503B Compounding Facility
Understanding 503B Outsourcing Facility
Belmar Pharma Solutions’ 503B outsourcing facility is regulated by the Food and Drug Administration (FDA) and produces sterile hormone pellets in bulk quantities and distributes them directly to prescribers. After years of pellet compounding at Belmar Pharmacy, we felt that the next step in improving our process and product would be to voluntarily adopt the FDA’s drug manufacturing rules for sterile outsourcing facilities. We opened Belmar Select Outsourcing as a 503B facility in January 2016.
What is a 503B Outsourcing Facility?
503B Outsourcing Facilities also called 503B facilities by the FDA, manufacture large batches of medications without prescriptions to be sold to doctors’ offices, clinics, hospitals, and other health facilities for office use.
Belmar has two kinds of facilities — a 503A compounding pharmacy and a 503B FDA-registered outsourcing facility. The 503A facility is our traditional compounding pharmacy, where we make individualized formulations, following a compounding prescription that you write for a specific patient. Our 503B outsourcing facility specializes in providing quality hormone pellet implants that we ship directly to your office.
What Hormone Pellets Does Belmar Offer?
Belmar compound manufactures hormone pellet implants in estradiol, testosterone, testosterone with cholesterol, progesterone, and anastrozole. Hormone pellet therapy can be used to treat many of the conditions addressed by bioidentical hormone replacement therapy, including:
- General menopause symptoms
- Loss of bone density
- Sexual dysfunction in men and women
- Muscle and strength loss due to declining hormones
- Hormonal-based mood disorders
- Breast cancer
- Other hormone-related conditions such as infertility, PMS, obesity, diabetes, Alzheimer’s, migraine headaches, PTSD, thyroid health, metabolic syndrome, and Parkinson’s
Pellet implants deliver bioidentical hormones in a way that’s similar to the body’s natural delivery system. In a simple, quick office procedure, you can use a trocar to insert the prescribed number of rice-grain-sized pellets under a patient’s skin near the hip. The pellets will release steady small amounts of hormone directly into the bloodstream for several months.
Belmar’s Focus on Quality
We believe we have the highest level of quality standards of any compounding pharmacy in the U.S. Every one of us cares about the safety of our medications and the health of your patients.
Our pellets are sterilized using advanced sterilization techniques, uniquely suited for this dosage form. Every batch is tested for potency and endotoxins.
We comply strictly with all the regulatory standards for 503B sterile facilities. As a 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 FDA inspection
- Comply with the Drug Enforcement Administration (DEA), which oversees controlled substances used in compounded preparations
We have our own policies that exceed even these industry standards. Our ingredients and compounds are tested and retested, randomly and continuously, by an independent lab, all the way from sourcing through distribution.
Why Should You Use Belmar for Your Office-Use Pellet Orders?
As a national 503B Compounding Facility with experience and significant investment in state-of-the-art manufacturing and clean room facilities, we offer:
- Reliability
- Carefully enforced high-quality standards
- Treatments for a range of health and wellness issues
- Batch size flexibility
- Fast turnaround on orders
- No contracts required
- Disposable or reusable trocars available with your pellet order
- Licensing in and shipment to 40 states
- Expert-level clinical education and consultation resources
- Free educational webinars
- Patient education to help your patients understand and take full advantage of the treatments you prescribe
- Outstanding Customer Service
- Inventory Management Assistance
- A team of Solutions Engineers to support your practice
Contact the Solutions Engineer in your state to help you complete a New Account Application to start ordering
If you would like to be contacted by one of our Solution Engineers to review pricing and other details, please complete our quick intake form.
If you already have a LifeFile account, place an order today.
We provide a formulary and lots more information targeted to clinicians on our website. Through our strategic partnership with the Hormonal Health Institute, you can have access to personalized training and self-study programs on hormone therapy and pellet therapy. You can also set up a one-on-one consultation with our clinical experts to get answers to any questions.
If you are a patient looking for more information on the benefits of compounding and compounded medications, check out our medication solutions pages to get started. Then have a talk with your doctor about whether compounding can help you become healthier or just keep the great health you have.
