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 and services provided 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 control, sterility, and safety that exceed those of traditional compounding pharmacies. The primary function of a 503B Compounding Pharmacy is the large-scale production of compounded medications for office use, which are then distributed to healthcare practitioners for patient administration within clinical settings.
The services at 2160 W State Road 434, Longwood, FL 32779 are specifically tailored for healthcare providers. Physicians, surgeons, veterinarians, and other medical professionals can source high-quality, sterile compounded preparations from this 503B Compounding Pharmacy. These preparations are essential for a wide range of medical applications, including office-based injections, IV therapies, surgical kits, and ophthalmic solutions. By providing these medications for office use, the 503B Compounding Pharmacy enables practitioners to enhance patient care with treatments that are not readily available as mass-produced, FDA-approved drugs, all while ensuring the highest level of sterility and potency.
The facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by highly trained pharmacists and technicians who specialize in sterile compounding. Every batch of medication produced is subject to stringent testing and quality assurance protocols as mandated by the FDA. This process ensures that every preparation leaving the facility meets precise specifications for purity, strength, and sterility. For healthcare providers, this means unparalleled reliability and trust in the medications they use to treat their patients.
Healthcare providers seeking a dependable source for compounded sterile preparations can connect with this 503B Compounding Pharmacy through its official website at https://503bcompoundingpharmacy.com/ or by calling (407)993-1381. The team is prepared to discuss specific compound formulations, availability, and the ordering process to support the medical community's needs from its location at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
What does it mean that this is a 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779?
It means this facility is an FDA-registered outsourcing facility that compounds large volumes of sterile medications for office use. It operates under stricter federal regulations than a traditional pharmacy, ensuring the highest standards of quality, sterility, and safety for healthcare providers.
Who can order from the 503B Compounding Pharmacy at this location?
Services are exclusively for healthcare practitioners, including physicians, surgeons, dentists, and veterinarians. Medications are compounded for office use and are not dispensed directly to individual patients at 2160 W State Road 434, Longwood, FL 32779.
What types of medications are compounded at this facility?
This 503B Compounding Pharmacy specializes in sterile preparations, such as injectables, IV bags, hormone injections, ophthalmic drops, and customized surgical kits. These are produced for healthcare providers to administer within their practice at 2160 W State Road 434, Longwood, FL 32779.
How does the quality assurance process work at this 503B Compounding Pharmacy?
As an FDA-registered outsourcing facility, every batch of medication undergoes rigorous sterility testing, potency verification, and endotoxin testing. This ensures all preparations meet exacting quality standards before being released to practitioners.
How can a healthcare provider place an order with this 503B Compounding Pharmacy?
Providers can initiate an order or inquire about available compounds by contacting the pharmacy directly at (407)993-1381 or by visiting the official website at https://503bcompoundingpharmacy.com/ to learn more about the process from 2160 W State Road 434, Longwood, FL 32779.