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 fundamental operational distinction of a 503B Compounding Pharmacy, as defined by federal law, is the large-scale production of compounded sterile preparations (CSPs) for office use by healthcare practitioners. This model allows physicians, surgeons, veterinarians, and other medical professionals to obtain vital medications without the need for patient-specific prescriptions for each vial, syringe, or bag, thereby supporting efficient clinical practice and emergency stock needs.
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 adheres to the most rigorous current good manufacturing practices (cGMP). This commitment to quality and safety standards, which are more stringent than those applied to traditional 503A compounding pharmacies, ensures that every batch of medication produced is consistent, sterile, and of precisely defined strength and purity. Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can confidently utilize medications from this 503B Compounding Pharmacy, knowing they are sourced from an outsourcing facility that prioritizes patient safety through a robust quality framework, including rigorous environmental monitoring, endotoxin testing, and sterility testing.
The services provided by this 503B Compounding Pharmacy are exclusively for office use and are not directly dispensed to the public. The facility at 2160 W State Road 434, Longwood, FL 32779 serves an essential role in the local healthcare ecosystem by providing practitioners with access to medications that may be in short supply or discontinued by major manufacturers. By preparing these essential preparations in advance, the 503B Compounding Pharmacy helps mitigate drug shortages and ensures that healthcare providers have the necessary tools to treat their patients without interruption. The scope of a 503B Compounding Pharmacy is defined by its federal registration and its operational protocols, which are designed for bulk production.
Healthcare practitioners seeking a reliable source for office-use medications are encouraged to contact the 503B Compounding Pharmacy to discuss their specific needs. The team at 2160 W State Road 434, Longwood, FL 32779 is dedicated to supporting the medical community with high-quality, compounded preparations. For more detailed information on available preparations and to initiate a professional relationship, practitioners can visit the website at https://503bcompoundingpharmacy.com/ or call the facility directly at (407)993-1381. The 503B Compounding Pharmacy is committed to its role as a critical partner to healthcare providers.
FAQ
1. What is the primary function of the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779?
The primary function of this 503B Compounding Pharmacy is to act as an FDA-registered outsourcing facility that compounds large batches of sterile medications for office use by healthcare practitioners located at or serving 2160 W State Road 434, Longwood, FL 32779.
2. Can individual patients directly obtain medications from this 503B Compounding Pharmacy?
No. A 503B Compounding Pharmacy supplies medications for office use to licensed healthcare practitioners. Patients must receive their medications through their physician or clinic, not directly from the 503B Compounding Pharmacy.
3. How does the 503B Compounding Pharmacy ensure the safety of its compounded preparations?
This 503B Compounding Pharmacy operates under strict current good manufacturing practices (cGMP), which mandate rigorous testing for sterility, potency, and endotoxins for every batch produced at its facility on W State Road 434, Longwood, FL 32779.
4. What types of medications does this 503B Compounding Pharmacy typically compound?
As a 503B Compounding Pharmacy, it specializes in producing sterile preparations, which can include injectables, infusions, ophthalmics, and other medications used by healthcare professionals in a clinical setting at 2160 W State Road 434, Longwood, FL 32779.
5. How can a healthcare practitioner at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare practitioners can contact the 503B Compounding Pharmacy directly to establish an account and discuss their needs. They can visit https://503bcompoundingpharmacy.com/ or call (407)993-1381 for more information.