Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
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.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. As a 503B outsourcing facility, we produce large batches of compounded sterile and non-sterile preparations for healthcare providers without patient-specific prescriptions. This model allows us to supply physicians, hospitals, and clinics with vital medications that are often on shortage or unavailable from conventional manufacturers.
The operations at our Longwood location are central to our mission. The facility at 2160 W State Road 434 is designed and maintained to meet rigorous federal standards. Our processes are governed by current Good Manufacturing Practices (cGMP), which are enforced by the FDA. This ensures that every preparation leaving our pharmacy is of consistent strength, quality, and purity. We invest in advanced analytical testing and environmental monitoring to validate the safety and potency of all our compounded products. For healthcare providers seeking a reliable source for compounded medications, our 503B outsourcing facility provides an essential service directly from our address in Longwood.
Our core service is the bulk compounding of medications for office use by medical practitioners. Healthcare professionals can confidently order from our extensive portfolio of preparations to support their practice needs at 2160 W State Road 434. We provide these medications in larger quantities for stock, enabling immediate administration to patients during office visits. This eliminates delays associated with traditional prescription filling and is crucial for medications that require immediate use, such as hormone injections, dermatological preparations, and ophthalmic solutions. By serving the local medical community from our specific location, we help enhance patient care and streamline clinical operations.
Engaging with our pharmacy is a straightforward process for medical practices. Orders are placed directly by authorized healthcare providers or their designated staff. Our team at 2160 W State Road 434 works diligently to process these orders efficiently. We provide comprehensive support to ensure a seamless procurement experience. You can explore our services and capabilities by visiting our website at https://503bcompoundingpharmacy.com/ or by calling our dedicated phone line at (407)993-1381 to speak with a representative. We are focused on serving the needs of medical professionals from our facility in Longwood.
Frequently Asked Questions
What does it mean that this is a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434 is registered with the FDA and complies with stricter federal standards, including current Good Manufacturing Practices (cGMP), for the bulk compounding of medications intended for office use by healthcare providers.
Who can place orders with 503B Compounding Pharmacy?
Orders are accepted exclusively from healthcare providers and medical facilities. Individual patient prescriptions are not dispensed directly from our location at 2160 W State Road 434. Medications are supplied for office use to be administered by medical professionals.
How do I place an order for my practice?
Healthcare providers can place orders by contacting our facility directly. You can initiate an order or inquire about our available preparations by calling (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/ for more information.
What types of medications does the facility compound?
As a 503B outsourcing facility at 2160 W State Road 434, we compound a wide range of sterile and non-sterile preparations in bulk, including but not limited to hormone therapy injections, pain management solutions, and other medications frequently used in clinical settings.
Why should a practice order from a 503B facility like yours?
Ordering from our FDA-registered facility at 2160 W State Road 434 ensures you receive medications produced under the highest standards of quality and safety. This provides assurance of potency, purity, and consistency for the medications you administer to your patients.