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. Located at 2160 W State Road 434, Longwood, FL 32779, this 503B Compounding Pharmacy provides medications for healthcare providers and facilities. The 503B Compounding Pharmacy model is distinct, focusing on the large-scale compounding of sterile preparations that are distributed for office use without patient-specific prescriptions.
The operations at 2160 W State Road 434, Longwood, FL 32779 are conducted under the strict regulatory framework applicable to a 503B Compounding Pharmacy. This includes adherence to Current Good Manufacturing Practices (cGMP), which are more rigorous than the standards applied to traditional compounding pharmacies. The 503B Compounding Pharmacy facility is subject to regular FDA inspections to ensure the quality, safety, and sterility of its compounded preparations. For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, this means access to a reliable supply of high-quality medications for office stock.
The services provided by this 503B Compounding Pharmacy are essential for supporting the medical community at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy compounds a range of sterile medications, including injectables, infusions, and ophthalmics, which are commonly used in clinical settings. By supplying these essential medications, the 503B Compounding Pharmacy enables healthcare providers to have necessary drugs readily available for immediate administration to patients during procedures or treatments.
Healthcare professionals seeking a dependable source for compounded medications can connect with this 503B Compounding Pharmacy. The team at 2160 W State Road 434, Longwood, FL 32779 is dedicated to upholding the standards required of an FDA-registered outsourcing facility. For more detailed information about the specific preparations available or to inquire about services, the 503B Compounding Pharmacy can be contacted directly. The website for the 503B Compounding Pharmacy is https://503bcompoundingpharmacy.com/ and the phone number is (407)993-1381.
FAQ
What does it mean that this is a 503B Compounding Pharmacy?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility that compounds large volumes of sterile medications for office use by healthcare providers, adhering to strict federal manufacturing standards.
Who can order from the 503B Compounding Pharmacy at 2160 W State Road 434?
The 503B Compounding Pharmacy primarily supplies medications to healthcare providers and medical facilities for their office stock. Orders are not typically placed by individual patients but by licensed professionals.
What types of medications does this 503B Compounding Pharmacy provide?
This 503B Compounding Pharmacy specializes in compounding sterile preparations, such as injectable medications, intravenous (IV) bags, and ophthalmic solutions, which are supplied to medical practices.
How does the 503B Compounding Pharmacy ensure medication safety?
As an FDA-registered 503B Compounding Pharmacy, the facility at 2160 W State Road 434, Longwood, FL 32779 follows Current Good Manufacturing Practices (cGMP) and undergoes regular FDA inspections to ensure the highest standards of quality and sterility.
How can a healthcare provider at this location place an order?
Healthcare providers interested in the services of this 503B Compounding Pharmacy can initiate the process by contacting the facility directly via their website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381.