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 and safety, including current Good Manufacturing Practices (cGMP), which are more rigorous than the standards applied to traditional compounding pharmacies. This ensures that every preparation leaving our facility meets stringent federal requirements for strength, quality, purity, and identity.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded medications for office use. This means we provide healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 with access to essential medications that are not commercially available. Physicians, surgeons, veterinarians, and other medical professionals can utilize our services to obtain the specific preparations necessary for their practice, ensuring they have the right medications on hand for patient care. Our operations are designed to support the local medical community by providing a reliable, quality-assured source for critical drugs.
Our services at the Longwood facility are distinct from a traditional retail pharmacy. We do not engage in direct patient dispensing for individual prescriptions. Instead, we work exclusively with healthcare providers, supplying them with medications for their office stock. This model allows practitioners to administer medications immediately during patient visits, procedures, or treatments without delay. The medications produced by 503B Compounding Pharmacy are vital for a wide range of applications, including office-based procedures, hormone replacement therapy, pain management, ophthalmic uses, and dermatological treatments.
Quality control is the foundation of everything we do at our location on W State Road 434. Our state-of-the-art facility features advanced environmental monitoring, rigorous testing protocols, and validated processes to guarantee sterility and potency. Every batch of medication is produced under controlled conditions and is subject to extensive quality assurance checks before it is released. This unwavering commitment to cGMP standards provides healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 with the confidence that the medications they use are safe, effective, and reliable for their patients.
Healthcare providers seeking a trusted partner for their compounding needs can connect with 503B Compounding Pharmacy. We invite local practitioners to visit our website at or call us at (407)993-1381 to learn more about our current product offerings and to discuss how our 503B compounding services can support your practice and enhance patient care at your facility on W State Road 434.
FAQ
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 complies with Section 503B of the FD&C Act. We operate under current Good Manufacturing Practices (cGMP), which are federal standards for drug manufacturing that ensure consistent quality, sterility, and safety of the medications we compound.
2. Can I, as a patient, come to your location to pick up a prescription?
No. 503B Compounding Pharmacy does not dispense medications directly to patients. We supply compounded medications exclusively to healthcare practitioners for office use. Your healthcare provider at 2160 W State Road 434, Longwood, FL 32779 may administer a medication we produced during your appointment.
3. What types of medications does 503B Compounding Pharmacy produce?
We produce a wide array of sterile and non-sterile compounded medications for office use. This includes preparations for pain management, hormone therapy, ophthalmology, dermatology, and other specialized treatments that are often unavailable from standard commercial manufacturers.
4. How can a healthcare provider at this location order from you?
Healthcare practitioners can place orders by contacting 503B Compounding Pharmacy directly. We encourage providers at 2160 W State Road 434, Longwood, FL 32779 to call us at (407)993-1381 or visit our website at to discuss their specific compounding needs and establish an account.
5. Why should a provider choose a 503B outsourcing facility over other compounders?
Choosing a 503B outsourcing facility like ours ensures the medications are produced under the highest federally mandated quality and safety standards (cGMP). This provides an added layer of assurance regarding the sterility, potency, and purity of the medications used on patients at your practice.