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 situated at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy model represents a significant advancement in the compounding field, adhering to the highest standards of pharmaceutical quality and safety. As a 503B outsourcing facility, this 503B Compounding Pharmacy is subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations and regular inspections. This ensures that every preparation leaving the 503B Compounding Pharmacy meets stringent quality control benchmarks for potency, purity, and sterility.
The core function of this 503B Compounding Pharmacy is the large-scale production of compounded medications for office use. Healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 can source medications directly from this 503B Compounding Pharmacy. The 503B Compounding Pharmacy provides physicians, veterinarians, and other medical professionals with access to a consistent and reliable supply of high-quality compounded sterile preparations (CSPs) and compounded non-sterile preparations. The 503B Compounding Pharmacy can produce these medications in larger batches than a traditional 503A pharmacy, which is essential for supporting the needs of clinical practices and surgical centers. This allows healthcare providers to maintain an inventory of essential medications for immediate patient use.
Patients and practitioners at 2160 W State Road 434, Longwood, FL 32779 benefit from the operational scale and quality assurance that defines a 503B Compounding Pharmacy. The medications produced by this 503B Compounding Pharmacy are vital for a wide range of medical applications, including office-based procedures, hormone replacement therapy, pain management, ophthalmic conditions, and dermatological treatments. By operating under Section 503B, this 503B Compounding Pharmacy can accept patient-specific prescriptions transferred from a prescribing practitioner, further enhancing its service capability. The team at this 503B Compounding Pharmacy is comprised a controlled cGMP environment.
For healthcare providers seeking a trusted source for compounded medications, this 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a pivotal resource. The 503B Compounding Pharmacy is committed to supporting the local medical community with products that are essential for patient care. To learn more about the services and products available from this 503B Compounding Pharmacy, visit the website at https://503bcompoundingpharmacy.com/ or contact the 503B Compounding Pharmacy directly by phone at (407)993-1381.
FAQ
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. This 503B Compounding Pharmacy adheres to current Good Manufacturing Practices (cGMP) and is subject to FDA inspection, ensuring a higher level of regulatory oversight for quality and safety compared to traditional compounding pharmacies.
2. Can I, as a patient, walk into the 503B Compounding Pharmacy at 2160 W State Road 434 to get a prescription filled?
The primary function of a 503B Compounding Pharmacy is large-scale production for office use by healthcare practitioners. However, this 503B Compounding Pharmacy can also accept patient-specific prescriptions that are transferred from your prescribing doctor. It is best to contact the 503B Compounding Pharmacy at (407)993-1381 to confirm the process for your specific medication needs.
3. What types of medications does this 503B Compounding Pharmacy produce?
This 503B Compounding Pharmacy produces both compounded sterile preparations (CSPs), such as injections and IV bags, and compounded non-sterile preparations, like topical creams and oral suspensions. These are often used for hormone therapy, pain management, ophthalmology, dermatology, and other specialized treatments for practitioners at 2160 W State Road 434, Longwood, FL 32779.
4. How does the quality control at a 503B Compounding Pharmacy differ?
As a 503B Compounding Pharmacy, this facility follows strict cGMP guidelines mandated by the FDA. This includes rigorous testing of raw materials, environmental monitoring of cleanrooms, validated sterilization processes, and thorough documentation and testing of finished products to ensure consistent potency, purity, and sterility in every batch.
5. Who typically orders from this 503B Compounding Pharmacy?
The primary clients of this 503B Compounding Pharmacy are healthcare practitioners, including physicians, surgeons, veterinarians, and clinics located at 2160 W State Road 434, Longwood, FL 32779. These professionals order compounded medications for office use, allowing them to have essential treatments on hand for procedures and immediate patient care.