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, located at 2160 W State Road 434, Longwood, FL 32779, is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation signifies our unwavering commitment to the highest standards of quality, safety, and regulatory oversight, far exceeding those of traditional compounding pharmacies. We serve a critical role in the healthcare supply chain by providing healthcare practitioners with access to essential medications that are often on shortage or unavailable from conventional manufacturers.
The core function of 503B Compounding Pharmacy is the production of medications in bulk for office use by healthcare providers. Physicians and practitioners in Longwood can confidently utilize our services to obtain the necessary medications for their practice, ensuring they have a reliable and compliant source for patient care. Our state-of-the-art facility at 2160 W State Road 434 is equipped with advanced technology and environmental controls to ensure the integrity and sterility of every preparation. Every batch we compound undergoes rigorous testing and quality control procedures to guarantee potency, purity, and safety before it is released for distribution.
By partnering with 503B Compounding Pharmacy at 2160 W State Road 434, healthcare providers gain a trusted ally in patient treatment. We alleviate the burden of in-office compounding, allowing practitioners to focus on patient care with the assurance that their medications are sourced from a facility that prioritizes excellence and regulatory adherence. Our team of highly skilled pharmacists and technicians is dedicated to upholding the strict protocols required of an FDA-registered outsourcing facility, ensuring every product meets precise specifications.
For healthcare providers seeking a dependable source for office-use medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a pillar of quality and reliability. We invite you to contact us to learn more about our services and how we can support your practice. Reach out to us via our website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
This designation means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with stringent federal standards for compounding, including current Good Manufacturing Practices (cGMP). This ensures a higher level of quality control and oversight compared to traditional pharmacies.
Can I, as a patient, order medications directly from 503B Compounding Pharmacy?
No. As an outsourcing facility operating under Section 503B, we compound medications in bulk for "office use" or "office stock." These medications are distributed to healthcare practitioners at 2160 W State Road 434 and other locations for administration to their patients within a clinical setting, not directly to individual patients for home use.
What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434 provide?
We specialize in compounding a wide range of sterile and non-sterile medications that are often on drug shortage lists or are not commercially available from major manufacturers. This includes various injectables, ophthalmics, and other preparations needed by healthcare providers for their practices.
How can a healthcare provider at 2160 W State Road 434 order from your facility?
Healthcare providers can initiate orders by contacting our facility directly. We recommend visiting our website at https://503bcompoundingpharmacy.com/ for more information or calling our dedicated line at (407)993-1381 to speak with a representative about our ordering process and product availability.
Why should a provider choose 503B Compounding Pharmacy over other compounders?
Choosing our facility at 2160 W State Road 434 ensures you are receiving medications from an FDA-registered outsourcing facility that adheres to the highest level of federal quality and safety standards. Our commitment to cGMP provides an added layer of assurance regarding the sterility, potency, and purity of the medications you use in your practice.