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, a 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations and regular FDA inspections. This ensures that every preparation leaving the facility meets stringent quality control benchmarks for potency, purity, and sterility.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are patient-specific but not individually identifiable, allowing for broader distribution to healthcare providers and facilities. The medications produced are essential for a wide range of therapeutic needs, including sterile injectables, ophthalmic preparations, and other dosage forms that are often in short supply from conventional manufacturers. By providing these critical medications, 503B Compounding Pharmacy serves as a vital component of the healthcare infrastructure, supporting local practitioners and ensuring patient access to necessary treatments.
Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can rely on 503B Compounding Pharmacy for a consistent and reliable supply of high-quality compounded medications. The facility's operations are designed to alleviate drug shortages and provide alternatives when commercially available products are unsuitable for a patient's specific needs due to allergies to certain dyes or preservatives, or when a required dosage strength is not commercially manufactured. The team of highly trained pharmacists and technicians utilizes state-of-the-art equipment and processes within a controlled environment to ensure the integrity of every preparation.
Patients and providers in Longwood benefit from the assurance that comes with sourcing medications from an FDA-registered facility. The operational transparency and adherence to cGMP standards mean that every batch is meticulously documented and tested, providing a level of quality control that is paramount for patient safety. For more detailed information about the facility's capabilities or to inquire about specific medications, you can visit the website at https://503bcompoundingpharmacy.com/ or contact the facility directly by phone at (407)993-1381.
Frequently Asked Questions
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 the U.S. Food and Drug Administration and operates in compliance with Section 503B of the FD&C Act. This subjects us to federal oversight, mandatory compliance with current Good Manufacturing Practices (cGMP), and routine FDA inspections to ensure the highest standards of quality and safety for all compounded preparations.
Who can order medications from 503B Compounding Pharmacy?
Medications are distributed to healthcare providers and facilities. Patients seeking medications compounded at our facility located at 2160 W State Road 434, Longwood, FL 32779 must have them ordered by their physician or other authorized healthcare professional, who will then receive the medication for administration or dispensing.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we specialize in compounding sterile preparations, including injectables, ophthalmic solutions, and other medications that are often on drug shortage lists or are not commercially available in the specific strength or formulation required by healthcare providers serving patients in our community.
How does the quality control process work at your facility?
Our quality control process at 2160 W State Road 434, Longwood, FL 32779 is extensive and follows strict cGMP protocols. This includes rigorous testing of components, in-process testing, finished preparation potency and sterility testing, and comprehensive documentation for every batch to ensure the identity, strength, quality, and purity of all medications we compound.
How can a healthcare provider at your location place an order or get more information?
Healthcare providers can obtain more information about our services and place orders by contacting 503B Compounding Pharmacy directly. The best methods are to call us at (407)993-1381 to speak with a representative or to visit our website at https://503bcompoundingpharmacy.com/ for further details.