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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is central to the operations at the facility located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, this pharmacy adheres to rigorous federal standards for quality, safety, and production scale that exceed those of traditional compounding pharmacies. The primary function of this facility is the large-scale compounding of sterile and non-sterile medications that are distributed for office use by healthcare practitioners. The medications produced are essential for a wide range of medical treatments and are provided to physicians, hospitals, and clinics.
The operations at 2160 W State Road 434 are defined by a commitment to cGMP (current Good Manufacturing Practices). This set of FDA-enforced regulations ensures that every batch of medication is consistently produced and controlled according to the highest quality standards. The environment at the Longwood facility is meticulously controlled, with sterile compounding suites designed to prevent contamination. Highly trained pharmacists and technicians utilize advanced technology and precise processes to compound medications that are not readily available commercially, ensuring practitioners at local medical practices have access to the specific formulations their patients need.
For healthcare providers serving the community, 503B Compounding Pharmacy at 2160 W State Road 434 serves as a critical partner. The facility provides practitioners with access to a reliable supply of high-quality, compounded medications for office administration. This allows local doctors to focus on patient care with the confidence that the medications they use are prepared under the strictest quality controls. The scope of compounding includes a significant focus on sterile injectables, which are essential for many therapeutic areas including hormone therapy, pain management, and ophthalmology.
The team at the Longwood location comprises skilled compounding professionals dedicated to the science of pharmacy. Their expertise ensures that every formulation is accurate, potent, and pure. The process involves stringent testing and validation to guarantee that each medication meets its specified identity, strength, quality, and purity characteristics. This unwavering dedication to quality and compliance makes 503B Compounding Pharmacy a trusted source for healthcare practitioners who require compounded medications for their practice at 2160 W State Road 434.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical professionals. The facility encourages practitioners to connect to discuss specific compounding needs and to place orders. The dedicated team is available to provide information and support, ensuring a seamless experience from inquiry to delivery. Healthcare providers can initiate contact by calling the facility directly at (407)993-1381 or by visiting the official website to learn more about the services and capabilities at https://503bcompoundingpharmacy.com/.
FAQ
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
This designation means the facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with stricter federal standards, including cGMP, for large-scale compounding of medications for office use by healthcare practitioners.
Who can order medications from 503B Compounding Pharmacy?
Medications compounded at the 2160 W State Road 434 location are prepared for office use and are distributed to healthcare practitioners, such as physicians, clinics, and hospitals, for administration to their patients.
What types of medications are compounded at the Longwood facility?
The 503B Compounding Pharmacy specializes in compounding a wide array of sterile and non-sterile medications, including but not limited to hormone replacement therapies, pain management solutions, and ophthalmic preparations, all under rigorous quality controls.
How does the quality control process work at this facility?
The facility at 2160 W State Road 434 operates under cGMP, which mandates extensive testing, environmental monitoring, and process validation to ensure every batch of medication meets precise standards for safety, potency, and purity.
How can a healthcare provider place an order or get more information?
Healthcare practitioners can contact the facility directly by phone at (407)993-1381 or visit the website at https://503bcompoundingpharmacy.com/ to inquire about services and place orders for compounded medications.