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?

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.

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?

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.

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.

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.

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.

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?

Developing pharmaceutical products for pediatric patients typically involves creating age-appropriate, weight-based dosing or considering complex formulations. Many commercially available drugs are not tailored for children, often containing unsafe excipients or being provided in dosage forms unsuitable for pediatric use.

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.