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. Our facility is precisely located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, our 503B outsourcing facility adheres to rigorous current good manufacturing practices (cGMP), ensuring that every preparation is produced under a level of scrutiny and standardization that prioritizes patient safety above all else.
The core function of 503B Compounding Pharmacy at 2160 W State Road 434 is the large-scale production of compounded sterile preparations (CSPs) for office use. We provide healthcare practitioners with access to a consistent and reliable supply of high-quality medications that are essential for their practice. Our services are designed to support the medical community by offering medications that may be in shortage, not commercially available, or required in specific formulations that are not offered by major pharmaceutical manufacturers. By operating from our facility in Longwood, we ensure a dependable source for these critical medications.
Our state-of-the-art facility at 2160 W State Road 434 is equipped with advanced environmental controls, including ISO-classified cleanrooms, to guarantee the sterility and potency of every preparation. Every process, from ingredient sourcing to final packaging, is meticulously controlled and documented. This unwavering dedication to cGMP standards provides healthcare providers and their patients with the utmost confidence in the medications they receive from 503B Compounding Pharmacy. We are a pivotal partner for the local medical community, enabling practitioners to focus on patient care with the assurance that their medication supply is secure, sterile, and of the highest quality.
For more detailed information about our compliance and offerings, we encourage you to visit our website at https://503bcompoundingpharmacy.com/. To speak directly with a representative regarding our services, please call us at (407)993-1381. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779, is registered with the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. This requires us to comply with stringent current good manufacturing practices (cGMP) for the production of compounded drugs, ensuring a higher level of safety, quality, and consistency compared to traditional compounding.
Who can receive medications directly from 503B Compounding Pharmacy?
As a 503B outsourcing facility, we provide compounded medications for "office use" by healthcare practitioners. We do not dispense medications directly to individual patients. Healthcare providers at practices near 2160 W State Road 434 can order medications from us to have on hand for administering to patients in their clinical setting.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434 specializes in producing compounded sterile preparations (CSPs). This includes a range of injectables, IV bags, ophthalmics, and other medications that must be sterile. We often compound medications that are on drug shortage lists or are not available from commercial manufacturers.
How does 503B Compounding Pharmacy ensure the quality of its compounded preparations?
Our location at 2160 W State Road 434 maintains ISO-classified cleanrooms, utilizes high-quality ingredients from approved suppliers, and follows rigorous cGMP protocols. Every batch undergoes thorough testing and quality control checks to verify sterility, potency, and purity before being released.
How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. You can reach us by phone at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more information on our ordering process and available formulations.