As a clinician or patient, you may be wondering about the differences between a 503A compounding pharmacy and a 503B outsourcing facility. Belmar Pharma Solutions has two kinds of facilities — six 503A compounding pharmacies and two 503B FDA-registered outsourcing facilities. The 503A pharmacies are our traditional compounding pharmacies, where we make individualized formulations, following a compounding prescription that providers write for a specific patient.
Our 503B outsourcing facilities manufacture large quantities of medications that do not require patient-specific prescriptions for distribution to doctors’ offices, clinics, hospitals, and other health facilities for office use.
Belmar Pharma Solutions’ 503B outsourcing facilities, called Belmar Select Outsourcing, are regulated by the Food and Drug Administration (FDA). At these two facilities, we produce sterile hormone pellets in large quantities and distribute them directly to prescribers for office use.
Belmar Select Outsourcing was the next logical step for Belmar Pharma Solutions after years of pellet compounding at Belmar Pharmacy. We determined that one of the best ways to improve our processes and products was to voluntarily adopt the FDA’s drug manufacturing rules for sterile outsourcing facilities. We opened our first Belmar Select Outsourcing as a 503B facility in January 2016, and our second 503B facility in December 2024.
What Hormone Pellets Are Produced in a 503B Outsourcing Facility?
Belmar Select Outsourcing compound manufactures hormone pellet implants in estradiol, testosterone, testosterone with cholesterol, and anastrozole. Hormone pellet therapy can be used to address many of the conditions that typically respond to bioidentical hormone replacement therapy, including:
- Menopause symptoms
- Loss of bone density
- Sexual dysfunction in men and women
- Muscle and strength loss due to declining hormones
- Hormonal-based mood disorders
Other hormone-related conditions such as:
- Infertility
- PMS
- Obesity
- Diabetes
- Alzheimer’s
- Migraine headaches
- PTSD
- Thyroid health
- Metabolic syndrome
- Parkinson’s
Pellet implants deliver bioidentical hormones in a way that’s similar to the body’s natural delivery system. In a simple office procedure, a provider uses a trocar to insert the prescribed number of rice-grain-sized pellets under a patient’s skin near the hip. The pellets then release steady small amounts of hormones directly into the bloodstream for several months.
Belmar Select Outsourcing’s Focus on Quality
We are committed to the highest level of quality standards of any outsourcing facility in the United States. Every single employee cares about the safety and quality of our pellets and injectable medications, and the health of patients.
Our pellets are sterilized using advanced sterilization techniques, uniquely suited for this dosage form. Every batch is thoroughly tested for potency and endotoxins.
We strictly comply with all the regulatory standards for 503B sterile facilities. As an FDA-registered outsourcing facility, we:
- Comply with Food and Drug Administration-enforced current good manufacturing practice (CGMP) requirements, similar to those required of major drug manufacturers
- Meet all applicable state requirements for registered outsourcing facilities
- Are subject to regular FDA inspections
- Comply with the Drug Enforcement Administration (DEA), which oversees controlled substances used in compounded preparations
Additionally, we have our own policies that exceed these industry standards. Our active pharmaceutical ingredients (APIs) and manufactured pellets are tested and retested, randomly and continuously by an independent lab at every step from sourcing through distribution.
Why Should You Use Belmar for Your Office-Use Pellet Orders?
As national 503B outsourcing facilities with years of experience and significant investment in state-of-the-art manufacturing and clean room facilities, we offer:
- Carefully enforced high-quality standards
- Fast turnaround times
- No contracts required
- Trocars available from several different manufacturers
- Licensing in and shipment to 48 states and District of Columbia
- Expert-level clinical education, including free provider webinars, and consultation resources
- Patient education to help your patients understand and take full advantage of the therapies you prescribe
- Outstanding customer service
- A team of Solutions Engineers to support your practice
If you are a healthcare provider interested in learning more about ordering pellets or sterile injectable medications for office use from Belmar Select Outsourcing, please contact one of our Solutions Engineers today.
