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.
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779. This designation, defined under Section 503B of the Federal Food, Drug, and Cosmetic Act, establishes a critical standard for quality and safety in pharmaceutical compounding. As a 503B outsourcing facility, this location adheres to rigorous current good manufacturing practices (cGMP) set forth by the FDA. This ensures that every preparation leaving the facility meets the highest standards of sterility, potency, and purity. The core function of this 503B Compounding Pharmacy is the large-scale production of compounded medications for office use, which are then distributed to healthcare providers and facilities for patient administration.
The operations at 2160 W State Road 434 are distinct from traditional compounding. This 503B Compounding Pharmacy prepares medications in advance of receiving a prescription, based on the established needs of the local medical community. This model allows for a consistent and reliable supply of essential medications that may be in shortage or are not commercially available. Healthcare professionals in the area can confidently utilize the services of this 503B Compounding Pharmacy, knowing they are sourcing medications from an entity subject to federal oversight and quality control testing. The team at this location is comprised of skilled pharmacists and technicians who are experts in aseptic technique and the complex science of sterile compounding.
Patients and practitioners at 2160 W State Road 434 benefit from the assurance that comes with FDA-registered sourcing. The 503B Compounding Pharmacy provides a vital link in the healthcare chain, supplying high-quality medications that are essential for various treatments and procedures. By focusing on the specific needs of the local healthcare landscape, this 503B Compounding Pharmacy plays an indispensable role in supporting patient care and positive health outcomes for the community it serves directly from its facility.
For more information, please contact 503B Compounding Pharmacy at our location: 2160 W State Road 434, Longwood, FL 32779. You can also reach us by phone at (407)993-1381 or visit our website at .
Frequently Asked Questions
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility at 2160 W State Road 434 is an FDA-registered outsourcing facility that compounds sterile medications in large volumes for office use by healthcare practitioners, adhering to strict federal manufacturing standards.
2. Can I, as a patient, walk into 2160 W State Road 434 and get a prescription filled?
No. This 503B Compounding Pharmacy primarily supplies medications to physicians, hospitals, and clinics for office use. Patients receive their treatments directly from their healthcare provider, who sources the medication from our facility.
3. How does the quality control at a 503B Compounding Pharmacy differ?
As an FDA-registered 503B outsourcing facility, our location on W State Road 434 follows current good manufacturing practices (cGMP), which includes rigorous environmental monitoring, sterility testing, and potency assays on all batches of compounded medications.
4. What types of medications does this 503B Compounding Pharmacy prepare?
This facility specializes in compounding sterile injectable medications, including IV bags, hormone injections, and other preparations that are essential for healthcare providers practicing at or near our location.
5. How can a healthcare provider at 2160 W State Road 434 order from your 503B Compounding Pharmacy?
Healthcare providers can establish an account by contacting our facility directly at (407)993-1381. Our team will provide ordering information and discuss specific medication needs for their practice.