Your compounding pharmacy of choice

A compounding pharmacy prepares customized medications for individual patients based on a healthcare provider’s prescription. Unlike traditional pharmacies that dispense mass-produced drugs, compounding pharmacies create personalized formulations by adjusting dosage, removing allergens, combining medications, or changing forms to better meet a patient’s specific needs.

There are two types of compounding pharmacies. 503A pharmacies compound medications for individual patients. 503B outsourcing facilities produce medications for healthcare practices and facilities.

Learn more about what compounding pharmacies do and how they may benefit you.

503A pharmacies are state-regulated compounding pharmacies that make individualized formulations following a prescription written for a specific patient by a specific prescriber. This designation refers to section 503A of the Food, Drug, and Cosmetic Act, which specifies requirements for the compounding of drug preparations for individual patients.

503A pharmacies are the “traditional” type of compounding pharmacy, producing individualized prescriptions. Medications, including hormones, prepared by a 503A compounding pharmacy, are intended for patient-specific use.

503B outsourcing facilities are large-scale, FDA-regulated facilities that produce compounded medications, including hormones. This designation refers to section 503B of the Food, Drug, and Cosmetic Act, which describes the requirements that must be met for drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility. The 503B designation was created with the passage of the Drug Quality and Security Act (DQSA) in 2013.

Belmar Pharma Solutions is designated as both a 503A compounding pharmacy and as a 503B outsourcing facility. Both 503A pharmacies and 503B outsourcing facilities play an important role in meeting the needs of clinicians and patients when it comes to delivering personalized medicine. So which is the correct choice for your healthcare practice? The answer depends on what you are trying to accomplish. When you need an individualized prescription compounded for a specific patient, a 503A pharmacy is the right choice.

When you need non-patient-specific compounded medications, including hormones for office use without a patient prescription, a 503B outsourcing facility is the right solution. This option enables clinicians to maintain a supply of customized formulations in quantity, allowing administration to patients during an office visit.