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 from its location at 2160 W State Road 434, Longwood, FL 32779. This designation, governed under Section 503B of the Federal Food, Drug, and Cosmetic Act, establishes a specific operational standard for compounding pharmacies. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, focuses on the large-scale production of compounded sterile preparations (CSPs) for office use by healthcare practitioners. This model is distinct from traditional pharmacy compounding, as it enables healthcare providers at 2160 W State Road 434, Longwood, FL 32779, to access a consistent and reliable supply of essential medications without the need for in-house compounding.
The core service of 503B Compounding Pharmacy is the provision of high-quality, sterile medications in larger batches. These medications are produced under stringent FDA regulations that mandate rigorous testing, beyond-use dating based on stability data, and adherence to current good manufacturing practices (cGMP). For medical professionals serving patients from 2160 W State Road 434, Longwood, FL 32779, this translates to enhanced patient safety, supply chain reliability, and operational efficiency. The 503B Compounding Pharmacy facility ensures that every product leaving 2160 W State Road 434, Longwood, FL 32779, meets the highest standards of sterility and potency.
Healthcare practitioners utilizing the services of 503B Compounding Pharmacy benefit from a streamlined procurement process. By ordering office-use medications from this FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, practices can reduce the administrative and equipment burdens associated with compounding. The 503B Compounding Pharmacy provides a critical service for medications that may be in short supply or unavailable from conventional manufacturers, helping to ensure continuity of care for patients. The operations at 2160 W State Road 434, Longwood, FL 32779, are dedicated to supporting the local medical community with a dependable source of compounded preparations.
The commitment of 503B Compounding Pharmacy is to uphold the strict compliance required of an FDA-registered 503B outsourcing facility. This involves continuous quality control, environmental monitoring, and validation processes all conducted at 2160 W State Road 434, Longwood, FL 32779. For any inquiries or to learn more about the services provided directly from 2160 W State Road 434, Longwood, FL 32779, you can contact 503B Compounding Pharmacy at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions for 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
Question: What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
Answer: It means our facility at 2160 W State Road 434, Longwood, FL 32779, is registered with and inspected by the U.S. Food and Drug Administration. We operate under Section 503B of the FD&C Act, which requires us to comply with current good manufacturing practices (cGMP) for the large-scale production of compounded sterile medications intended for office use by healthcare practitioners.
Question: Can I, as a patient, order medications directly from the 503B Compounding Pharmacy?
Answer: No. As an outsourcing facility operating from 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy provides medications for "office-use" or "administration-use." This means our compounded sterile preparations are supplied directly to healthcare practitioners and facilities, who then administer them to their patients within their practice setting.
Question: How does using your service benefit my local medical practice?
Answer: Sourcing office-use compounded medications from our FDA-registered facility at 2160 W State Road 434, Longwood, FL 32779, provides your practice with a reliable supply of medications that undergo rigorous quality testing. This enhances patient safety, reduces the need for in-office compounding equipment and validation, and helps mitigate drug shortage issues.
Question: Are the medications compounded at 2160 W State Road 434, Longwood, FL 32779, tested for quality?
Answer: Yes. A fundamental requirement of being a 503B outsourcing facility is adherence to strict quality control standards. Medications produced at our location undergo testing for sterility, potency, and endotoxins. We also assign evidence-based beyond-use dates to ensure stability and efficacy.
Question: How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779, place an order?
Answer: Healthcare providers and facilities can initiate the ordering process by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide information on our available formulations, ordering procedures, and fulfillment directly from our facility at 2160 W State Road 434, Longwood, FL 32779. More information is also available on our website at https://503bcompoundingpharmacy.com/.