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. Functioning under the stringent federal regulations of Section 503B of the Drug Quality and Security Act, this 503B Compounding Pharmacy is distinct from traditional compounding pharmacies. The 503B designation signifies adherence to the highest level of pharmaceutical compounding standards, which includes current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving the facility meets rigorous testing for potency, sterility, and purity. The primary mission of this 503B Compounding Pharmacy is to provide healthcare providers and patients in Longwood with access to high-quality, bulk-compounded medications that are not otherwise commercially available.
The services provided by this 503B Compounding Pharmacy are focused on non-patient-specific, office-use medications. Healthcare professionals at practices and clinics can utilize the preparations from this 503B Compounding Pharmacy to stock their offices for immediate administration to patients during treatments and procedures. The portfolio of preparations available from this 503B Compounding Pharmacy often includes a wide array of sterile injectables, such as hormone replacement therapy (HRT) solutions, ophthalmologic injections, and other specialized parenteral medications. By sourcing these critical medications from an FDA-registered 503B Compounding Pharmacy, healthcare providers at 2160 W State Road 434 can be assured of product consistency, reliability, and regulatory compliance.
Operating from 2160 W State Road 434, Longwood, FL 32779, this 503B Compounding Pharmacy is a vital local resource for the medical community. The facility is equipped with state-of-the-art cleanrooms and advanced analytical technology to support its compounding operations. The team at this 503B Compounding Pharmacy consists of highly trained pharmacists and technicians who are experts in sterile compounding techniques and quality assurance protocols. For healthcare providers seeking a trusted partner for their office-use medication needs, this 503B Compounding Pharmacy offers a dependable and compliant solution. To learn more about the specific preparations available or to inquire about services, contact this 503B Compounding Pharmacy directly at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this is a 503B Compounding Pharmacy?
This 503B Compounding Pharmacy is an FDA-registered outsourcing facility. This federal designation means our operations at 2160 W State Road 434, Longwood, FL 32779 are governed by Section 503B of the Drug Quality and Security Act and must comply with current Good Manufacturing Practices (cGMP), which include rigorous testing for sterility, potency, and stability.
2. As a patient, can I walk into the 503B Compounding Pharmacy at 2160 W State Road 434 to get a prescription filled?
No. This 503B Compounding Pharmacy primarily produces non-patient-specific medications for office use by healthcare providers. Patients should contact their healthcare provider directly, who may use medications compounded at this 503B Compounding Pharmacy during in-office procedures.
3. Who can order from this 503B Compounding Pharmacy location?
This 503B Compounding Pharmacy provides its preparations to licensed healthcare providers and facilities. Orders are typically placed by physicians, clinics, and hospitals for use within their practice at 2160 W State Road 434, Longwood, FL 32779.
4. How does the quality assurance at a 503B Compounding Pharmacy differ from a traditional pharmacy?
As a 503B Compounding Pharmacy, our facility is subject to FDA oversight and must meet cGMP standards. This involves extensive environmental monitoring, validated processes, and independent testing of finished preparations for sterility and potency, which goes beyond the standards required of traditional 503A compounding pharmacies.
5. How can a healthcare provider at 2160 W State Road 434 start ordering from your 503B Compounding Pharmacy?
Healthcare providers can initiate the process by contacting this 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide information on account setup, our available preparations, and the ordering process to integrate our services into their practice.