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 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 provides a critical service by producing large-scale compounded medications. The 503B designation signifies a commitment to the highest standards of quality, safety, and sterility, as required by federal law for an outsourcing facility. This makes 503B Compounding Pharmacy a vital resource for healthcare providers and patients who require medications that are not commercially available.
The core function of 503B Compounding Pharmacy is the preparation of compounded sterile preparations (CSPs) in bulk quantities. These medications are produced without patient-specific prescriptions and are distributed to healthcare facilities for office use. The team of highly trained pharmacists and technicians at the 2160 W State Road 434 facility utilizes state-of-the-art technology and rigorous testing protocols to ensure every preparation meets exacting standards. This process includes stringent environmental controls, validation of sterility, and stability testing, providing practitioners with confidence in the medications they administer.
For healthcare professionals serving patients in Longwood, the services of 503B Compounding Pharmacy are indispensable. The pharmacy provides access to essential medications that may be in shortage or are not commercially manufactured. By offering a reliable source for high-quality, compounded medications, 503B Compounding Pharmacy supports local clinics, hospitals, and practices in maintaining uninterrupted patient care. The facility’s adherence to current Good Manufacturing Practices (cGMP) ensures a level of quality control that goes beyond traditional compounding.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical practices located near 2160 W State Road 434. Healthcare providers can confidently order the necessary medications, knowing they are sourced from a trusted, FDA-registered outsourcing facility right in their community. The dedicated staff is committed to supporting the local medical landscape with professionalism and expertise.
To learn more about the specific formulations available or to discuss your facility's needs, contact 503B Compounding Pharmacy directly. The team can be reached by phone at (407)993-1381. Detailed information about their compliance, services, and the importance of the 503B designation can also be found on their official 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 operates under Section 503B of the FD&C Act. This requires us to comply with rigorous federal standards for production, testing, and quality control, including current Good Manufacturing Practices (cGMP), which are more extensive than those required for traditional compounding pharmacies.
2. Who can order medications from 503B Compounding Pharmacy?
Medications produced at our 2160 W State Road 434 location are prepared for office use and are distributed to healthcare practitioners and facilities. These are not patient-specific medications dispensed directly to individuals but are instead provided to licensed professionals for administration within their practice.
3. What types of medications does 503B Compounding Pharmacy prepare?
As a 503B compounding pharmacy, we specialize in producing large-scale compounded sterile preparations (CSPs). This often includes medications that are on shortage or are not available from commercial manufacturers, providing a critical supply for local healthcare providers at 2160 W State Road 434, Longwood, FL 32779.
4. How does 503B Compounding Pharmacy ensure medication safety and sterility?
Our facility employs advanced environmental monitoring, validated sterilization processes, and comprehensive testing protocols. Every batch of medication is produced under strict aseptic conditions and undergoes rigorous quality assurance testing to ensure potency, purity, and sterility before it is released for distribution.
5. How can a healthcare facility at 2160 W State Road 434 place an order?
Healthcare facilities and practitioners can initiate an order or make an inquiry by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide information on available formulations, ordering procedures, and delivery options specific to our location.