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 from its location at 2160 W State Road 434, Longwood, FL 32779. Functioning under the stringent regulatory framework of Section 503B of the Federal Food, Drug, and Cosmetic Act, this 503B Compounding Pharmacy is distinct from traditional compounding pharmacies. The designation as a 503B outsourcing facility signifies a commitment to the highest standards of quality, safety, and consistency in the preparation of compounded medications. The facility at 2160 W State Road 434, Longwood, FL 32779 adheres to rigorous Current Good Manufacturing Practices (cGMP), which are the same standards required of major pharmaceutical manufacturers. This ensures that every batch of medication produced is subject to extensive testing, quality control, and validation processes, providing healthcare providers and patients with a level of assurance that is critical for patient care.
The core service of this 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for office use. This model is designed to support the practices of physicians, surgeons, veterinarians, and other healthcare providers who require immediate access to reliable, pre-made medications for their procedures and treatments. By maintaining an inventory of frequently used compounds, the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 enables healthcare professionals to obtain vital medications without the delay and resource expenditure associated with in-house or patient-specific compounding. This is particularly crucial for medications with short shelf-lives or those needed for urgent care situations, allowing for efficient and effective patient treatment directly from the provider's office.
Patients who receive medications prepared by the 503B Compounding Pharmacy benefit from the knowledge that their therapy was produced in an environment of unparalleled quality. The facility's operations are focused on non-patient-specific, office-use compounding, meaning the medications are dispensed to the prescribing practitioner rather than directly to the patient. The practitioners serving the community can then utilize these ready-made compounds for a variety of applications, including hormone replacement therapy, ophthalmologic treatments, pain management solutions, and other injectable medications. The staff at the 503B Compounding Pharmacy location at 2160 W State Road 434, Longwood, FL 32779 works closely with the medical community, providing a critical service that supports local healthcare delivery and enhances patient outcomes through access to high-quality compounded preparations.
For more information on the services provided or to inquire about how this facility can support your practice, please contact 503B Compounding Pharmacy directly. The team is available to answer questions and provide detailed information about their processes and available formulations.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Address: 2160 W State Road 434, Longwood, FL 32779
Frequently Asked Questions
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility that compounds large volumes of sterile medications for office use by healthcare providers. It operates under stricter federal regulations, including Current Good Manufacturing Practices (cGMP), compared to a traditional 503A pharmacy.
2. Can I, as a patient, pick up my prescription directly from your location?
No. The 503B Compounding Pharmacy primarily compounds medications for office use, which are then distributed to healthcare providers. Your prescribing physician or veterinarian at their practice would administer or dispense the medication to you from their supply, which they obtained from our facility.
3. What types of medications does the 503B Compounding Pharmacy at 2160 W State Road 434 prepare?
This 503B Compounding Pharmacy specializes in compounding sterile injectable medications, such as hormone therapies, peptides, ophthalmologic solutions, and pain management formulations. These are provided in batches to medical practices for use in their treatment protocols.
4. How does the 503B model benefit my local doctor or veterinarian?
It allows healthcare providers at practices near 2160 W State Road 434, Longwood, FL 32779 to access reliable, high-quality, pre-made compounded medications without investing in their own compounding infrastructure. This saves them time and resources while ensuring their patients receive medications produced under the highest safety standards.
5. How can a medical practice at 2160 W State Road 434 place an order with your 503B Compounding Pharmacy?
Healthcare providers and their authorized staff can contact the 503B Compounding Pharmacy directly by phone at (407)993-1381 to discuss their needs, place orders, and arrange for delivery or pickup of compounded medications for their office use.