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 at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation means we adhere to the highest current good manufacturing practices (cGMP), providing healthcare practitioners and patients with medications that meet rigorous standards for quality, safety, and potency. We serve a critical role in the healthcare supply chain, particularly during drug shortages or when commercially available products do not meet the specific clinical needs of patients.
The core function of 503B Compounding Pharmacy is the production of medications in larger batches for office use by healthcare providers. Physicians, surgeons, dermatologists, and other medical professionals located at and serving 2160 W State Road 434, Longwood, FL 32779 can rely on our facility for a consistent supply of high-quality compounded preparations. Our portfolio includes a wide array of sterile preparations, such as injectables, ophthalmics, and irrigation solutions, as well as non-sterile formulations like topical creams and capsules. By outsourcing their compounding needs to our 503B facility, local healthcare providers can ensure patient access to necessary medications while maintaining efficiency in their practice operations.
Patients who receive medications prepared by 503B Compounding Pharmacy benefit from the assurance that comes with FDA-registered oversight. Every batch produced within our facility undergoes stringent quality control testing, including sterility testing, endotoxin testing, and potency analysis. This level of quality control, which goes beyond traditional pharmacy compounding, is a fundamental requirement of our 503B status. For the community at 2160 W State Road 434, Longwood, FL 32779, this translates to a trusted source for medications that are critical for treatments, procedures, and ongoing care.
Engaging with 503B Compounding Pharmacy is a streamlined process for healthcare providers. Orders can be placed directly through our dedicated systems, and our team is committed to reliable fulfillment and delivery. We encourage medical professionals at 2160 W State Road 434, Longwood, FL 32779 to explore how our services can support their practice and enhance patient care. For more detailed information about our capabilities or to initiate an order, please contact us directly.
Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
Frequently Asked Questions
1. 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 complies with strict federal standards for compounding medications in large volumes. We operate under Section 503B of the FD&C Act, which requires adherence to current Good Manufacturing Practices (cGMP) for consistent quality and safety.
2. As a patient at 2160 W State Road 434, Longwood, FL 32779, can I order medications directly from 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy does not dispense medications directly to patients. We compound medications in bulk for "office use" by licensed healthcare providers. Your physician or clinician at this location would order and keep our preparations in their office to administer or dispense to you during your treatment.
3. What types of medications does 503B Compounding Pharmacy produce for local providers?
Our facility at 2160 W State Road 434, Longwood, FL 32779 produces a range of sterile and non-sterile compounded medications. This includes injectables, IV bags, ophthalmics, topical creams, and other formulations that are often used by physicians, surgery centers, and dermatologists in their practice.
4. How does 503B Compounding Pharmacy ensure the quality of its compounded medications?
Quality is paramount. As a 503B outsourcing facility, we are required to perform rigorous quality control testing on our products, including sterility, endotoxin, potency, and identity testing. This provides an additional layer of safety and reliability for healthcare providers and their patients at our location.
5. How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly to establish an account and discuss their specific needs. Our team will guide them through the ordering process. Please reach out to us via our website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381 for more information.