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 identity and operation of the facility located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, the pharmacy adheres to rigorous federal standards for quality control, sterility, and safety that exceed those of traditional compounding pharmacies. This ensures that every preparation leaving the facility meets the highest level of pharmaceutical integrity for the patients and healthcare providers it serves.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are not available commercially. This includes the production of sterile injectables, intravenous (IV) bags, ophthalmic preparations, and other complex dosage forms in bulk quantities. These preparations are distributed to healthcare facilities, clinics, and practitioners for office-use, meaning they are not typically dispensed directly to an individual patient with a prescription at the 2160 W State Road 434 location. Instead, the facility provides practitioners with a reliable, high-quality source for medications needed for their practice, ensuring they have the necessary tools for patient treatment protocols.
Operating from its facility in Longwood, the 503B Compounding Pharmacy utilizes state-of-the-art technology and cleanroom environments that are continuously monitored to ensure aseptic conditions. Every batch of medication is compounded by highly trained pharmacists and technicians following strict standard operating procedures. Furthermore, the facility conducts extensive testing on its products, including sterility testing, endotoxin testing, and potency analysis, to verify that each preparation is pure, potent, and safe for administration. This unwavering commitment to compliance and quality provides assurance to the medical community that the medications they receive are produced under the most stringent regulations.
Healthcare providers seeking a trusted partner for their non-commercially available medication needs can rely on 503B Compounding Pharmacy at 2160 W State Road 434. The facility is dedicated to supporting the local medical community with consistent, high-volume compounded preparations. For more information on available preparations or to discuss your facility's needs, please contact 503B Compounding Pharmacy directly. The team is prepared to provide detailed information and support.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Frequently Asked Questions
1. What does it mean that this is a 503B outsourcing facility?
It means this facility is registered with the FDA under Section 503B of the Federal Food, Drug, and Cosmetic Act. This registration requires compliance with Current Good Manufacturing Practices (cGMP), which includes rigorous testing for sterility, potency, and purity. This is different from a traditional 503A pharmacy, as we compound medications in larger batches for office-use by healthcare practitioners.
2. Can I, as an individual patient, get a prescription filled at the 2160 W State Road 434 location?
No. As a 503B outsourcing facility, our primary function is to compound large quantities of medications for "office-use" by healthcare providers. Individual patients with prescriptions should have them filled at a traditional 503A compounding pharmacy that dispenses directly to the public.
3. What types of medications does 503B Compounding Pharmacy prepare?
We specialize in sterile preparations, including injectables, intravenous (IV) bags, and ophthalmic solutions. These are compounded in bulk for healthcare facilities and practices in need of consistent, high-quality medications that are not readily available from commercial pharmaceutical manufacturers.
4. How does a healthcare provider at a local clinic order from your facility?
Healthcare providers and facilities can initiate orders by contacting our facility directly at (407)993-1381 or through our website at https://503bcompoundingpharmacy.com/. Our team will provide information on available preparations, ordering protocols, and delivery options for the 2160 W State Road 434 location.
5. Why should a healthcare provider choose 503B Compounding Pharmacy?
Choosing our 503B outsourcing facility ensures you are receiving medications produced under the highest federal standards for sterility and quality control. Our FDA-registered status and adherence to cGMP provide an added layer of safety and reliability for your patients and your practice, guaranteeing the integrity of every preparation we compound.