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 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 preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of quality control, current good manufacturing practices (cGMP), and rigorous testing protocols mandated by federal law. This ensures that every preparation leaving our pharmacy meets stringent specifications for potency, purity, and sterility.
The core function of 503B Compounding Pharmacy is to provide bulk quantities of compounded medications for office use by healthcare practitioners. We serve the medical community at our location on 2160 W State Road 434, Longwood, FL 32779, enabling physicians, surgeons, oncologists, and other healthcare providers to have essential medications readily available for patient care. Our preparations are not dispensed directly to individual patients but are distributed to licensed practitioners for administration in their practice settings. This model supports efficient and safe patient treatment by providing access to medications that may be commercially unavailable or in short supply.
Our services at the Longwood facility are defined by our regulatory status. The 503B designation signifies our commitment to operating on a larger scale than a traditional compounding pharmacy, with enhanced FDA oversight. This includes comprehensive environmental monitoring, validated sterilization processes, and stability testing to guarantee the integrity of our preparations. Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can confidently utilize our medications, knowing they are produced under a framework designed for maximum patient safety and consistency.
503B Compounding Pharmacy specializes in a range of preparations critical for modern medical practice. This includes sterile injectables, ophthalmics, and other dosage forms required in hospitals, clinics, and surgical centers. By focusing on office-use compounding, we help alleviate drug shortages and provide access to vital therapies. Our team of highly trained pharmacists and technicians utilizes state-of-the-art equipment within our controlled environment to ensure every product is compounded with precision and accuracy.
For healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 seeking a reliable source for high-quality, office-use compounded medications, 503B Compounding Pharmacy is a trusted partner. We are committed to supporting the local medical community with FDA-registered outsourcing services. For more information or to discuss your practice's needs, please contact us via our website at or by phone at (407)993-1381.
Frequently Asked Questions
1. 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 under Section 503B of the FD&C Act. This requires us to comply with stringent current good manufacturing practices (cGMP), undergo regular FDA inspections, and report any adverse events, ensuring the highest level of quality and safety for the compounded medications we produce.
2. Can I, as a patient, pick up my prescription directly from your location?
No. 503B Compounding Pharmacy prepares medications exclusively for office use by healthcare practitioners. We do not compound patient-specific prescriptions. Medications produced at our facility on 2160 W State Road 434, Longwood, FL 32779 are distributed to licensed physicians and healthcare providers for administration to their patients within their practice.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility specializes in preparing bulk quantities of sterile compounded medications, such as injectables, ophthalmics, and other formulations that are often used in hospitals, surgical centers, and clinical settings. These are medications that may be on shortage or not commercially available, providing essential support to healthcare providers at 2160 W State Road 434, Longwood, FL 32779.
4. How does a healthcare provider at 2160 W State Road 434 order from your pharmacy?
Healthcare practitioners can establish an account with 503B Compounding Pharmacy by contacting us directly. Orders can be placed by calling our facility at (407)993-1381. Our team will work with you to understand your practice's specific needs and provide information on our available preparations and ordering process.
5. Why should a healthcare provider choose a 503B outsourcing facility over other compounders?
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 compliance with cGMP standards and direct FDA oversight means healthcare providers can be confident in the sterility, potency, and purity of the medications they use in their practice, ultimately enhancing patient care.