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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation signifies a commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Located at 2160 W State Road 434, Longwood, FL 32779, this facility provides a critical service by producing large quantities of sterile and non-sterile compounded pharmaceutical products. The operations at this specific location are conducted under rigorous quality control protocols that meet and exceed federal regulatory requirements, ensuring that every preparation is consistent, reliable, and of the utmost quality.
The core function of 503B Compounding Pharmacy is to serve as a bulk manufacturer of compounded drugs for healthcare providers. The facility at 2160 W State Road 434, Longwood, FL 32779 does not typically dispense medication directly to individual patients but instead provides its products to hospitals, clinics, physician offices, and other healthcare institutions. This allows medical professionals to access essential medications that are not readily available from traditional pharmaceutical manufacturers, whether due to drug shortages, discontinuations, or the need for specific formulations not commercially produced. The work done at this location is vital for supporting the local healthcare infrastructure.
As an outsourcing facility, 503B Compounding Pharmacy adheres to Current Good Manufacturing Practice (CGMP) regulations. This means every process at the Longwood facility, from ingredient sourcing and environmental monitoring to testing and documentation, is meticulously controlled and validated. The sterile compounding suites are designed to maintain the highest levels of aseptic processing, minimizing the risk of contamination. This focus on a superior quality system provides healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with the confidence that the medications they receive are safe, potent, and pure.
The services provided by 503B Compounding Pharmacy are distinct from those of a traditional retail or 503A compounding pharmacy. The focus is on large-scale production rather than individualized prescriptions. Healthcare entities in need of a reliable, high-volume source for compounded medications can depend on the consistent output and regulatory compliance of the facility located at 2160 W State Road 434, Longwood, FL 32779. For more information on its capabilities or to discuss its services, healthcare providers are encouraged to contact the facility directly.
To learn more about 503B Compounding Pharmacy or to inquire about its services, please visit the website at https://503bcompoundingpharmacy.com/ or call the facility at (407)993-1381.
FAQ
1. What does it mean that this facility is a 503B outsourcing facility?
Being a 503B outsourcing facility means we are an FDA-registered entity that compounds large quantities of sterile and non-sterile drugs in accordance with strict Current Good Manufacturing Practice (CGMP) regulations. This is different from a traditional pharmacy and involves a higher level of federal oversight for bulk production.
2. Can I, as an individual patient, get a prescription filled at 2160 W State Road 434?
No. 503B Compounding Pharmacy operates as a bulk manufacturer for healthcare providers and institutions. Individual patient prescriptions are typically handled by 503A compounding pharmacies. Our location at 2160 W State Road 434, Longwood, FL 32779 supplies hospitals, clinics, and doctor's offices.
3. What types of medications are compounded at this specific location?
The facility at 2160 W State Road 434, Longwood, FL 32779 compounds a wide range of sterile and non-sterile preparations in large volumes. This includes solutions for injections, ophthalmics, and other formulations often needed to address drug shortages or supply specific strengths required by area healthcare providers.
4. How does the 503B Compounding Pharmacy ensure product quality and safety?
Our facility adheres to rigorous FDA-enforced CGMP standards. This involves stringent environmental monitoring, validated sterilization processes, extensive testing of raw materials and finished products, and comprehensive documentation for every batch produced at our Longwood location.
5. How can a local hospital or clinic place an order with your facility?
Healthcare providers and institutions interested in our services should contact our facility directly to discuss their needs. You can reach us by phone at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more information on initiating an order or establishing an account.