INQUIRIES
Medical professionals with a private practice provide your patients with efficacious weight loss treatment that keeps them happy, healthy and coming back month after month.
As your provider we promise a pure product, produced in a 503b lab, with an adequate supply to meet your needs with no interruption.
503B FACILITES - ACCEPT NOTHING LESS
What is a FDA 503B Outsourcing Facility?
It is a facility located at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B under the Drug Quality and Security Act (DQSA).
What are the Requirements for a 503B Outsourcing Facility?
503B license outsourcers must comply with state and federal guidelines and meet strict Current Good Manufacturing Process (cGMP) standards. They must compound drugs under the direct supervision of a licensed pharmacist within the facility and have their compounded drugs and facility routinely inspected by the FDA.
What are the Benefits of a 503B Outsourcing Facility?
503B facilities are held to higher standards of safety and quality and must follow strict testing standards for sterility, potency, and endotoxins. Our robotic manufacturing facility gives us the ability to produce higher volumes which provides major cost savings to 503B healthcare partners and customers.
THE BLUE PEN DIFFERENCE
Our manufacturing facility operates under FDA’s cGMP standards and with a 503B license which holds us to a higher standard. Our semaglutide has an FDA’s National Drug Code Number, which makes it easier for prescribers to identify and track the medication, ensuring that patients receive the correct treatment.
Our product is pure semaglutide. We do not mix with untested ingredients like a peptide or B12 as there is no science related to the safety and efficacy of such mixtures.
Our FDA registered manufacturer is also a 503B facility and has the ability to produce large, consistent quantities providing major cost savings to healthcare partners and customers.
Our product comes reconstituted and it is not lyophilized. Which means we do not freeze dry the product. We believe that this process could impact the quality and efficacy of semaglutide. Plus, we use less packagaing material when shipping which reduces our carbon footprint.
Since you and or your patient do not have to reconstitute this will save time and energy. This also leaves less room for any mistakes in dosing.
