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. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations, which ensures that every batch of medication we produce meets stringent quality assurance testing and control measures.
The services provided by 503B Compounding Pharmacy at our Longwood location are specifically designed for office use by healthcare practitioners. We provide physicians, surgeons, veterinarians, and other qualified medical professionals with access to a reliable supply of high-quality, sterile and non-sterile compounded preparations. Our extensive capabilities allow us to support the specific needs of medical practices by producing medications in larger batch quantities, which are then available for immediate administration to patients within a clinical setting. This model enhances efficiency for healthcare providers and ensures patient access to essential medications that may be on shortage or are not commercially available.
Our state-of-the-art facility at 2160 W State Road 434 is equipped with advanced technology and maintained by a highly skilled team of pharmacists and technicians. Every step of our process, from sourcing pure, high-grade active pharmaceutical ingredients (APIs) to the final packaging and labeling, is meticulously controlled and documented. This unwavering dedication to quality and safety provides the medical community in Longwood with the confidence that the medications they use are prepared with precision and care. We are a pivotal partner for healthcare providers, enabling them to focus on patient care with the assurance that their compounded medication needs are being met by a trusted, federally regulated source.
To learn more about our services or to place an order, healthcare providers can contact 503B Compounding Pharmacy directly. We invite you to visit our website at https://503bcompoundingpharmacy.com/ for detailed information about our capabilities and compliance. You can also reach our facility by phone at (407)993-1381 to speak with a representative who can assist with your specific compounding requirements.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. This subjects us to federal oversight and mandatory compliance with current Good Manufacturing Practices (cGMP), ensuring the highest level of quality, sterility, and safety for the compounded medications we produce.
Who can order medications from 503B Compounding Pharmacy at this location?
Our services are exclusively for healthcare practitioners. Physicians, surgeons, veterinarians, and other qualified medical professionals with prescribing authority can order medications from our facility at 2160 W State Road 434 for office use in treating their patients.
What types of compounded medications does 503B Compounding Pharmacy provide?
We provide both sterile and non-sterile compounded preparations in batch quantities. This includes a wide range of medications such as sterile injectables, ophthalmics, hormone therapy preparations, and other formulations that are often on national shortage or are not commercially available from large-scale manufacturers.
How does ordering from 503B Compounding Pharmacy benefit my practice in Longwood?
Ordering from our facility provides your practice with a reliable, local source of high-quality compounded medications. Our batch production ensures consistent supply, reduces preparation time for clinical staff, and guarantees that all medications meet rigorous federal quality standards, allowing you to enhance patient care with confidence.
How can I place an order or get more information?
Healthcare providers can obtain more information or place an order by contacting our facility directly. Please call us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ to learn more about our specific services and compliance documentation.