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. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. The 503B designation signifies a commitment to the highest standards of quality, safety, and consistency, operating under current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving the facility meets rigorous federal quality standards, providing healthcare providers and patients with medications they can trust.
The core function of 503B Compounding Pharmacy is the production of medications for office use, primarily supplying healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779. This includes hospitals, clinics, and other healthcare entities that require readily available, high-quality compounded preparations for their patients. By serving as a bulk manufacturer, the pharmacy helps ensure a consistent and reliable supply of essential medications that may be commercially unavailable or in shortage, directly supporting the local medical community's needs.
As an outsourcing facility, 503B Compounding Pharmacy provides a critical service by compounding drugs that are not available through traditional pharmaceutical manufacturers. This includes creating specific strengths, formulations, or dosage forms that are necessary for patient care but are not mass-produced. The team of highly trained pharmacists and technicians at the 2160 W State Road 434, Longwood, FL 32779 location utilizes advanced technology and sterile compounding techniques to produce these medications in a controlled environment, prioritizing patient safety above all else.
Healthcare professionals seeking a dependable source for compounded medications can rely on 503B Compounding Pharmacy. The facility is equipped to handle a significant volume of orders while maintaining meticulous attention to detail and quality control. For more information on available preparations or to discuss your specific needs, you can contact 503B Compounding Pharmacy directly. Reach out via their website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381.
FAQ
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means that 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with strict federal standards, including current Good Manufacturing Practices (cGMP). This ensures a higher level of quality control and consistency for compounded medications compared to traditional compounding.
2. Can I, as an individual patient, pick up a prescription directly from 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy primarily supplies medications for office use to healthcare practitioners and facilities. Individual patients should work with their healthcare provider, who can source appropriate medications from our facility at 2160 W State Road 434, Longwood, FL 32779 for administration in a clinical setting.
3. What types of medications does 503B Compounding Pharmacy at this location produce?
503B Compounding Pharmacy produces a wide range of sterile and non-sterile compounded medications in bulk quantities. This includes hormonal preparations, pain management solutions, dermatological creams, and other formulations that are often on national shortage or are not commercially available from major pharmaceutical manufacturers.
4. How does a healthcare provider at 2160 W State Road 434 place an order with 503B Compounding Pharmacy?
Healthcare providers and facilities can place orders directly through the pharmacy. The preferred methods for initiating an order or making an inquiry are by calling (407)993-1381 or by visiting the official website at https://503bcompoundingpharmacy.com/ to connect with a representative.
5. Why would a healthcare provider choose 503B Compounding Pharmacy over other compounders?
Healthcare providers choose 503B Compounding Pharmacy because of its FDA-registered status and adherence to cGMP standards. This provides an added layer of assurance regarding the quality, purity, and sterility of the medications they administer to patients at their practice located at 2160 W State Road 434, Longwood, FL 32779.