounding Matters Now More Than Ever

In a health care system that often feels one-size-fits-all, compounding is where personalization lives. We fill gaps during drug shortages, remove allergens for sensitive patients, create formulations for animals and adjust dosages outside the standard range. It’s a space where pharmacists can innovate and directly impact outcomes.

The gratitude I hear from patients makes it all worth it. Sometimes it’s a quick thank-you. Other times it’s more profound, like the husband who told me his wife’s compounded medication “saved our marriage.” Those moments stay with you.

We also work to keep compounding visible in Maylands. That means showing up at local health fairs, collaborating with clinics and hospitals, and offering consultations to help people understand their options. The more the community knows what’s possible, the more people we can help.

Advice for Future Compounders — and Why I’ll Never Stop

If you’re considering compounding, invest in your training and get hands-on experience wherever you can. Learn the regulations, master the techniques and stay curious. This field rewards persistence and attention; a willingness to keep learning is essential.

For me, compounding has been a career of constant growth and fulfillment. Every prescription is a problem to solve, an opportunity to help and a chance to make a difference. That’s what keeps me going, and that’s what personalized medicine means to me. I can’t imagine doing anything else.

Building Stronger Veterinary Connections: Marketing Strategies for Compounding Pharmacies

Wed, 13 Aug 2025 15:06:00 GMT

by Mark Gonzalez, PharmD, PCCA Clinical Compounding Pharmacist

As compounding pharmacists, we’re used to juggling complex responsibilities — solving medication challenges with creativity, staying up to date with evolving science and technology, responding promptly to patients and prescribers, and carrying ourselves with professionalism in all situations. But there's one more responsibility that’s just as critical, yet often underutilized: marketing. Marketing is more than selling a product or service — it’s about building relationships. For compounding pharmacies looking to grow their veterinary services, effective marketing can make the difference between staying invisible or becoming indispensable.

Rethinking Marketing: Relationships Over Revenue

Some define marketing as advertising and sales. But for compounders, a more fitting definition might be this: “the pursuit, establishment and nurturing of relationships between a business and its customers.” Just like compounding itself, marketing is personal. The truth is, no matter how exceptional your service is, if veterinarians and pet owners don’t know you exist — or don’t understand what you offer — your efforts may go unnoticed. That’s why investing in relationship-driven marketing is essential to your success.

Veterinary Compounding: A Crowded and Competitive Space

The veterinary compounding niche is competitive, and many pharmacists find it challenging to break in. National players dominate with broad offerings and low prices, making it difficult for local compounders to stand out — unless they market themselves strategically. Thankfully, there are proven, real-world strategies you can adopt — not theoretical ideas, but battle-tested, cost-effective tactics that build long-term partnerships with veterinary clinics and pet owners. Let’s explore how innovation, education, responsiveness and professionalism — four values we already live by — can be harnessed for impactful marketing.

Innovative Marketing: Be Memorable

Great marketing, like great compounding, is all about creativity. Most veterinary offices are flooded with generic brochures and long lists of formulations. That’s why it pays to be different. One of the most successful veterinary marketing campaigns I’ve used involved something delightfully simple: a homemade brownie board. Here’s how it worked: I engraved my pharmacy’s contact information onto a 12x18 wooden cutting board, stacked it with homemade brownies and dropped it off at veterinary offices. Each board came with a standing invitation — call me for a brownie refill and get a quick update on the “Veterinary Concept of the Month.” It was a hit. The staff started calling me — not the other way around. It turned cold calls into warm conversations. And best of all, it cost very little. The takeaway? Good food and creative thinking can be a powerful gateway to meaningful relationships.

Educational Marketing: Empower Pet Owners

Your target audience isn’t just veterinarians — it’s also pet owners. They are, after all, the ones giving medications at home, and their experience can make or break treatment outcomes. Hosting an in-store or community seminar is a great way to connect. Use the opportunity to educate families on the basics of medicating pets: how species differ, what dosage forms are available and tips for handling picky patients. These events don’t have to be elaborate — just an hour of your time can deliver significant impact. An informed pet owner is more likely to return to your pharmacy and recommend your services. Education builds trust, and trust builds loyalty.

Responsive Marketing: Be the Local Lifeline

One area where local compounders have a natural advantage over national competitors is responsiveness. While large multistate veterinary compounders often offer attractive pricing, they may struggle with turnaround time and shipping costs. That’s where you step in. Market your pharmacy as a fast, responsive, locally rooted alternative. Emphasize your ability to provide same-day or next-day service, consult directly with the veterinarian and tailor compounds to the patients’ needs — without the wait. Even if you don’t get every order, you’ll become the go-to provider when time is critical or when a personal touch is needed.

Professional Marketing: Lead With Compassion

Marketing doesn’t always look like a pitch. Sometimes, it looks like a kind gesture. One of the most impactful forms of outreach I’ve seen is also one of the simplest: sending a handwritten sympathy card when a pet passes away. A custom memorial plaque with the pet’s name and photo can mean the world to a grieving family. These moments of compassion don’t go unnoticed. They show your pharmacy isn’t just a business — it’s part of the community. And that level of sincerity builds deeper emotional connections than any ad ever could.

Final Thoughts: Lead With Heart

Marketing doesn’t have to be complicated, expensive or pushy. When done with authenticity and purpose, it becomes a natural extension of the values that already define our profession. Whether you’re just starting to build your veterinary services or looking to deepen your existing relationships, think beyond flyers and discounts. Think about how you can show up — creatively, educationally, responsively and compassionately — for both veterinary professionals and pet owners. Because the best marketing isn’t about getting attention. It’s about earning trust.

Profiles in Personalized Medicine: John Ortego, PharmD

Mon, 28 Jul 2025 19:45:33 GMT

Before I even started pharmacy school, I knew I wanted to own an independent pharmacy. That dream always included compounding. I saw it as essential, not just for building a business, but for offering patients something more meaningful. Something more personal.

My first exposure came through an elective in school, followed by a rotation that turned into a full-time position at Grandpa’s Compounding Pharmacy in Placerville, California. That experience became foundational. I spent four years there, learning the ropes, watching what it meant to be a true community compounder. Eventually, I opened Parkside Compounding Pharmacy 40 miles down the road in Sacramento, and eight years later, I bought Grandpa’s files. That move doubled my compound script volume overnight and brought my journey full circle.

Why I Stayed Independent, and Why I Joined PCCA

At the beginning, I tried going it alone. I had my own formulas and sourced ingredients from wherever I could. I even whipped up a homemade VanPen® knockoff for my transdermals. But as my patient base grew and the complexity of compounds increased, I knew it was time to take things to the next level. That meant joining PCCA.

Their formulas, their bases, their support — it’s all been game-changing. The research & development are second to none. The clinical support and education are unmatched. But what’s stuck with me the most is the culture. PCCA’s team is welcoming, collaborative and professional in a way that motivates me to build the same kind of atmosphere in my own pharmacy. I’ve been a member for over a decade now, and I can honestly say I’m in it for the long haul.

The Word I Come Back to Is Hope

One of my earliest mentors told me, “What we sell here is hope.” And that’s stuck with me. When patients walk through our doors, they’ve often exhausted every other option. They’ve tried medications that didn’t work or treatments that left them feeling worse. So when we hand them a compound, customized just for them, it represents something bigger: a path forward.

Hope also applies to me. In a pharmacy landscape dominated by pharmacy benefit managers (PBMs), rigid contracts and razor-thin margins, compounding is the part of my business I can actually control. It’s where I can invest and consistently see growth. It’s the piece that gives me professional satisfaction and financial stability, now and into the future.

Changing Lives, One Solution at a Time

Minnie’s story is one I’ll never forget. She’d struggled with hypothyroidism for years, allergic to the fillers and dyes in synthetic thyroid meds. When WP Thyroid® was pulled from the market, things got worse. She found us through our website and, with guidance from the LDN Foundation in the United Kingdom, reached out.

We worked closely with her physician to start a titration protocol with low-dose naltrexone (LDN). Nine months later, she no longer needed thyroid medication. After 24 years of trying every option available, she felt clear-headed, energetic and pain-free. Her brain fog lifted. Her muscle aches disappeared. Her quality of life changed completely.

These are the kinds of moments that remind you why this work matters.

Bringing Compounding to the Community

We’ve found success through creativity and consistency. My director of sales and marketing, Michele Alvord, and I regularly give lunch-and-learns at local vet clinics. We sponsor events like the annual Doggy Dash to support the animal shelter, and we’ve even flown in guest speakers to educate health care professionals in our dedicated presentation space. Our weight loss program, driven by compounded semaglutide in SubMagna® SL HMW, has seen huge traction, and we’re using Instagram to keep that momentum going.

SubMagna, by the way, is my current favorite PCCA base. It’s anhydrous, masks bitterness and boosts mucosal absorption — perfect for our sublingual semaglutide suspensions. We’ve gone all in on the weight loss space because of it, and it’s been incredibly rewarding.

Compounding Is Part of Who I Am

At this point, compounding isn’t just something I do — it’s part of who I am. I’m a dad. A business owner. A potter in my free time. But professionally, what sets me apart is being a local expert in personalized medicine. In my little corner of the world, people look to me for answers, and I take that seriously.

If you’re a pharmacist or technician considering compounding, here’s my advice: Find a way in. Be willing to start small. Show up when others won’t. Make yourself available. I’ve hired foreign-trained pharmacists who started at minimum wage just to earn their licensure hours. Now they’re full-time team members. This field rewards persistence — and curiosity.

There’s nothing quite like it.

Exploring the Oncology Potential of Mebendazole and Ivermectin: What Compounding Pharmacists Should Know

Fri, 11 Jul 2025 21:32:13 GMT

As compounding pharmacists, we’re often on the front lines when patients and providers start exploring emerging therapies — especially those that live in the grey space between hopeful promise and clinical validation. The recent PCCA webinar on Mebendazole and Ivermectin in Oncology addressed just that. If you missed it, here are the key takeaways, insights and cautionary notes from the session — tailored for your role behind the counter and in the consult room.

Why Mebendazole and Ivermectin?

Interest in repurposing these antiparasitic agents for oncology stems from both urgency and practicality. Drug development is notoriously slow and expensive — especially in oncology — so repurposing already-approved medications is a logical pursuit.¹

Mebendazole, in particular, has emerged as a compelling candidate due to its low toxicity profile and its potential to disrupt cancer cell mitosis via microtubule inhibition. Similarly, ivermectin has shown promising anti-inflammatory and anticancer properties in preclinical models.

But with promise comes responsibility. Let’s break it down.

The Appeal of Mebendazole in Oncology

Potential Mechanism of Action

Mebendazole exerts its antihelminthic activity by inhibiting microtubule formation — disrupting cell division and leading to cellular apoptosis.¹
Other microtubule inhibitors, like paclitaxel and vincristine, are already used in oncology.²
Unlike many microtubule inhibitors, mebendazole also targets the colchicine binding site, potentially overcoming resistance mechanisms like P-glycoprotein expression.^3,4

Preclinical Data Highlights

Numerous cell-line studies demonstrate synergy with standard chemotherapeutics like paclitaxel and docetaxel. ^5,6
Shows potential in enhancing radiation sensitivity and preventing metastasis via a reduction in cancer stemness.^7,8

Human Evidence (Still Early)

Several case reports suggest possible disease stabilization and partial remissions, though it should be noted controlled clinical trials are needed.^9,10
A phase I- maximum tolerable dose study in glioblastoma patients found that doses up to 200 mg/kg/day were well tolerated with minimal toxicity that was reversible upon dose reduction.¹¹
A phase II trial in glioblastoma patients showed modest improvement in survival but not enough to move forward to phase III.¹²

Pharmacokinetics

Low bioavailability (5–10%) that increases significantly when administered with a high-fat meal
C_max 137.4 ng/mL at a dose of 10 mg/kg
T_max 2–4 hours¹³

Formulation Matters

Polymorph C of mebendazole has the best ability to cross the blood-brain barrier and the greatest potential.¹⁴
It’s susceptible to conversion to less desirable polymorphs (A or B) with the addition of heat and moisture.¹⁵

What About Ivermectin?

Mechanism and Activity

Inhibits glutamate-gated chloride channels (parasite-specific)¹⁶
Has anti-inflammatory activity in rosacea via NF-kappa B inhibition¹⁷

Preclinical Promise

Cell line studies show ivermectin targets multiple cancer-related pathways including Akt/mTOR and PAK1.¹⁷
Proposed mechanism in triple-negative breast cancer (TNBC) is SIN3A inhibition — potentially turning “cold” tumors “hot.”^17,18

Clinical Use: Thin Data

Mostly anecdotal reports and case series
One case series reported improved symptoms and reduced tumor markers in 3 patients using ivermectin as part of a combination regimen of repurposed medications.¹⁹
Long-term safety data in humans is limited.

Compounding and Dosing Considerations

Mebendazole

Dosing in oncology may require significantly higher dosing than antihelmintic protocols.
Avoid combining with metronidazole (risk of Stevens-Johnson Syndrome).
Monitor LFTs and CBC.

Ivermectin

Dosing for oncology is not yet well-defined.
Not water soluble — anhydrous suspensions may be useful for patients who can’t take tablets.
Interacts with idelalisib, an anticancer drug — always do a full med review.

Combination Products?

Mechanistically, mebendazole and ivermectin may complement one another, but their pharmacokinetics don’t align — making a combined formulation illogical. Separate dosing regimens are advised if used concurrently.

Regulatory Realities and Clinical Ethics

PCCA Vice President of Clinical Services Matt Martin, PharmD, BCSCP, reinforced that marketing around these agents must be handled with extreme care:

Don’t overstate preclinical or anecdotal findings.
Distinguish clearly between in vitro, in vivo and human data.
Avoid claims about safety or efficacy, even indirectly — especially in marketing materials.

FDA’s essential copy guidance still applies. Even if a patient needs a high number of tablets, FDA expects use of the commercially available product unless there's a clinical necessity for a different strength, form or route (e.g., suspension for dysphagia).

Final Thoughts

There is real scientific interest in these agents, but the human data are early and limited. As pharmacists, our role is to provide evidence-based guidance and work closely with oncology teams when these agents are considered.

At PCCA, we’ll continue to share updates as new data emerge. Until then, remember:

Preclinical promise ≠ clinical proof
Formulation integrity matters — especially with polymorph-sensitive APIs.
Regulatory caution isn’t optional — it’s a requirement.

Questions or compounding challenges? Reach out to PCCA’s Clinical Services team. We're here to help you navigate the science, safety and regulatory expectations.

Stay tuned for future webinars and ongoing resources from PCCA Clinical Services.

Guerini, Andrea Emanuele, et al. “Mebendazole as a Candidate for Drug Repurposing in Oncology: An Extensive Review of Current Literature.” Cancers, vol. 11, no. 9, 1 Sept. 2019, p. 1284, www.mdpi.com/2072-6694/11/9/1284, https://doi.org/10.3390/cancers11091284. Accessed 6 June 2025.
Perez, E. A. “Microtubule Inhibitors: Differentiating Tubulin-Inhibiting Agents Based on Mechanisms of Action, Clinical Activity, and Resistance.” Molecular Cancer Therapeutics, vol. 8, no. 8, 1 Aug. 2009, pp. 2086–2095, https://doi.org/10.1158/1535-7163.mct-09-0366.
Lee, Yeuan Ting, et al. “Benzimidazole and Its Derivatives as Cancer Therapeutics: The Potential Role from Traditional to Precision Medicine.” Acta Pharmaceutica Sinica B, vol. 13, no. 2, 21 Sept. 2022, www.sciencedirect.com/science/article/pii/S2211383522003999, https://doi.org/10.1016/j.apsb.2022.09.010.
McLoughlin, Eavan C., and Niamh M. O’Boyle. “Colchicine-Binding Site Inhibitors from Chemistry to Clinic: A Review.” Pharmaceuticals, vol. 13, no. 1, 1 Jan. 2020, p. 8, www.mdpi.com/1424-8247/13/1/8, https://doi.org/10.3390/ph13010008.
Zhang, Jie, and Yanyan Cui. “Synergistic Inhibition of Proliferation and Induction of Apoptosis in Oral Tongue Squamous Cell Carcinoma by Mebendazole and Paclitaxel via PI3K/AKT Pathway Mitigation.” Naunyn-Schmiedeberg’s Archives of Pharmacology, vol. 398, no. 5, 30 Nov. 2024, pp. 5881–5893, https://doi.org/10.1007/s00210-024-03670-y. Accessed 6 June 2025.
Rushworth, Linda K., et al. “Repurposing Screen Identifies Mebendazole as a Clinical Candidate to Synergise with Docetaxel for Prostate Cancer Treatment.” British Journal of Cancer, vol. 122, no. 4, 17 Dec. 2019, pp. 517–527, https://doi.org/10.1038/s41416-019-0681-5.
Tang, Jie-Yu, and Yun-Xi Peng. “USP5 Binds and Stabilizes EphA2 to Increase Nasopharyngeal Carcinoma Radioresistance.” International Journal of Biological Sciences, vol. 21, no. 3, June 2025, pp. 893–909, pubmed.ncbi.nlm.nih.gov/39897046/, https://doi.org/10.7150/ijbs.102461.
Joe, Natalie, and Inês Godet. “Mebendazole Prevents Distant Organ Metastases in Part by Decreasing ITGβ4 Expression and Cancer Stemness.” Breast Cancer Research, vol. 24, no. 1, 28 Dec. 2022, https://doi.org/10.1186/s13058-022-01591-3. Accessed 6 June 2025.
Dobrosotskaya, Irina Y., et al. “Mebendazole Monotherapy and Long-Term Disease Control in Metastatic Adrenocortical Carcinoma.” Endocrine Practice, vol. 17, no. 3, 1 May 2011, pp. e59–e62, www.sciencedirect.com/science/article/abs/pii/S1530891X20404434, https://doi.org/10.4158/EP10390.CR. Accessed 6 June 2025.
Nygren, Peter, and Rolf Larsson. “Drug Repositioning from Bench to Bedside: Tumour Remission by the Antihelmintic Drug Mebendazole in Refractory Metastatic Colon Cancer.” Acta Oncologica, vol. 53, no. 3, 28 Oct. 2013, pp. 427–428, https://doi.org/10.3109/0284186x.2013.844359. Accessed 6 June 2025.
Gallia, Gary L, et al. “Mebendazole and Temozolomide in Patients with Newly Diagnosed High-Grade Gliomas: Results of a Phase 1 Clinical Trial.” Neuro-Oncology Advances, vol. 3, no. 1, 1 Jan. 2021, https://doi.org/10.1093/noajnl/vdaa154. Accessed 6 June 2025.
Menon, Nandini Sharrel, et al. “Mebendazole in Recurrent Glioblastoma: Results of a Phase 2 Randomized Study.” Journal of Clinical Oncology, vol. 40, no. 16_suppl, 1 June 2022, pp. 2029–2029, https://doi.org/10.1200/jco.2022.40.16_suppl.2029. Accessed 6 June 2025.
Song, Bomi, et al. “Repurposing of Benzimidazole Anthelmintic Drugs as Cancer Therapeutics.” Cancers, vol. 14, no. 19, 22 Sept. 2022, p. 4601, https://doi.org/10.3390/cancers14194601.
Meco, Daniela, et al. “Emerging Perspectives on the Antiparasitic Mebendazole as a Repurposed Drug for the Treatment of Brain Cancers.” International Journal of Molecular Sciences, vol. 24, no. 2, 10 Jan. 2023, p. 1334, www.ncbi.nlm.nih.gov/pmc/articles/PMC9862092/, https://doi.org/10.3390/ijms24021334. Accessed 6 June 2025.
Calvo, Natalia L., et al. “Mebendazole Crystal Forms in Tablet Formulations. An ATR-FTIR/Chemometrics Approach to Polymorph Assignment.” Journal of Pharmaceutical and Biomedical Analysis, vol. 122, Apr. 2016, pp. 157–165, https://doi.org/10.1016/j.jpba.2016.01.035.
Tang, Mingyang, et al. “Ivermectin, a Potential Anticancer Drug Derived from an Antiparasitic Drug.” Pharmacological Research, vol. 163, 1 Jan. 2021, p. 105207, www.ncbi.nlm.nih.gov/pmc/articles/PMC7505114/, https://doi.org/10.1016/j.phrs.2020.105207. Accessed 6 June 2025.
Kaur, Baneet, et al. “Ivermectin: A Multifaceted Drug with a Potential beyond Anti-Parasitic Therapy.” Curēus, 12 Mar. 2024, www.ncbi.nlm.nih.gov/pmc/articles/PMC11008553/, https://doi.org/10.7759/cureus.56025. Accessed 6 June 2025.
Yeon Jin Kwon, et al. “Selective Inhibition of SIN3 Corepressor with Avermectins as a Novel Therapeutic Strategy in Triple-Negative Breast Cancer.” Molecular Cancer Therapeutics, vol. 14, no. 8, 1 Aug. 2015, pp. 1824–1836, https://doi.org/10.1158/1535-7163.mct-14-0980-t. Accessed 6 June 2025.
Ishiguro, Tatsuaki, et al. “Synergistic Anti-Tumor Effect of Dichloroacetate and Ivermectin.” Cureus, 3 Feb. 2022, https://doi.org/10.7759/cureus.21884. Accessed 6 June 2025.

The Rx for a Genius Life

Tue, 08 Jul 2025 21:08:18 GMT

I’m Max Lugavere — a health and science journalist, New York Times bestselling author, filmmaker and host of The Genius Life podcast. I’ve spent more than a decade obsessed with answering one core question: how can we live better, longer — and feel amazing doing it?

A SON’S JOURNEY

My work is deeply personal. When my mom was diagnosed with a rare form of dementia in her 50s, I was launched into the world of health research not as an expert, but as a desperate son. That experience completely changed the trajectory of my life. I began interviewing scientists, doctors and researchers and having some really powerful conversations led me to explore how food affects the brain and cognitive aging. This journey culminated in my first book, Genius Foods.

IN PURSUIT OF THE GENIUS LIFE

Since then, I’ve written two more books — The Genius Life and Genius Kitchen — which dig deeper into evidence-based wellness, from the importance of sleep and stress management to the power of real, whole foods. I also co-directed a documentary called Little Empty Boxes that chronicles my journey with my mom and what I learned about the health system — and myself — along the way. It’s the most meaningful project I’ve ever worked on.

RELAYING WHAT I’VE LEARNED

I’ve shared the findings of my work on numerous platforms: television talk shows, popular podcasts, at wellness festivals and academic conferences. In my experience, audiences hunger for honest, empowering information.

Recently, I had the honor of being invited to Washington, D.C., where I participated in Senate-level conversations on public health and food policy — topics I care about deeply. It’s an uphill battle, but I believe we’re close to a turning point.

WHY I’M SPEAKING AT ThinkNext 2025

If there’s one thorough line in all my work, it’s this: I believe people deserve honest conversations about our health. We live in a world where corporate interests often distort science, where our food environment sets us up to fail, and where most health care is really sick care. My mission is to help people cut through the noise, reclaim their health and show up for life with strength, clarity and purpose.

How can my research and experience with The Genius Life inform your work as a compounder? Let’s find out Day 1, at ThinkNext 2025.

We’re Raising the Bar on Quality: PCCA Becomes First to Earn USP Verification for Compounding Bases

Wed, 02 Jul 2025 22:19:00 GMT

At PCCA, we strive to lead through innovation and are defined by our unwavering commitment to quality. That’s why we’re proud to share some exciting news: LoxOral® and Anhydrous SuspendIt®, two of our most widely used proprietary bases, are now part of the U.S. Pharmacopeia (USP) Ingredient Verification Program for Excipients.

We’re honored to be the first FDA-registered supplier to receive USP Verification for compounding bases. We proactively pursued and invested in this program to verify the quality of our bases, even though regulations do not require it. We believe raising the bar on quality isn’t just a choice, it’s a responsibility.

Why USP Verification Matters

USP sets public quality standards that are used in over 140 countries. Earning the USP Verified Mark for Excipients means a product has met USP’s rigorous testing, review and auditing criteria for manufacturing process and quality.

For us, this verification recognition isn’t just a credential — it’s a reflection of who we are. It shows that when we say our bases are trusted quality, consistent and reliable, we have the science and third-party confirmation to prove it.

A Closer Look at Our USP Verified Excipient Bases

Currently, our two USP Verified Excipient bases are:

LoxOral: An all-in-one compounding excipient designed for oral capsules, facilitating the easy mixing of diverse active pharmaceutical ingredients.
Anhydrous SuspendIt: A specially designed, water-free oral base that mixes easily with liquids and offers improved taste and broader applications.

These bases have been trusted by compounding pharmacists for years. Now, they carry the USP Verified Mark for Excipients — offering a new level of confidence for you and your patients.

Proactive, Not Reactive

This achievement reflects our commitment to leading the industry, not just keeping up with it. As our CEO Gus Bassani, PharmD, puts it:

“This validation milestone demonstrates our ‘Quality without Compromise’ core value in action. Confirmation of quality through independent verification reinforces our promise to pharmacies and patients alike. By undertaking this approach, we help our members compound with confidence.”

And we’re not stopping here. We’re actively working toward USP Verification for additional proprietary bases — part of our longstanding investment in research, innovation and raising the bar for quality in pharmaceutical compounding.

What This Means for You

The USP Verified distinction sets PCCA’s products apart, adding a powerful mark of quality to complement the exceptional performance and functionality of our compounding bases. When you choose PCCA, you’re choosing more than a base — you’re choosing trusted quality, scientific rigor and a partner committed to your success.

We’re proud to take this step forward with you, and we’ll continue to lead with integrity, innovation and a focus on what matters most: your ability to serve patients with confidence.

Profiles in Personalized Medicine: Jody Gilby, BSP

Thu, 19 Jun 2025 22:04:00 GMT

When I opened Sprucewood Pharmacy in Lloydminster, Alberta, compounding wasn’t just an untapped opportunity — it was a missing piece in our community’s care. Patients were already coming in with prescriptions for custom medications, but we had to outsource them. I knew there had to be a better way. That’s what set me on the path to create a lab of our own and start solving problems directly, right here at home.

A Path Built on Collaboration

What drew me to compounding was its creativity — and the chance to offer real alternatives for patients who couldn’t get what they needed off the shelf. Early on, I reached out to a colleague and my PCCA rep, both of whom encouraged me to dive in. At the time, there wasn’t a single compounding pharmacy in Lloydminster. That made the decision easy — we had an opportunity to offer something truly valuable to the community.

PCCA was instrumental in helping me get started. Their team guided me through designing a lab that met Alberta’s new USP standards and supported me every step of the way. That support hasn’t stopped. Over the past seven years, they’ve been a steady source of education, regulatory guidance, product innovation and clinical support — all of which have helped me grow and specialize, especially in areas like hormone replacement therapy.

Compounding, at its core, is collaborative. It’s a daily conversation between pharmacists, patients and physicians. And when people in the community start recognizing your expertise, they begin to seek you out — not just for a prescription, but for help solving problems.

Moments That Matter

One of the most rewarding parts of this work is seeing the impact it has on people’s lives. I think about Linda, who came to me after a series of severe urinary tract infections that just wouldn’t respond to antibiotics. I ran a hormone panel and, working with her physician, recommended BHRT and vaginal estriol. I also identified Hashimoto’s thyroiditis and we started her on low-dose naltrexone (LDN). The change was dramatic — her energy came back, the infections stopped and she felt healthy again.

Another example: our growing group of pediatric patients with congenital heart disease. These kids receive complex care in major urban hospitals, but when they come home, they often need medications in formats that don’t exist commercially. We’re able to compound those medications locally, making their daily lives easier and reducing the burden on families who already have so much to manage.

These aren’t flashy stories, but they’re meaningful. They’re why I do what I do.

Building Trust and Visibility

In a community like ours, word of mouth is everything. And the feedback we hear most often is that we’re “the pharmacy that offers alternatives.” That reputation didn’t happen by accident. We’ve held lunch-and-learns with local physicians, spoken at community events and shared what compounding can do, particularly around BHRT and pain management. I also provide hormone consults in collaboration with physicians and nurse practitioners, which has led to more referrals and stronger relationships across the board.

Compounding has shaped my career in ways I never expected. Thanks to the training and resources from PCCA, I’ve been able to expand my scope, challenge myself and bring new value to the patients I serve. It’s a field that keeps you curious, and that’s what makes every day worth it.

For Anyone Considering Compounding

If you’re a pharmacist or technician thinking about getting into compounding, here’s my advice: Do it. It’s an evolving, dynamic field that rewards curiosity and keeps you growing. Every day presents new challenges — and new chances to make a difference.

And if you’re wondering about my go-to PCCA base? MucoLox™, hands down. Mixed with VersaBase® Cream, it’s been a game changer for our vaginal estriol patients — they find it easy to use and effective, which improves compliance.

At the end of the day, compounding is about relationships. It’s about being the one who says, “We can figure this out.” And for me, that’s the most rewarding part of the job.

What goes into a PCCA Formula?

Tue, 10 Jun 2025 14:24:00 GMT

If you've ever downloaded a formula from the PCCA database and thought, “Wow, that was easy,” you’re not wrong — but behind that single click is a mountain of work, innovation and science. In a recent episode of The Mortar & Pestle podcast, PCCA Senior Formulation Specialist & Project Manager Stacey Lemus, BS, gave us a behind-the-scenes look at the engine that drives PCCA’s formulation development.

For compounders, this isn’t just nitty gritty minutiae — it’s a reminder of the care, rigor and intelligence behind every formula you use.

The Formulation Team: Small but Mighty

PCCA’s Formulation Development team is a tight crew of eight, including four compounding pharmacists, two lab formulation specialists, a PhD scientist and the legendary Martha — an admin powerhouse who’s been with PCCA since the typewriter era. This team works across departments and alongside the Research & Development and Clinical Services teams to develop, review, test and refine more than 9,000 formulations in the database.

From Idea to Tested Formula

A formulation request can be driven by a whole host of needs — new APIs, novel dosage forms, drug shortages or general requests. Regardless of where it comes from, every request undergoes a thorough review process:

Clinical need: Is there a therapeutic gap this formula fills?
Feasibility: Will it compound well? Is it chemically compatible? Do we have the necessary excipients and equipment?
Regulatory compliance: Does it meet FDA’s 503A and USP requirements?
Stability and performance: Will it hold up for its full beyond-use date?

Some formulations are picture-perfect on the first try. Others go through 10, 15 or even 20 trials. The work doesn’t stop at “good enough” — it continues until the formula is not just viable but reproducible.

The Evolution of Bases — and What It Means for You

New bases like SuspendIt® and Anhydrous SuspendIt® have changed the game in oral suspensions. But they’ve also added complexity for the team. Creating a new base means evaluating hundreds of popular formulations to determine which should be updated, expanded or recreated using the new vehicle.

Important insight: older formulas aren’t necessarily retired — they’re often maintained to serve specific patient needs (e.g., sugar-free, soy-free or minimal excipient formulas).

The team now also develops formulations using commercially available drug products (CADPs), a nod to real-world pharmacy workflows, shortages and cost constraints.

Why Substitutions Can Be Challenging

One of the biggest member questions? “Can I sub out this base or excipient?”

Short answer: maybe — but tread carefully. Swapping a wetting agent, changing a flavor or using a different supplier's chemical could alter solubility, stability or even trigger unwanted chemical reactions — especially in anhydrous systems.

Many of PCCA’s formulas do more than provide instructions — they act as data-driven blueprints based on PCCA products. And that data isn’t cheap — FormulaPlus™ studies can cost up to $50,000 each to develop.

FormulaPlus: The Gold Standard

As of today, there are over 225 FormulaPlus formulations in the PCCA database. These extended beyond-use date formulas are tested using stability study protocols that utilize stability-indicating assays, along with USP 51 antimicrobial effectiveness and container closure testing, when applicable.

About 75 of them are bracketed, meaning they apply to a range of strengths, giving pharmacists more flexibility without compromising stability.

And this number is growing — PCCA adds approximately 20 new FormulaPlus studies each year.

Lessons from the Bench

Stacey’s personal journey — from compounding technician in a member pharmacy to developing formulation processes at PCCA — underscores one powerful message: Never stop learning.

In her early days, she didn’t understand why a cream got gritty over time or how an ointment mill worked beyond “reducing grittiness.” Now, she knows those issues stemmed from solubility limits, precipitation or particle size — and that the “why” matters just as much as the “what.”

For technicians and pharmacists alike, Stacey encourages ongoing education and a healthy respect for the science behind compounding. PCCA’s blog and training resources offer valuable insights into choosing the right wetting agents, gelling agents, preservatives and more.

Final Takeaway: It’s More Than Just a Formula

When you pull a formulation from the PCCA database, you’re benefiting from:

Months of lab work
Hours of research
Decades of experience
Cross-functional teamwork
Real-world applicability
Regulatory foresight
And sometimes 20+ failed attempts before that successful one

It’s not just a number on a page — it’s an investment in your success.

PCCA members with clinical services access can explore the full formula database anytime. Curious about membership? Find out how a PCCA membership can benefit your compounding practice.

Optimizing the Patient Experience with the Right HRT Base: Insights from the Webinar

Wed, 28 May 2025 13:00:00 GMT

As compounders, we know that hormones get a lot of attention — but the base plays a critical role in the potential success of the therapy. During PCCA’s recent webinar, “Choosing the Right HRT Base for Patient Success,” Sara Hover, RPh, FAARM, along with seasoned compounders Jim Hrncir, RPh, and Madison Peach-Keen, PharmD, shared hard-earned insights on how base selection can elevate your HRT practice.

If you missed it, here’s a breakdown of the key takeaways — with the compounding pharmacist in mind.

Don’t Underestimate the Base

We all know APIs matter — but the delivery system can greatly contribute to clinical outcomes, adherence and patient satisfaction. The base you choose isn’t just a carrier; it influences absorption, stability, patient experience and the beyond-use date (BUD) that can be assigned to the preparation.

As Sara explained: “It’s not just that a base is anhydrous or hydrous — it’s about how it delivers the medication for the patient, how it supports the pharmacist’s workflow and how it meets the prescriber’s goals for the patient.”

From the Trenches: Jim Hrncir on What Works

A longtime HRT educator and compounder, Jim highlighted a success story with a complex vulvodynia case that responded only after he compounded estradiol, testosterone and naltrexone in PCCA’s Ellage® Anhydrous Vaginal. The patient was already on vaginal BHRT with little relief — but within one week of switching bases and formulation strategy, her pain dramatically improved.

His go-to favorite bases?

Atrevis Hydrogel®: A game-changer for male transdermal testosterone, especially for patients losing efficacy on standard creams.
VersaBase® Cream and Lipoderm®: Reliable options with predictable results.
Ellage Anhydrous Vaginal: For patients with sensitivities.
MucoLox™: Mucosal delivery for patients requiring better retention.

Jim’s advice: “Don’t push your belief system. Work within the practitioner’s [existing framework]. If they trust serum testing, meet them there — but equip them with the right tools and science.”

For the Newer Pharmacies: Lessons from Madison Peach-Keen

Six months into launching her own compounding pharmacy, Madison emphasized differentiation through education and uncompromising quality. Her BHRT strategy centers on:

Sourcing all hormones and bases from PCCA
Regularly educating providers with concise, clinically relevant updates
Leading with Anhydrous VersaBase® HRT for BUDs, texture and patient preference

Madison also swears by MucoLox + VersaBase® Gel as a combo for vaginal applications when enhanced mucosal contact time is needed, and favors Ellage Anhydrous Vaginal for its potential to minimize leakage.

Pro tip: “Education is critical. If you’re new to HRT, start with mastering the science, then teach your providers. That’s how you build credibility and grow volume.”

Anhydrous vs. Hydrous: Know When to Use What

Anhydrous bases provide greater BUD limits for nonsterile compounded preparations in USP 795. Longer BUDs for both hydrous and anhydrous nonsterile preparations are also available through PCCA’s FormulaPlus™ program. The decision about what base is most appropriate for each patient relies on the triad of patient care and communication between the prescriber, the pharmacist and the patient.

Key anhydrous points:

Anhydrous VersaBase HRT: Excellent glide, non-greasy feel and strong patient acceptance
Ellage Anhydrous Vaginal: Designed with mucoadhesive and self-emulsifying properties — engineered for high retention and hormone release
BUD advantage: Studies support 180-day dating for bracketed ranges. Anhydrous preparations have greater BUD limits in USP 795 and PCCA studies support 180-day dating for bracketed ranges of several formulations.

Backed by Data: What the Studies Show

Sara shared multiple in-house studies comparing hormone release and absorption using PCCA bases vs. alternatives. The verdict? Up to 4x greater absorption with PCCA’s VersaBase Cream for progesterone, and 2.7x more testosterone delivery with Atrevis compared to a competitor base.

These studies aren’t just internal wins — they’re talking points to show why you choose the bases that you use for your patients.

Bottom Line: It’s About Options and Outcomes

Your base can be the differentiator in your market. Offer patients and providers more than one texture or form, and you open doors for possibly improved adherence and outcomes.

Here’s what to keep in mind:

Build protocols around your best-performing bases.
Stay on top of base-specific absorption data.
Leverage BUD testing to streamline workflow and reduce waste.
Teach providers how and why base selection matters.
And when in doubt, let patients try the feel of the base — texture and feel can be critical.

Want to explore more? PCCA’s HRT Virtual Symposium is coming up July 24-25 — all online, jam-packed and worth your time.

Profiles in Personalized Medicine: Heather Tierney, CPhT

Wed, 14 May 2025 13:54:00 GMT

I first dipped my toes into health care as a candy striper when I was a teenager. I loved it — taking care of people, being a small part of their healing journeys. Later, when a friend opened a nursing home pharmacy called Geri Care Pharmacy, I started working there and fell head over heels for pharmacy work. AfterGeri Care closed, I reconnected with my childhood friend Claire, whose father owned Wheeler Pharmacy in Lexington, Kentucky, and the rest is history.

I was working as a certified pharmacy technician at Wheeler Pharmacy when an opportunity opened up in compounding. I had no clue what I was stepping into, but I went to PCCA's Technique for Technicians training (now CORE Compounding Training), which was a game-changer. I think I was the only one there who had never even looked at a compounding formula before! But that experience lit a fire in me, and by September 2007, I officially became the lead compounding technician at Wheeler, and I've been here ever since.

Two Pharmacies, One Big Mission

Wheeler Pharmacy has a rich history in Lexington, Kentucky. Claire's father started the original pharmacy in 1958 after graduating from the University of Kentucky. In 2012, we had the chance to expand and separate our services by opening a dedicated compounding pharmacy just across the street from the original location.

Today, the original Wheeler Pharmacy still runs as a traditional retail pharmacy, while our custom compounding location focuses solely on creating personalized medications for both people and pets. In fact, I think we're the sole compounding-only pharmacy that serves both humans and animals in Lexington!

The Personal Touch That Makes All the Difference

One thing that’s always been important to me is patient connection. Every patient who works with me gets my business card with my cell number. I want them to feel like they have direct access to someone who cares. I think that’s a big reason patients choose us over bigger chains — they know we truly care.

Our pharmacy setup is intentionally nontraditional. When patients walk into Wheeler's Custom Compounding, my desk is the first thing they see. It's not about counters and barriers — it's about creating a welcoming environment where patients feel at ease. That personal touch sets the tone for the kind of care they’re going to receive.

No Two Days Are the Same — And I Love It

Every day at the pharmacy is a little bit different, which is one of the things I love most about my job. I start my mornings by processing our "to-do" list in the software system and reaching out to patients to confirm if they still need their refills — we don't just automatically fill them, because circumstances can change. We also call or text when prescriptions are ready, helping to keep patients informed and involved in their care.

Some days, we're whipping up hundreds of suppositories. Other days, it's lollipops, HRT creams or troches. The variety keeps it exciting — no monotonous pill-counting here! You truly never know what you'll walk into, and that unpredictability keeps me energized.

Precision Matters: Safeguarding Our Patients

Compounding requires an incredible level of precision and attention to detail. We rely heavily on our integrated software and scale systems, which have built-in hard stops for margins of error. If the weight isn't right or the wrong chemical is scanned, the system won't let you move forward.

Each master formula is detailed enough that any trained technician could walk into the lab and complete the preparation without error. Quality assurance is a top priority for us — certain dosage forms even require mathematical verification to ensure consistency. The safety measures we have in place today are incredibly advanced, and I wouldn't have it any other way.

Helping Doctors Think Outside the Box

One of the challenges we still face in compounding is a lack of awareness among doctors about what we can do. Many physicians aren't trained in compounding during their schooling, so they naturally stick to what they know.

I see my role as an educator, helping providers realize that customized solutions exist. Whenever I have the opportunity to visit a medical office, I do my homework first — nothing's worse than walking into a meeting unprepared. When doctors learn about the possibilities we can offer, they're often excited to collaborate.

Sometimes it's the patients themselves who advocate for compounding solutions. I once worked with a mom whose teenage son was prescribed promethazine in a rectal suppository — not ideal for a 16-year-old! I suggested a promethazine gel instead, which could simply be applied to the wrist. After some advocacy on the mom's part, the doctor changed the prescription, and everyone was happier (especially the teenage boy!).

A Patient Success Story I'll Never Forget

One of the most memorable patients we've ever had started working with us when she was just three weeks old. She was born without the enzyme needed to process sugar and was misdiagnosed early on with liver cancer.

Once she was correctly diagnosed with fructose-1,6-bisphosphatase deficiency, we had to custom-make almost every medication for her, because traditional formulations contained sugars or fillers that could have harmed her. We collaborated closely with PCCA to vet every ingredient, down to the tiniest excipients.

Today, she’s 17 years old and thriving. Her mom often tells us, "Without you, we wouldn't have her." Being a part of her journey has been one of the most meaningful experiences of my career.

The Importance of Sleep — and How to Support It

Wed, 07 May 2025 17:41:00 GMT

The Importance of Sleep — and How to Support It

In a culture that often celebrates hustle and productivity, sleep tends to fall low on the priority list. Yet, getting enough high-quality sleep is one of the most powerful tools for maintaining long-term health. It's not just about avoiding grogginess the next day — sleep plays a key role in everything from physical repair to emotional resilience and mental sharpness.

HOW SLEEP AFFECTS THE BODY AND BRAIN

Physical Restoration

During sleep, the body carries out essential repair work. Muscles recover, immune cells strengthen their defenses and energy stores are replenished. Sleep also plays a role in regulating blood pressure, managing inflammation and balancing hormones related to hunger and stress.

When sleep is disrupted or insufficient, these functions are compromised. Over time, poor sleep can contribute to issues such as weight gain, high blood pressure, blood sugar imbalances and weakened immunity.

Cognitive and Emotional Balance

Sleep also directly impacts how the brain processes information, makes decisions and regulates mood. Even short-term sleep loss can make it harder to concentrate, remember important details and handle stress. Over longer periods, ongoing sleep deprivation may increase the risk of anxiety and depression.

Rhythm and Routine

The body operates on a 24-hour internal clock known as the circadian rhythm. This rhythm responds to light and dark signals and guides the natural cycles of sleep and wakefulness. Melatonin, a hormone released in response to darkness, plays a big role in signaling that it’s time to rest. Disrupting this rhythm — through irregular sleep times, screen exposure late at night or shift work — can make it harder to fall asleep or stay asleep.

WHAT GETS IN THE WAY OF RESTFUL SLEEP?

There are plenty of reasons people struggle with sleep, and most of them are part of modern life:

Stress and busy minds that won’t slow down at bedtime
Caffeine or alcohol too close to the end of the day
Screen time late at night, especially with phones or laptops
Irregular routines that throw off the body’s internal clock
Noisy, too-warm or uncomfortable sleep environments

Even when people know how important sleep is, changing habits can take time. That’s why it helps to build better routines and sometimes seek extra support when needed.

SIMPLE WAYS TO SUPPORT BETTER SLEEP

Improving sleep doesn’t always require dramatic changes. Small shifts can make a big difference over time:

Keeping a consistent sleep and wake schedule — even on weekends
Creating a wind-down routine with dim lighting and relaxing activities
Avoiding bright screens an hour before bed
Keeping the bedroom cool, dark and quiet
Limiting stimulants and heavy meals before bedtime
Spending time in natural light during the day to support healthy circadian rhythms

For those who still find restful sleep elusive, even with good habits in place, natural supplements can offer an extra layer of support.

SUPPLEMENTAL SUPPORT FOR SLEEP

Wellness Works’ Sleep Perfect Formula (10338) was created as a natural option to support restful, high-quality sleep without the grogginess that can come with some over-the-counter or prescription options.

What It Offers

This formula blends time-tested nutrients and calming botanicals known to promote relaxation and encourage healthy sleep cycles. It’s designed to be non-habit-forming and can be used as part of a broader routine for better rest.

Here’s a look at some of the key ingredients:

Melatonin – This naturally occurring hormone supports the body’s sleep-wake cycle, especially helpful when adjusting to time zone changes or irregular schedules.
5-HTP – A precursor to serotonin and melatonin, it helps support mood and sleep quality.
GABA and L-Theanine – These compounds promote calmness by helping to settle an overactive nervous system.
Valerian Root, Passion Flower, Hops and Chamomile – Traditional herbs known for their gentle calming effects, used for centuries to support sleep.
Magnesium – An essential mineral that supports muscle relaxation and nervous system balance.

Intended Use

Sleep Perfect Formula is suitable for adults seeking occasional support for better sleep. It can be taken 30-45 minutes before bedtime, ideally as part of a relaxing evening routine.

The Wellness Works Difference

Wellness Works helps independent pharmacies develop a profitable revenue stream by empowering them with high-quality and extensively-tested products and ingredients they can count on to help their patients. We offer our pharmacies an innovative line of products and private labeling with no minimum purchasing requirements or setup fees.

FINAL THOUGHTS

Sleep isn't something to catch up on later — it’s a vital part of staying well today. Supporting healthy sleep can enhance physical recovery, boost mental clarity and build emotional resilience. While habits and routines form the foundation, gentle support from supplements like Sleep Perfect Formula may help create the conditions for deeper, more restful sleep.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Profiles in Personalized Medicine: James Anderson, Jr., DPh

Thu, 24 Apr 2025 22:51:30 GMT

At first glance, Renew Compounding Pharmacy might resemble a small-town pharmacy with neighborly charm and prompt service. But step inside, and you’ll find something deeper: an operation where science, compassion and customized care work in tandem to improve patients’ lives.

Owner James Anderson and his colleague Michael Whatley aren’t just pharmacists; they’re problem-solvers, educators and deeply invested community members. For them, compounding is a commitment to creating options where few exist — and building relationships that go far beyond the prescription pad.

The Power of Individualization

Big pharmacy serves medicine for the masses, but we’re individualized. We’re doing things to help people avoid filler issues, dye issues — whatever their specific needs are.

That mindset drives every aspect of the Renew philosophy. Each compound is made with precision, tailored to the individual’s tolerance and condition. Our focus is on effectiveness, safety and customization — not volume or speed.

There’s real satisfaction in knowing you’re helping people in a way they can’t find elsewhere. We’re hands-on. We’re listening, adjusting and building something specific for each person.

A Life-Changing Compound

We’ve helped a lot of patients over the years, but one story stands out. Shortly after completing training at PCCA, I was approached by a friend of my wife whose cancer treatments were making it impossible for her to function.

Her nausea was so intense she couldn’t even watch food commercials. Cooking for her family used to be a joy, but she couldn’t go near the kitchen.

We researched, consulted with PCCA and uncovered a promising formula for use in a hospital setting. After gaining approval from her doctor, we compounded the medication and hand-delivered it.

The change was immediate and dramatic. She was back in the kitchen, spending time with her family and finding small but meaningful joys again.

She told me it changed her quality of life. That’s when I realized what we’re truly capable of doing through compounding.

From Lightbulb Moment to Business Model

That experience helped shape our future. We began leaning into compounding more seriously, eventually deciding to create a compounding-only pharmacy — leaving behind the constraints and distractions of retail operations.

A patient once told me, “You must feel so proud knowing you’re making something with your hands that you can’t get at any other pharmacy.” And she was absolutely right.

Personalized Care in the Face of Policy Threats

As regulatory pressures increase — especially surrounding hormone therapy — we must remain vocal about the importance of preserving patient access to personalized care.

If patients ever lost access to compounded HRT, you’d see chaos. We hear from people all the time about how much better they feel now that they’re on a personalized hormone regimen. You take that away, and it’s not just a policy decision — it’s a direct hit to people’s quality of life.

We’re grateful for advocates like U.S. Congresswoman Diana Harshbarger, a PCCA member and pharmacist, for pushing back against efforts to limit compounding. She knows the impact this has on patients. When someone on Capitol Hill becomes a patient in need of compounded medication themselves, that’s when it finally starts to click.

The Renew Difference

At Renew, the approach is hands-on and highly personal. We know most of our customers by name. They appreciate the speed, the service and the fact that they’re getting a pure, customized product they can actually tolerate.

At Renew, patients get more than a prescription — they get a partner. Whether it’s hormone therapy, allergy-sensitive formulations or hard-to-source treatments, our team is committed to going the extra mile.

This is personalized medicine from start to finish. We don’t just fill a script and move on. We get involved. We care. And that’s what makes all the difference.

Advice for Future Compounders

For anyone thinking about compounding, we say: Come hang out with us. Watch what we do. Ask questions. We’ve had students and pharmacists visit us, and we’re happy to share what we’ve learned.

You also need the right support system. We wouldn’t attempt this without PCCA. Their training, their Clinical Services team and the quality of their ingredients — we rely on them daily.

That trust is especially important when it comes to sourcing. We don’t use unfamiliar suppliers or mystery vendors. I’ve toured PCCA’s facilities. I’ve seen how they test and retest every ingredient. I know what I’m getting when I order from them, and that gives me the confidence to do my part well.

Sublingual Semaglutide: Dosing Considerations, Patient Care and Regulatory Insights

Tue, 22 Apr 2025 13:00:00 GMT

Sublingual Semaglutide: Dosing Considerations, Patient Care and Regulatory Insights

In the world of GLP-1 receptor agonists, semaglutide has become a key player for several health conditions. But with growing patient demand and evolving regulations, healthcare providers are looking beyond traditional injections to explore new ways to deliver this powerful therapy.

One of the most promising alternatives? Sublingual administration.

In this article, we’ll discuss several considerations for sublingual semaglutide, including patient care and regulatory compliance.

Why Sublingual Semaglutide?

Peptide drugs like semaglutide are notoriously difficult to deliver orally; when taken by mouth, up to 1% of the drug is absorbed under ideal conditions.

Sublingual dosing offers an alternative route of administration by allowing absorption directly into the bloodstream through the mucosal tissue, bypassing the gastrointestinal system and first-pass metabolism. This may improve bioavailability and make therapy more accessible for patients who struggle with injections.

Best Practices for Sublingual Administration

Sublingual therapy isn’t as simple as “place and swallow.” For improved absorption, the medication should stay in contact with the sublingual or buccal tissue for as long as possible.

The minimum hold time is 30 seconds, but ideally, patients should aim for 5 to 15 minutes. Increased contact time with the sublingual tissue may help with sublingual absorption. Swallowing the compounded preparation would likely result in very limited absorption.

Pro Tips for Better Absorption:

Take the dose on an empty stomach or away from meals to minimize salivation and swallowing.
Avoid eating or drinking for at least 15–30 minutes after dosing.
Try holding the dose while reading, watching TV or during quiet moments to extend the hold time.

Dosing Strategies: Start Low, Go Slow

Sublingual semaglutide should follow a titration approach, with typical starting doses of 0.5 mg to 1 mg daily for new patients. Increase the dose every 4 weeks, if needed, based on patient response.

Beyond Weight Management

While GLP-1 medications like semaglutide are best known for their role in weight management and diabetes, emerging research is pointing to broader therapeutic potential, including:

Cardiovascular risk reduction
Neuroprotection
Anti-inflammatory effects
Support for conditions like depression and alcohol use disorder

Patient Considerations and Monitoring

As with any GLP-1 therapy, thoughtful patient selection and regular monitoring are essential, with special attention paid to:

GI Side Effects: Nausea is common, especially during titration. Starting low and increasing gradually helps manage this.
Hormonal Health: Check thyroid, sex hormones and metabolic labs — hormonal imbalances can blunt the effectiveness of GLP-1 therapies.
Pregnancy: Avoid use during pregnancy or for women planning conception within 2 months.
Supplementation: Support patients with vitamin D, magnesium, zinc and sufficient protein to prevent muscle loss during weight reduction.

Regulatory Insights: Staying Compliant

Compounded semaglutide, whether sublingual or injectable, sits under a shifting regulatory microscope. Shortages of commercial GLP-1 drugs initially opened the door for compounding, but as supply chains recover, the rules are tightening.

Key points for pharmacies:

Be cautious with marketing: Avoid calling compounded semaglutide “safe and effective” or comparing it directly to FDA-approved products.
Stay up to date: Legal cases and FDA guidance are still evolving.
Consult legal experts: If you’re unsure about what’s allowed, a healthcare attorney with FDA experience is an important ally.

Individualized Care is Essential

An important takeaway from the latest research and clinical experience is that patient care must remain personalized. Flexibility and close monitoring are essential.

Final Thoughts

Sublingual semaglutide is more than just an alternative to injections — it represents a significant opportunity to improve access, adherence and possibly unlock new therapeutic applications.

As with any evolving treatment landscape, the best results come from careful dosing, ongoing education and staying current on regulatory developments.

Whether you’re a prescriber, pharmacist or patient, the message is clear: Personalized care, open communication and compliance are the keys to success.

PCCA members with clinical services access may contact our Clinical Services team for help with sublingual semaglutide and other compounding concerns.