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. This 503B Compounding Pharmacy is situated at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy model represents a significant advancement in pharmaceutical compounding, focusing on the large-scale production of compounded sterile preparations (CSPs) for office use by healthcare practitioners. The 503B Compounding Pharmacy facility adheres to the most rigorous federal standards for sterility, quality, and safety, which are mandated for all 503B outsourcing facilities.
The core mission of this 503B Compounding Pharmacy is to provide healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with access to a reliable and consistent supply of high-quality compounded medications. The 503B Compounding Pharmacy produces medications that are often in short supply or unavailable from traditional manufacturers. By operating as a 503B Compounding Pharmacy, the facility is subject to ongoing FDA inspection and must meet Current Good Manufacturing Practice (cGMP) regulations. This ensures that every preparation leaving the 503B Compounding Pharmacy meets exacting standards for potency, purity, and sterility, providing practitioners and their patients with a superior level of confidence.
The services provided by this 503B Compounding Pharmacy are distinct from traditional compounding. The 503B Compounding Pharmacy primarily supplies medications for office-administered use, meaning healthcare professionals can utilize these preparations within their practice at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy's portfolio includes a wide array of sterile preparations, which are essential for various therapeutic areas. The operational focus of this 503B Compounding Pharmacy is on quality assurance, patient safety, and supporting the local medical community with essential pharmaceutical products that are manufactured under the highest level of regulatory oversight.
For healthcare providers seeking a trusted source for compounded sterile preparations, this 503B Compounding Pharmacy serves as a critical partner. The 503B Compounding Pharmacy is committed to transparency and compliance, providing an essential service from its location at 2160 W State Road 434, Longwood, FL 32779. To learn more about the specific preparations available or to discuss how the 503B Compounding Pharmacy can support your practice, please contact the facility directly. The 503B Compounding Pharmacy can be reached by phone at (407)993-1381 or through their official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions for 503B Compounding Pharmacy
What does it mean that this is a 503B Compounding Pharmacy?
It means this facility is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. This 503B Compounding Pharmacy complies with stricter federal standards, including Current Good Manufacturing Practices (cGMP), and is subject to routine FDA inspections to ensure the highest levels of quality, sterility, and safety for all compounded preparations.
Who can receive medications from this 503B Compounding Pharmacy?
This 503B Compounding Pharmacy primarily supplies medications for office use by healthcare practitioners. Medications are provided to licensed healthcare providers for administration to patients within their practice at 2160 W State Road 434, Longwood, FL 32779. This 503B Compounding Pharmacy does not typically dispense medications directly to individual patients based on a prescription.
What types of medications does this 503B Compounding Pharmacy produce?
This 503B Compounding Pharmacy specializes in producing large-scale batches of compounded sterile preparations (CSPs). These are typically medications that are on drug shortage lists or are not commercially available from traditional pharmaceutical manufacturers, ensuring healthcare providers at 2160 W State Road 434, Longwood, FL 32779 have access to critical medications.
How does the quality assurance of a 503B Compounding Pharmacy differ?
As a 503B Compounding Pharmacy, the facility must adhere to cGMP standards, which are the same rigorous quality standards required of conventional drug manufacturers. This includes extensive testing of components, rigorous environmental monitoring, and validated processes to ensure every preparation meets strict specifications for identity, strength, quality, and purity.
How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers can contact the 503B Compounding Pharmacy directly to discuss their needs and place an order. The 503B Compounding Pharmacy can be reached at the phone number (407)993-1381. More information about the services and available preparations can also be found on the 503B Compounding Pharmacy's website at https://503bcompoundingpharmacy.com/.