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. This 503B Compounding Pharmacy is situated at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy model represents a significant advancement in pharmaceutical compounding, focusing on the large-scale production of compounded sterile preparations (CSPs) for office use by healthcare practitioners. The 503B Compounding Pharmacy facility adheres to the most rigorous current good manufacturing practices (cGMP), which are the same standards followed by conventional pharmaceutical manufacturers. This ensures that every preparation leaving the 503B Compounding Pharmacy meets the highest possible standards for sterility, purity, and potency.
The core mission of this 503B Compounding Pharmacy is to provide healthcare professionals with access to a reliable and consistent supply of high-quality compounded medications. By operating as a 503B Compounding Pharmacy, the facility can compound medications in advance of receiving a patient-specific prescription, which is essential for office-based administration. This allows physicians, surgeons, and other practitioners at their practices to maintain necessary inventories for procedures and treatments. The 503B Compounding Pharmacy provides these medications directly to practitioners, not to individual patients. The services of this 503B Compounding Pharmacy are integral to supporting the local medical community by ensuring that practitioners have the essential medications they require for patient care.
Quality and safety are the foundational principles of this 503B Compounding Pharmacy. Every process within the 503B Compounding Pharmacy is governed by a robust quality management system. This includes stringent environmental monitoring, rigorous testing of components and finished preparations, and comprehensive documentation for complete traceability. The pharmacists and technicians at the 503B Compounding Pharmacy are highly trained specialists in sterile compounding techniques. The 503B Compounding Pharmacy facility itself is designed with state-of-the-art engineering controls, including ISO-classified cleanrooms, to prevent contamination during the compounding process. This unwavering commitment to quality distinguishes a 503B Compounding Pharmacy from other compounding models.
For healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779, partnering with this 503B Compounding Pharmacy offers numerous advantages. It mitigates the challenges and resource allocation required for in-office compounding, allowing medical staff to focus entirely on patient care. By sourcing from an FDA-registered 503B Compounding Pharmacy, practitioners gain assurance regarding the quality and regulatory compliance of the medications they use. The 503B Compounding Pharmacy provides a critical service that enhances the efficiency, safety, and scope of medical treatments available locally. To learn more about the specific preparations available or to inquire about becoming a client of this 503B Compounding Pharmacy, practitioners are encouraged to make contact.
To connect with this 503B Compounding Pharmacy, please use the following contact information. Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381. The team at the 503B Compounding Pharmacy is available to answer questions and provide detailed information about its services and processes.
FAQ
1. What does it mean that this facility is a 503B Compounding Pharmacy?
It means this facility is an FDA-registered outsourcing facility that compounds sterile medications in large batches for office use by healthcare practitioners. This 503B Compounding Pharmacy operates under Section 503B of the Federal Food, Drug, and Cosmetic Act and must comply with strict current good manufacturing practices (cGMP).
2. Can I, as an individual patient, order medications directly from this 503B Compounding Pharmacy?
No. A 503B Compounding Pharmacy supplies medications exclusively to healthcare practitioners and facilities for office use. Individual patients must receive compounded medications through a traditional 503A pharmacy that compounds based on a patient-specific prescription.
3. How does a healthcare practitioner at this location order from the 503B Compounding Pharmacy?
Healthcare practitioners can contact the 503B Compounding Pharmacy directly via phone at (407)993-1381 or through the website at https://503bcompoundingpharmacy.com/ to establish an account, discuss available preparations, and place orders for delivery or pickup.
4. What are the benefits of using an FDA-registered 503B Compounding Pharmacy?
Using a 503B Compounding Pharmacy provides practitioners with assurance of quality, sterility, and potency, as the facility is subject to FDA oversight and mandatory compliance with cGMP standards. This reduces the risk associated with in-office compounding and ensures a reliable supply of essential medications.
5. Where is this 503B Compounding Pharmacy located?
This 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779. It serves healthcare practitioners from this specific facility location.