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 regular FDA inspections. This ensures that every batch of medication produced is consistent, sterile where required, and of the utmost pharmaceutical grade. The team at the Longwood facility is dedicated to serving the specific needs of healthcare providers and their patients by producing medications that are not otherwise commercially available.
The core service of 503B Compounding Pharmacy at 2160 W State Road 434 is the large-scale compounding of prescription medications. This process involves the combining, mixing, or altering of ingredients to create a medication tailored to the needs of an individual patient or, more commonly for a 503B, for office use by healthcare practitioners. The facility is equipped to handle a wide range of compounding needs, including sterile and non-sterile preparations. Healthcare professionals in Longwood rely on 503B Compounding Pharmacy for a consistent and reliable supply of high-quality medications for their practice, from hormone replacement therapies and dermatological preparations to pain management solutions. The focus is on providing practitioners with the tools they need to offer personalized patient care.
Operating as a 503B outsourcing facility means that the pharmacy at 2160 W State Road 434 adheres to a level of quality control that is paramount. Every step of the compounding process, from sourcing raw active pharmaceutical ingredients (APIs) from FDA-registered suppliers to the final product testing and packaging, is governed by strict protocols. This includes extensive testing for potency, sterility, and endotoxins for injectable medications. For healthcare providers in Longwood, this translates to absolute confidence in the medications they administer or dispense. The assurance of quality and safety is the foundation of the service provided by 503B Compounding Pharmacy, making it a trusted partner for the local medical community.
The team at 503B Compounding Pharmacy understands the critical nature of the medications they produce. The pharmacists and technicians working at the Longwood location are highly trained specialists in the art and science of pharmaceutical compounding. Their expertise ensures that every prescription is compounded with precision and accuracy. The facility is designed to maintain a controlled environment, particularly for its sterile compounding suites, which are essential for preventing contamination. This dedicated focus on expertise and environment guarantees that the medications leaving the facility are not only effective but also safe for patient use, upholding the highest professional and ethical standards.
503B Compounding Pharmacy is committed to being an accessible and reliable resource for healthcare providers at 2160 W State Road 434. The facility is designed for efficiency and scale, enabling it to meet the demands of local practices without compromising on quality or turnaround time. For more detailed information about its services or to initiate an order, healthcare providers are encouraged to contact the facility directly. The knowledgeable staff is available to answer questions and provide support. 503B Compounding Pharmacy can be reached by phone at (407)993-1381 or through its website at https://503bcompoundingpharmacy.com/.
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 and inspected by the U.S. Food and Drug Administration. We operate under Section 503B of the FD&C Act and must comply with strict current Good Manufacturing Practice regulations, which govern the quality and safety of our compounded medications on a federal level.
Who can order medications from 503B Compounding Pharmacy at this location?
Our services are provided directly to healthcare providers and practitioners. We supply medications for office use, meaning a healthcare professional can order and keep a supply of our compounded medications at their practice to administer or dispense to their patients in Longwood as needed.
What types of medications does 503B Compounding Pharmacy compound?
As a 503B outsourcing facility, we compound a broad range of both sterile and non-sterile prescription medications. This includes, but is not limited to, hormone therapies, pain management solutions, dermatological creams, and other preparations that are not commercially available from large pharmaceutical manufacturers.
How does the quality control process work at your Longwood facility?
Quality control is integral to our operation. We source ingredients from approved suppliers and subject our compounded batches to rigorous testing for potency, sterility, and endotoxins. This ensures every medication that leaves 2160 W State Road 434 meets exact specifications and is safe for patient use.
How can a healthcare provider in Longwood place an order with 503B Compounding Pharmacy?
Healthcare providers can contact our facility directly to discuss their needs and place an order. We can be reached by phone at (407)993-1381. Additional information and resources are also available on our website at https://503bcompoundingpharmacy.com/.