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 is a critical distinction that sets this facility apart from traditional compounding pharmacies, signifying adherence to the most rigorous federal standards for quality, safety, and production scale. Located at 2160 W State Road 434, Longwood, FL 32779, this 503B outsourcing facility provides a vital service by producing large batches of compounded sterile preparations (CSPs) and non-sterile preparations without patient-specific prescriptions. These bulk medications are then distributed to healthcare facilities and practitioners for office use, ensuring they have essential, often critical, drugs on hand for immediate patient care.
The core function of 503B Compounding Pharmacy is to act as a reliable and compliant source for healthcare providers. By operating under strict Current Good Manufacturing Practices (cGMP), the facility guarantees a level of sterility, purity, and consistency that is paramount for patient safety. The medications produced at the 2160 W State Road 434 location are trusted by medical professionals because every batch undergoes rigorous testing and quality control procedures mandated by the FDA. This process significantly reduces the risk of contamination, incorrect dosage, or medication errors, providing peace of mind to both practitioners and their patients.
Healthcare providers who source their medications from 503B Compounding Pharmacy benefit from a dependable supply chain for drugs that may be commercially unavailable or experiencing a shortage. The team of highly skilled pharmacists and technicians at the Longwood facility utilizes state-of-the-art technology and cleanroom environments to compound a wide array of preparations. This operational model allows clinics, hospitals, surgical centers, and other healthcare entities in need of a consistent supply of high-quality compounded medications to partner with a local, federally regulated source. The focus remains exclusively on serving the professional medical community from its facility at 2160 W State Road 434, Longwood, FL 32779.
For more information on the services provided or to inquire about becoming a client, you can contact 503B Compounding Pharmacy directly. The team is available to discuss specific needs and compliance details. Reach out via their website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
This means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and operates in compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. We adhere to stringent Current Good Manufacturing Practices (cGMP), which are the same standards required of major pharmaceutical manufacturers, ensuring the highest levels of quality, sterility, and safety in all our compounded preparations.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy distributes compounded medications to healthcare practitioners and facilities for office use. This includes hospitals, clinics, surgical centers, and other medical practices. We do not compound patient-specific medications for individual consumers directly; all orders are placed by licensed healthcare professionals or institutions.
3. What types of medications are compounded at your Longwood location?
As a 503B outsourcing facility, we compound large batches of both sterile and non-sterile preparations that are commonly used in clinical settings. This can include sterile injectables, ophthalmics, and other formulations that may be on drug shortage lists or are not otherwise available from commercial manufacturers. All production occurs exclusively at our location on 2160 W State Road 434.
4. How does ordering from a 503B outsourcing facility benefit our medical practice?
Ordering from our facility ensures you receive medications produced under the highest federal quality standards. This mitigates risk for your practice and your patients by providing assurance of product sterility, potency, and purity. It also offers a reliable supply chain for essential drugs that may be subject to national shortages.
5. How can I start ordering from 503B Compounding Pharmacy?
Healthcare providers and facilities interested in our services can initiate the process by contacting our team directly. We will guide you through the necessary steps for setting up an account. You can reach us for more information at our website, https://503bcompoundingpharmacy.com/, or by calling us at (407)993-1381.