Compounding is the art and science of preparing customized medications to meet the specific needs of patients when commercially available products are not suitable. Compounded medications are created by licensed pharmacists who combine, alter, or tailor ingredients to produce a formulation designed for an individual or, in some cases, for office and institutional use.
Compounding allows providers to address therapeutic gaps and overcome barriers that standard medications cannot resolve, including:
Discontinued or backordered drugs – recreating essential therapies no longer available.
Allergen-free formulations – eliminating dyes, gluten, lactose, or preservatives.
Custom strengths and dosage forms – adjusting concentrations or delivery methods to meet unique patient populations (pediatrics, geriatrics, palliative care).
Alternative routes of administration – preparing medications as capsules, liquids, topical creams, troches, injections, or other delivery systems.
Combination therapies – integrating multiple active ingredients into a single, convenient preparation.
Compounding is governed by State and Federal Laws and further guided by USP standards such as <795>, <797>, and <800>. Depending on the setting, compounding may fall under:
503A pharmacies – patient-specific prescriptions.
503B outsourcing facilities – large-scale, FDA-regulated sterile compounding for office and hospital use.
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