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 service provision at our specific location: 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, the pharmacy adheres to rigorous federal standards for quality, safety, and production scale 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 from this address.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs). This is not a retail pharmacy for individual patient walk-in prescriptions but rather a facility that prepares medications in bulk for physician offices, hospitals, and clinics. The preparations are created in a controlled environment with advanced sterility assurance testing and are intended for office use by healthcare professionals. The operations are strictly confined to the facility at 2160 W State Road 434, Longwood, FL 32779, ensuring all production and quality control are managed on-site under the strict guidelines mandated for a 503B entity.
Quality assurance is the foundational principle of 503B Compounding Pharmacy. The processes employed at the Longwood facility include beyond-use date assignment based on validated stability studies, environmental monitoring, and comprehensive endotoxin and sterility testing. This meticulous approach to compounding provides healthcare providers with the confidence that the medications they administer to their patients are of the highest possible quality and safety. The facility's commitment is to support the local medical community with reliable, FDA-registered compounded medications produced right here at 2160 W State Road 434.
Engaging with 503B Compounding Pharmacy is designed for healthcare entities. The facility works directly with physicians, surgeons, veterinarians, and other licensed medical practitioners to supply them with the necessary medications for their practice needs. The service model is built on reliability, consistency, and a shared commitment to patient safety. For any inquiries regarding services or to place an order, healthcare providers can contact 503B Compounding Pharmacy directly at (407)993-1381 or visit the official website at https://503bcompoundingpharmacy.com/ for more detailed information.
Frequently Asked Questions
1. What exactly is a 503B outsourcing facility?
A 503B outsourcing facility is an FDA-registered entity that compounds drugs in accordance with the standards outlined in Section 503B of the Federal Food, Drug, and Cosmetic Act. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under these federal regulations, which require compliance with Current Good Manufacturing Practices (cGMP) for large-scale production of sterile medications primarily for office use by healthcare providers.
2. Can I come to your location at 2160 W State Road 434 to pick up a personal prescription?
No. 503B Compounding Pharmacy is not a retail pharmacy. The facility compounds medications in bulk for healthcare providers and their offices. It does not dispense medications directly to individual patients for personal use from this location. All preparations are shipped directly to the ordering healthcare practice.
3. Who can order from 503B Compounding Pharmacy?
Orders are accepted from licensed healthcare professionals and their associated practices, including medical doctors, veterinarians, hospitals, and clinics. The facility at 2160 W State Road 434, Longwood, FL 32779 serves these professionals by providing them with high-quality, sterile compounded medications for administration within their practice setting.
4. How does the 503B designation at your Longwood location ensure quality?
The 503B designation mandates that our facility on W State Road 434 adheres to strict federal cGMP standards. This includes rigorous environmental monitoring, sterility testing, stability studies to assign accurate beyond-use dates, and thorough documentation of all processes. This ensures every batch of medication produced meets elevated safety and quality benchmarks.
5. How do I contact your facility to discuss services or place an order?
Healthcare providers interested in the services provided by 503B Compounding Pharmacy can contact the facility directly by calling (407)993-1381. Additional information about capabilities and ordering processes is available on the official website at https://503bcompoundingpharmacy.com/.