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, and provides medications for office use by healthcare practitioners.
The primary function of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications that are distributed for office use. Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can utilize our services to obtain ready-to-administer medications for their patients. This model supports physicians, surgeons, dermatologists, and other medical professionals by ensuring they have a reliable, quality-assured supply of necessary drugs, which enhances patient care and practice efficiency. Our processes are designed to provide a consistent and scalable supply of compounded preparations.
Our state-of-the-art facility at 2160 W State Road 434 is designed to meet the stringent requirements for an outsourcing facility. This includes advanced environmental controls, validated sterilization processes, and robust quality assurance testing. Every batch of medication is compounded under a comprehensive quality management system. This ensures that every preparation leaving our facility meets precise specifications for potency, purity, and sterility, providing practitioners and their patients with the utmost confidence in the medications they use.
503B Compounding Pharmacy provides a critical service to the healthcare community at 2160 W State Road 434, Longwood, FL 32779. By supplying bulk compounded medications for office use, we enable healthcare providers to focus on patient care without the logistical challenges of in-office compounding. Our role is to be a trusted partner to medical professionals, ensuring they have access to high-quality medications that are essential for treatments, procedures, and patient protocols. We operate with integrity and a unwavering focus on patient safety.
For more detailed information about our services and compliance standards, or to speak with our team, please contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/. Our facility welcomes inquiries from healthcare providers at 2160 W State Road 434, Longwood, FL 32779 seeking a dependable source for compounded medications.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA under Section 503B. We compound large volumes of sterile and non-sterile medications for office use by healthcare practitioners and must adhere to strict cGMP regulations, which include rigorous testing and quality control standards beyond those of a traditional pharmacy.
Who can order medications from 503B Compounding Pharmacy?
Our services are designed for healthcare practitioners with prescribing authority. Medical professionals at 2160 W State Road 434, Longwood, FL 32779 can order compounded medications from our facility for office use to administer or dispense to their patients within their practice.
Can individual patients pick up prescriptions directly from your location?
No. 503B Compounding Pharmacy operates as a wholesale distributor to healthcare professionals, not a retail pharmacy. Patients should receive their medications directly from their prescribing healthcare provider at the provider's practice location, not from our facility at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy prepare?
As an outsourcing facility, we compound a range of preparations, including sterile injectables, ophthalmics, and other dosage forms that are in need for office-based practices. All medications are prepared in batches under cGMP standards at our location on 2160 W State Road 434, Longwood, FL 32779.
How do I verify the quality and safety of your compounded products?
Our registration as a 503B outsourcing facility requires us to comply with federal cGMP standards. This includes stringent environmental monitoring, validated processes, and independent testing for potency, sterility, and endotoxins. Quality assurance reports and certificates of analysis are available upon request for healthcare providers at 2160 W State Road 434, Longwood, FL 32779.