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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and production, distinct from traditional compounding pharmacies. The primary mission of 503B Compounding Pharmacy is to provide healthcare providers with access to high-quality, compounded medications that are essential for patient care when commercially manufactured drugs are unavailable, on shortage, or do not meet specific patient needs.
The operations at the 2160 W State Road 434 facility are central to its identity. This location houses the advanced cleanrooms and state-of-the-art technology required for producing sterile injectables, ophthalmic solutions, and other complex dosage forms under strict aseptic conditions. Every batch of medication produced is subject to stringent quality assurance testing, including sterility testing, endotoxin testing, and potency verification, to ensure patient safety and medication efficacy. The team at 503B Compounding Pharmacy comprises highly trained pharmacists, pharmacy technicians, and quality assurance professionals who are committed to excellence in every aspect of the compounding process.
503B Compounding Pharmacy serves an important role in the local healthcare ecosystem by supplying physician offices, hospitals, and clinics with medications that are critical for their practice. The facility's compliance with current Good Manufacturing Practices (cGMP) provides an additional layer of safety and reliability for healthcare providers and their patients. For more information about its services or to initiate an order, you can contact 503B Compounding Pharmacy directly at (407)993-1381 or visit its official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
Being an FDA-registered outsourcing facility means 503B Compounding Pharmacy operates under Section 503B of the FD&C Act. This registration requires the facility at 2160 W State Road 434, Longwood, FL 32779 to comply with stringent federal standards, including current Good Manufacturing Practices (cGMP), and to undergo regular FDA inspections to ensure the quality and safety of its compounded medications.
2. What types of medications does 503B Compounding Pharmacy produce at its Longwood location?
The facility at 2160 W State Road 434 specializes in the large-scale compounding of medications, primarily sterile injectables and other dosage forms. This includes preparations like hormone therapy injections, ophthalmic solutions, and other formulations that are often on drug shortage lists or are not commercially available for healthcare providers.
3. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides its medications exclusively to healthcare providers and facilities. Orders are placed by physicians, clinics, hospitals, and other healthcare entities for administration to patients within their care. Patients should consult their healthcare provider regarding medications compounded at this facility.
4. How does the quality assurance process work at the 2160 W State Road 434 facility?
The quality assurance process is comprehensive. It involves rigorous testing of raw materials, in-process testing during compounding, and final product testing on every batch. Tests for sterility, endotoxins, potency, and stability are conducted to ensure every medication leaving the facility meets its specified quality attributes.
5. How can a healthcare provider at a local clinic place an order?
Healthcare providers can place an order by contacting 503B Compounding Pharmacy directly at (407)993-1381. The team will provide information on ordering procedures, product availability, and can address any specific questions related to the compounding services available from the 2160 W State Road 434 location.