Pharmacy compounding is the preparation of customized medications when commercially manufactured drug products do not meet the needs of an individual patient. In these situations, compounding pharmacists help fill gaps by preparing medications for a wide range of fields, including dermatology, oncology, pediatrics, and women’s health.
Rather than dispensing a drug exactly as it is produced by a pharmaceutical manufacturer, a compounding pharmacist combines, mixes, or modifies ingredients to create a medication tailored to a patient’s specific requirements.
When is Compounding Appropriate?
503A compounding should only be performed under a specific set of circumstances, as authorized under section 503A of the Federal Food, Drug, & Cosmetic Act and FDA guidance under two main scenarios:
- If a commercially available drug is not offered in the dosage form, strength, or combination needed, a prescriber may order a compounded version. FDA guidance permits compounding when a suitable commercial product is unavailable, allowing providers to tailor therapy to a patient’s needs.
- When an FDA-approved drug is in shortage, a provider can prescribe a compounded version to maintain continuity of care, allowing compounding to provide a substitute during shortages, helping to preserve a patient’s treatment plan.
Regardless of the scenario, a valid, patient-specific prescription is always required, and as an Alliance for Pharmacy Compounding (APC) report noted, it falls on the prescriber to determine whether a compounded drug is necessary, as well as its dosage form or strength.
Scope of Compounding
Compounding is an established segment of pharmacy practice in America, with an estimated 1-3% of all prescriptions written for compounded medications, showing that many patients and even pets benefit from these medications. According to the APC, the top 5 compounding therapies by volume were hormone replacement therapy, veterinary, GLP-1s, dermatology, and men’s health.
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In an APC survey of hundreds of compounding pharmacies across the country, the vast majority stated that they dispense traditional FDA-approved medications in addition to compounded therapies, with only 13% being compounding-only. The median 503A compounding pharmacy dispensed 350 compounded prescriptions per week and worked with about 150 different prescribers to provide roughly 100 unique formulations each week, underscoring how widespread compounding is in healthcare.
Recent trends also show how compounders respond to emerging therapeutic demand. One-third of surveyed pharmacies reported preparing compounded GLP-1 medications for diabetes or weight management sourced from 503B outsourcing facilities within the past two years, reflecting increased interest in newer treatments when specific dosages or formulations are not readily available.
How Patients and Providers Benefit from Compounding
These survey results show the scale of compounding in modern healthcare and many ways in which patients and providers benefit from access to compounded medicine. Compounded medications serve a variety of patient-specific situations:
Custom Dosage Forms or Strengths
A child, pet, or adult may need a liquid form of a medicine that is only sold as adult tablets, or a low dose that manufacturers don’t produce.
- Allergies and sensitivities: Some patients have allergies to excipients or dyes in commercial medications and need a formulation without those ingredients.
- Discontinued medications: Some older drugs may have been discontinued by their manufacturer, but a compounding pharmacist can sometimes recreate them if needed, provided the drug was not discontinued due to safety risks.
- Specialized therapies: Custom hormone replacement dosages or pain-management creams tailored to an individual are often compounded. The APC report found that hormone therapies make up 36% of compounded prescriptions by volume, reflecting their personalized nature.
- Veterinary needs: Animals often can’t take standard human pills, so 80% of pharmacies that compound non-sterile preparations (and 49% that compound sterile preparations) prepare medications for humans and veterinary patients.
These scenarios illustrate how compounding is integrated into patient care. The APC noted that compounding pharmacists have been doing this for generations, filling gaps when needed.
Oversight and Quality Standards
Because compounded medications are prepared outside of large-scale commercial manufacturing, clear standards and in-house oversight play an important role in ensuring quality. Compounding pharmacies follow the guidelines established by the United States Pharmacopeia (USP), which outline expectations for areas such as environmental controls, ingredient verification, and preparation stability. According to the APC survey, many pharmacies also invest in additional evaluation of their formulations, and 34% reported conducting stability studies for non-sterile preparations and 29% for sterile preparations.
Many pharmacies also take extra steps to ensure the safety of their compounded preparations, with some obtaining voluntary accreditations from organizations like the Pharmacy Compounding Accreditation Board or NABP programs to demonstrate their commitment to quality.
Appropriate training and experience are also important. The median compounding pharmacist in the APC survey has roughly 25 years of experience and about 19 years specifically in compounding. Technicians often hold certifications in sterile compounding. These trained professionals follow standardized protocols to minimize errors.
Compounding pharmacies operate under multiple layers of oversight that include federal law, USP guidelines, state licensure, and professional standards to help ensure quality and consistency. This strong regulatory framework is what makes compounding a trusted part of the healthcare system.
Partnering with Healthcare Providers
For prescribers, knowing when and how to use compounding can expand treatment options. In practice, this means a clinician prescribes a compounded medicine because they have determined it will meet their individual patient’s needs when a commercial medication cannot. Providers may specify desired ingredients, strengths, and administration routes based on their clinical judgment, and pharmacists can suggest stability considerations, a collaboration that ensures patients get exactly what they need.
Partnering with VLS Pharmacy & New Drug Loft
For healthcare providers, understanding compounding helps identify patients who may benefit from customized medications, and partnering with a trained compounding pharmacy ensures that those medications are prepared with transparency, quality, and accountability. VLS Pharmacy & New Drug Loft remains focused on supporting personalized patient care through responsible compounding practices. Through transparent processes and open communication with the providers we work with, we strive to be a reliable partner in delivering patient-specific medication solutions and supporting informed, collaborative care.
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Reach out to our team to learn about best practices and to partner with our experts on custom, compounded medications for your patients. All medications from VLS Pharmacy and New Drug Loft are prepared in a lab that follows safety and quality standards per our status as a 503A pharmacy.
