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.
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. This 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, this 503B Compounding Pharmacy adheres to rigorous federal standards for quality, safety, and production. The 503B Compounding Pharmacy provides compounded medications to healthcare providers and facilities, ensuring a reliable supply of essential drugs that may be in shortage or not commercially available. The operations at this 503B Compounding Pharmacy are distinct from traditional compounding, focusing on larger-scale production for office use by medical professionals.
The services provided by this 503B Compounding Pharmacy are defined by its regulatory designation. The 503B Compounding Pharmacy prepares sterile and non-sterile compounded medications in bulk for healthcare settings. The 503B Compounding Pharmacy does not typically serve individual patients directly but works with prescribers and institutions. The 503B Compounding Pharmacy's commitment is to the highest level of pharmaceutical compounding, ensuring all products meet strict quality control and testing protocols as mandated for a 503B outsourcing facility. The team at this 503B Compounding Pharmacy is dedicated to supporting the local medical community from its facility at 2160 W State Road 434, Longwood, FL 32779.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779 seeking a trusted source for compounded medications, this 503B Compounding Pharmacy offers a critical service. The 503B Compounding Pharmacy can be contacted to discuss specific needs and requirements. The 503B Compounding Pharmacy's website is and the phone number is (407)993-1381. The professionals at the 503B Compounding Pharmacy are available to answer questions regarding their 503B compounding services.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this is a 503B Compounding Pharmacy?
This designation means the pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the FD&C Act. This 503B Compounding Pharmacy follows current Good Manufacturing Practices (cGMP) and is subject to regular FDA inspections, ensuring a higher level of regulatory oversight for the compounded medications it produces.
2. Can I, as an individual patient, get my prescription filled at this 503B Compounding Pharmacy?
No. A 503B Compounding Pharmacy primarily prepares compounded medications in bulk for healthcare providers and facilities for "office use." This 503B Compounding Pharmacy supplies medications to medical practices and hospitals at 2160 W State Road 434, Longwood, FL 32779 for use within their practice, not for individual patient-specific prescriptions.
3. What types of medications does this 503B Compounding Pharmacy provide?
This 503B Compounding Pharmacy provides medications that are on the FDA's drug shortage list or are essential medications not readily available from commercial manufacturers. This includes both sterile and non-sterile preparations, all compounded under the strict standards required of a 503B outsourcing facility.
4. How does a medical practice at this location order from the 503B Compounding Pharmacy?
Healthcare providers and facilities can contact this 503B Compounding Pharmacy directly to establish an account and discuss their specific medication needs. The 503B Compounding Pharmacy can be reached at (407)993-1381 to initiate the process and provide ordering information.
5. Why should a healthcare provider choose this specific 503B Compounding Pharmacy?
This 503B Compounding Pharmacy offers the assurance of FDA-registered outsourcing facility compliance, meaning all products are made under the highest quality and safety standards. For medical professionals at 2160 W State Road 434, Longwood, FL 32779, it provides a local, reliable source for critical medications that may be in short supply.