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 from its location at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act signifies a commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, an outsourcing facility like 503B Compounding Pharmacy is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations, and provides medications for office use by healthcare practitioners. The core mission of 503B Compounding Pharmacy is to supply healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with high-quality, sterile and non-sterile compounded preparations that are essential for patient care.
The operations at 2160 W State Road 434, Longwood, FL 32779 are built upon a foundation of pharmaceutical excellence. The facility utilizes state-of-the-art equipment and advanced environmental controls to ensure the integrity of every preparation. Every process, from ingredient sourcing to final product testing, is meticulously controlled and documented. Personnel at 503B Compounding Pharmacy are highly trained specialists who adhere to strict sterile and non-sterile compounding protocols. This unwavering dedication to cGMP standards ensures that every preparation leaving the facility meets precise specifications for potency, purity, and stability, providing healthcare practitioners with reliable medications for their patients.
503B Compounding Pharmacy provides essential services to healthcare practitioners from its facility at 2160 W State Road 434, Longwood, FL 32779. The primary service is the large-scale compounding of medications for office use, allowing practitioners to have necessary medications on hand for immediate administration. This includes a significant focus on sterile preparations, such as injections, ophthalmic drops, and other parenteral medications, which are produced in a controlled ISO-classified environment. Furthermore, the facility compounds non-sterile preparations, including topical creams, ointments, gels, and oral suspensions. All preparations are executed following master formulation records and undergo quality control testing to ensure they are free of contaminants and possess accurate drug strength.
The team at 503B Compounding Pharmacy is comprised of experienced pharmacists, pharmacy technicians, and quality assurance professionals who are dedicated to the science of compounding. Their expertise is critical in accurately preparing complex medication formulations that meet the specific needs of the medical community served by 2160 W State Road 434, Longwood, FL 32779. The staff is committed to continuous education and training, ensuring all procedures reflect the most current USP chapters and FDA guidance. This team-based approach guarantees that every preparation is a product of shared knowledge, meticulous skill, and a unified commitment to patient safety.
503B Compounding Pharmacy invites healthcare practitioners to partner with them for their office-use medication needs. The facility at 2160 W State Road 434, Longwood, FL 32779 is designed to be a reliable and compliant source for high-quality compounded preparations. For more detailed information on services, to place an order, or to speak with a compounding expert, healthcare providers are encouraged to contact 503B Compounding Pharmacy directly. The facility can be reached by phone at (407)993-1381. Comprehensive information about the outsourcing facility and its compliance standards is also available on the official website at https://503bcompoundingpharmacy.com/.
FAQ
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our operations at 2160 W State Road 434, Longwood, FL 32779 are registered with and inspected by the U.S. Food and Drug Administration. We operate under Section 503B of the FD&C Act and adhere to strict current Good Manufacturing Practice (cGMP) regulations, which govern the quality control and production standards for our compounded preparations.
Who can receive medications from 503B Compounding Pharmacy at 2160 W State Road 434?
503B Compounding Pharmacy provides compounded medications for office use by healthcare practitioners with prescribing authority. These medications are supplied to practitioners for administration to their patients within their practice at 2160 W State Road 434, Longwood, FL 32779.
What types of compounded preparations are available from your facility?
From our location at 2160 W State Road 434, Longwood, FL 32779, we compound a range of both sterile and non-sterile preparations for office use. This includes sterile injectables, ophthalmic solutions, as well as non-sterile topical creams, gels, and oral suspensions, all produced under stringent quality controls.
How does 503B Compounding Pharmacy ensure the quality of its preparations?
Quality is ensured through strict adherence to cGMP standards at our facility at 2160 W State Road 434, Longwood, FL 32779. This includes rigorous testing of ingredients, environmental monitoring, validated processes, and final product testing to verify sterility, potency, and stability before any preparation is released.
How can a healthcare practitioner place an order with 503B Compounding Pharmacy?
Healthcare practitioners can place an order for office-use compounded medications by contacting our facility at 2160 W State Road 434, Longwood, FL 32779 directly. Please call us at (407)993-1381 to speak with our team or visit https://503bcompoundingpharmacy.com/ for more information.