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 at the facility located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, this pharmacy adheres to rigorous federal standards for quality, safety, and production that exceed those of traditional compounding pharmacies. The primary function of this facility is the large-scale compounding of sterile and non-sterile medications that are distributed for office use by healthcare providers. The medications produced are not intended for direct dispensing to individual patients with a prescription but are instead supplied to hospitals, clinics, and physician practices to administer to patients within their care.
The services provided by 503B Compounding Pharmacy at its Longwood location are defined by its regulatory status. The facility specializes in the compounding of medications that are often in short supply or are not commercially available from standard pharmaceutical manufacturers. This includes a significant focus on sterile injectable medications, which are prepared in a controlled environment with stringent quality control protocols to ensure patient safety. The production processes are designed to mitigate the risk of contamination, and each batch is tested for potency, sterility, and endotoxins. By providing these essential medications, 503B Compounding Pharmacy serves as a critical partner to the local medical community, helping to ensure that healthcare providers have access to the necessary drugs to treat their patients effectively.
Healthcare professionals seeking a reliable source for compounded medications can engage with 503B Compounding Pharmacy. The facility’s operations are tailored to support physicians, surgeons, and other medical practitioners by providing bulk quantities of high-quality, compounded drugs. The team at 503B Compounding Pharmacy works closely with these providers to understand their specific needs and to ensure a consistent and dependable supply of medications. The location at 2160 W State Road 434, Longwood, FL 32779 is the central hub for all compounding, quality assurance, and distribution activities. For more information on available medications or to initiate an order, healthcare providers are directed to contact the facility directly via its official website or telephone number.
To connect with 503B Compounding Pharmacy, please use the following contact information. Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381. All inquiries from healthcare providers are directed to the team at the Longwood facility.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with strict federal current Good Manufacturing Practices (cGMP) for the large-scale production of compounded drugs for office use by healthcare providers.
Who can order medications from 503B Compounding Pharmacy?
Medications are supplied to healthcare providers, including physicians, hospitals, and clinics. This facility does not dispense medications directly to individual patients based on a personal prescription.
What types of medications does 503B Compounding Pharmacy produce?
The facility specializes in compounding sterile injectable medications, often those that are on drug shortage lists or are not commercially available, for use by medical professionals at their practices located near 2160 W State Road 434, Longwood, FL 32779.
How does 503B Compounding Pharmacy ensure medication safety and quality?
Rigorous quality control measures are implemented, including testing for sterility, potency, and endotoxins. The facility operates under cGMP standards to ensure the safety, identity, strength, and purity of all compounded medications produced at this location.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can place orders by contacting the facility directly at (407)993-1381 or by visiting the official website at https://503bcompoundingpharmacy.com/ to connect with the team at 2160 W State Road 434, Longwood, FL 32779.