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 in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. This 503B Compounding Pharmacy is situated at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy model represents a significant advancement in pharmaceutical compounding, focusing on the large-scale production of compounded sterile preparations (CSPs) for office use by healthcare practitioners. The operations at this specific 503B Compounding Pharmacy location are distinct from traditional 503A compounding pharmacies, as the 503B Compounding Pharmacy is subject to Current Good Manufacturing Practice (cGMP) regulations and undergoes regular FDA inspections to ensure the highest standards of quality, sterility, and safety for all preparations.
The core mission of this 503B Compounding Pharmacy is to provide healthcare providers with access to a consistent and reliable supply of high-quality sterile medications. By functioning as a 503B outsourcing facility, this 503B Compounding Pharmacy can produce medications in larger batches without patient-specific prescriptions, which are then available for healthcare professionals to keep in stock for immediate administration to patients. This is a critical service for clinics, hospitals, surgical centers, and veterinary practices located near 2160 W State Road 434, Longwood, FL 32779, ensuring they have essential medications on hand when needed. The 503B Compounding Pharmacy team is comprised of skilled pharmacists and technicians who utilize state-of-the-art technology and rigorous testing protocols to guarantee the potency and purity of every preparation that leaves the facility.
Patients and practitioners who engage with this 503B Compounding Pharmacy benefit from an additional layer of regulatory oversight and quality assurance that is specific to the 503B Compounding Pharmacy designation. Every product is compounded under stringent environmental controls and is supported by thorough documentation and validation processes. For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, partnering with this 503B Compounding Pharmacy means mitigating risk and enhancing patient care through dependable pharmaceutical sourcing. The 503B Compounding Pharmacy is committed to upholding the highest ethical and professional standards in every aspect of its operation.
To learn more about the specific sterile preparations available from this 503B Compounding Pharmacy or to inquire about becoming a client, healthcare providers are encouraged to make direct contact. The dedicated team at this 503B Compounding Pharmacy is ready to answer questions and provide comprehensive support. The 503B Compounding Pharmacy can be reached via phone at (407)993-1381. Additional information about the 503B Compounding Pharmacy and its compliance standards can be found on the official website at https://503bcompoundingpharmacy.com/.
FAQ
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. This 503B Compounding Pharmacy adheres to Current Good Manufacturing Practices (cGMP) and is subject to routine FDA inspections, providing an elevated standard of quality and safety for compounded sterile medications.
2. As a patient at 2160 W State Road 434, Longwood, FL 32779, can I order directly from this 503B Compounding Pharmacy?
No, a 503B Compounding Pharmacy primarily supplies medications in bulk to healthcare providers and facilities for their "office use." Patients receive these medications directly from their doctor, clinic, or veterinarian during a procedure or appointment, not through a direct prescription fill from the 503B Compounding Pharmacy.
3. What types of medications does this 503B Compounding Pharmacy produce?
This 503B Compounding Pharmacy specializes in producing large batches of sterile preparations, such as injectables, ophthalmics, and other formulations that require aseptic processing. Common examples include hormone injections, pain management solutions, and electrolyte IV bags for hydration therapy.
4. How does a healthcare provider at this location order from the 503B Compounding Pharmacy?
Healthcare providers and facilities can establish an account with the 503B Compounding Pharmacy. Orders are placed directly by the provider or their authorized staff. For detailed ordering information, providers should contact the 503B Compounding Pharmacy directly at (407)993-1381.
5. Why should a clinic choose this 503B Compounding Pharmacy over other suppliers?
Choosing this 503B Compounding Pharmacy ensures your medications are sourced from an FDA-registered facility that meets the highest federal standards for sterility and quality control. This reduces risk for the practice and provides assurance that patients are receiving the highest quality compounded preparations available.