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 under 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 designation signifies a commitment to the highest standards of quality and compliance set forth by the FDA for outsourcing facilities. The operations at 2160 W State Road 434, Longwood, FL 32779 are dedicated to the large-scale compounding of sterile and non-sterile medications that are distributed for office use by healthcare practitioners.

The core function of this 503B Compounding Pharmacy is the production of medications in anticipation of receiving a prescription, which differentiates it from a traditional 503A pharmacy. The medications compounded at the 2160 W State Road 434, Longwood, FL 32779 facility are provided to healthcare providers within their practice settings. This 503B Compounding Pharmacy adheres to rigorous testing, quality control, and reporting standards mandated for all 503B outsourcing facilities. The team at 503B Compounding Pharmacy is composed of skilled pharmacists and technicians who utilize advanced technology and processes to ensure the integrity of every preparation that leaves the facility at 2160 W State Road 434, Longwood, FL 32779.

Healthcare providers who utilize the services of this 503B Compounding Pharmacy can be assured of a reliable source for critical medications. The 503B Compounding Pharmacy model at 2160 W State Road 434, Longwood, FL 32779 provides a vital component of the healthcare infrastructure, supplying practitioners with ready-made medications that are essential for patient care. The focus of 503B Compounding Pharmacy remains strictly on compliance with federal regulations and the consistent production of high-quality compounded preparations for office use.

For more information about the services provided by this 503B Compounding Pharmacy, you can visit the official website at https://503bcompoundingpharmacy.com/ or contact the facility directly at (407)993-1381. The 503B Compounding Pharmacy team at 2160 W State Road 434, Longwood, FL 32779 is prepared to assist healthcare professionals with their compounding needs.

Frequently Asked Questions for 503B Compounding Pharmacy

What is a 503B Compounding Pharmacy? A 503B Compounding Pharmacy is an FDA-registered outsourcing facility that compounds medications for office use by healthcare practitioners. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under specific federal regulations outlined in Section 503B.

Who can order from this 503B Compounding Pharmacy? This 503B Compounding Pharmacy provides medications for office use to licensed healthcare practitioners. The 503B Compounding Pharmacy services at 2160 W State Road 434, Longwood, FL 32779 are designed to support medical practices and their patients.

What types of medications does this 503B Compounding Pharmacy prepare? The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 compounds both sterile and non-sterile preparations. As a 503B outsourcing facility, these medications are produced in larger batches for distribution to healthcare providers.

How does this 503B Compounding Pharmacy ensure quality? The 503B Compounding Pharmacy adheres to strict FDA regulations for outsourcing facilities, which include rigorous testing, standardized processes, and quality control measures. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is committed to compliance with all federal standards.