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.

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.

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.

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.

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.

Charting the Course for Your Pharmacy’s Success

Wed, 22 Jan 2025 20:15:00 GMT

Running a pharmacy without a strategy is like navigating a stormy sea without a compass. As a pharmacy owner, you're often caught up in daily operations, reacting to the chaos of the days, weeks and months. Before you know it, the year has flown by and you're simply celebrating survival. This article explains how strategic planning benefits your practice, including tips to get started. I remember this feeling from my years as an owner. At the end of each year, I had grand plans for the year ahead with big goals in mind. Somehow, even without focused strategic planning, my pharmacy would achieve many of those goals. However, it wasn't until I truly understood the importance of strategic planning that I felt in control and found it easier to achieve and even surpass my goals.

Strategic Planning: The Key to Growth

The relentless pace of pharmacy operations may make you feel there is no time for strategic planning. However, operating without a clear plan leads to missed opportunities, lack of growth and burnout for everyone on the team.

Imagine having clear goals and improved team accountability. Picture your business achieving the big-picture goals you've been meaning to tackle for years, all within the next 1-2 years. What impact would that have on you and your team?

Planning may feel overwhelming, especially in an industry where so much changes quickly. You might wonder, "What's the point of planning when the plan is likely to change?" Planning aligns your goals with action steps and accountability check-ins to ensure you reach your goals. It's okay if some goals change along the way. A strategic plan guides decisions and prioritizes efforts. A team accustomed to working from a detailed plan will be better prepared to pivot if needed.

Tips for Getting Started

Start with the End in Mind: What do you want your business to look like in 5 years, 3 years, 1 year? What do you want your personal life to look like in those timeframes?
Define Your Goals: Clearly outline what you aim to achieve.
Plan Your Path: What needs to be done in order to get there?
Identify Key Team Members: Recognize who will help you get there.
Outline Action Steps: Break down the goals into actionable quarterly (90-day) increments.

Even in a chaotic environment, it's possible to carve out time for planning. Block off a half-day each quarter for strategic planning. Can you find 3-4 hours per quarter to sit down and create a simple plan? It doesn't have to be elaborate. Start by writing down your top 3 goals for the next quarter and identify a few action steps for each goal.

The easiest part of strategic planning is making the plan. Plans tend to fail if there's no follow-through. You and your team must be held accountable. Regular team meetings to check progress and make necessary adjustments are crucial. Utilizing a strategy worksheet, accountability software or an accountability coach can also be helpful.

Small, consistent efforts can lead to significant results. Like anything, practice makes perfect, so stick with it! If you feel like the captain of a boat in a stormy sea, simply hoping to navigate safely, take the time to work on a plan and take back control of your destiny. The peace of mind a well-prepared and well-executed plan provides is profound. When you look back on your year and see what you've accomplished compared to years without a plan, you'll undoubtedly prioritize strategic planning moving forward.

A successful compounding pharmacy owner for more than 20 years, Laura offers guidance to create strategic plans that take your practice to the next level. See how Business Accelerator can assist you strategically plan for success, engage and empower your staff, improve operations and attain growth.

Listen to Laura as she shares very personal experiences as a compounding pharmacist and pharmacy owner, as well as how investments in the right support system provided a fast-track to success, in this episode of the Mortar & Pestle podcast.

Bacterial Vaginosis: A Persistent Challenge

Thu, 16 Jan 2025 16:42:55 GMT

by Deborah H. Clark, RPh, FACVP, PCCA Clinical Compounding Pharmacist

Bacterial vaginosis (BV) is the most common vaginal infection that affects women around the globe. In addition to its effects on total health, BV can significantly impact reproductive wellness. The condition is thought to originate from a decrease of Lactobacilli in the vagina, resulting in an imbalance in the natural vaginal microbiome.¹ In the following article, we explore the pathogens associated with BV and challenges with commercial treatments, as well as compounding options and an innovative base that may potentially improve patient compliance.

Common and Uncommon Pathogens

One of the more common pathogens associated with BV is Gardnerella; however, other pathogens can be present. According to researchers, many studies have demonstrated the relation of Gardnerella vaginalis with other bacteria in causing BV, such as Lactobacillus, Prevotella and anaerobes. In addition, patients with BV may be infected with Mobiluncus, Bacteroides, Peptostreptococcus, Fusobacterium, Veillonella, Eubacterium, Mycoplasma hominis, Ureaplasma urealyticum, Streptococcus viridans and Atopobium vaginae. In many cases, the infecting pathogen will form a biofilm that makes the infection persistent and treatment challenging.²

Diagnosis and Compounding Options

Most patients present with a complaint of a malodorous discharge; a diagnosis of BV is then made through physical exam and testing. In some cases, physicians will treat empirically, using commercially available antibiotic vaginal suppositories, gels or creams. Clindamycin and metronidazole are two agents that are commonly selected and administered in these patients. When these agents fail to resolve the infection, many practitioners will consult a compounding pharmacist to discuss test results; the compounding pharmacist may then suggest more culture and sensitivity testing for specific bacterial strains.

Additional culture and sensitivity testing will confirm what organisms are present to employ a more targeted approach when choosing active pharmaceutical ingredients (APIs). As stated earlier, a biofilm is normally present, so the addition of a biofilm disrupting agent, such as edetate disodium in a 0.5% concentration, would be a smart addition to the formulation.³

Ellage^® Anhydrous Vaginal: The Base of Choice

Using the right base vehicle is important when compounding preparations for BV patients. Ellage Anhydrous Vaginal is an excellent option due to its consistent delivery of APIs and potential improvement of compliance.

Ellage contains a self-emulsifying drug delivery system that creates a microemulsion when it contacts vaginal fluid. This emulsion releases APIs from the base into the mucosa. Once the APIs are released, the emulsification system holds the APIs to the surface, prolonging contact time. The combination of excellent release properties and prolonged contact time helps facilitate the action of the antimicrobials used in treating BV patients.

Leakage is a common complaint from patients using vaginal preparations and may affect compliance. In vitro testing (PCCA Document #99816) showed Ellage is likely to adhere to vaginal tissue for a long period of time without leakage or messiness, despite vaginal secretions. In vitro testing (PCCA Documents #99817 and #99818) also showed safety with minimal irritation on the vaginal mucosal tissue and no effect on vaginal pH (PCCA Document #99815). Ellage is an anhydrous vehicle, offering the option of longer beyond-use dates (BUDs*).

Commonly requested formulas for patients with BV include PCCA Formula #13836, PCCA Formula #13858, PCCA Formula #14396 and PCCA Formula #14584.

PCCA members with clinical services access may view and/or download PCCA Ellage formulations — including formulas with FormulaPlus™ BUD and stability studies — after logging on to our Members-Only Website. Clinical services access also allows members to contact our Clinical Services team for additional information on compounding Ellage preparations for patients with BV and other compounding concerns.

*USP 795 establishes BUD limits by type of preparation in the absence of a USP−NF Compounded Preparation Monograph or CNSP-specific stability information.

PCCA is recognized as the leader of quality products, education and advocacy in the compounding industry. Find out how a PCCA membership can benefit your compounding practice.

References

Kairys N, Carlson K, Garg M. Bacterial Vaginosis. [Updated 2024 May 6]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Accessed December 2024at https://www.ncbi.nlm.nih.gov/books/NBK459216/
Girerd P and Riven M, Price TM, et al. Bacterial Vaginosis. Medscape > Drugs & Diseases > Obstetrics & Gynecology. Accessed December 2024 at https://emedicine.medscape.com/article/254342-overview
Finnegan S, Percival SL. EDTA: An Antimicrobial and Antibiofilm Agent for Use in Wound Care. Adv Wound Care (New Rochelle). 2015 Jul 1;4(7):415-421. Accessed December 2024 at https://pubmed.ncbi.nlm.nih.gov/26155384

These statements are provided for educational purposes only. They have not been evaluated by the Food and Drug Administration, and are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care or encourage its abandonment.

Easing Drug & Disease Side Effects in Hospice Patients

Fri, 03 Jan 2025 00:30:22 GMT

by Sam Hamburger, PharmD Candidate, PCCA Clinical Services Intern, and Beau Harger, PharmD, PCCA Clinical Compounding Pharmacist/Training Instructor

The fundamental purpose of hospice is to help patients retain comfort, dignity and quality of life as they approach the end of life. During this stage, nausea and vomiting — either caused by medication side effects or from symptoms of a disease — are common. These and other side effects may lead to unnecessary stress and patient discomfort.¹ In the following article, we review a commonly used topical gel that lessens nausea and vomiting,² as well as the PCCA base vehicle that may enhance penetration of active pharmaceutical ingredients (APIs).

ABH Gel: Common & Customized

ABH gel is often used to help patients with nausea, vomiting and delirium during hospice and palliative care. The gel’s name comes from the API brands that are used in it — lorazepam (Ativan^®), diphenhydramine (Benadryl^®) and haloperidol (Haldol^®).

Lorazepam is a short-acting benzodiazepine used in patients with anxiety, shortness of breath and nausea. It acts on postsynaptic GABA receptors — a type of receptor in the brain that responds to the neurotransmitter gamma-aminobutyric acid (GABA) — located in multiple sites within the central nervous system (CNS). Sedation and confusion are common side effects.

Diphenhydramine is a first-generation antihistamine that acts on the histamine-1 (H-1) receptor. It is used for sedation, nausea and the extrapyramidal effects — the involuntary movement disorders such as tardive dyskinesia — of dopamine antagonists. Considered an anticholinergic medication, it causes a variety of side effects, including drowsiness, constipation, confusion, dry mouth, agitation, anxiety and urinary retention.

Haloperidol is a first-generation antipsychotic that acts primarily by inhibiting the D2 dopaminergic receptor — a protein that plays a key role in many brain functions. The API is used to sedate and calm patients. It carries an increased risk of extrapyramidal side effects, and oral haloperidol has a higher risk of delirium and mortality in palliative care patients.³

As a topical application, ABH gel is typically administered on the wrist, rubbed behind the ears or on the bottom of the feet.

Since ABH gel is not commercially available, compounding pharmacies may compound ABH preparations tailored to meet the unique needs of individual patients. The formulation should use a base vehicle that is smooth to the touch and that delivers exceptional API permeation through various levels of the skin.

Studied Results: PermE8^® Anhydrous Gel

PermE8 Anhydrous Gel ticks all of these boxes. Not only does it feature a silky texture that spreads quickly compared to other topical preparations, but it also can hold multiple APIs — including salt forms — in one compounded preparation. And due to water activity (Aw) of less than 0.6 (<.6), PermE8 offers the potential for longer beyond-use dates (BUDs).* Extended BUDs benefit not only compounding pharmacies by helping to lower operating costs but also hospice providers and caretakers due to fewer pharmacy refills.⁴

The need to deliver exceptional API permeation through various levels of the skin was supported in an independent study that compared the percutaneous absorption of ketoprofen in a formulation using PermE8 Anhydrous Gel to a formulation using PCCA Lipoderm®. Results indicated no significant difference between the two formulations (see Figure 1). Researchers concluded that the extent and rate of absorption in the PermE8 formulation is comparable to the industry-leading, permeation-enhancing Lipoderm.⁴

Figure 1
Across donor summary: the mean percutaneous absorption and distribution of ketoprofen in two compounded formulas after 48 hours diffusion.

PCCA members with clinical services access may view and/or download PCCA formulations to compound ABH gel preparations after logging on to our Members-Only Website. Clinical services access also allows members to contact our Clinical Services team for additional information on compounding ABH gel, hospice and palliative care or other compounding concerns.

PCCA is recognized as the leader of quality products, education and advocacy in the compounding industry. Find out how a PCCA membership can benefit your compounding practice.

*USP 795 establishes BUD limits by type of preparation in the absence of a USP−NF Compounded Preparation Monograph or CNSP-specific stability information.

References

Blaszczyk AT, Bailey TA, Tapia S. ABH Gel: Comforting Cure or Pricey Placebo?. J Am Med Dir Assoc. 2021;22(1):23-27. Accessed December 2024 at https://pubmed.ncbi.nlm.nih.gov/33246839/
Moon RB. ABHR Gel in the Treatment of Nausea and Vomiting in the Hospice Patient. Int J Pharm Compd. 2006;10(2):95-98. Abstract accessed December 2024 at https://pubmed.ncbi.nlm.nih.gov/23974181/
Dahal A, Neupane R, Boddu SH, et al. Percutaneous Absorption of Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol from ABH Gel. Int J Pharm Compd. 2020;24(2):168-175. Abstract accessed December 2024 at https://pubmed.ncbi.nlm.nih.gov/32196480/
PCCA Science. PCCA PermE8™ Anhydrous Ge Product Information Sheet. Document number 99608; 2018. Accessed December 2024 at PCCA Members-Only Website
PCCA Science. (2018) PermE8/Lipoderm Technical Report: Evaluation of the in vitro Human Skin Percutaneous Absorption of Ketoprofen in PCCA PermE8 Anhydrous Gel vs. PCCA Lipoderm . Document number 99732. Accessed December 2024 at PCCA Members-Only Website.

Hazardous Drug Wipe Sampling: Do I have to?

Thu, 05 Dec 2024 21:41:00 GMT

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

USP 800 discusses Environmental Quality and Control (Section 6) related to environmental wipe sampling for hazardous drug (HD) surface residue. This is not a requirement in USP 800; instead, it is stated that this should be performed routinely. What does this mean for those who handle HDs and why should compounders consider performing routine HD wipe sampling?

When handling HDs, the goal is to minimize exposure through different containment control strategies, from receiving through administration. Containment controls used in practice can be looked at as a hierarchy, with personal protective equipment (PPE) as the least effective and elimination of the HD as most effective. Elimination of HD handling is not an option in most cases, so one must utilize proper engineering controls such as negative pressure rooms, biological safety cabinets, containment ventilated enclosures and closed system transfer devices.

Other forms of containment controls include proper donning and doffing of PPE and removal of HDs through deactivation, decontamination, cleaning and disinfecting (DDCD). Containment can also be achieved through proper administrative controls such as HD communication, training and assessment of risk. Still, even if you follow all containment strategies, how do you know if they are working and that your staff and patients are not exposed?

HD wipe sampling can determine if your containment control strategies are working properly to reduce the risk of HD exposure to your team in any step of the handling processes.

What and where should I test?

USP 800 recommends HD wipe sampling be performed as a baseline at least every six months. Once you identify the areas to test, wipe sampling is a fairly simple process. It is recommended to test at various locations in your facility, starting from the time the HD enters the facility until the time it leaves. There are several companies that offer a wipe sampling kit. The contents may include a set of instructions, tubes for collection, a template to measure the area for collection and a swab used for sampling in each location. It is important to follow the instructions carefully and properly document the HDs to be tested and the corresponding areas within the facility that were swabbed.

USP 800 states the following areas should be tested when performing wipe sampling; however, it would be best to identify high-touch areas throughout the facility — again, from receiving to dispensing/administration — when possible:

Interior of the C-PEC and equipment contained in it
Pass-through chambers
Surfaces in staging or work areas near the C-PEC
Areas adjacent to C-PECs (e.g., floors directly under C-PEC, staging and dispensing area)
Areas immediately outside the HD buffer room or the C-SCA
Patient administration areas

A good place to start is to look at where HDs are handled throughout your facility. In a community pharmacy, this includes areas where patients pick up HD medications. In a health system, consider including medication rooms and patient rooms. Identify locations that have the highest touch rates to determine which areas to sample.

You also need to determine which drugs to test. Depending on the testing company you choose, you can test for a variety of drugs — from antineoplastics to hormones and even drugs such as spironolactone or finasteride. Consider testing for the HD drugs used most frequently in your facility.

What do I do with the sampling results?

Sampling results appear as a quantity if a drug is detected or listed if the drug(s) tested was not detected or present in the area sampled. Some companies color the results if a detected HD is higher than average.

If detectable contamination is found, the designated person is required to identify, document and contain the source of contamination. This can be done by creating an “environmental action plan,” a detailed document that outlines strategies and processes, including actions, timelines, responsible parties and measurable goals. Tracking and trending the wipe sampling results can drive change in your facility to contain the identified HD.

Again, there is not an established action limit for HD contamination levels, so any detectable amount will need to be addressed. Wipe sample results should be used to drive change and improve processes. Changes may include revising the DDCD process, seeking alternatives to HD storage or the use of a closed system transfer device.

Sampling data can be shared with staff to show where HD contamination is working and where it isn’t. Once you start collecting data, you will be able to keep track of sampled locations and start to trend results. The results may never reach zero, but using HD wipe sampling data should lead to a reduction in HD contamination levels.

PCCA members with clinical service access may contact our Clinical Services team for additional information on HD wipe sampling and other compounding concerns.

PCCA is recognized as the leader of quality products, education and advocacy in the compounding industry. Find out how a PCCA membership can benefit your compounding practice.

Reference

United States Pharmacopeia. Online Subscription Required.

Partnerships Between 503A Pharmacies and 503B Outsourcing Facilities

Wed, 27 Nov 2024 15:31:09 GMT

by Bruno Onwukwe, PharmD Candidate, PCCA Clinical Services Intern, and Celeste Zizzamia, PharmD, BCSCP, PCCA Clinical Compounding Pharmacist

Sections of the FDA’s Drug Quality and Security Act (DQSA) distinguish compounding pharmacies (503A) from outsourcing facilities (503B). Due to several factors, many of which are related to drug shortages and the USP 797/USP 800 updates, 503A pharmacies are considering partnering with 503B entities for compounded sterile preparations and/or hazardous materials. We’ll discuss the differences between 503A pharmacies and 503B outsourcing facilities, review Section 503B and summarize how to effectively evaluate 503B compounding pharmacies for a potential partnership.

Key Differences

A 503A designated pharmacy may compound drugs only for an individual patient with a prescription from a qualified provider. In addition, 503A pharmacies are regulated by a state board of pharmacy, which may follow standards set by the United States Pharmacopeia (USP). In contrast, a 503B outsourcing facility does not require a prescription but must adhere to the FDA’s Current Good Manufacturing Practice (CGMP) regulations. Additional differences between 503A and 503B pharmacies related to compounding sterile and/or hazardous materials include:

Description	503A	503B
Standards	USP 797	CGMP
Regulatory Body	State Board of Pharmacy	FDA
Prescription Requirement	Yes	No
Office-Use Compounding	No	Yes
Max Batch Size	250	N/A
Release Testing	BUD Dependent	Yes
Beyond-Use Date	≤180¹	Stability Study Dependent
Interstate Distribution Limit	<5%	N/A

1. For a compounded sterile product (CSP) that has been terminally sterilized, stored frozen, passed sterility and all applicable tests for Category 3.

The 503A pharmacies that compound sterile preparations and/or hazardous materials can benefit from partnering with 503B outsourcing facilities. Forming a partnership may allow the 503A pharmacy to potentially mitigate risks, reduce operational costs, provide expanded services and improve customer satisfaction.

USP chapters 797 and 800 outline the minimum standards for sterile compounding and compounding hazardous materials. Although currently not adopted by all states, 503A pharmacies should consider implementing the USP standards as best practices in patient care and safety — even if doing so may pose challenges. USP updates include increased environmental monitoring, cleaning and disinfecting, garbing requirements, media-fill testing, personnel training, safety and more.

Wholesale Prohibitions for 503B

Section 503B(a)(8) of DQSA discusses the restrictions on wholesaling for outsourcing facilities. Compounded preparations must not be sold or transferred by an entity other than the outsourcing facility that compounded the product — wholesale distributors, pharmaceutical repackagers and relabelers, marketing firms and websites cannot participate in the sale and transfer of compounded preparations. Section 503B(a)(8) does not, however, prohibit the administration of a compounded product in a healthcare setting, nor its dispensing under a prescription.

The FDA Draft Guidance, which determines standard industry practice, clarified in June 2023 that a 503B outsourcing facility may sell its compounded products to a 503A pharmacy. Therefore, 503A state-licensed pharmacies or federal facilities may dispense compounded products in partnership with outsourcing facilities, opening the possibility of increased partnership between the two entities.

Evaluation Criteria for 503B Partnership

Many factors should be taken into consideration when deciding to partner with a 503B outsourcing facility, including:

Appropriate Licensures and Registrations — Investigate whether the 503B facility has appropriate licensure and registration within the states you intend to operate in.
Compliance with Prohibition on Wholesaling — 503As cannot buy from brokers and must directly purchase compounded products from their 503B partner. 503As, however, may use group purchasing organizations (GPOs) to negotiate contract pricing.
Quality Customer Service — Ensure the 503B facility provides reliable information for inventory, processing and shipping.
Regulatory History — Review their track record of FDA Form 483s, FMD-145s, warning letters, product recalls and other events that may call into question their conditions.

In addition, 503B outsourcing facilities must comply with CGMPs to ensure that safe, quality compounds are prepared and dispensed to patients. Some facilities have not been FDA inspected; however, evaluating the facility’s systems will help to discern CGMP compliance. An evaluation should include:

Audits
Facility Certification
Environmental Monitoring Data
Cleaning and Disinfection Program
Quality Unit
Quality Control
Standard Operating Procedures
Investigations
Personnel Training
Validation Activities
Supplier Qualification Program
Master and Batch Production Records
Equipment
Container-Closure Systems
Laboratory Controls (Method Suitability/Validation/Stability Studies)

Many 503A pharmacies that compound sterile preparations and whose state boards of pharmacy implemented USP 797 updates face a pivotal crossroad. Collaboration with a 503B outsourcing facility may pave the way toward a partnership which can increase efficiencies and free up time for pharmacists and technicians to focus efforts in different areas of patient care activities.

More information about FDA-registered outsourcing facilities can be found at https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities.

References

FDA. Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act. Guidance Document. June 2023. Accessed January 2024 at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/prohibition-wholesaling-under-section-503b-federal-food-drug-and-cosmetic-act
FDA. Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. Guidance for Industry. Draft Guidance. January 2020. Accessed January 2024 at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/current-good-manufacturing-practice-guidance-human-drug-compounding-outsourcing-facilities-under
FDA. 21 CFR Part 21 – Current Good Manufacturing Practice for Finished Pharmaceuticals. Accessed January 2024 at https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211
USP <797> Pharmaceutical Compounding – Sterile Preparations. 01 May 2024. Accessed January 2024 at https://doi.usp.org/USPNF/USPNF_M99925_08_01.html

Microdosing GLP-1 RAs: Fad or Forever?

Fri, 22 Nov 2024 15:58:06 GMT

by Jennifer Lines, PharmD Candidate, PCCA Clinical Services Intern, and Catherine Henderson, PharmD, PCCA Clinical Compounding Pharmacist

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have revolutionized metabolic health and weight management, leading to a host of new weight loss wonder drugs. But did you know that recent evidence shows these new drugs may do more than just help with weight loss and diabetes? And at a fraction of the standard dose?

Looking Back on GLP-1 RAs

Originally discovered in the saliva of the Gila monster, exenatide — a GLP-1 RA— was approved as a twice-daily injection by the FDA in 2005 for adults with type 2 diabetes.¹ Within the past decade, longer-acting GLP-1 RA formulations entered the market as once-weekly, self-administered injectable pens — most notably, semaglutide.

Recent FDA approvals and indications for products containing semaglutide include the reduction of cardiovascular risk in patients with type 2 diabetes and body weight reduction for obesity. New research, however, reveals the potential for additional benefits of the drugs.

Potential Benefits of GLP-1 RAs

Known for their metabolic benefits, emerging studies suggest GLP-1 RAs may help improve kidney function, cardiovascular health, non-alcoholic fatty liver disease, Alzheimer's disease and Parkinson’s disease.²

GLP-1 RAs, such as semaglutide, also show potential anti-inflammatory properties. Although the specific mechanisms are not understood, reports indicate that semaglutide can modulate inflammatory processes by reducing levels of interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α) and high-sensitivity C-reactive protein (hsCRP).

In an animal model, semaglutide demonstrated neuroprotective effects and improved cognitive function by inhibiting the release of inflammatory cytokines mediated by the NLRP3 inflammasome, a protein involved in regulating the innate immune system and inflammatory responses.

GLP-1 receptors are also found on different immune cells, such as neutrophils and eosinophils, and their activation has modulatory effects on immune responses and inflammatory processes associated with these types of cells.³

What Is Microdosing?

Microdosing is not an official medical term; it refers to taking less than the standard dose of a medication to achieve benefits while potentially minimizing undesirable side effects.

The term microdosing has risen in popularity in recent years. Initially, it referred to taking small doses of psychedelic drugs to alleviate symptoms of depression and anxiety, or boost mood and creativity. Interest in microdosing GLP-1 RAs is growing among many holistic physicians.⁴

Endogenous GLP-1 vs. Exogenous GLP-1 RAs

At normal physiological levels, active GLP-1 levels peak around 30-60 minutes after ingesting a meal before being rapidly degraded by the enzyme dipeptidyl peptidase-4 (DPP-4). During DPP-4 inhibition, levels of active GLP-1 increase up to 2-3 times. However, with exogenous GLP-1 RAs, active levels of GLP-1 RAs can rise to 10-30 times the normal physiological levels (depending on the agent used) and maintain steadily high levels independent of meal ingestion. One of the most common reasons patients discontinue GLP-1 RA treatment is due to gastrointestinal side effects, which could be attributed to the markedly high GLP-1 RA levels.⁵

Microdosing GLP-1 RAs

Anecdotal discussions between holistic practitioners suggest microdosing semaglutide may help people lose weight while limiting side effects. Naturopathic physician Dr. Tyna Moore, for example, suggests people with reduced GLP-1 levels may benefit from lower dosing and slowly increasing to the patient’s normal physiological levels. Dr. Moore also believes that slower, more sustainable weight loss allows the body more time to adjust to changes in weight, reducing the side-effect profile and potentially leading to better long-term success.⁶

While there are no clinical studies exploring the concept of microdosing GLP-1 RAs, it may be a useful tool for a holistic metabolic health strategy. It is important to remember that GLP-1 RAs are only one piece of the puzzle and should always be recommended in conjunction with diet, exercise and lifestyle modifications.

Smaller doses of GLP-1 RAs may not benefit those with severe metabolic dysfunction or those needing substantial weight loss. However, it may be helpful to those seeking a more gradual approach to weight loss while potentially providing overall health benefits like anti-inflammatory and neuroprotective effects.

While the safety of GLP-1 RAs is well established, current scientific evidence on the efficacy of microdosing GLP-1 RAs is lacking and further research is required to assess its benefits at lower doses.⁷

PCCA members with clinical services access may contact our Clinical Services team for help with microdosing GLP-1 RAs and other compounding concerns.

References

Paternoster S, Falasca M. Dissecting the Physiology and Pathophysiology of Glucagon-Like Peptide-1. Front Endocrinol (Lausanne). 2018;9:584. Published 2018 Oct 11. doi:10.3389/fendo.2018.00584
Laurindo LF, Barbalho SM, Guiguer EL, et al. GLP-1a: Going beyond Traditional Use. Int J Mol Sci. 2022;23(2):739. Published 2022 Jan 10. doi:10.3390/ijms23020739
Yaribeygi H, Maleki M, Jamialahmadi T, et al. Anti-inflammatory benefits of semaglutide: State of the art. J Clin Transl Endocrinol. 2024;36:100340. Published 2024 Mar 28. doi:10.1016/j.jcte.2024.100340
Mammoser G. (fact checked by Seladi-Shulman J.) Ozempic Microdosing Is Gaining Popularity. Does It Work for Weight Loss? Healthline. Published 2024 Oct 17. https://www.healthline.com/health-news/ozempic-microdosing-weight-loss
Smits MM, Holst JJ. Endogenous glucagon-like peptide (GLP)-1 as alternative for GLP-1 receptor agonists: Could this work and how?. Diabetes Metab Res Rev. 2023;39(8):e3699. doi:10.1002/dmrr.3699
Fitzgerald, J. (Host). (2023, October 12). Is Ozempic a miracle medicine? Heal Thy Self w/ Dr. G #283 [Video]. YouTube. https://www.youtube.com/watch?v=xI37HDVEMjo
Smits MM, Van Raalte DH. Safety of Semaglutide [published correction appears in Front Endocrinol (Lausanne). 2021 Nov 10;12:786732. doi: 10.3389/fendo.2021.786732]. Front Endocrinol (Lausanne). 2021;12:645563. Published 2021 Jul 7. doi:10.3389/fendo.2021.645563

What’s in Store at the LDN Virtual Conference

Fri, 15 Nov 2024 03:53:03 GMT

Individuals who suffer from symptoms of gastrointestinal, autoimmune, dermatological and pain conditions make up 80% of the patient population. But here’s the good news: multiple studies indicate that low-dose naltrexone (LDN) may potentially help many of these conditions. Take a sneak peek at topics our Clinical Services team will discuss during the Low-Dose Naltrexone One-Day Virtual Conference on Thursday, November 21, 2024.

The Immune System — Autoimmune Conditions and the Benefits of LDN

by Catherine Henderson, PharmD, PCCA Clinical Compounding Pharmacist

LDN has long been touted for its effects in autoimmune disorders. Understanding the mechanisms of LDN action involves diving deeper into immune system function and the irregularities that occur in autoimmune disorders. We’ll explore the data related to LDN’s various mechanisms for improving disease symptomatology and quality of life, as well as review real world published studies and cases of LDN use in various autoimmune disorders.

Dermatological Inflammatory Diseases and LDN

by Nat Jones, RPh, FAPC, PCCA Clinical Compounding Pharmacist

LDN is growing in popularity in the dermatology world. It has proven to be beneficial for pruritus and inflammation due to its ability to attenuate toll-like receptors found in the skin. We’ll discuss two cases: one of a tattoo allergic reaction and one of hidradenitis suppurativa (HS). Tattoo reactions to the coloring agents can be intense and difficult to treat. HS is a chronic inflammatory, potentially scarring, skin disease primarily affecting apocrine gland-rich areas of the body (axillary, groin, perianal, perineal regions and abdominal folds), often mediating pain and considerable morbidity, both physical and psychological.

The Use of LDN in Veterinary Patients

by Katy Hecker, PharmD, PCCA Clinical Compounding Pharmacist

As pet owners, we lovingly share many things with our pets including treats, affection and half of the bed. Research suggests we also share similarities in physiological function, disease state manifestation and treatment modalities utilized. Join in the discussion and learn more about the science behind LDN for veterinary clinical indications including behavioral disorders, atopic dermatitis, osteoarthritis, cancer, inflammatory bowel disease (IBD) and more!

Perimenopause and Menopause Are Inflammatory Conditions: The Use of LDN for Hormones and Weight Loss

by Sara Hover, RPh, FAARM, PCCA Director of Clinical Services

Understanding the inflammatory processes that characterize perimenopause and menopause will shed light on how the hormonal changes contribute to weight gain and obesity. Central to this discussion is the shift in estrogen profiles — from estradiol, which possesses anti-inflammatory properties, to estrone, a pro-inflammatory estrogen that becomes predominant during menopause. This hormonal transition fosters an inflammatory state that can disrupt metabolism and promote adiposity. Additionally, the presentation will explore various options aimed at reducing inflammation and managing weight effectively. Key strategies include optimizing sleep quality, utilizing probiotics to support gut health and implementing LDN as an innovative therapeutic approach. Attendees will gain a comprehensive understanding of the biological mechanisms linking menopause to inflammation and weight gain, along with practical interventions to enhance health and well-being during this pivotal life stage.

Using LDN for Chronic Pain Conditions

by Tricia Heitman, PharmD, PCCA Clinical Compounding Pharmacist

LDN is gaining attention for its anti-inflammatory properties and its ability to manage pain and opioid addiction. By acting on the opioid receptors at lower doses, LDN enhances endorphin production, which can help reduce inflammation and alleviate pain associated with various conditions such as arthritis, fibromyalgia and autoimmune disorders. Many patients report significant relief from chronic pain and inflammation while taking LDN. We will discuss the appropriate doses and review the literature associated with LDN and pain.

LDN for Gut Inflammatory Disorders

by Ranel A. Larsen, PharmD, PCCA Clinical Compounding Pharmacist

LDN is emerging as a promising therapeutic option for enhancing gut health, particularly in the context of IBD and irritable bowel syndrome (IBS). LDN helps to regulate immune responses, improve epithelial barrier function and reduce inflammation within the gut, all of which are critical for maintaining intestinal homeostasis. In IBD, LDN may lower disease activity and enhance quality of life, while in IBS, it can alleviate symptoms such as pain and bloating. Overall, LDN's role in improving gut health underscores its therapeutic potential to support management of complex gastrointestinal disorders.

How to Market LDN Studies

by Mark Gonzalez, PharmD, PCCA Clinical Compounding Pharmacist

Today’s compounding pharmacist wanting to effectively market LDN to practitioners and patients has access to tools that were not as available 20 years ago when LDN started to become popular. Clinical studies, therapeutic reviews and case series are now readily available to substantiate what were once only theories on the effectiveness of naltrexone in autoimmune disorders. These studies span a wide array of specialties and medical conditions. Research groups such as the LDN Research Trust, publications such as the series of three LDN books and many of the clinical presentations given on the subject of LDN all reference these studies. The pharmacist and marketer must leverage the power of this data as part of their communication to both the practitioner and the patient they are marketing to. With the additional aid of social media, positive patient stories can accompany the data from these clinical studies to make for attractive and effective marketing.

Register for the Low-Dose Naltrexone One-Day Virtual Conference today and get more details — plus more information — on the potentials of LDN. We look forward to additional discussions and answering your questions!

A Personalized Approach to HRT for Perimenopausal Women

Thu, 14 Nov 2024 04:23:17 GMT

by Sara Hover, RPh, FAARM, PCCA Director of Clinical Services

Perimenopause is a unique phase in a woman’s life, marked by fluctuating hormones and a wide range of symptoms. Hormone replacement therapy (HRT) can offer relief, but a one-size-fits-all approach may not yield the best results. A personalized approach, tailored to each woman’s unique hormonal profile, lifestyle and symptoms, can make all the difference in managing this transition effectively. Let’s explore the factors that contribute to low estrogen, the role of cortisol and progesterone, and why a customized approach to HRT is essential for perimenopausal women.¹

Understanding Estrogen Levels in Perimenopause

Estrogen is a key hormone for various bodily functions, from reproductive health to mood regulation. During perimenopause, estrogen levels fluctuate and eventually decline when menopause is reached. Several factors can contribute to low estrogen levels during perimenopause.

First, the natural abatement of ovarian function plays a major role; as women approach menopause, ovarian follicles reduce in number and function, resulting in decreased estrogen production. Genetic predisposition can also influence estrogen levels, as some women have genetic factors that may lead to an earlier or more abrupt drop. Additionally, lifestyle factors, including diet, stress and physical activity levels, significantly impact estrogen. For instance, poor nutrition or extreme physical training can suppress estrogen production.² Another crucial factor is high cortisol levels. Chronic stress increases cortisol, which may inhibit the body’s ability to produce adequate estrogen.³

By identifying these factors, healthcare providers can develop a more precise treatment plan, addressing not only hormonal imbalances but also lifestyle factors that might be exacerbating symptoms. During perimenopause, women are still making estrogen — maybe in an erratic fashion — but identifying the cause of low estrogen is most important. We should not give estrogen until there is certainty that the patient has entered menopause. Keep in mind that the testing results are a one-time snapshot of that moment and results may vary over time.¹

The Role of Cortisol in Perimenopausal Health

Cortisol, often referred to as the “stress hormone,” is produced by the adrenal glands and plays a significant role in managing stress and regulating metabolism. For perimenopausal women, high cortisol levels can have several consequences. Elevated cortisol can lead to increased fatigue and mood swings, as it causes feelings of exhaustion, irritability and mood fluctuations. It also disrupts other hormones; high cortisol can hinder estrogen production, exacerbating symptoms like hot flashes, insomnia and night sweats.

Furthermore, cortisol impacts progesterone levels due to a phenomenon known as “pregnenolone steal.” Since cortisol production draws on the same hormonal precursor (pregnenolone) that produces progesterone, the body under stress prioritizes cortisol production over progesterone, potentially leading to imbalances.⁴ By managing cortisol levels through stress reduction techniques, exercise and lifestyle modifications, women can help balance their hormones and reduce the intensity of perimenopausal symptoms.

Progesterone: The Balancing Hormone

Progesterone plays a vital role in regulating estrogen, stabilizing mood, promoting restful sleep and reducing anxiety. During perimenopause, progesterone levels begin to decline as ovulation becomes irregular, leading to several potential challenges.

One significant issue is estrogen dominance; when progesterone is low, estrogen may dominate, resulting in symptoms such as weight gain, bloating, breast tenderness and mood swings. Progesterone also affects sleep and anxiety levels, as it has a calming effect on the brain. Low levels of progesterone may lead to sleep disturbances and heightened anxiety, making this transitional phase more challenging.⁵ In addition, progesterone supports bone health, so declining levels can impact bone density over time.⁶ Replenishing progesterone through bioidentical hormones or other supplements, as determined by a healthcare provider, can help mitigate these symptoms and maintain hormonal balance.

Benefits of a Personalized HRT Approach

A personalized HRT approach considers each woman’s unique hormonal profile, lifestyle factors and symptom severity. This approach offers several distinct advantages. First, targeted hormone support is possible by measuring hormone levels and monitoring symptoms, allowing health care providers to recommend specific combinations and dosages of estrogen, progesterone and other hormones based on individual needs.

Personalized HRT plans address underlying causes; beyond hormone therapy, they may include lifestyle and nutritional adjustments to address root causes such as high cortisol or low progesterone. Ultimately, a personalized approach enhances a woman’s quality of life by addressing a broad range of factors — from hormonal imbalances to lifestyle changes — so she can experience a smoother perimenopausal transition with improved energy, mood and sleep quality.

Perimenopause doesn’t have to be a time of discomfort and uncertainty. A personalized approach to HRT empowers women to navigate this transition with a clear, effective and safe plan. With proper guidance, perimenopausal women can regain control over their bodies, ensuring that their unique needs are met. Whether through bioidentical hormone therapy, lifestyle changes or stress management, each woman deserves an individualized strategy that supports her well-being through this important life stage.

PCCA members with clinical services access may contact our Clinical Services team to answer any questions about HRT and other compounding concerns.

References

Smith, P., What You Must Know About Women’s Hormones. 2nd. Ed. Garden City Park, NY: Square One Publishing, 2022.
Delamater L, Santoro N. Management of the Perimenopause. Clin Obstet Gynecol. 2018 Sep;61(3):419-432. doi: 10.1097/GRF.0000000000000389. Accessed 2024 at https://pubmed.ncbi.nlm.nih.gov/29952797/
Woods NF, Mitchell ES, Smith-Dijulio K. Cortisol levels during the menopausal transition and early postmenopause: observations from the Seattle Midlife Women's Health Study. Menopause. 2009 Jul-Aug;16(4):708-18. Accessed 2024 at https://pubmed.ncbi.nlm.nih.gov/19322116/
Solano ME, Arck PC. Steroids, Pregnancy and Fetal Development. Front Immunol. 2020;10:3017. Published 2020 Jan 22. Accessed 2024 at https://pmc.ncbi.nlm.nih.gov/articles/PMC6987319/
Stefaniak M, Dmoch-Gajzlerska E, Jankowska K, et al. Progesterone and Its Metabolites Play a Beneficial Role in Affect Regulation in the Female Brain. Pharmaceuticals. 2023; 16(4):520. Accessed 2024 at https://pubmed.ncbi.nlm.nih.gov/37111278/
Mills EG, Yang L, Nielsen MF, et al. The Relationship Between Bone and Reproductive Hormones Beyond Estrogens and Androgens [published correction appears in Endocr Rev. 2021 Nov 16;42(6):872. doi: 10.1210/endrev/bnab024]. Endocr Rev. 2021;42(6):691-719. Accessed 2024 at https://pubmed.ncbi.nlm.nih.gov/33901271/

The Best Jam Compounding Fest in the Land — Until Next Year!

Wed, 30 Oct 2024 15:00:00 GMT

ThinkNext: International Seminar 2024 (ThinkNext: ISTX24), held October 17 - 19 in Houston, Texas, was a huge success with well over 500 rockstar compounders from around the world. We’re sharing seminar highlights and memorable takeaways that make PCCA members return year after year.

The following summaries, however, do not give justice to the many workshops and presentations offered at ThinkNext: ISTX24. Nor do they capture the energy, networking, educational pearls, laughter and good times shared. You’ve got to be there to fully appreciate and experience the best jam compounding fest in the land.

Clinical Presentations

Compounding Ideas for Dermatology and Wound Care
PCCA Clinical Pharmacist Nat Jones, RPh, FAPC, discussed compounding options for hair growth, ideas for topical anti-aging face formulations and understanding wounds and evaluation options for step-by-step wound care.
Hospice and Palliative Care in Veterinary Medicine
PCCA Vice President of Creative Development Chris Simmons, RPh, and PCCA Clinical Compounding Pharmacist Mark Gonzalez, PharmD, defined hospice and palliative care, described the disease states commonly seen in the veterinary hospice/palliative care setting, shared compounded options and discussed the value compounding brings to this area of veterinary medicine.

Innovation

Behind the Science: PCCA Innovation
PCCA Chief Scientific Officer Gus Bassani, PharmD, and PCCA Director of Research & Development Daniel Banov, RPh, MS, shared new data from scientific studies conducted on EctoSeal P2G ™ and SubMagna™ SL HMW that members can share with prescribers.
Leadership and How to Fail Like a Boss
Keynote speaker Dave Aspery, “the father of biohacking,” pointed out how the five F's: "fear, food, fertility, friends and forgiveness," drive a person's energy, also noting how our life expectancy and longevity are influenced by our physical and mental health.

Marketing

New Trends in Social Media
Magnolia Pharmacy owner and president Steve Hoffart, PharmD, shared tips on how to use social media to market your pharmacy in your community and to federal legislators.
A Practical Approach to AI and How I Use It
Las Colinas Compounding & Wellness Pharmacy’s Stacy Hightower, CPhT, FAPC, discussed game-changing AI and how she develops marketing campaigns, gains consumer insights and increases pharmacy revenue using this powerful tool.

Revenue Generation

Building Supplement Sales
PCCA Director of Member Engagement Erin Michael, MBA, MS, CPhT, FAPC, and PCCA Director of Business Solutions Laura Pfaffenberger, PharmD, discussed market trends for dietary supplements and how to tap into this lucrative niche.
What Is Your Job?
Williamsburg Drug Company owner and pharmacist T.W. Taylor, RPh, shared how consultation services provided by his pharmacy helped his patients restore their health and increase his pharmacy’s revenue.
Business Accelerator: Move Your Pharmacy Forward — Faster
PCCA Director of Business Solutions Laura Pfaffenberger, PharmD, took the stage and announced Business Accelerator, which offers workable solutions that address staffing, operations, strategy and growth specific to compounding pharmacies.

Regulatory Concerns

Implications of Your Marketing from a Regulatory Perspective
PCCA Clinical Services Director Matt Martin, PharmD, BCSCP, and PCCA Director of Member Engagement Erin Michael, MBA, MS, CPhT, FAPC, discussed the regulatory considerations that apply when promoting your practice, best practices for promoting your services without making claims and the standards images should meet before being used in promotional content.
PCCA Public Affairs
PCCA Vice President of Public Affairs, Education and Human Relations Lizzie Harbin opened the Regulatory, Public Affairs and Industry Partner Panel by discussing the importance of advocating for our industry. Lizzie then invited CEO of the Alliance for Pharmacy Compounding Scott Brunner, CAE, and CEO of the National Community Pharmacists Association Doug Hoey, RPh, MBA, to discuss imminent threats to pharmacies: compounding hormones, pharmacy benefit managers (PBMs) and direct and indirect remuneration (DIR) fees, as well as the role of telehealth in pharmacies.

Award-Winning Members

Joseph P. Navarra, RPh, FACA, FAPC, owner of Town Total Compounding Center in Woodbury, New York, and board chair of the Alliance for Pharmacy Compounding, was named PCCA’s 2024 M. George Webber, PhD, Compounding Pharmacist of the Year.
Stacy Hightower, CPhT, FAPC, of Las Colinas Pharmacy Compounding & Wellness in Irving, Texas, owned by Jim and Jan Hrncir, was honored as PCCA’s inaugural Compounding Technician of the Year.
Jerry Beamer, RPh, co-owner of Andrews Apothecary in Winston-Salem, North Carolina, was honored as the recipient of the 2024 L. David Sparks Advocacy Award.
Isha Gupta, PharmD, MBA, owner of HatchRx Compounding Pharmacy in Long Island, New York, was honored as the recipient of the 2024 George Roentsch, RPh, New Innovator Award.

We thoroughly enjoyed rocking out with our PCCA members, sponsors and friends and look forward to seeing more new and familiar faces next year at ThinkNext: International Seminar 2025 — the best jam compounding fest in the land.

Subclinical Hypothyroidism: Weight, Testing and Medication Absorption

Wed, 09 Oct 2024 15:41:00 GMT

Thyroid health plays a pivotal role in regulating metabolism, energy levels and overall well-being.1 Among the spectrum of thyroid disorders, subclinical hypothyroidism often flies under the radar due to its subtle symptoms. However, its implications on weight management warrants closer attention. Taking a closer look into what subclinical hypothyroidism entails, its connection to weight loss challenges, the importance of appropriate testing, and how excipients in medications can influence thyroid hormone absorption can help many patients with this elusive condition.

What Is Subclinical Hypothyroidism?

Subclinical hypothyroidism (SCH) is a mild form of hypothyroidism where the thyroid gland doesn't produce enough thyroid hormones to meet the body's needs, but the deficiency isn't severe enough to cause overt symptoms. It's characterized primarily by elevated thyroid-stimulating hormone (TSH) levels, while free thyroxine (free T4) and free triiodothyronine (free T3) levels remain within the normal range but might not be what is considered optimal. When TSH is elevated, this indicates that the pituitary gland is sending out a stronger signal to the thyroid to produce more hormones.² It is always important to look at a complete thyroid panel to obtain the full picture, such as looking at both the free T4 and free T3. T4 is a prohormone for T3, and the body converts it to T3 as it is needed. T3 is the hormone that actually interacts with the receptor and does the work, so to speak.³

Subclinical Hypothyroidism and Weight Management

Thyroid hormones are integral to regulating metabolism — the rate at which the body converts food into energy. Even subtle imbalances can influence weight management. When thyroid levels are lower, the metabolic rate is slowed as well as the patient typically is more fatigued. A sluggish metabolism can make weight loss more challenging. And a patient with low energy has a difficult time staying committed to an exercise regimen.

However, it's essential to note that the relationship between SCH and weight is complex. While overt hypothyroidism is more directly linked to weight gain, SCH's impact can vary among individuals. Some may experience weight fluctuations, while others may not notice significant changes.²

Importance of Appropriate Testing

Accurate diagnosis is crucial for effective management of SCH, especially when addressing weight-related concerns. As previously mentioned, TSH, free T4 and free T3 are essential to be included in the thyroid panel. In addition to those components, it is also very beneficial to look at peroxidase antibodies (TPOAb). If these antibodies are elevated, it can indicate autoimmune thyroiditis, a common cause of SCH.⁴In addition to antibodies, a lipid panel is essential since thyroid hormones can influence cholesterol metabolism. For some patients, an atypical rise in lipids is a sign that there could be thyroid dysfunction.⁵

Treatment Options for Subclinical Hypothyroidism

The decision to treat SCH hinges on several factors, including TSH levels, presence of symptoms, age and underlying health conditions.²It is also key to evaluate adrenal function before beginning thyroid supplementation. Adrenal insufficiency is actually a contraindication for thyroid replacement.⁶

The Role of Excipients in Thyroid Medication Absorption

When it comes to managing SCH, thyroid hormone replacement therapy, such as levothyroxine or Thyroid USP (Porcine), is commonly prescribed. However, the efficacy of these medications isn't solely dependent on the active ingredient. Excipients play a crucial role in the drug's absorption and effectiveness. Common excipients in thyroid medications include fillers such as lactose, microcrystalline cellulose and magnesium stearate. Excipients can influence how well the active hormone is absorbed in the gastrointestinal tract.⁷ For instance, certain fillers might bind to thyroid hormones, reducing their availability, while others, such as PCCA LoxOral®, can enhance dissolution, potentially leading to improved absorption.

Subclinical hypothyroidism is a nuanced condition that, despite its subtlety, can influence various aspects of health, including weight management. Recognizing its signs, understanding the importance of appropriate testing and being aware of how excipients affect medication absorption are vital steps in effective management. If a patient suspects thyroid imbalances or is facing challenges with weight management despite a healthy lifestyle, consulting with a healthcare professional for comprehensive evaluation and personalized treatment is essential. Pharmacists should empower patients with knowledge and help them take proactive steps towards optimal thyroid health and overall well-being.

References

Liu G, Liang L, Bray GA, et al. Thyroid hormones and changes in body weight and metabolic parameters in response to weight loss diets: the POUNDS LOST trial. Int J Obes (Lond). 2017 Jun;41(6):878-886. doi: 10.1038/ijo.2017.28. Epub 2017 Jan 31. Accessed October 2024 at https://pubmed.ncbi.nlm.nih.gov/28138133/
Azim S, Nasr C. Subclinical hypothyroidism: When to treat. Cleve Clin J Med. 2019 Feb;86(2):101-110. doi: 10.3949/ccjm.86a.17053. Erratum in: Cleve Clin J Med. 2019 Jun;86:392. Accessed October 2024 at https://pubmed.ncbi.nlm.nih.gov/30742580/
Armstrong M, Asuka E, Fingeret A. Physiology, Thyroid Function. [Updated 2023 Mar 13]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Accessed October 2024 at https://www.ncbi.nlm.nih.gov/books/NBK537039/
Rugge B, Balshem H, Sehgal R, et al. Screening and Treatment of Subclinical Hypothyroidism or Hyperthyroidism [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011 Oct. (Comparative Effectiveness Reviews, No. 24.) Introduction. Accessed October 2024 at https://www.ncbi.nlm.nih.gov/books/NBK83492/
Kumar M, Dheeraj D, Kant R, Kumar A. The Association Between Anti-Thyroid Peroxidase Antibody and Dyslipidemia in Subclinical Hypothyroidism Among the Rural Population of Central India. Cureus. 2022 Feb 17;14(2):e22317. doi: 10.7759/cureus.22317. Accessed October 2024 at https://pubmed.ncbi.nlm.nih.gov/35317033/
AbbVie. Highlights of Prescribing Information, Synthroid. 2024 Feb Updates. Accessed October 2024 at https://www.rxabbvie.com/pdf/synthroid.pdf Accessed 10/2/2024
Patel H, Stalcup A, Dansereau R, Sakr A. The effect of excipients on the stability of levothyroxine sodium pentahydrate tablets. Int J Pharm. 2003 Oct 2;264(1-2):35-43. doi: 10.1016/s0378-5173(03)00387-9. Accessed October 2024 at https://pubmed.ncbi.nlm.nih.gov/12972334/

GLP-1: The Naturally Produced Hormone

Wed, 04 Sep 2024 17:00:00 GMT

You’re likely familiar with semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) used in commercially available prescription medicines for treatment of type 2 diabetes and obesity. Are you aware that GLP-1 — the hormone semaglutide is designed to induce — is naturally produced by the body to help promote healthy blood sugar levels, curb cravings and maintain a healthy weight? Or aware of the bacterium in the gut microbiota that induces natural production of GLP-1?

GLP-1: Key to Blood Glucose Homeostasis

GLP-1 is part of a group of metabolic hormones — called incretin hormones — that help decrease blood glucose levels. The majority of GLP-1s are produced by L-cells lining the small intestine and colon; smaller quantities are secreted by the pancreas and the central nervous system.

In the pancreas, GLP-1 stimulates the release of insulin, increases the amount of insulin-producing pancreatic cells (beta cells) and reduces the release of glucagon — a hormone that raises blood sugar levels. GLP-1 also signals appetite centers in the brain, indicating a sense of fullness during and between meals by slowing gastric emptying.

Primarily triggered by food consumption, GLP-1 release occurs 10 – 15 minutes after eating. Although it remains in the blood system for several hours, nerve activity and other hormones can affect GLP-1 production and levels. For example, somatostatin, a hormone principally produced in the nervous and digestive systems, reduces GLP-1 production; dipeptidyl peptidase-4, an enzyme expressed on the surface of cells, terminates the blood glucose lowering action of GLP-1.^1,2

Remarkably, GLP-1 is glucose-dependent — it reduces blood glucose levels only after a person eats; it does not reduce glucose levels on its own. In clinical studies, GLP-1 administered intravenously to fasting patients failed to reduce blood sugar levels compared with patients who consumed a meal. This inability to induce hypoglycemia, or low blood sugar levels, in IV-administered GLP-1 led to the development of GLP-1 receptor agonists.²

Gut Microbiota Affects GLP-1

The human gut, commonly known as the gastrointestinal (GI) tract, possesses more than 1,000 microbial species that form a complex ecological community known as the gut microbiota. Composed of bacteria, viruses, yeast, fungi and other microorganisms, the gut microbiota plays a pivotal role in health and disease. It serves several functions, including fermentation of food, protection against pathogens, immune response stimulation and vitamin production. Composition, proportion and diversity of an individual’s gut microbiota are affected by genetics, lifestyle (diet), drugs (frequency/use of antibiotics), aging and other factors.^3-5

Microbial metabolites, such as secondary bile acids, short-chain fatty acids, lipopolysaccharide and others within the gut microbiota, trigger GLP-1 secretion. Eating certain foods — eggs, nuts (almonds, pistachios and peanuts), high-fiber grains (oats, barley and whole wheat), avocados, olive oil and vegetables (Brussels sprouts, broccoli and carrots) — has shown to support GLP-1 levels.^5-7

Multiple studies have linked gut dysbiosis — a change or imbalance in the diversity, composition and functions of the microbiota — to reduced GLP-1 levels. Reduced GLP-1 levels are directly associated with development of metabolic disorders, including type 2 diabetes and obesity.^3-8

Probiotics Support Gut Health

In addition to eating GLP-1-supportive foods, specific strains of probiotics can significantly alter the gut microbiome and increase GLP-1 production. For example, the probiotic Akkermansia muciniphila (A. municiphila) secretes a protein that induces natural production of GLP-1. A unique strain of A. municiphila, AH39, targets the mucosal layer of the gut, which is critical for retaining gut barrier integrity and promoting healthy inflammatory markers. It also promotes healthy systemic metabolic outcomes within the gut lining.^9,10

The Bifidobacterium animalis HN019 strain promotes the production of short-chain fatty acids in the gut microbiota. It also supports the intestinal barrier function and promotes healthy inflammatory markers.

The Bifidobacterium animalis B420 strain aids in weight management and supports metabolic health by influencing gut microbiota composition and promoting the production of short-chain fatty acids that support energy metabolism and contribute to GLP-1 secretion.

Lactobacillus rhamnosus GG is believed to support gastrointestinal health and immune balance. It may help promote the structural and functional integrity of the gut barrier. It also supports the composition and activity of the gut microbiome, promoting an increase in beneficial bacteria and the production of short-chain fatty acids. These actions may help maintain a healthy intestinal environment, promote healthy inflammatory markers and support metabolic functions.

Clostridium butyricum nourishes the gut lining, promotes healthy inflammatory markers and supports healthy barrier function. Clostridium butyricum 10 is known for its butyrate-producing capabilities. Butyrate is a primary energy source for colonocytes, supporting their health and promoting a robust intestinal barrier. It also supports the healthy expression of tight junction proteins, further enhancing barrier integrity.¹⁰

Many misrepresent the naturally occurring GLP-1 hormone with GLP-1 RA. It’s important, however, to recognize the distinctions. For individuals who cannot tolerate or afford GLP-1 RAs, options, including dietary food choices and probiotic nutritional supplements, are available.

References

Society for Endocrinology. Your Hormones: Glucagon-like peptide 1. Last reviewed July 2021. Accessed August 2024 at https://www.yourhormones.info/hormones/glucagon-like-peptide-1/
Nadkarni P, Chepurny OG, Holz GG. Regulation of glucose homeostasis by GLP-1. Prog Mol Biol Transl Sci. 2014;121:23-65. https://doi:10.1016/B978-0-12-800101-1.00002-8
Tomaro-Duchesneau C, LeValley SL, Roeth D, et al. Discovery of a bacterial peptide as a modulator of GLP-1 and metabolic disease. Sci Rep. 2020; 10:4922. https://doi.org/10.1038/s41598-020-61112-0
Zeng Y, Wu Y, Zhang Q, et al. Crosstalk between glucagon-like peptide 1 and gut microbiota in metabolic diseases. mBio 15:e02032-23. https://journals.asm.org/doi/10.1128/mbio.02032-23
Afzaal M, Saeed F, Shah YA, et al. Human gut microbiota in health and disease: Unveiling the relationship. Front Microbiol. 2022; 13:999001. https://www.frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2022.999001
Wang Q, Lin H, Shen C, et al. Gut microbiota regulates postprandial GLP-1 response via ileal bile acid-TGR5 signaling. Gut Microbes. 2023; 15(2). https://doi.org/10.1080/19490976.2023.2274124
Pederson T. What Foods Increase GLP-1 Levels? Healthline. 2024. Medically reviewed by Adam Bernstein, MD, ScD. Accessed August 2024 at https://www.healthline.com/health/foods-that-increase-glp-1
Li HY, Zhou DD, Gan RY, et al. Effects and Mechanisms of Probiotics, Prebiotics, Synbiotics, and Postbiotics on Metabolic Diseases Targeting Gut Microbiota: A Narrative Review. Nutrients. 2021;13(9):3211. https://doi:10.3390/nu13093211
Rodrigues VF, Elias-Oliveira J, Pereira ÍS, et al. Akkermansia muciniphila and Gut Immune System: A Good Friendship That Attenuates Inflammatory Bowel Disease, Obesity, and Diabetes. Front Immunol. 2022;13:934695. https://doi:10.3389/fimmu.2022.934695
Wellness Works. Metabolic Probiotic with Akkermansia Product Data Sheet. 2024. Accessed August 2024 at https://beta.pccarx.com/prod_data/10444-Metabolic-Probiotic-with-Akkermansia.pdf

Challenges in Pediatric Compounding: Excipients and Dosage Forms

Wed, 14 Aug 2024 13:48:00 GMT

by Rudesha Sanders, PharmD Candidate, PCCA Clinical Services Intern, and Tricia Heitman, PharmD, PCCA Clinical Compounding Pharmacist

Developing pharmaceutical products for pediatric patients generally requires age appropriate, weight-based dosing or extensive formula considerations. Most commercially available drug products are not formulated with pediatric populations in mind; they are often generated using unsafe excipients or produced in inappropriate dosage forms.¹

Excipients with Known Toxicity in Neonates

We should eliminate the use of these known excipients in compounds for neonatal (birth – 28 days) patients as much as possible due to toxicities:

Benzyl alcohol
Ethyl alcohol
Propylene glycol
Parabens

Benzyl alcohol intoxication can lead to metabolic acidosis and possible respiratory depression; ethyl alcohol is known to cause neurotoxicity and cardiovascular problems in pediatric patients; and high doses of propylene glycol can affect the central nervous system.²

In addition, the above-mentioned excipients are known to accumulate more in a neonate’s system due to the baby’s premature and underdeveloped organs — exercise caution if including any of the excipients in a compounded preparation.

Caution should also be exercised with other excipients, including benzalkonium chloride; polysorbate; peanut oil or other known food-related allergens such as lactose, sorbitol, sucrose, aspartame, saccharin, artificial colors; as well as sulfites such as sodium metabisulfite and sodium bisulfite, which may cause allergy-like reactions.^1-3

Excipient Concerns for Infants and Children

As infants (ages 29 days – < 2 years) and children (ages 2 years – < 12 years) grow, so do their organ systems; however, excipients remain a concern. Ethyl alcohol should be avoided in children under 2 years of age. Children 2 to 5 years of age should receive no more than a 6 mg/kg/dose of ethyl alcohol daily, with less than 0.5% percent volume in volume (v/v). Children 6 years and older should receive no more than 75 mg/kg/dose of ethyl alcohol daily; ages 6 to 12 years should receive less than 5% (v/v) of ethyl alcohol daily; and children ages 12 and older should receive less than 10% (v/v) of ethyl alcohol per day.^1,3

Benzyl alcohol is contraindicated in children 3 years old and younger. Polyethylene glycol should be used with caution in infants. It is recommended to use propylene glycol with caution in children less than 4 years old.²

Pediatric Dosage Forms and Safety Considerations

We should always be mindful of the types of dosage forms used when compounding preparations for children. Dosage forms should always be individualized to accommodate the child’s age, specific needs and preferences, as well as always dispensed in child-resistant packaging.

Oral suspensions, for example, are generally formulated in oil bases and pose a threat for aspiration, which can lead to lipoid pneumonia.^3,4 To reduce this risk, children under 2 years of age or children at high risk for aspiration should have oral suspensions formulated with aqueous bases. SuspendIt^® Anhydrous is a great base for pediatric patients: it’s preservative free; its anhydrous property allows for the potential of extended beyond-use dates (BUDs) and convenience for a parent or caregiver; its ability to mix easily with water, juice or other flavored liquids may possibly improve patient adherence; and its self-emulsifying drug delivery system allows use in nasogastric feeding tubes without clogging.⁶

Avoid using lollipops in children younger than 5 years of age due to the potential choking hazard — where the stick dislodges from the preparation — unless the child is closely supervised by a caregiver or medical personnel. Other challenges include flavoring issues and that lollipops must remain in the mouth for an extended period before they completely dissolve.

Like lollipops, hard troches should also be avoided in children under 5 years of age. In the event other dosage forms are not available or possible, ensure the child is closely monitored and supervised by a caregiver or medical personnel. Gelatin troches may be an option for children 2 years and older who have their primary teeth and can safely chew and swallow.⁷

Suppositories are generally a safe option in pediatric patients; just ensure use of the smallest size suitable for the dosage quantity.

Topical dosage forms are often a convenient and effective way to dose a child. The volume dispensed should be accurately measured and based on the patient’s age and weight. If a child has siblings, pets or attends school, instruct the child’s parents or caregivers to avoid placing the topical medication in an area where accidental transference to another child, caregiver or pet could occur.⁸

Remaining mindful and cautious of formulations and dosage forms used to compound preparations for neonates and infants will help reduce the accumulation of harmful toxicities. Applying the right dosage form with consideration toward the child’s age, specific needs and preferences, as well as their height and weight, will help ensure the safety and efficacy of compounded medications for pediatric patients.

References

Rouaz K, Chiclana-Rodríguez B, Nardi-Ricart A, et al. Excipients in the Paediatric Population: A Review. Pharmaceutics. 2021;13(3):387. Published 2021 Mar 13. doi:10.3390/pharmaceutics13030387 Accessed July 2024 at https://pubmed.ncbi.nlm.nih.gov/33805830/
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). (2022). General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products: Guidance for Industry. Accessed July 2024 at https://digirepo.nlm.nih.gov/catalog/nlm:nlmuid-9918486678506676-pdf
Bobillot M, Delannoy V, Trouillard A, et al. Potentially Harmful Excipients: State of the Art for Oral Liquid Forms Used in Neonatology and Pediatrics Units. Pharmaceutics. 2024;16(1):119. Published 2024 Jan 17. Accessed July 2024 at https://pubmed.ncbi.nlm.nih.gov/38258129/
Annobil SH, el Tahir M, Kameswaran M, Morad N. Olive oil aspiration pneumonia (lipoid) in children. Trop Med Int Health. 1997;2(4):383-388. Accessed July 2024 at https://pubmed.ncbi.nlm.nih.gov/9171848/
Sias SM, Ferreira AS, Daltro PA, et al. Evolution of exogenous lipoid pneumonia in children: clinical aspects, radiological aspects and the role of bronchoalveolar lavage. J Bras Pneumol. 2009;35(9):839-845. Accessed July 2024 at https://pubmed.ncbi.nlm.nih.gov/19820809/
Banov D, Liu Y, Ip K, Shan A, Vu C, Zdoryk O, Bassani A, Carvalho M. Analysis of the Physical Characteristics of an Anhydrous Vehicle for Compounded Pediatric Oral Liquids. Pharmaceutics. 2023;15(11):2642. Published 2023 Nov 20. Accessed July 2024 at https://pubmed.ncbi.nlm.nih.gov/38004620/
CDC (Last Reviewed 2022), Nutrition, Choking Hazards. Accessed July 2024 at https://www.cdc.gov/nutrition/infantandtoddlernutrition/foods-and-drinks/choking-hazards.html
Committee for Medicinal Products for Human Use. Reflection Paper: Formulations of Choice for the Paediatric Population. European Medicines Agency. Published 2006 Jul 28. Accessed July 2024 at https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-formulations-choice-paediatric-population_en.pdf

Nonsterile Pharmacy Training: Mastering the Role of the Designated Person

Wed, 24 Jul 2024 20:43:54 GMT

Revisions to USP 795, which went into effect November 1, 2023, introduce a new position for compounders: the Designated Person. This person or group of persons are responsible for creating and overseeing training, reviewing compounding staff competencies and maintaining training records for all compounding staff members. In this blog, we review the key responsibilities of the Designated Person for training standards and explore solutions that may help drive greater efficiencies in your compounding pharmacy’s training program.

by Jerra Banwarth, RPh, FAPC, PCCA Director of Online Education

Key Responsibilities of the Designated Person

As the guardian of pharmacy training, competency testing and recordkeeping, the Designated Person must:

Develop Training Programs: Create, implement and maintain a comprehensive training program that aligns with USP 795 requirements, including detailed, engaging and effective training materials.
Ensure Core Competencies: Competency isn't just about experience; it's about demonstrable skills. The Designated Person must ensure that all personnel involved in compounding are competent in their tasks, which involves annual assessments and practical evaluations of required competencies which are documented and tracked yearly.
Document and Track Training: Accurately record all staff training activities, completion rates and competency assessments; manage and track records; and make appropriate updates to training materials.
Implement Standard Operating Procedures (SOPs): Ensure staff members read, understand and adhere to the facility’s SOPs. This includes keeping the documents current and relevant to the pharmacy's daily operations on an annual basis.
Create Quality Assurance & Control with Corrective Actions: The designated person must create and manage a quality assurance and quality control program. Any deviation from those established standards will require immediate attention. The Designated Person must investigate, document and implement corrective actions for any out-of-specification events, ensuring continuous quality improvement.

Streamline Nonsterile Pharmacy Training Responsibilities with eLearning

We developed the PCCA eLearning Compounding Training & Learning Management System to simplify training and provide management efficiencies to ensure compounding pharmacies retain compliance.

Comprehensive eLearning Platform: Our eLearning platform delivers ready-made, interactive and USP-compliant training courses that cater to different learning styles (auditory, visual and tactile), enabling retention of information.
Customizable Competency Assessments: The competency assessment templates are customizable to fit specific procedures and equipment used in your pharmacy, saving significant time while ensuring assessments are relevant, consistent and comprehensive.
Automated Tracking and Documentation: The eLearning Management System included with the platform automates tracking and documentation of training and competency assessments. Expiration alerts serve as reminders for annual training and assessments while easy access to documents streamlines administrative processes.
Integration of SOPs: Integrating your facility’s SOPs into the Learning Management System can ensure that staff are not only reading but also understanding and applying these procedures. Interactive and scenario-based lessons make SOPs more relatable and easier to remember, helping staff understand and apply procedures.
Continuous Updates: Ongoing updates ensure training content remains current with industry changes, helping to maintain compliance and the overall quality of compounded products.

The role of the Designated Person is undeniably challenging, but with the right tools and solutions, it becomes manageable and even rewarding. By leveraging PCCA’s comprehensive eLearning Compounding Training & Learning Management System, the Designated Person can effectively implement and sustain robust training programs. This ensures compliance with USP 795 and fosters a culture of excellence and continuous improvement within your compounding pharmacy.

Click to learn more about how our eLearning Compounding Training & Learning Management System can help your pharmacy and request a free demo!

PCCA members with clinical services access may contact our Clinical Services team for help with USP 795 compliance and other compounding concerns.

THE PCCA BLOG

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Combination Products?

Regulatory Realities and Clinical Ethics

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Proactive, Not Reactive

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HOW SLEEP AFFECTS THE BODY AND BRAIN

Physical Restoration

Cognitive and Emotional Balance

Rhythm and Routine

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SIMPLE WAYS TO SUPPORT BETTER SLEEP

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Intended Use

The Wellness Works Difference

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Sublingual Semaglutide: Dosing Considerations, Patient Care and Regulatory Insights

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Best Practices for Sublingual Administration

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Beyond Weight Management

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Regulatory Insights: Staying Compliant

Individualized Care is Essential

Final Thoughts

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Strategic Planning: The Key to Growth

Tips for Getting Started

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Common and Uncommon Pathogens

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References

Easing Drug & Disease Side Effects in Hospice Patients

ABH Gel: Common & Customized

Studied Results: PermE8® Anhydrous Gel

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Hazardous Drug Wipe Sampling: Do I have to?

What and where should I test?

What do I do with the sampling results?

Reference

Partnerships Between 503A Pharmacies and 503B Outsourcing Facilities

Key Differences

Wholesale Prohibitions for 503B

Ellage^® Anhydrous Vaginal: The Base of Choice

Studied Results: PermE8^® Anhydrous Gel