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 from its facility at 2160 W State Road 434, Longwood, FL 32779. As an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act, this pharmacy adheres to the highest standards of quality and safety in the preparation of compounded medications. The 503B designation signifies a commitment to producing large volumes of sterile and non-sterile medications in advance of or without receiving a prescription, primarily for office use by healthcare practitioners. The team at this location is dedicated to serving the specific needs of the local medical community with reliability and precision.
The core function of 503B Compounding Pharmacy is to provide healthcare professionals with access to essential medications that are not readily available from commercial manufacturers. This includes medications that may be in short supply, discontinued, or not offered in a specific strength or formulation required for patient care. By preparing these medications under strict, federally enforced current good manufacturing practices (cGMP), the facility at 2160 W State Road 434 ensures a level of quality control that goes beyond traditional compounding. This provides local practitioners and their patients with confidence in the integrity, sterility, and potency of every preparation.
Services at this location are specifically tailored for office-use by physicians, veterinarians, hospitals, and clinics. The pharmacy does not typically serve individual patients directly but acts as a critical support system for the healthcare providers who do. This allows local practitioners to obtain the necessary medications to administer to their patients during office visits, procedures, or treatments. The staff at 503B Compounding Pharmacy works closely with these providers to understand their needs and ensure a consistent supply of high-quality compounded preparations.
Quality assurance is the foundation of all operations at 2160 W State Road 434. Every process, from ingredient sourcing to final packaging, is conducted under a rigorous quality system that includes extensive testing, environmental monitoring, and detailed documentation. This meticulous approach ensures that every batch of medication meets its predefined specifications for identity, strength, purity, and quality. For the healthcare providers in Longwood, this means they can trust that the medications they use are prepared with the utmost care and in full compliance with federal regulations.
503B Compounding Pharmacy is an integral partner to the local healthcare ecosystem at 2160 W State Road 434. By providing a reliable source of high-quality, compounded medications, the facility enables medical professionals to deliver superior care to their patients. For more information or to discuss your practice's specific needs, you can contact the facility directly. The team is available to provide detailed information about available formulations and compliance protocols.
Website: | Phone: (407)993-1381
Frequently Asked Questions
1. What does it mean that this is a 503B outsourcing facility?
It means this pharmacy is registered with the FDA and operates under Section 503B of the Federal Food, Drug, and Cosmetic Act. This requires compliance with stringent current good manufacturing practices (cGMP) for sterility, testing, and quality control, which are more rigorous than the standards applied to traditional compounding pharmacies.
2. Can I, as an individual patient, pick up a prescription at 2160 W State Road 434?
No. 503B Compounding Pharmacy primarily prepares medications for office-use by healthcare practitioners. Individual patient prescriptions are typically not dispensed directly from this facility. You should consult with your healthcare provider, who can administer medications obtained from our facility during your appointment.
3. What types of medications does this location compound?
The facility at 2160 W State Road 434 compounds a wide range of sterile and non-sterile preparations, including medications that are on shortage, have been discontinued by manufacturers, or require a specific formulation not available commercially. These are prepared in batches for healthcare providers to use in their practice.
4. How do I, as a healthcare provider, order from this facility?
Healthcare providers can place orders by contacting the facility directly via phone at (407)993-1381. The team will work with you to understand your practice's requirements and provide information on available medications, ordering processes, and delivery options to your office.
5. How does the quality assurance process work at this location?
Every batch of medication undergoes a comprehensive quality control process. This includes testing raw materials, in-process testing, finished product testing, and strict environmental monitoring of the cleanrooms to ensure sterility. Detailed records are maintained for every batch to ensure full traceability and compliance with cGMP regulations.