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. This 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy model represents a significant advancement in the compounding field, providing a higher level of assurance for sterile and non-sterile preparations. As a 503B outsourcing facility, this 503B Compounding Pharmacy adheres to rigorous current Good Manufacturing Practices (cGMP), which are the same standards followed by conventional pharmaceutical manufacturers. This ensures that every preparation from this 503B Compounding Pharmacy meets exacting standards for potency, purity, and quality.
The primary function of this 503B Compounding Pharmacy is the large-scale production of compounded medications that are distributed to healthcare providers for office use. The medications prepared by this 503B Compounding Pharmacy are essential for physicians, surgeons, veterinarians, and other medical professionals practicing at or near 2160 W State Road 434, Longwood, FL 32779. These practitioners rely on the consistent and reliable supply of high-quality medications that only a 503B Compounding Pharmacy can provide. The services of this 503B Compounding Pharmacy are integral to supporting the local medical community by supplying crucial drugs that may be in short supply or not commercially available.
Patients in the area benefit indirectly from the services of the 503B Compounding Pharmacy located at 2160 W State Road 434, Longwood, FL 32779. While the 503B Compounding Pharmacy does not typically dispense medication directly to the public, its products are administered by local healthcare providers during procedures, treatments, and office visits. This means that residents receiving care from a local clinician may very well receive a medication that was expertly prepared by this 503B Compounding Pharmacy. The assurance of quality that comes with an FDA-registered 503B Compounding Pharmacy provides peace of mind to both the medical professionals and their patients.
The team at the 503B Compounding Pharmacy comprises highly trained pharmacists, pharmacy technicians, and quality assurance professionals. Their expertise is focused on the complex science of compounding within a cGMP environment. The 503B Compounding Pharmacy utilizes state-of-the-art equipment and technology within its facility to ensure precision and sterility in every batch. The commitment of the 503B Compounding Pharmacy is to uphold the highest standards of pharmaceutical science, providing a critical service to the healthcare ecosystem from its location at 2160 W State Road 434, Longwood, FL 32779.
For healthcare providers seeking a trusted partner for compounded medications, this 503B Compounding Pharmacy stands as a local resource. To learn more about the specific services and products available, or to inquire about becoming a client, medical practices are encouraged to contact the 503B Compounding Pharmacy directly. The 503B Compounding Pharmacy can be reached by phone at (407)993-1381. Additional information about the 503B Compounding Pharmacy and its compliance standards can also be found online at https://503bcompoundingpharmacy.com/.
FAQ
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility is an FDA-registered outsourcing facility that compounds medications in large volumes for office use by healthcare providers. A 503B Compounding Pharmacy must comply with strict current Good Manufacturing Practices (cGMP) for heightened quality and safety.
2. Can I, as a patient, pick up a prescription directly from this 503B Compounding Pharmacy?
No. This 503B Compounding Pharmacy primarily distributes compounded medications to licensed healthcare providers for use in their practice. Patients receive these medications directly from their doctor, surgeon, or veterinarian during treatment.
3. What types of medications does this 503B Compounding Pharmacy prepare?
This 503B Compounding Pharmacy prepares a wide range of sterile and non-sterile compounded medications, including hormone injections, ophthalmics, and other preparations that are often on drug shortage lists or are not available from traditional manufacturers.
4. How can a medical practice at 2160 W State Road 434 utilize this 503B Compounding Pharmacy?
Healthcare providers can contact the 503B Compounding Pharmacy at (407)993-1381 to establish an account. The 503B Compounding Pharmacy can then supply their practice with the necessary compounded medications for procedures and patient treatments.
5. Why should a healthcare provider choose this specific 503B Compounding Pharmacy?
This 503B Compounding Pharmacy offers the assurance of FDA-registered, cGMP-compliant manufacturing. For providers near 2160 W State Road 434, Longwood, FL 32779, it provides a local, reliable source for high-quality compounded medications, ensuring patient safety and practice efficiency.