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.
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under 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 safe and compliant production of compounded medications. As a 503B outsourcing facility, we adhere to rigorous current good manufacturing practices (cGMP) set forth by the FDA, ensuring that every preparation leaving our pharmacy meets the highest standards of quality, sterility, and potency. This designation distinguishes us from traditional compounding pharmacies and provides healthcare providers and patients at our location with an elevated level of confidence in the medications they receive.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are patient-specific but not individually identifiable until the point of dispensing. We provide these preparations for office use by healthcare practitioners serving the community at 2160 W State Road 434, Longwood, FL 32779. This allows physicians, surgeons, and other medical professionals to have essential medications readily available for immediate administration during procedures, treatments, or appointments, without the delay of patient-specific compounding. Our operations are strictly focused on this non-patient-specific, office-use model as defined by federal regulation.
Our services at 2160 W State Road 434, Longwood, FL 32779 include the compounding of a wide array of sterile preparations. This encompasses injectables, IV bags, ophthalmics, and other sterile solutions that are critical in clinical settings. Every batch is produced in our state-of-the-art cleanroom environment by our highly trained staff, which includes pharmacists and quality assurance professionals. We implement a robust quality control program with stringent testing protocols, including sterility testing, endotoxin testing, and stability studies, to verify the safety and efficacy of every product we compound.
503B Compounding Pharmacy serves as a vital partner to the local medical community. By providing reliable access to high-quality, office-use compounded medications, we support healthcare providers in delivering efficient and effective patient care directly from our location at 2160 W State Road 434, Longwood, FL 32779. We are committed to upholding the strict compliance and quality standards mandated for a 503B outsourcing facility, ensuring the integrity of the drug supply chain for the practitioners and patients we serve.
For more information or to discuss how our services can support your practice, please contact us. Website: | Phone: (407)993-1381
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that you are a 503B outsourcing facility?
Being a 503B outsourcing facility means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with strict federal current good manufacturing practices (cGMP). This ensures the medications we compound for office use meet rigorous standards for sterility, potency, and quality that are comparable to those of conventional drug manufacturers.
2. Can I, as a patient, order medications directly from your pharmacy?
No. 503B Compounding Pharmacy operates under federal regulations that permit us to compound medications for "office use" by healthcare practitioners. Patients must receive our compounded preparations through their physician or healthcare provider who has ordered them for administration during treatment at their practice.
3. What types of medications do you compound at your Longwood location?
At our facility at 2160 W State Road 434, we specialize in compounding sterile preparations, including injectable medications, intravenous (IV) solutions, and ophthalmic drops. These are compounded in batches for healthcare providers to have on hand for procedures and treatments.
4. How do healthcare providers at this location order from you?
Healthcare providers and practices can establish an account with our pharmacy by contacting us directly. Orders can be placed for non-patient-specific, office-use compounded medications to be available at our location for pick-up or delivery to their practice. Please call (407)993-1381 to speak with our team.
5. Why should a provider choose a 503B outsourcing facility over a traditional compounding pharmacy?
Choosing a 503B outsourcing facility like ours at 2160 W State Road 434, Longwood, FL 32779 provides an added layer of safety and quality assurance. Our mandatory adherence to cGMP standards, which include extensive testing and quality control protocols, offers providers confidence in the sterility and consistency of the medications they use in their practice.