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 operates as an FDA-registered outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is a critical distinction that sets this facility apart from traditional compounding pharmacies. Located at 2160 W State Road 434, Longwood, FL 32779, this 503B outsourcing facility adheres to the highest current good manufacturing practices (cGMP) mandated by the FDA. This ensures that every preparation leaving the facility meets rigorous standards for sterility, potency, purity, and stability. The primary function of this 503B Compounding Pharmacy is the large-scale production of compounded medications for office use, which are then distributed to healthcare providers and facilities.
The services provided at 2160 W State Road 434, Longwood, FL 32779 are specifically designed for healthcare practitioners. Physicians, surgeons, veterinarians, and other medical professionals can source high-quality, ready-made compounded medications from this 503B Compounding Pharmacy for use in their practices. This model allows healthcare providers to have essential medications on hand without the need for in-office compounding, saving valuable time and resources while ensuring patient safety through FDA oversight. The 503B Compounding Pharmacy produces a significant volume of sterile and non-sterile preparations, including injectables, ophthalmics, topicals, and other dosage forms that are in high demand within clinical settings.
Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, this 503B Compounding Pharmacy is equipped with state-of-the-art technology and staffed by a team of highly trained pharmacists, technicians, and quality assurance professionals. Every batch of medication is subjected to extensive testing and quality control checks to verify its integrity and compliance with strict regulatory standards. The commitment to cGMP at this location guarantees a level of consistency and reliability that is essential for healthcare providers who depend on these medications for their patients. The 503B Compounding Pharmacy provides a vital link in the healthcare supply chain, offering a dependable source for critical drugs that may be in short supply or unavailable from conventional manufacturers.
For healthcare providers seeking a trusted partner for their medication needs, the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a pillar of quality and safety. The facility's operations are dedicated to supporting the local medical community by providing access to a broad range of compounded preparations that are manufactured under the most stringent regulatory framework. To learn more about the services available or to inquire about specific preparations, you can contact the 503B Compounding Pharmacy via their website at or by phone at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this is a 503B Compounding Pharmacy?
This means our facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility. We operate under Section 503B of the Federal Food, Drug, and Cosmetic Act, which requires us to comply with strict current good manufacturing practices (cGMP) for the large-scale production of compounded medications intended for office use by healthcare providers.
2. Can I as an individual patient pick up my prescription at 2160 W State Road 434?
No. The 503B Compounding Pharmacy at this location provides medications for office use to healthcare practitioners and facilities. Individual patient prescriptions are typically compounded and dispensed by a traditional 503A pharmacy. Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can order medications from us to administer to their patients within their practice.
3. What types of medications does the 503B Compounding Pharmacy at this location produce?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 produces a wide array of sterile and non-sterile compounded preparations. This includes injectables, ophthalmics, topical creams and gels, and other dosage forms that are commonly used in clinical and surgical settings by healthcare professionals.
4. How does the 503B Compounding Pharmacy ensure the quality of its products?
As an outsourcing facility operating under cGMP standards at 2160 W State Road 434, Longwood, FL 32779, we implement rigorous quality control processes. This includes testing raw materials, in-process testing, and finished preparation sterility and potency testing. Our entire operation is designed to meet the elevated safety and quality standards enforced by the FDA.
5. How can a healthcare provider at this location place an order?
Healthcare providers interested in the services of the 503B Compounding Pharmacy can initiate the process by contacting our facility directly. You can reach us by phone at (407)993-1381 to speak with a representative or visit our website at for more information on our available preparations and ordering procedures specific to our operations at 2160 W State Road 434, Longwood, FL 32779.