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 from its location at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act establishes a critical operational standard, distinguishing this facility from traditional compounding pharmacies. The 503B outsourcing facility is subject to rigorous current good manufacturing practice (cGMP) regulations and undergoes regular FDA inspections. This ensures that all preparations produced at the Longwood facility meet the highest standards of quality, purity, and consistency for the healthcare providers and patients it serves.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications that are not available commercially. This includes medications that may be in short supply, discontinued by manufacturers, or require a specific formulation not offered by standard pharmaceutical companies. By operating from 2160 W State Road 434, this facility provides healthcare practitioners in Longwood with a reliable, domestic source for these essential medications. The preparations are compounded in bulk by the 503B outsourcing facility without patient-specific prescriptions and are then distributed to hospitals, clinics, and physician offices for office use, ensuring practitioners have the necessary medications on hand for patient care.
Quality and safety are the foundational principles of 503B Compounding Pharmacy. Every process at the Longwood location, from ingredient sourcing to final testing, is governed by strict protocols. Ingredients are sourced from FDA-registered and approved suppliers, and each component is rigorously tested for identity, potency, and purity. The sterile compounding suites are designed to meet ISO Class 7 and 5 standards, with environmental monitoring conducted continuously to ensure aseptic conditions. Finished products undergo stringent analytical testing to verify sterility, potency, and endotoxin levels before they are released for distribution, providing an unparalleled level of safety assurance.
For healthcare providers at practices and facilities near 2160 W State Road 434, engaging with this 503B outsourcing facility offers significant advantages. It mitigates the risks associated with drug shortages and provides access to high-quality, compounded preparations that adhere to federal manufacturing standards. The team at 503B Compounding Pharmacy is dedicated to supporting the local medical community with a consistent and dependable supply of critical medications, all produced within the compliant and advanced environment of its Longwood facility.
To learn more about the services and products available from this specific outsourcing facility or to inquire about becoming a client, you can contact 503B Compounding Pharmacy directly. The team can be reached at (407)993-1381 for detailed discussions. Comprehensive information regarding compliance, available formulations, and the operational scope of the 503B outsourcing facility is also available on the official website at https://503bcompoundingpharmacy.com/.
FAQ
1. What does it mean that this is a 503B outsourcing facility at 2160 W State Road 434? It means this specific facility is registered with the FDA under Section 503B of the FD&C Act. This registration requires the 503B outsourcing facility to comply with stringent cGMP standards and undergo federal inspections, ensuring the medications compounded at this Longwood location meet high-quality benchmarks for office use by healthcare providers.
2. Who can order medications from the 503B Compounding Pharmacy in Longwood? Medications compounded at this 503B outsourcing facility are intended for office use by healthcare practitioners and are distributed to hospitals, clinics, and physician practices. Healthcare providers can order these preparations for their practice located near 2160 W State Road 434 without needing individual patient prescriptions.
3. What types of medications does this 503B outsourcing facility compound? The 503B outsourcing facility at this location specializes in compounding preparations that are on the drug shortage list or are not commercially available. This includes a range of sterile injectables, ophthalmics, and other formulations that are essential for healthcare providers serving patients in the area.
4. How does the 503B outsourcing facility ensure medication safety? The 503B outsourcing facility employs a multi-layered quality assurance system. This includes testing all incoming ingredients, compounding within controlled ISO-classified cleanrooms, and conducting rigorous final product testing for sterility, potency, and endotoxins before any preparation is released from the Longwood facility.
5. How can a local practice start ordering from 503B Compounding Pharmacy? Healthcare practices interested in the services of this 503B outsourcing facility can initiate the process by contacting the facility directly at (407)993-1381 or by visiting the website at https://503bcompoundingpharmacy.com/ to establish an account and discuss specific medication needs available from the Longwood location.