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 standard in pharmaceutical compounding, focusing on producing large volumes of sterile and non-sterile compounded medications for office use by healthcare practitioners. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 adheres to rigorous federal quality standards, including current Good Manufacturing Practices (cGMP), which are more comprehensive than the standards applied to traditional 503A compounding pharmacies.

The primary function of this 503B Compounding Pharmacy is to supply healthcare providers with ready-to-use compounded medications. Physicians, surgeons, veterinarians, and other medical professionals serving patients from the 2160 W State Road 434, Longwood, FL 32779 location can source high-quality, pre-made compounded drugs from this 503B Compounding Pharmacy for direct administration in a clinical setting. The 503B Compounding Pharmacy provides a reliable and compliant source for medications that are often on shortage or are not commercially available from large-scale manufacturers. By operating as a 503B Compounding Pharmacy, the facility ensures that every batch of medication is produced under a heightened level of quality control, sterility assurance, and testing protocols mandated by the FDA.

Patients receiving treatments that involve medications sourced from this 503B Compounding Pharmacy can have confidence in the quality and consistency of their care. The 503B Compounding Pharmacy's registration with the FDA and its adherence to cGMP standards provide an additional layer of safety. The team at the 503B Compounding Pharmacy located at 2160 W State Road 434, Longwood, FL 32779 is comprised of skilled pharmacists and technicians who are dedicated to the precise science of large-scale compounding. For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, utilizing the services of this 503B Compounding Pharmacy streamlines inventory management and ensures immediate access to critical medications.

To learn more about the specific services and products available from this 503B Compounding Pharmacy, healthcare providers are encouraged to make direct contact. The 503B Compounding Pharmacy can be reached by phone at (407)993-1381. Detailed information about the 503B Compounding Pharmacy's capabilities, compliance, and processes is available on the official website at https://503bcompoundingpharmacy.com/. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is committed to supporting the local medical community with federally compliant compounded pharmaceutical solutions.

Frequently Asked Questions for 503B Compounding Pharmacy

1. What does it mean that this is a 503B Compounding Pharmacy? This 503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation means the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 must comply with stricter federal standards, including current Good Manufacturing Practices (cGMP), for the production of compounded medications.

2. Who can order medications from this 503B Compounding Pharmacy? This 503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Physicians, surgeons, veterinarians, and other qualified medical professionals operating at or near 2160 W State Road 434, Longwood, FL 32779 can order compounded preparations from this 503B Compounding Pharmacy for administration to their patients within a clinical setting.

3. Can individual patients pick up prescriptions directly from this 503B Compounding Pharmacy? The 503B Compounding Pharmacy business model is focused on supplying other healthcare providers. Typically, individual patient prescriptions are handled by traditional 503A compounding pharmacies. Patients of providers who use medications from this 503B Compounding Pharmacy located at 2160 W State Road 434, Longwood, FL 32779 receive their treatment directly in the provider's office.

4. How does the 503B Compounding Pharmacy ensure medication safety? As a 503B Compounding Pharmacy, the facility follows rigorous cGMP protocols. This includes extensive testing of components and finished products, validation of sterility methods, environmental monitoring, and comprehensive documentation for every batch produced at the 2160 W State Road 434, Longwood, FL 32779 location, ensuring a high level of quality and safety.