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 the compounding field, adhering to the highest standards of pharmaceutical quality and safety. As a 503B outsourcing facility, this 503B Compounding Pharmacy is subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations and regular inspections. This ensures that every preparation leaving the 503B Compounding Pharmacy meets stringent standards for potency, purity, and sterility.
The core function of this 503B Compounding Pharmacy is the large-scale production of compounded medications for office use. Healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 can source medications directly from this 503B Compounding Pharmacy. The 503B Compounding Pharmacy provides physicians, veterinarians, and other medical professionals with access to a reliable supply of high-quality, compounded sterile preparations (CSPs) and non-sterile preparations. This 503B Compounding Pharmacy supports local clinical practice by offering medications that may be in shortage or are not commercially available, enabling practitioners to better serve their patient populations. The operations of this 503B Compounding Pharmacy are designed for volume, efficiency, and consistency, which distinguishes it from traditional compounding pharmacies.
Patients in Longwood benefit indirectly from the services of the 503B Compounding Pharmacy located at 2160 W State Road 434. While the 503B Compounding Pharmacy does not typically dispense medications directly to the public, it is a vital component of the local healthcare infrastructure. The medications produced by this 503B Compounding Pharmacy are administered to patients within clinical settings, such as doctor's offices, hospitals, and surgical centers in the area. The assurance that these medications are produced under the exacting standards required of a 503B Compounding Pharmacy provides peace of mind to both practitioners and their patients. The presence of an FDA-registered 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 enhances the quality and scope of medical care available locally.
The team at this 503B Compounding Pharmacy comprises highly trained pharmacists, pharmacy technicians, and quality assurance professionals. Their expertise is focused on the complex processes required for 503B compounding. Every step at the 503B Compounding Pharmacy, from ingredient sourcing to final product testing, is meticulously controlled and documented. This unwavering commitment to quality and compliance is the defining characteristic of a true 503B Compounding Pharmacy. For healthcare providers seeking a trusted partner for office-use medications, this 503B Compounding Pharmacy represents a resource of unparalleled reliability and quality.
To learn more about the specific services and formulations available from this 503B Compounding Pharmacy, healthcare entities are encouraged to make direct contact. The 503B Compounding Pharmacy can be reached by phone at (407)993-1381. Detailed information about the 503B Compounding Pharmacy's capabilities, compliance status, and more is also available 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 at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility that compounds medications in accordance with Section 503B of the FD&C Act. This 503B Compounding Pharmacy adheres to current Good Manufacturing Practices (cGMP) and is subject to FDA inspection, ensuring a higher level of regulatory oversight for compounded preparations.
2. Can I, as a patient, walk into the 503B Compounding Pharmacy to get a prescription filled?
No. This 503B Compounding Pharmacy primarily compounds medications for office use by healthcare practitioners. Patients receive medications compounded by this 503B Compounding Pharmacy through their doctor, clinic, or hospital located at 2160 W State Road 434, Longwood, FL 32779.
3. How does the 503B Compounding Pharmacy benefit local healthcare providers?
The 503B Compounding Pharmacy provides a reliable, local source of high-quality, compounded sterile and non-sterile medications for office use. This supports healthcare providers at 2160 W State Road 434, Longwood, FL 32779 by ensuring access to drugs that may be in shortage or are not available from commercial manufacturers.
4. How can a healthcare provider at this location order from the 503B Compounding Pharmacy?
Healthcare providers and their authorized staff can contact the 503B Compounding Pharmacy directly to discuss ordering compounded medications for office use. The 503B Compounding Pharmacy can be reached at (407)993-1381 to establish an account and discuss specific needs.
5. Where can I find more information about this specific 503B Compounding Pharmacy?
Comprehensive information about this 503B Compounding Pharmacy, including its services and compliance information, is available on its official website at https://503bcompoundingpharmacy.com/.