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 at 2160 W State Road 434, Longwood, FL 32779 with a reliable source for patient-specific medications that are not commercially available.
The core function of 503B Compounding Pharmacy is the preparation of compounded medications in bulk for office use by healthcare practitioners. This means that physicians, surgeons, veterinarians, and other medical professionals practicing at or near 2160 W State Road 434, Longwood, FL 32779 can order these preparations for their patients without the need for individual patient-specific prescriptions for each vial or tube. This model is essential for medications used in clinics, hospitals, and surgical centers, such as sterile injectables, ophthalmics, and topical creams, ensuring that healthcare providers have the necessary preparations on hand for immediate use during procedures and treatments.
503B Compounding Pharmacy distinguishes itself through its commitment to compliance and quality. Unlike traditional 503A pharmacies, an outsourcing facility registered under 503B is subject to Current Good Manufacturing Practice (cGMP) regulations, mandatory FDA inspections, and more stringent testing requirements for identity, strength, quality, and purity. For medical professionals serving the community at 2160 W State Road 434, Longwood, FL 32779, this provides an added layer of confidence and safety, knowing the medications they use are produced under the highest standards of pharmaceutical manufacturing.
The services provided by 503B Compounding Pharmacy are exclusively for healthcare facilities and practitioners. Patients seeking compounded medications for individual use under a personal prescription are served by traditional compounding pharmacies (503A facilities). The focus at 2160 W State Road 434, Longwood, FL 32779 remains on supporting the local medical community with a consistent, high-quality supply of essential medications that are critical for patient care. For more information or to inquire about services, please contact 503B Compounding Pharmacy at their website: or by phone at (407)993-1381.
FAQ
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 large volumes for office use by healthcare practitioners. It operates under stricter federal regulations than a traditional compounding pharmacy, following Current Good Manufacturing Practices (cGMP) for enhanced safety and quality assurance at 2160 W State Road 434, Longwood, FL 32779.
2. Can I, as a patient, get my personal prescriptions filled at this location?
No. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 provides medications exclusively for healthcare providers and facilities for office use. Patients with individual prescriptions should contact a traditional 503A compounding pharmacy for their personal medication needs.
3. What types of medications does this 503B outsourcing facility typically compound?
The 503B Compounding Pharmacy specializes in compounding sterile preparations like injectables, IV bags, and ophthalmics, as well as non-sterile preparations such as topical creams and ointments. These are supplied in bulk to medical practices and hospitals serving the area around 2160 W State Road 434, Longwood, FL 32779.
4. How does a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can place orders directly with 503B Compounding Pharmacy by calling (407)993-1381. The facility will work with the practice to establish an account and fulfill orders for office-use medications.
5. Why should a clinic at this location use a 503B outsourcing facility instead of a 503A pharmacy?
Using a 503B outsourcing facility like ours at 2160 W State Road 434, Longwood, FL 32779 ensures the medications are produced under cGMP standards, which include rigorous testing and quality controls mandated by the FDA. This provides a higher level of safety and consistency for medications used in a clinical setting on patients.