Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act, providing large-scale, sterile compounded medications to healthcare systems across the United States. The pharmacy is built to serve hospitals, surgery centers, clinics, and licensed healthcare providers that require consistent, compliant, and scalable access to compounded pharmaceuticals without patient-specific prescriptions. Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy follows current Good Manufacturing Practice (cGMP) standards and is subject to routine FDA inspection. This places it in a fundamentally different category than traditional 503A pharmacies. The focus is not retail compounding or one-off prescriptions. The focus is controlled production, batch consistency, sterility assurance, and regulatory discipline. The facility specializes in sterile injectable and non-sterile compounded medications designed to address drug shortages, support procedural efficiency, and improve supply chain reliability for healthcare providers. All production is performed in ISO-classified cleanroom environments using validated processes, documented quality systems, and lot-level traceability. Each batch undergoes appropriate sterility, endotoxin, and potency testing based on risk level and formulation requirements. 503B Compounding Pharmacy prioritizes transparency and compliance over speed or marketing claims. Products are compounded using USP-grade ingredients sourced from vetted suppliers, with full documentation available for healthcare partners. Beyond production, the pharmacy supports client institutions with regulatory documentation, recall readiness, adverse event reporting protocols, and consistent supply planning. The company exists to solve real operational problems for healthcare organizations. Drug shortages, inconsistent manufacturers, and unreliable distributors create risk for patient care. A properly run 503B facility reduces that risk by acting as a compliant, predictable manufacturing partner rather than a reactive supplier.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is central to our mission of providing high-quality compounded medications for patients at our location: 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, we adhere to rigorous federal standards for production, testing, and control that exceed those of traditional compounding pharmacies. This ensures that every preparation leaving our facility meets the highest levels of potency, purity, and sterility. Our operations are dedicated to serving the specific needs of healthcare providers and their patients from our facility in Longwood.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are patient-specific yet produced in bulk for office use by healthcare practitioners. The medications prepared at 2160 W State Road 434 are distributed to clinics and hospitals for use when a commercially available drug is not suitable for a patient's needs. This includes creating formulations that are sterile, non-sterile, and hormone-based, all manufactured under a strict quality control environment. Our work supports physicians and surgeons in the local medical community by providing them with reliable, ready-to-administer medications that are essential for their practice and patient care protocols.
Our facility at 2160 W State Road 434 is equipped with state-of-the-art technology and staffed by a team of highly trained pharmacists and technicians. Every process, from ingredient sourcing to final packaging, is meticulously controlled and documented. This unwavering commitment to compliance and quality means that healthcare providers who utilize our services can have absolute confidence in the medications they receive. We are a critical partner to the medical community, enabling them to offer personalized treatment options that are not otherwise available through standard pharmaceutical channels.
For more information about the services provided by 503B Compounding Pharmacy, or to speak with a representative, please contact us directly. You can reach us by phone at (407)993-1381 or visit our website to learn more about our compliance and capabilities at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with Current Good Manufacturing Practice (cGMP) regulations. This ensures the medications we compound meet stringent federal standards for sterility, potency, and purity, providing a higher level of assurance than traditional pharmacy compounding.
Who can receive medications from 503B Compounding Pharmacy?
Medications compounded at our facility are distributed to healthcare practitioners for "office use" and are not dispensed directly to individual patients. Physicians, clinics, and hospitals can utilize our services to obtain bulk compounded preparations for use in their practices located near 2160 W State Road 434.
What types of medications does 503B Compounding Pharmacy prepare?
Our FDA-registered outsourcing facility at 2160 W State Road 434 specializes in compounding a range of preparations, including sterile injectables, hormone replacement therapies, and other non-sterile medications that are prescribed by healthcare providers for their patients when a commercially manufactured drug is not appropriate or available.
How does a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can initiate orders by contacting our facility directly at (407)993-1381. Our team will provide information on ordering procedures, available formulations, and delivery options for services provided from 2160 W State Road 434.
Why would a healthcare provider choose 503B Compounding Pharmacy?
Healthcare providers choose our services because of our commitment to quality and compliance as an FDA-registered 503B outsourcing facility. By sourcing from us at 2160 W State Road 434, they ensure their patients receive medications produced under the most rigorous quality control standards available for compounded drugs.