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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation signifies a commitment to the highest standards of quality, safety, and compliance in pharmaceutical compounding. Located at 2160 W State Road 434, Longwood, FL 32779, this facility specializes in the large-scale compounding of sterile and non-sterile medications that are not available commercially. The 503B Compounding Pharmacy model ensures that healthcare providers in the local community have access to a reliable source for patient-specific medications that meet rigorous federal quality standards.
The core function of the 503B Compounding Pharmacy at 2160 W State Road 434 is the production of medications in larger batches for office use by healthcare practitioners. This is distinct from traditional compounding, as it operates under the oversight of the FDA, adhering to Current Good Manufacturing Practices (cGMP). This provides an added layer of assurance for physicians, surgeons, veterinarians, and other medical professionals who utilize these medications for their patients. The facility's processes are designed to ensure sterility, potency, and purity, which is critical for medications such as injectables, ophthalmics, and other preparations that require an aseptic environment.
Patients and prescribers who utilize the services of this 503B Compounding Pharmacy benefit from its specialized role in the healthcare ecosystem. By focusing on outsourcing facility operations, the pharmacy provides physicians with access to necessary medications that may be in short supply or discontinued by major manufacturers. The location at 2160 W State Road 434, Longwood, FL 32779, serves as a centralized hub for the compounding and distribution of these vital drugs, supporting the local medical community with consistent, high-quality pharmaceutical options.
For more information about the services provided, you can visit the 503B Compounding Pharmacy website at or contact the facility directly by phone at (407)993-1381. The team is available to assist healthcare providers with their specific medication needs and to provide detailed information about the compounded preparations available from this FDA-registered outsourcing facility.
Frequently Asked Questions
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility is an FDA-registered outsourcing facility that compounds medications in accordance with Section 503B of the Federal Food, Drug, and Cosmetic Act. This registration requires adherence to stricter Current Good Manufacturing Practices (cGMP) for higher-volume production compared to a traditional pharmacy.
2. Who can order medications from this 503B Compounding Pharmacy?
Medications are typically distributed for "office use" and are ordered by licensed healthcare practitioners, including physicians, surgeons, and veterinarians, for administration to patients within their practice at 2160 W State Road 434, Longwood, FL 32779.
3. Can I as a patient walk in and get a prescription filled?
No. As a 503B outsourcing facility, the primary function is to supply medications to healthcare providers for office use. Patients should work directly with their prescribing healthcare provider, who can order the necessary compounded medications from this facility.
4. What types of medications does this 503B Compounding Pharmacy prepare?
The facility compounds a range of sterile and non-sterile medications that are not commercially available, including various injectables, ophthalmics, and other preparations that meet specific needs of the local medical community served from 2160 W State Road 434.
5. How do I contact this 503B Compounding Pharmacy?
You can contact the facility by calling (407)993-1381. Healthcare providers can also find more information online at .