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, it adheres to rigorous federal standards for quality control, testing, and production, providing healthcare providers with a reliable source for patient-specific medications that are not commercially available.
The core service of 503B Compounding Pharmacy is the preparation of compounded medications in bulk for office use by healthcare practitioners. This means that physicians, surgeons, dermatologists, and other medical professionals in the area can source high-quality, pre-made medications for their procedures and treatments directly from this facility. By operating under strict Current Good Manufacturing Practices (cGMP), 503B Compounding Pharmacy ensures that every batch of medication is consistent, pure, and potent, offering a critical level of assurance for both practitioners and their patients at 2160 W State Road 434, Longwood, FL 32779.
Patients benefit indirectly through the care provided by their local healthcare providers who utilize the medications compounded at this location. The services enable medical practices to offer tailored therapeutic solutions, including hormone replacement therapy (HRT) medications, sterile injectables for pain management, ophthalmologic solutions, and other specialized formulations. The facility's commitment to compliance and safety makes it a vital partner to the medical community, supporting personalized patient care from its location on W State Road 434.
For more information or to speak with a representative, please contact 503B Compounding Pharmacy directly. Website: | Phone: (407)993-1381. The facility is situated at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
1. What does it mean that this is a 503B compounding pharmacy?
Being a 503B compounding pharmacy means this facility is an FDA-registered outsourcing facility that compounds medications in large volumes for office use by healthcare providers. It operates under stricter federal regulations, including Current Good Manufacturing Practices (cGMP), which are different from the standards applied to traditional 503A compounding pharmacies.
2. Can I, as a patient, pick up my prescription directly from your location?
No, 503B Compounding Pharmacy provides medications primarily for office use by healthcare practitioners. Your physician or healthcare provider will order and receive the compounded medications at their practice to administer to you during your appointment or procedure. Patients do not typically pick up individual prescriptions from this facility at 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does this 503B facility compound?
This FDA-registered outsourcing facility compounds a wide range of sterile and non-sterile medications in bulk. This includes, but is not limited to, sterile injectables for pain management, hormone therapy preparations, ophthalmologic drops, and other customized formulations that are not readily available from commercial pharmaceutical manufacturers.
4. How does the quality control at a 503B outsourcing facility benefit me?
The stringent cGMP standards require rigorous testing for potency, sterility, and purity of every batch produced. This high level of quality control provides an added layer of safety and consistency for the medications your healthcare provider uses in your treatment, offering greater peace of mind regarding the products administered to you.
5. How can my doctor order from your pharmacy?
Healthcare providers can contact 503B Compounding Pharmacy directly to establish an account and discuss their specific compounding needs. They can reach the facility by phone at (407)993-1381 for more information on the ordering process and available formulations from the location at 2160 W State Road 434, Longwood, FL 32779.