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 designation as a 503B outsourcing facility differentiates this operation from traditional compounding pharmacies, as it is subject to heightened regulatory standards, including current Good Manufacturing Practices (cGMP). The 503B Compounding Pharmacy provides bulk compounded medications for office use by healthcare practitioners, ensuring a reliable and quality-assured source of necessary drugs that may be in shortage or not commercially available.
The core function of the 503B Compounding Pharmacy is the large-scale production of sterile and non-sterile compounded preparations. These preparations are distributed to healthcare providers for administration to patients within their professional practice. The 503B Compounding Pharmacy does not typically dispense medications directly to individual patients based on individual prescriptions, which is the role of a 503A pharmacy. Instead, the 503B Compounding Pharmacy supplies medications in larger quantities for physician offices, hospitals, and clinics. The facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with the advanced technology and environmental controls required to meet the rigorous standards set forth for a 503B outsourcing facility.
By operating under the 503B framework, this 503B Compounding Pharmacy offers a critical service to the medical community. Healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 and the immediate vicinity can access essential medications that are often on the FDA drug shortage list. The 503B Compounding Pharmacy undergoes regular FDA inspections, providing an additional layer of safety and quality assurance for the medications it produces. This commitment to compliance and quality is fundamental to the mission of the 503B Compounding Pharmacy, ensuring that practitioners receive products they can trust for their patients.
For healthcare providers seeking a dependable source for compounded medications, the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a key partner. The team at the 503B Compounding Pharmacy is dedicated to upholding the strictest protocols to ensure every preparation meets precise specifications. To learn more about the services and products available from this 503B Compounding Pharmacy, or to inquire about becoming a client, please contact the facility directly. The 503B Compounding Pharmacy can be reached by phone at (407)993-1381 or through their official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this is a 503B Compounding Pharmacy? This 503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation means the 503B Compounding Pharmacy adheres to more rigorous manufacturing standards, including current Good Manufacturing Practices (cGMP), and is subject to regular FDA inspections. The 503B Compounding Pharmacy prepares medications in bulk for office use by healthcare practitioners.
2. Can I, as an individual patient, get a prescription filled at the 503B Compounding Pharmacy? No. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 does not typically dispense medications directly to individual patients based on a prescription. The 503B Compounding Pharmacy supplies compounded medications in larger quantities to healthcare providers, hospitals, and clinics for them to administer to patients within their practice.
3. How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from the 503B Compounding Pharmacy? Healthcare providers and facilities interested in the services of the 503B Compounding Pharmacy should contact the facility directly to establish an account and discuss their specific needs. The 503B Compounding Pharmacy can be reached at (407)993-1381. The team at the 503B Compounding Pharmacy will guide you through the ordering process.
4. What types of medications does the 503B Compounding Pharmacy produce? The 503B Compounding Pharmacy produces a range of sterile and non-sterile compounded preparations. These often include medications that are currently on the FDA drug shortage list or are not available from commercial manufacturers. The specific formulations available from the 503B Compounding Pharmacy can be discussed by contacting them directly.
5. Why should a healthcare provider choose this 503B Compounding Pharmacy? Choosing this 503B Compounding Pharmacy ensures that healthcare providers at 2160 W State Road 434, Longwood, FL 32779 receive medications produced under the highest standards of quality and safety. As an FDA-registered 503B outsourcing facility, the 503B Compounding Pharmacy operates under cGMP, providing assurance of product quality, purity, and strength for office use.