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 in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation means we adhere to the highest federal standards for quality control, testing, and production, providing healthcare practitioners and patients with medications they can trust.
The core function of 503B Compounding Pharmacy is the production of medications that are not commercially available. This includes creating formulations without non-essential allergens like dyes or preservatives, compounding for patients requiring specific dosage strengths not found in mass-produced drugs, and producing medications that have been discontinued by major pharmaceutical manufacturers. All processes at our Longwood location are performed under rigorous environmental controls and quality assurance protocols to ensure patient safety and medication efficacy.
As a 503B outsourcing facility, our primary service is providing these compounded medications in bulk to healthcare providers for office use. This allows physicians, dermatologists, veterinarians, and other medical professionals practicing in and around Longwood to have immediate access to critical medications for their patients. Our operations support local healthcare delivery by ensuring practitioners have a reliable, quality-focused source for the specific medications their treatment plans require.
Our team at 2160 W State Road 434 is comprised of skilled pharmacists and technicians who are experts in the science of pharmaceutical compounding. We utilize advanced technology and equipment to maintain the sterility and precision required for every batch of medication that leaves our facility. The 503B Compounding Pharmacy is committed to upholding the integrity of the pharmaceutical supply chain for the local medical community by providing a vital service that fills the gaps left by traditional drug manufacturing.
For more information about the services provided directly from our Longwood facility, or to speak with our team, please contact us. We are available to assist healthcare providers and their patients.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Location: 2160 W State Road 434, Longwood, FL 32779
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific 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). This ensures the medications we compound meet the highest standards for quality, purity, and strength.
Can I pick up my compounded medication directly from your Longwood location?
As a 503B outsourcing facility, our primary operation is supplying compounded medications in bulk for office use by licensed healthcare practitioners. Patients should receive their medications directly from their prescribing doctor or clinic, which sources from our facility.
What types of medications does 503B Compounding Pharmacy produce?
Our facility in Longwood compounds a wide range of sterile and non-sterile medications that are not available off-the-shelf. This includes customized dosage forms, allergen-free formulations, and drugs that are currently in shortage or have been discontinued by larger manufacturers.
How do I know if my doctor uses 503B Compounding Pharmacy?
You can ask your healthcare provider if they source their office-use medications from our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779. Many local practices rely on us for high-quality compounded pharmaceuticals.
Who can I contact at your facility for more information?
Healthcare providers and their staff can contact our pharmacy team directly for information about our services and products. You can reach us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more details.