Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
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.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is a critical distinction that sets this facility apart from traditional compounding pharmacies. Located at 2160 W State Road 434, Longwood, FL 32779, this outsourcing facility adheres to the most rigorous federal standards for quality, safety, and production. The operations at this specific location are dedicated to the large-scale compounding of sterile and non-sterile medications that are distributed to healthcare providers for office use, ensuring a vital supply of essential drugs that may be in shortage or are not commercially available.
The core function of 503B Compounding Pharmacy is to provide healthcare practitioners with access to high-quality, compounded medications that they can use within their practice. By operating under Section 503B, the facility is exempt from the patient-specific prescription requirement of traditional 503A pharmacies, allowing for the anticipatory compounding of medications. This model is essential for supporting the medical community at 2160 W State Road 434, Longwood, FL 32779, by ensuring that physicians and clinicians have the necessary pharmaceutical tools on hand to treat their patients effectively and without delay. The medications produced are made in bulk and are subject to current Good Manufacturing Practices (cGMP), which include stringent testing for potency, purity, and sterility.
Patients receiving treatments that utilize medications from 503B Compounding Pharmacy can have confidence in the product's integrity. The facility's commitment to compliance with FDA regulations provides an added layer of safety and reliability. For any inquiries regarding the services provided directly to healthcare providers from this location, you can contact 503B Compounding Pharmacy at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with Section 503B of the FD&C Act. This requires adherence to current Good Manufacturing Practices (cGMP) for the large-scale production of compounded medications, which includes rigorous testing and quality control standards that exceed those of traditional compounding pharmacies.
Who can order medications from 503B Compounding Pharmacy?
Medications are distributed to healthcare practitioners for office use. This facility provides medications to physicians, clinics, and other healthcare providers who then administer them to patients within their practice at 2160 W State Road 434, Longwood, FL 32779. Medications are not dispensed directly to individual patients without a prescription from their provider.
What types of medications does 503B Compounding Pharmacy produce?
As an outsourcing facility, it compounds both sterile and non-sterile medications in bulk. This often includes medications that are currently in drug shortage or are not available from commercial manufacturers, providing a critical supply for healthcare providers serving the community at 2160 W State Road 434, Longwood, FL 32779.
How does the quality assurance at this location work?
The quality assurance processes at 503B Compounding Pharmacy are mandated by federal cGMP regulations. This involves extensive testing of raw materials, in-process testing, and finished preparation sterility and potency testing to ensure every medication that leaves the facility at 2160 W State Road 434, Longwood, FL 32779 meets strict safety and quality specifications.
How can a healthcare provider at this location place an order?
Healthcare providers interested in the services of 503B Compounding Pharmacy can initiate the process by contacting the facility directly. For ordering information and to establish an account, providers should call (407)993-1381 or visit the official website at https://503bcompoundingpharmacy.com/ for more details.