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 at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act establishes a distinct category of compounding pharmacy. The 503B Compounding Pharmacy at this location adheres to rigorous federal standards for quality, safety, and production scale that exceed those of traditional compounding pharmacies. This facility provides a critical service by producing large batches of compounded sterile preparations (CSPs) and non-sterile preparations for office use by healthcare practitioners, ensuring a reliable supply of essential medications that may be commercially unavailable or in shortage.
The operations at 2160 W State Road 434 are central to the mission of a 503B outsourcing facility. The compounding pharmacy at this address manufactures medications without patient-specific prescriptions, which are then distributed to hospitals, clinics, and physician offices for administration to patients within their care. This model allows healthcare providers at 2160 W State Road 434, Longwood, FL 32779 to access vital medications, including IV bags, epidurals, ophthalmics, and other injectables, that are prepared under the strictest aseptic conditions and current good manufacturing practices (cGMP). The 503B Compounding Pharmacy provides these practitioners with the assurance of working with an entity that undergoes regular FDA inspections and stringent quality control testing.
For healthcare professionals and facilities sourcing medications from 2160 W State Road 434, Longwood, FL 32779, the 503B Compounding Pharmacy offers a significant advantage in mitigating drug shortages. By compounding preparations that are on the FDA drug shortage list or are no longer available from major manufacturers, this outsourcing facility provides a consistent and quality-assured alternative. The compounding pharmacy’s commitment to compliance and patient safety is embedded in every process, from ingredient sourcing to final product sterility testing, making it a trusted partner for the medical community.
Engaging with the 503B Compounding Pharmacy is designed for healthcare practitioners. The services provided from 2160 W State Road 434, Longwood, FL 32779 are tailored for office-use procurement rather than direct patient dispensing. Healthcare providers can coordinate with the compounding pharmacy to ensure a steady supply of necessary medications for their practice needs. To learn more about the specific preparations available or to discuss how this 503B outsourcing facility can support your practice, visit the website at https://503bcompoundingpharmacy.com/ or contact the facility directly at (407)993-1381.
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 large volumes of sterile and non-sterile medications for office use by healthcare practitioners. It operates under stricter federal regulations, including cGMP and routine FDA inspections, compared to a traditional 503A pharmacy.
2. Can I, as a patient, order my prescriptions directly from this location?
No. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 provides medications for office use to healthcare practitioners and facilities. Patients must receive their medications through their doctor, clinic, or hospital, which sources from this outsourcing facility.
3. What types of medications does this 503B outsourcing facility typically produce?
The compounding pharmacy at this location specializes in producing compounded sterile preparations (CSPs) like injectables, IV bags, and ophthalmics, often focusing on medications that are currently in national shortage or are not commercially available for healthcare providers to use.
4. How can a healthcare practice at 2160 W State Road 434 work with this compounding pharmacy?
Healthcare practices can establish an account with the 503B Compounding Pharmacy to order compounded medications for office use. Inquiries regarding setting up an account and available preparations should be directed to (407)993-1381.
5. How do I get more information about the services at this specific location?
For detailed information about the services provided specifically from 2160 W State Road 434, Longwood, FL 32779, you can visit the official website at https://503bcompoundingpharmacy.com/ or call the facility at (407)993-1381.