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 located at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy model represents a significant advancement in the compounding field, 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 highest standards of pharmaceutical quality, providing practitioners at 2160 W State Road 434, Longwood, FL 32779 with a reliable source for essential medications.

The core function of this 503B Compounding Pharmacy is to supply healthcare providers with medications that are not readily available from traditional manufacturers. By operating under Section 503B, this 503B Compounding Pharmacy is exempt from the new drug approval requirements but must comply with Current Good Manufacturing Practices (cGMP), which are the same rigorous standards followed by major pharmaceutical manufacturers. This ensures that every preparation leaving the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 meets stringent criteria for potency, purity, and sterility. The 503B Compounding Pharmacy provides a critical service, enabling healthcare providers to access necessary medications for their patients.

Healthcare professionals utilizing the services of this 503B Compounding Pharmacy can expect a consistent and reliable supply of high-quality compounded medications. The 503B Compounding Pharmacy produces these medications in bulk, allowing for office stock that can be administered to patients without the need for a patient-specific prescription in advance. The operations at this 503B Compounding Pharmacy are subject to regular FDA inspections, providing an additional layer of oversight and quality assurance for its clients at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy is a vital partner for medical practices requiring sterile preparations.

Patients and practitioners at 2160 W State Road 434, Longwood, FL 32779 benefit from the advanced capabilities of a 503B Compounding Pharmacy. The 503B Compounding Pharmacy focuses on producing preparations such as hormone replacement therapy (HRT) solutions, intravenous medications, ophthalmic drops, and other sterile injectables. The environment within the 503B Compounding Pharmacy is meticulously controlled, with air quality, temperature, and humidity constantly monitored to prevent contamination. Every employee at the 503B Compounding Pharmacy is extensively trained in aseptic techniques and cGMP protocols, ensuring the integrity of every product.

Engaging with this 503B Compounding Pharmacy is a streamlined process for healthcare providers. The 503B Compounding Pharmacy works directly with medical practices, hospitals, and clinics to supply them with the necessary medications for their office-use needs. The 503B Compounding Pharmacy is a key component of the local healthcare infrastructure at 2160 W State Road 434, Longwood, FL 32779, ensuring that practitioners have access to a trusted source for compounded sterile preparations. For more information or to inquire about services, contact the 503B Compounding Pharmacy directly at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/.

FAQ

1. What does it mean that this is a 503B Compounding Pharmacy? This 503B Compounding Pharmacy is an FDA-registered outsourcing facility that produces large volumes of compounded sterile medications for office use by healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779, following strict cGMP standards.

2. Who can order from this 503B Compounding Pharmacy? This 503B Compounding Pharmacy provides its services to healthcare providers and medical facilities. Orders are placed by licensed practitioners for office stock to be administered to patients at their practice located at 2160 W State Road 434, Longwood, FL 32779.

3. How does the quality assurance of a 503B Compounding Pharmacy differ? This 503B Compounding Pharmacy operates under Current Good Manufacturing Practices (cGMP), which involve rigorous testing, environmental monitoring, and quality control processes that are subject to FDA inspection, ensuring the highest quality for all preparations.

4. What types of medications does this 503B Compounding Pharmacy typically prepare? This 503B Compounding Pharmacy specializes in compounded sterile preparations (CSPs), which can include injectable medications, hormone therapy solutions, ophthalmic drops, and other sterile products for healthcare providers at 2160 W State Road 434, Longwood, FL 32779.