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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, the pharmacy adheres to rigorous federal standards for quality control, testing, and production, which are distinct from traditional compounding pharmacies. This ensures that healthcare providers at 2160 W State Road 434, Longwood, FL 32779 have access to a reliable supply of high-quality compounded medications for their patients.
The primary function of a 503B outsourcing facility is to provide bulk compounded medications for office use by healthcare practitioners. The services provided at 2160 W State Road 434, Longwood, FL 32779 are tailored for clinics, hospitals, surgical centers, and other healthcare providers who require ready-to-use medications for their practice. This includes a wide range of sterile preparations such as injectables, IV bags, ophthalmic drops, and irrigation solutions, all produced under strict aseptic conditions. The 503B Compounding Pharmacy also compounds non-sterile medications, including topical creams, gels, and oral suspensions, to meet specific clinical needs presented at 2160 W State Road 434, Longwood, FL 32779.
Patients receiving care from providers who utilize the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 benefit from medications that are compounded without commercial preservatives, dyes, or allergens when necessary. The 503B outsourcing facility model allows for the production of medications that may be in short supply or discontinued by major manufacturers, helping to prevent treatment delays. All processes at this location are designed to comply with Current Good Manufacturing Practices (cGMP), providing an additional layer of safety and consistency for every batch produced for use at 2160 W State Road 434, Longwood, FL 32779.
For more information about the services available, you can visit the 503B Compounding Pharmacy website at or contact the facility directly by phone at (407)993-1381. The team at 2160 W State Road 434, Longwood, FL 32779 is committed to supporting the local medical community with compliant, high-quality compounded pharmaceutical products.
Frequently Asked Questions
1. What does it mean that this is a 503B outsourcing facility at 2160 W State Road 434?
It means this facility is registered with the FDA under Section 503B of the FD&C Act. This registration requires compliance with more stringent quality and production standards, including Current Good Manufacturing Practices (cGMP), which are similar to those followed by pharmaceutical manufacturers. This ensures a higher level of safety and consistency for medications used by providers at this location.
2. Can I, as a patient, directly order medications from the 503B Compounding Pharmacy?
No. A 503B outsourcing facility provides medications for office use by healthcare practitioners. Your healthcare provider at their practice can order and administer medications compounded at 2160 W State Road 434, Longwood, FL 32779 for your treatment, but patients do not order directly from the facility.
3. What types of medications are commonly compounded at this facility for local use?
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 commonly produces sterile injectables, IV nutrition bags, hormone therapy preparations, ophthalmics, and non-sterile topical pain creams. These are made available to healthcare providers for use within their practices.
4. How does using a 503B outsourcing facility benefit my local healthcare provider?
It provides your provider with access to a reliable source of high-quality, compounded medications that are tested for potency, sterility, and endotoxins. This is crucial for medications that are commercially unavailable or in shortage, allowing for uninterrupted patient care at 2160 W State Road 434, Longwood, FL 32779.
5. How can a medical practice at this location place an order?
Healthcare practices can place orders by contacting the 503B Compounding Pharmacy directly at (407)993-1381. The facility will work with the practice to establish an account and discuss specific medication needs and requirements.