Compounding Pharmacy

What is Compounding

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.


 

Why Compounding Matters in Clinical Practice

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.


 

Regulatory Framework

Compounding is governed by the Federal Food, Drug, and Cosmetic Act (FDCA) 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.


 

Melbourne Pharma’s Role in Compounding

At Melbourne Pharma, compounding is at the core of what we do. By combining clinical expertise, advanced facilities, and strict quality standards, we empower providers with:

  • Patient-centered solutions for individualized care.

  • Reliable sterile preparations for hospitals, clinics, and office-based practices.

  • Confidence in compliance with state and federal regulations.

Our mission: to deliver compounded therapies that expand treatment possibilities, enhance safety, and optimize outcomes for every patient.

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