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 central to the identity and operations at our specific location: 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, we are distinct from traditional compounding pharmacies. We engage in large-scale, non-patient-specific compounding of sterile and non-sterile medications, adhering to rigorous federal current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving our facility meets the highest standards of quality, purity, and potency for the healthcare providers we serve at 2160 W State Road 434, Longwood, FL 32779.
The core function of 503B Compounding Pharmacy is to provide bulk compounded medications to healthcare practitioners and facilities. The medications produced at our Longwood facility are essential for hospitals, clinics, surgery centers, and other healthcare providers who require reliable, high-volume supplies of critical drugs. Our work at 2160 W State Road 434, Longwood, FL 32779 supports the local medical community by mitigating drug shortages, providing essential medications that may be commercially unavailable, and ensuring a consistent supply of high-quality compounded preparations. The operations are strictly regulated and monitored, with a focus on sterility assurance and precise formulation.
Patients do not order directly from a 503B outsourcing facility. Instead, healthcare providers based at or serving patients from 2160 W State Road 434, Longwood, FL 32779 source our medications to administer to their patients under professional care. This model allows physicians and clinicians to be confident in the quality and consistency of the medications they use, knowing they are produced under the strictest FDA oversight. The team at 503B Compounding Pharmacy is comprised of skilled pharmacists, chemists, and technicians dedicated to upholding the stringent protocols required for 503B compliance at our Longwood location.
For healthcare entities operating at or near 2160 W State Road 434, Longwood, FL 32779, partnering with our 503B outsourcing facility offers a significant advantage. It provides access to a dependable source for compounded medications that are manufactured with a level of quality control that meets or often exceeds that of conventional drug manufacturers. Our presence at this specific address is a commitment to supporting the local healthcare infrastructure with essential pharmaceutical services that are both reliable and of the utmost quality.
To learn more about our services or to inquire about how 503B Compounding Pharmacy can support your practice, please contact us directly. Our team is ready to provide detailed information about our capabilities and compliance standards.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Location: 2160 W State Road 434, Longwood, FL 32779
Frequently Asked Questions
1. What does it mean that this is a 503B outsourcing facility?
It means 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered facility that compounds large volumes of sterile and non-sterile medications in advance of a prescription. We operate under strict federal current Good Manufacturing Practices (cGMP) for quality assurance.
2. Can I, as a patient, order medication directly from this location?
No. As an outsourcing facility under Section 503B, we provide medications to healthcare providers and facilities, not directly to patients. Your physician or clinic at 2160 W State Road 434, Longwood, FL 32779 would order and administer our preparations as part of your treatment.
3. What types of healthcare providers use your services at this address?
Our services are designed for hospitals, surgery centers, clinics, and other healthcare practitioners who require bulk, reliable supplies of compounded medications for their patients at or near 2160 W State Road 434, Longwood, FL 32779.
4. How does using a 503B outsourcing facility benefit my local healthcare provider?
It provides healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with access to high-quality, consistently formulated medications that help address drug shortages and ensure they have the necessary supplies to treat their patients effectively and safely.
5. How can a practice at this location start ordering from you?
Healthcare providers can initiate the process by contacting 503B Compounding Pharmacy directly via our website at https://503bcompoundingpharmacy.com/ or by calling our main line at (407)993-1381 to discuss specific needs and establish an account.