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 pharmaceutical compounding, focusing on the large-scale production of compounded sterile preparations (CSPs) for office use by healthcare practitioners. As a 503B outsourcing facility, this 503B Compounding Pharmacy adheres to rigorous current Good Manufacturing Practices (cGMP), which are the same standards followed by conventional pharmaceutical manufacturers. This ensures a level of quality, consistency, and sterility assurance that goes beyond traditional compounding practices.

The core mission of this 503B Compounding Pharmacy is to provide healthcare professionals with access to a reliable supply of high-quality, sterile medications that are not readily available from standard commercial sources. The 503B Compounding Pharmacy produces these medications in advance of receiving a prescription, allowing for immediate availability. This is a critical service for medical practices, hospitals, and surgical centers, enabling them to obtain necessary medications without delay. The team at this 503B Compounding Pharmacy includes highly trained pharmacists and technicians who utilize state-of-the-art technology and controlled environments to ensure every preparation meets exacting standards for purity, potency, and sterility.

Patients and practitioners visiting or utilizing the services of the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 benefit from the assurance that comes with FDA oversight and cGMP compliance. The 503B Compounding Pharmacy provides a vital link in the healthcare chain, ensuring that practitioners have the necessary tools to provide optimal patient care. For more information on the specific sterile preparations available from this 503B Compounding Pharmacy, healthcare providers are encouraged to visit the official website at https://503bcompoundingpharmacy.com/ or contact the facility directly at (407)993-1381.

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 adheres to current Good Manufacturing Practices (cGMP) for the production of compounded sterile preparations, ensuring a higher level of regulatory oversight and quality control compared to traditional compounding.

2. Who can receive medications from this 503B Compounding Pharmacy? As a 503B outsourcing facility, this 503B Compounding Pharmacy provides medications primarily for "office use" or "office stock" by healthcare practitioners. These medications are administered to patients within a clinical setting. Individual patient prescriptions are typically not dispensed directly to the public from this 503B Compounding Pharmacy location at 2160 W State Road 434, Longwood, FL 32779.

3. How does a healthcare provider order from this 503B Compounding Pharmacy? Healthcare providers and facilities can order compounded sterile preparations from this 503B Compounding Pharmacy for use in their practice. To inquire about available medications, place an order, or set up an account, providers should contact the 503B Compounding Pharmacy directly at (407)993-1381 or through the official website at https://503bcompoundingpharmacy.com/.

4. What are the benefits of using a 503B Compounding Pharmacy? The primary benefit of utilizing this 503B Compounding Pharmacy is the assurance of quality and safety. Because this 503B Compounding Pharmacy operates under cGMP standards and FDA oversight, healthcare providers can be confident in the sterility, potency, and purity of the medications they use for patient procedures and treatments at their practice.