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 sterile and non-sterile compounded medications in large batches for healthcare providers. This model allows us to supply physician offices, hospitals, and clinics with high-quality medications that are not readily available from traditional pharmaceutical manufacturers.
The services provided by 503B Compounding Pharmacy at our Longwood location are distinct from traditional compounding. Our focus is on producing medications for office-use by healthcare professionals, ensuring they have the necessary supplies to treat their patients effectively. The medications compounded at 2160 W State Road 434 are created in a controlled environment that meets stringent federal standards for quality and sterility. This provides an essential resource for the medical community, offering access to critical drugs that may be in shortage or require a specific formulation not commercially available.
By operating as a 503B outsourcing facility, 503B Compounding Pharmacy undergoes regular FDA inspections and must meet specific quality standards for every batch of medication produced. This includes extensive testing of components, in-process materials, and finished drug products. For healthcare providers utilizing our services at 2160 W State Road 434, this translates to a reliable source of compounded medications that are produced with a consistent level of quality and safety. Our role is to support the local healthcare infrastructure by providing these essential pharmaceutical products directly to practitioners.
503B Compounding Pharmacy is committed to serving the needs of healthcare professionals from our facility in Longwood. Our operations are designed to be a dependable component of the medical supply chain, ensuring that practitioners have access to the compounded medications they require for their practice. The team at 2160 W State Road 434 is dedicated to upholding the highest standards of pharmaceutical compounding as defined by federal regulations for 503B outsourcing facilities.
For more information about the services provided by 503B Compounding Pharmacy, you can visit our website at https://503bcompoundingpharmacy.com/ or contact our facility directly by phone at (407)993-1381. Our location at 2160 W State Road 434, Longwood, FL 32779 is the center of our operations, where we focus on producing high-quality compounded medications for healthcare providers.
Frequently Asked Questions
What type of compounding does 503B Compounding Pharmacy provide at 2160 W State Road 434?
503B Compounding Pharmacy is an FDA-registered outsourcing facility that produces large batches of compounded medications for office-use by healthcare providers. Our services at this location are focused on supplying physician offices, hospitals, and clinics.
Can individual patients pick up prescriptions directly from the facility at 2160 W State Road 434?
As a 503B outsourcing facility, our primary function is to supply medications to healthcare practitioners for use in their practice. Medications are typically not dispensed directly to individual patients from this location.
How does the 503B model at the Longwood location ensure medication quality?
Our facility at 2160 W State Road 434 operates under strict current good manufacturing practices (cGMP) and is subject to FDA oversight. This includes rigorous testing and quality control procedures for all compounded medications produced.
What is the advantage of using a 503B outsourcing facility like yours for healthcare providers?
Healthcare providers using our services at 2160 W State Road 434 benefit from access to consistently prepared, high-quality medications that are often needed during drug shortages or when a specific commercial product is unavailable.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers interested in our services can contact 503B Compounding Pharmacy directly at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more information. All operations are conducted from our facility at 2160 W State Road 434, Longwood, FL 32779.