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 and services provided 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 control, sterility, and safety that exceed those of traditional compounding pharmacies. The primary function of this facility is the large-scale compounding of medications for office use, which are then distributed to healthcare practitioners for administration to patients within their care. The medications produced are essential for a wide range of medical treatments and procedures.
The services at 2160 W State Road 434, Longwood, FL 32779 are specifically designed for healthcare providers. The 503B Compounding Pharmacy provides physicians, surgeons, veterinarians, and other medical professionals with access to a consistent and reliable supply of high-quality compounded sterile preparations (CSPs). These preparations are vital for use in hospitals, clinics, surgical centers, and other clinical settings. By outsourcing their compounding needs to this FDA-registered facility, healthcare providers can be assured of receiving products that are manufactured under the strictest current good manufacturing practices (cGMP). This allows medical professionals to focus on patient care with the confidence that the medications they use meet the highest standards of pharmaceutical quality.
The team at 503B Compounding Pharmacy is comprised of skilled pharmacists, pharmacy technicians, and quality assurance professionals who are dedicated to the precise science of compounding. Every process, from ingredient sourcing to final product testing, is meticulously controlled and documented. The environment at the Longwood facility is a controlled cleanroom, which is essential for producing sterile injectables, ophthalmics, and other preparations that are free from contamination. This unwavering commitment to quality and safety ensures that every vial, syringe, or bag dispensed from 2160 W State Road 434, Longwood, FL 32779 is of the utmost integrity and efficacy.
Healthcare providers seeking a trusted partner for their office-use medication needs are encouraged to connect with 503B Compounding Pharmacy. The facility welcomes inquiries and orders from medical practices in need of reliable compounded pharmaceuticals. To learn more about the specific formulations available or to discuss your practice's needs, you can visit the official website at https://503bcompoundingpharmacy.com/ or contact the pharmacy directly by phone at (407)993-1381. The team is prepared to provide detailed information and support to the medical community.
Frequently Asked Questions
1. What does it mean that this is a 503B outsourcing facility?
It means this facility is registered with the FDA under Section 503B of the FD&C Act. This registration requires compliance with stricter production standards, including current Good Manufacturing Practices (cGMP), which govern quality control, testing, and reporting to ensure the safety and sterility of all medications produced at 2160 W State Road 434, Longwood, FL 32779.
2. Can I as an individual patient pick up my prescription at this location?
No. 503B Compounding Pharmacy provides medications for office use by healthcare providers. Individual patient prescriptions are typically handled by traditional 503A compounding pharmacies. This facility supplies medications in bulk to physicians, hospitals, and clinics, who then administer them to their patients.
3. What types of medications does the Longwood facility compound?
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile preparations (CSPs). This includes a wide array of injectables, intravenous (IV) bags, ophthalmics, and other medications that must be prepared in an sterile environment for use in clinical settings.
4. How do I, as a healthcare provider, place an order?
Healthcare providers can place orders by contacting the pharmacy directly at (407)993-1381. The team will guide you through the ordering process, discuss your specific needs, and provide information on available formulations and delivery options to your practice.
5. Why should our practice source medications from this specific 503B facility?
Sourcing from this FDA-registered outsourcing facility ensures you receive medications produced under the highest standards of pharmaceutical manufacturing. This provides an added layer of safety and quality assurance for your patients and reduces the regulatory burden and liability on your practice compared to in-office compounding.