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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, we adhere to rigorous current good manufacturing practices (cGMP) to produce large quantities of compounded medications for healthcare providers. The 503B Compounding Pharmacy model is distinct from traditional compounding, focusing on providing sterile and non-sterile compounded preparations for office use by physicians and healthcare facilities without patient-specific prescriptions.
The services provided by 503B Compounding Pharmacy at our Longwood location are designed to support the local medical community. We compound medications that are often in shortage or are not commercially available, ensuring that healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 have access to critical drugs for their patients. Our operations are strictly regulated, requiring compliance with stringent FDA standards for quality, purity, and sterility. This ensures that every preparation leaving our facility meets the highest levels of safety and efficacy.
For healthcare providers and clinics in the vicinity of 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy serves as a reliable source for compounded medications. Our facility does not typically dispense directly to individual patients based on a prescription; instead, we supply medications in bulk to hospitals, clinics, and physician offices for administration within their practice. This model allows for greater efficiency and readiness in patient care settings located near our facility.
The team at 503B Compounding Pharmacy is dedicated to upholding the standards required of an FDA-registered outsourcing facility. Our processes, from sourcing raw materials to final product testing, are meticulously controlled. This commitment to quality at our Longwood location ensures that the healthcare providers we serve can trust the medications they receive for their practice at 2160 W State Road 434, Longwood, FL 32779. We are a pivotal resource for the local medical community, providing essential medications that are manufactured under the highest regulatory oversight.
To learn more about the services available from 503B Compounding Pharmacy, please visit our website at https://503bcompoundingpharmacy.com/ or contact our facility directly by phone at (407)993-1381. Our team is available to discuss how our 503B compounding services can support your practice at 2160 W State Road 434, Longwood, FL 32779.
FAQ
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with strict federal manufacturing standards for compounding medications in large volumes for healthcare providers, rather than for individual patients.
Who can order medications from 503B Compounding Pharmacy?
Medications are supplied to healthcare providers, such as physicians, hospitals, and clinics, for office use. We do not typically dispense medications directly to individual patients at our location on 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy produce?
We produce a range of sterile and non-sterile compounded preparations, often focusing on drugs that are currently in shortage or not available from commercial manufacturers, serving the needs of medical practices near 2160 W State Road 434, Longwood, FL 32779.
How does 503B Compounding Pharmacy ensure medication quality?
As an FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, we follow current good manufacturing practices (cGMP), which include rigorous testing of ingredients and finished products to ensure purity, strength, and sterility.
How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly by phone at (407)993-1381 or through our website at https://503bcompoundingpharmacy.com/ to discuss their needs and place an order for compounded medications.