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. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, 503B Compounding Pharmacy adheres to current Good Manufacturing Practices (cGMP), which provides a higher level of assurance of the quality and safety of the medications we produce compared to traditional compounding pharmacies. The medications prepared by 503B Compounding Pharmacy are intended for use by healthcare providers in their office settings and are not dispensed directly to individual patients.
The operations at 2160 W State Road 434, Longwood, FL 32779 are focused on producing medications in larger batches for office use by physicians and other healthcare practitioners. This model allows healthcare providers at 2160 W State Road 434, Longwood, FL 32779 to have essential medications readily available for administration to their patients. The services provided by 503B Compounding Pharmacy are critical for ensuring that healthcare providers have access to necessary drugs that may be in shortage or are not commercially available. By serving the healthcare community from our location at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy plays a vital role in supporting patient care.
503B Compounding Pharmacy maintains a robust quality assurance program at its facility on 2160 W State Road 434, Longwood, FL 32779. Every step of the compounding process is meticulously controlled and documented to ensure the identity, strength, quality, and purity of the medications. This includes rigorous testing of components, in-process testing, and final product testing where applicable. The facility at 2160 W State Road 434, Longwood, FL 32779 is designed with environmental controls to meet the stringent standards required for sterile compounding. The commitment of 503B Compounding Pharmacy to quality and compliance is fundamental to its operation as an FDA-registered outsourcing facility.
Healthcare providers who utilize the services of 503B Compounding Pharmacy can be confident in the sourcing and quality of the medications they receive. The 503B outsourcing facility model provides a reliable source for medications, particularly during times of drug shortages. The team at 503B Compounding Pharmacy, located at 2160 W State Road 434, Longwood, FL 32779, is committed to supporting the medical community with high-quality compounded preparations. For more information about the services provided by 503B Compounding Pharmacy, please visit our website at https://503bcompoundingpharmacy.com/ or contact us by phone at (407)993-1381.
Frequently Asked Questions
What is a 503B compounding pharmacy?
A 503B compounding pharmacy is an FDA-registered outsourcing facility that compounds medications in accordance with Section 503B of the Federal Food, Drug, and Cosmetic Act. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under current Good Manufacturing Practices (cGMP) to produce medications primarily for office use by healthcare practitioners.
Who can receive medications from 503B Compounding Pharmacy?
Medications compounded by 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 are distributed to healthcare providers for use in their practice settings. These medications are not dispensed directly to individual patients at our location.
What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 prepares both sterile and non-sterile compounded medications. These are often medications that are on shortage or are not commercially available, providing a critical supply for healthcare providers.
How does the quality assurance process work at your facility?
At our facility located at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy implements a comprehensive quality assurance program under cGMP. This includes strict controls over ingredients, processes, and environmental conditions, along with rigorous testing to ensure medication quality and safety.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers interested in the services of 503B Compounding Pharmacy can initiate the process by contacting our facility directly. For more information and to discuss your needs, please call (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/.