Integrative & Personalized Medicine

What makes personalized compounding different

Personalized compounding starts with a documented clinical reason. Federal law restricts compounding drugs that are essentially copies of commercially available products, and the exception is a change made for an identified individual patient that the prescriber determines produces a significant difference for that patient [1].

In practice that means a strength no manufacturer makes, a form the patient can actually take, or a formula without an ingredient the patient reacts to. Preference alone is not the standard, and the FDA recommends an FDA approved drug when one is available and appropriate [2].

How Mixwell supports these practices

• Custom strengths, including doses far below or between commercial tablet sizes
• Capsules, creams, gels, troches, and oral liquids, depending on the order
• Formulas without a specific dye, gluten, lactose, or preservative when a patient reacts to one
• Several prescribed actives consolidated into one preparation
• Preparations a practice cannot source commercially in the form it needs

Evidence in this field is uneven, and we report it as it stands. Low dose naltrexone is an example. A small randomized crossover trial in 2013 reported reduced pain in women with fibromyalgia [3], while a 2024 randomized trial of 99 women found 6 mg daily was not superior to placebo for pain, with a possible signal for memory problems [4]. An accompanying commentary framed the result as another disappointment for the field [5]. Whether a preparation fits a patient is the prescriber's decision.

Working with our pharmacist

Our pharmacist talks through strengths, bases, and dosage forms with the practice before compounding, and asks what the preparation needs to do that a commercial product cannot. The prescription should state the active ingredients and strengths, the form, the quantity, the directions, and the clinical reason for the customization. Batch records document every preparation, and finished preparations ship across California.

When a drug appears on the FDA drug shortages list, the FDA does not consider it commercially available, which changes what a pharmacy may prepare while the shortage lasts [1]. We check that list rather than assume.