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, located at 2160 W State Road 434, Longwood, FL 32779, is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. We are dedicated to providing high-quality, sterile compounded medications for healthcare providers and their patients within the Longwood community. Our facility adheres to stringent quality control measures and cGMP standards to ensure the safety and efficacy of every preparation. We specialize in producing a wide range of compounded medications, offering customized solutions to meet specific clinical needs. Our commitment is to serve the Longwood area with reliable and expertly prepared pharmaceutical compounds. For inquiries or to discuss your compounding needs, please visit our website at https://503bcompoundingpharmacy.com/ or call us at (407)993-1381.

Frequently Asked Questions:

Q1: What types of compounded medications does 503B Compounding Pharmacy offer at this Longwood location?A1: At our 2160 W State Road 434, Longwood, FL 32779 facility, we offer a variety of sterile compounded medications designed to meet specific patient and physician requirements.

Q2: Is 503B Compounding Pharmacy registered with the FDA for its operations in Longwood?A2: Yes, 503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B at our 2160 W State Road 434, Longwood, FL 32779 location.

Q3: How can I place an order for compounded medications from your Longwood facility?A3: You can place an order by visiting our website at https://503bcompoundingpharmacy.com/ or by calling our Longwood office directly at (407)993-1381.

Q4: What quality standards does 503B Compounding Pharmacy follow at its Longwood site?A4: Our Longwood facility at 2160 W State Road 434 adheres to strict quality control measures and current Good Manufacturing Practices (cGMP) as required for 503B outsourcing facilities.