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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and production that exceed those of traditional compounding pharmacies, providing a critical component of the pharmaceutical supply chain for healthcare providers.
The core function of 503B Compounding Pharmacy is the preparation of medications in anticipation of receiving a prescription, or in response to a bulk order, for use by healthcare facilities and practitioners serving their patients. The medications produced at the 2160 W State Road 434 facility are formulated for dispensing by licensed practitioners and are not typically dispensed directly to the public. This model ensures that healthcare providers in need of specific compounded formulations have access to a reliable, high-volume source of medications that meet strict quality and sterility assurances.
Operating from its location at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy utilizes state-of-the-art cleanroom technology and environmental monitoring systems. Every batch of medication is compounded under controlled conditions by highly trained personnel following current good manufacturing practices (cGMP). This commitment to excellence ensures that every product leaving the facility is of the highest quality, purity, and potency, providing practitioners with the confidence they require for patient care.
The services provided by 503B Compounding Pharmacy are essential for healthcare delivery. By producing medications that may be commercially unavailable or in shortage, the facility helps ensure patient access to necessary treatments. Healthcare providers can rely on the consistent and compliant production of compounded formulations from this specific, FDA-registered location. For more information on its operations or to inquire about services, contact 503B Compounding Pharmacy directly at (407)993-1381 or visit its website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with stringent federal standards for compounding, including current good manufacturing practices (cGMP). This ensures a higher level of quality control and testing for the medications we produce compared to traditional pharmacy compounding.
2. Can I, as an individual patient, get my prescriptions filled directly at 2160 W State Road 434?
No. 503B Compounding Pharmacy operates as a bulk manufacturer for healthcare providers. Medications are produced in large batches and distributed to hospitals, clinics, and physician offices. Patients must receive their medications through their licensed healthcare provider who sources from our facility.
3. What types of medications does 503B Compounding Pharmacy produce at its Longwood location?
Our FDA-registered outsourcing facility at 2160 W State Road 434 specializes in the compounding of both sterile and non-sterile medications. This includes a wide range of formulations that are often in shortage or not available from commercial manufacturers, providing essential options for practitioners.
4. How does a healthcare provider at a local clinic order from your facility?
Healthcare providers and facilities can initiate orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide information on ordering procedures, available formulations, and compliance requirements for utilizing an FDA-registered outsourcing facility.
5. Why should a healthcare provider choose 503B Compounding Pharmacy for compounded medications?
Choosing our facility at 2160 W State Road 434, Longwood, FL 32779 ensures access to medications produced under the highest standards of quality and safety mandated by the FDA. Our commitment to cGMP provides assurance of product integrity, sterility, and potency for patient administration.