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 in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. As a 503B outsourcing facility, we produce large batches of compounded sterile and non-sterile preparations for office use by healthcare practitioners. This enables physicians, surgeons, and other medical professionals at clinics and practices to have essential medications readily available for their patients without the need for individual patient-specific prescriptions in advance.
The operations at 503B Compounding Pharmacy are distinct from traditional compounding. Our facility is subject to rigorous FDA oversight, current Good Manufacturing Practice (cGMP) regulations, and mandatory reporting of adverse events. This ensures that every preparation leaving our facility at 2160 W State Road 434, Longwood, FL 32779 meets stringent standards for potency, purity, and sterility. We provide healthcare providers with a reliable and trusted source for high-quality medications, including sterile injectables, ophthalmics, and other formulations that are often in short supply or unavailable from conventional pharmaceutical manufacturers.
Our core service is the large-scale compounding of medications for office-use. Healthcare practitioners can order these preparations to stock their offices, ensuring they have the necessary medications on hand for procedures, treatments, and immediate patient needs. This model supports the efficient operation of medical practices by providing a secure and compliant supply chain for critical drugs. The team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who utilize state-of-the-art technology and equipment within our facility to ensure precision and quality in every batch.
For healthcare providers seeking a dependable partner for their medication needs, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a pillar of quality and reliability. We invite local medical practices to contact us to discuss how our services can support patient care. You can reach us by phone at (407)993-1381 or learn more about our compliance and offerings on our 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. We adhere to current Good Manufacturing Practices (cGMP) and are subject to federal oversight, which includes routine FDA inspections. This ensures the medications we compound for office use meet the highest standards for safety, identity, strength, quality, and purity.
2. Who can order medications from 503B Compounding Pharmacy?
Our services are designed for healthcare practitioners, including physicians, surgeons, ophthalmologists, and other medical professionals. Medications are compounded for "office use," meaning they are supplied to a practitioner's office or clinic for administration to patients within their practice. We do not compound medications for individual patients based on a direct prescription from a consumer.
3. What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy specializes in compounding sterile preparations, including injectables, ophthalmics, and other formulations. We often compound medications that are on drug shortage lists or are otherwise unavailable from standard manufacturers, providing a critical supply for medical practices located near our facility at 2160 W State Road 434, Longwood, FL 32779.
4. How does the ordering process work for a medical practice?
Healthcare practitioners or their authorized staff can initiate an order by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will work with you to understand your practice's needs, provide information on available formulations, and guide you through the required documentation for ordering office-use compounded medications from our location.
5. How can I verify the compliance and quality standards of 503B Compounding Pharmacy?
As an FDA-registered 503B outsourcing facility, our compliance is a matter of public record. You can verify our registration with the FDA. Furthermore, we are committed to transparency regarding our quality processes. You can learn more about our standards and protocols by visiting our website at https://503bcompoundingpharmacy.com/ or by speaking directly with our quality assurance team.