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What does working with a 503B Outsourcing Facility mean for my practice?
Because Belmar Select Outsourcing is a Registered 503B Outsourcing Facility and has applied for a DEA manufacturing license, you may order hormone pellet implants in bulk and have them shipped directly to your office. We do not require patient specific prescriptions, nor do we require contracts like other 503B Outsourcing Facilities.
What is a 503B Outsourcing Facility?
In an effort to improve patient safety, the President signed the Drug Quality and Security Act (DQSA) November 27, 2013. This act allowed compounding pharmacies to voluntarily register as a 503B Outsourcing Facility for the compounding manufacturing of sterile medications.
These facilities are regulated and inspected directly by the FDA according to a risk-based schedule. Pharmacies that become registered facilities must comply with cGMP practices, which are rules and guidelines similar to those required of major drug manufacturers.
Click here for current listings of FDA Registered Outsourcing Facilities.