What is Belmar Select Outsourcing?
Belmar Select Outsourcing is our national 503B outsourcing facility regulated by the U.S. Food and Drug Administration (FDA). We operate two 503B locations that compound manufacture sterile hormone pellets and sterile injectable testosterone cypionate blends in large-scale quantities for direct distribution to prescribers.
As a 503B outsourcing facility, the products we dispense are not patient-specific prescriptions, but office-use pellets and testosterone cypionate blends that can be shipped directly to a prescriber office or healthcare facility. Between our two facilities, Belmar Select Outsourcing is licensed to ship to 48 states, including California and Washington D.C.
Benefits
As a national 503B outsourcing facility with two locations, with vast experience and significant investment in state-of-the-art manufacturing and clean room facilities, we offer:
- No contracts required
- Expert-level medication education, including free webinars
- Available pharmacists for clinical support
- Outstanding customer service
- Trocars available from external manufacturers
- Solutions Engineers to support your practice
Quality
When it comes to bioidentical hormone replacement therapy (BHRT), pellets are often the preferred option for patients seeking hormonal support during menopause and andropause. Pellet quality is extremely important for patient safety and prescriber trust. Pellet ingredients matter, as does the pellet manufacturing process.
During the manufacturing process, Belmar Select Outsourcing’s pellets are 100% weight tested and visually inspected. The pellets are packaged in glass vials designed to maintain the sterility of the unopened product. BSO pellets are then terminally sterilized using e-beam radiation, which ensures the encased pellet is free from contamination. This method allows the penetrating beam to sterilize the pellet inside and out.
Belmar Select Outsourcing’s liquid injectable vials are manufactured through an equally rigorous process. These vials are designed to maintain the sterility of the unopened product complete with a flip-off cap that serves as a tamper-evident seal. Each vial is 100% visually inspected for particulates and then terminally sterilized via e-beam radiation.
The final step in the process is independent third-party testing to confirm that both our pellets and liquid injectable vials meet established standards for identity, strength, quality, and purity. These rigorous measures ensure that our sterile, compounded pellets and injectable formulations consistently uphold Belmar’s unwavering commitment to patient safety and exceptional product quality.
Compliance
Belmar Select Outsourcing purchases the ingredients for our compound manufactured products from FDA-registered drug facilities. The supplier qualification program our facility has in place ensures all manufacturers and suppliers providing Belmar’s pharmaceutical ingredients are registered and certified by the appropriate regulating bodies.
As a registered outsourcing facility, Belmar Select Outsourcing is compliant with all the regulatory standards for 503B sterile facilities, including:
- FDA-enforced current good manufacturing practice (CGMP) requirements. These requirements are similar to those of major drug manufacturers.
- State requirements. State-specific regulatory boards enforce standards for every aspect of 503B outsourcing.
- FDA inspection. 503B outsourcing facilities are subject to routine FDA inspection.
- Drug Enforcement Administration (DEA). Agency that holds 503B outsourcing facilities accountable by overseeing the proper handling of controlled substances, from registration and recordkeeping to security and reporting.
We perform regular inspections of our own facilities to ensure our medications uphold established standards and are securely stored. While many compound manufacturers meet these expectations, we exceed them, holding our facilities to the highest criteria.
Medications
- Testosterone
- Testosterone Cypionate/Dehydroepiandrosterone (DHEA)
- Testosterone Cypionate/Anastrozole
- Testosterone Pellets
- Estradiol Pellets
- Anastrozole Pellets
What are these medications?
Belmar Select Outsourcing compound manufactures bioidentical hormone pellets for in-office insertion. Belmar sterile compounds hormone pellet implants with estradiol, testosterone, testosterone (cholesterol), and anastrozole.
Our injectable blends for office use are combinations of testosterone cypionate/DHEA and testosterone cypionate/anastrozole in grapeseed oil. Testosterone Cypionate is a form of testosterone replacement therapy that is designed to absorb when administered intramuscularly (IM) or subcutaneously (SC). Testosterone Cypionate Injectable Blends are compounded preparations that combine testosterone cypionate with DHEA (dehydroepiandrosterone) or anastrozole.
Place an Office-Use Order
Our Credentials:
NABP®Accredited
LegitScript
503A
503B
California Sterile License
Commonly Asked Questions About Our 503B Outsourcing Facility
Belmar’s 503A pharmacies ship to all 50 states, Washington, DC, Puerto Rico, and Guam. Belmar’s 503B Outsourcing Facilities ship to 48 states and Washington, DC.
There are a number of factors that affect turnaround time. Most 503A prescriptions are prepared within 3 to 5 business days of order verification and payment. Please consider compounding time when choosing shipping options. 503B orders are often shipped the day after you submit your order when all medications are in stock.
Place an order here.
While any one pharmacy cannot be both 503A and 503B, Belmar Pharma Solutions consists of six 503A pharmacies and two 503B outsourcing facilities.
Ordering from a 503B outsourcing facility enables clinicians to maintain a supply of medications, including hormones that are not commercially available. This allows clinicians the flexibility to provide care that meets their patients’ needs.
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.
Yes, contact us and we can provide the information you need about formulary, pricing, and applications. Our most commonly prescribed compounded medications and hormones are available for your review.
Contact us and we can provide the information you need about formulary, pricing, and applications for both 503A and 503B. If you have immediate questions and would like to speak to a Solutions Engineer, someone is available to help you Monday through Friday during business hours.
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.
We help ensure consistent quality by: Sourcing ingredients exclusively from FDA-registered facilities, performing independent testing from sourcing through distribution, meeting all applicable cGMP guidelines (for 503B) and USP guidelines (for 503A), and maintaining key industry certifications, including those shown in the footer of this page.
There are numerous differentiators between Belmar Pharmacy and other national and local compounding pharmacies. You will find our experince, quality, and compliance details when you read “Why Belmar?”
