503B Compounding Pharmacy

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.

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Contact Information

Address:

2160 W State Road 434, Longwood, FL 32779

Phone:

(407)993-1381

Website

https://503bcompoundingpharmacy.com/

Location

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 the compounding field, adhering to the highest standards of pharmaceutical quality and safety. As a 503B outsourcing facility, this 503B Compounding Pharmacy is subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations and regular inspections. This ensures that every preparation leaving the 503B Compounding Pharmacy meets stringent standards for potency, purity, and sterility.

The core function of this 503B Compounding Pharmacy is the large-scale production of compounded medications for office use. Healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 can source essential medications directly from this 503B Compounding Pharmacy. The 503B Compounding Pharmacy provides physicians, surgeons, veterinarians, and other medical professionals with a reliable and compliant source for sterile injectables, ophthalmics, and other preparations needed for patient procedures and treatments. By utilizing the services of this 503B Compounding Pharmacy, practitioners gain access to a consistent supply of high-quality medications without the burden and regulatory complexity of in-office compounding.

Patients and practitioners at 2160 W State Road 434, Longwood, FL 32779 benefit from the operational scale and quality assurance that defines a 503B Compounding Pharmacy. The 503B Compounding Pharmacy facility is equipped with state-of-the-art environmental controls, including ISO-classified cleanrooms, to ensure the integrity of all sterile preparations. Every batch produced by this 503B Compounding Pharmacy undergoes thorough testing and quality control checks. This commitment to excellence at the 503B Compounding Pharmacy provides an unparalleled level of confidence in the medications used in clinical settings. The 503B Compounding Pharmacy serves as a critical partner in the local healthcare ecosystem, supporting better patient outcomes through reliable access to essential drugs.

To learn more about the specific formulations and services available from this 503B Compounding Pharmacy, healthcare entities are encouraged to make direct contact. The 503B Compounding Pharmacy can be reached for professional inquiries at the phone number (407)993-1381. Comprehensive information regarding the 503B Compounding Pharmacy’s capabilities, regulatory status, and product listings can be found on the official website at https://503bcompoundingpharmacy.com/.

FAQ

What does it mean that this is a 503B Compounding Pharmacy? It means this facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility that compounds large volumes of sterile medications for office use by healthcare practitioners, adhering to strict federal manufacturing standards.

Who can order from the 503B Compounding Pharmacy? This 503B Compounding Pharmacy provides medications for office use to licensed healthcare practitioners, including physicians, surgeons, ophthalmologists, and veterinarians, who practice at or serve patients from 2160 W State Road 434, Longwood, FL 32779.

What types of medications does this 503B Compounding Pharmacy produce? This 503B Compounding Pharmacy specializes in compounding sterile preparations, such as injectables, IV bags, and ophthalmic drops, that are commonly used in clinical and surgical settings at 2160 W State Road 434, Longwood, FL 32779.

How does the 503B Compounding Pharmacy ensure medication safety? This 503B Compounding Pharmacy operates under cGMP guidelines, utilizes ISO-classified cleanrooms, and conducts rigorous potency, sterility, and endotoxin testing on its preparations to ensure the highest level of safety for patients at 2160 W State Road 434, Longwood, FL 32779.