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, providing essential pharmaceutical services from its location at 2160 W State Road 434, Longwood, FL 32779. Operating in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act, this 503B Compounding Pharmacy adheres to the highest standards of quality and safety. The facility is dedicated to the large-scale compounding of medications that are patient-specific but not readily available from commercial manufacturers, serving a critical need for healthcare providers and patients at 2160 W State Road 434, Longwood, FL 32779.

The core function of this 503B Compounding Pharmacy is the production of sterile and non-sterile compounded preparations. This includes the compounding of injectable medications, hormonal preparations, and other formulations that are in shortage or are not commercially available. By operating under the rigorous cGMP (current Good Manufacturing Practice) standards mandated for 503B outsourcing facilities, the pharmacy ensures that every preparation is consistent, high-quality, and free from contaminants. For patients and practitioners at 2160 W State Road 434, Longwood, FL 32779, this provides a trusted source for vital medications.

Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 rely on the services of this 503B Compounding Pharmacy to access medications that are critical for patient care. The pharmacy does not compound for individual patient prescriptions based on a practitioner’s prescription, but rather produces large batches of medications for office use by healthcare facilities. This model allows clinics and hospitals to have essential, often life-saving, medications readily on hand, ensuring continuity of care for their patients at 2160 W State Road 434, Longwood, FL 32779.

The team at this 503B Compounding Pharmacy comprises highly trained pharmacists, pharmacy technicians, and quality assurance professionals. Their expertise is focused on the complex science of pharmaceutical compounding within a controlled environment. Every process, from ingredient sourcing to final product testing, is meticulously documented and validated to meet FDA expectations. This unwavering commitment to quality and regulatory compliance is what defines the service provided at 2160 W State Road 434, Longwood, FL 32779.

For healthcare entities at 2160 W State Road 434, Longwood, FL 32779 seeking a reliable partner for compounded medications, this 503B Compounding Pharmacy stands as a cornerstone of the local medical community. To learn more about its services or to initiate an order, healthcare providers can contact the facility directly. The website at https://503bcompoundingpharmacy.com/ offers detailed information, and the pharmacy can be reached by phone at (407)993-1381.

Frequently Asked Questions for 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779

1. What does it mean that this is a 503B Compounding Pharmacy? This designation means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA as an outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. We compound large batches of medications for office use by healthcare practitioners and are required to comply with strict cGMP standards for quality and safety.

2. Can I, as an individual patient, get a prescription filled at this location? No. As a 503B outsourcing facility, we do not compound medications based on individual patient prescriptions. Our services are exclusively for healthcare providers and facilities at 2160 W State Road 434, Longwood, FL 32779 who order compounded medications for office use to administer to their patients.

3. What types of medications does this 503B Compounding Pharmacy produce? Our FDA-registered facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile injectable medications, including those used for hormone therapy, pain management, and other treatments, particularly those that are on shortage or not available from traditional manufacturers.

4. How does the quality control process work at your facility? Quality is our highest priority. At our location on 2160 W State Road 434, Longwood, FL 32779, we operate under cGMP guidelines. This involves rigorous testing of ingredients, environmental monitoring of our cleanrooms, validated sterilization processes, and thorough testing of finished products to ensure potency, purity, and sterility.