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 at 2160 W State Road 434, Longwood, FL 32779. This designation, granted under Section 503B of the Federal Food, Drug, and Cosmetic Act, signifies the highest level of regulatory compliance and quality assurance in the pharmaceutical compounding industry. As a 503B outsourcing facility, this pharmacy is distinct from traditional compounding pharmacies, as it prepares large batches of compounded sterile preparations (CSPs) for office use by healthcare practitioners without patient-specific prescriptions. The operations at 2160 W State Road 434, Longwood, FL 32779 are conducted under the strictest cGMP (current Good Manufacturing Practice) standards as enforced by the FDA, ensuring every preparation meets rigorous criteria for sterility, potency, and purity.
The core function of 503B Compounding Pharmacy at its Longwood facility is to provide healthcare providers with access to essential medications that may be in shortage or are not commercially available. By preparing these medications in an FDA-inspected environment, the pharmacy provides a critical and reliable supply chain for physicians, surgeons, hospitals, and clinics. The services rendered from 2160 W State Road 434, Longwood, FL 32779 are vital for supporting the local medical community, enabling practitioners to obtain necessary drugs for their procedures and patient treatment plans with the utmost confidence in the product's quality and safety. The pharmacy’s role is to be a backbone of support for the healthcare infrastructure operating in and around the 2160 W State Road 434 address.
Quality control is the paramount principle guiding every action at 503B Compounding Pharmacy. The facility at 2160 W State Road 434, Longwood, FL 32779 employs a state-of-the-art environmental monitoring program, advanced analytical testing, and validated processes to guarantee the integrity of every compounded preparation that leaves the facility. This unwavering commitment to quality, from sourcing raw materials to final product release, is what defines the 503B outsourcing facility and differentiates it from other entities. For healthcare providers seeking a trusted partner for their non-patient-specific medication needs, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a pillar of reliability and excellence.
To learn more about the services available from this specific outsourcing facility or to inquire about its current product listings, healthcare providers can make contact directly. The phone number for 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is (407)993-1381. Further information can also be found online at .
Frequently Asked Questions
1. What does it mean that this is a 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779?
It means this facility is registered with the FDA under Section 503B of the FD&C Act. This registration requires the pharmacy at 2160 W State Road 434, Longwood, FL 32779 to comply with stringent federal standards, including cGMP, for producing compounded sterile preparations for office use by healthcare practitioners.
2. Can I as an individual patient get a prescription filled at 503B Compounding Pharmacy?
No. The 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 prepares medications in bulk for healthcare providers to use in their practice. Individual patients must work with their prescribing physician, who may source certain medications from this facility for office-based administration.
3. How does the 503B Compounding Pharmacy ensure the sterility of its products?
The facility at 2160 W State Road 434, Longwood, FL 32779 adheres to strict cGMP protocols. This includes rigorous environmental controls, continuous particulate and microbial monitoring of cleanrooms, and comprehensive testing of finished preparations to validate sterility, potency, and purity before release.
4. Who is authorized to place an order with this specific location?
Orders are accepted from licensed healthcare providers and healthcare facilities. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 provides medications for office use and does not dispense directly to the public. Providers can initiate an order by calling (407)993-1381.
5. Where can I find a list of medications compounded at this facility?
A current list of products compounded and available from the 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 can be obtained by contacting the pharmacy directly at (407)993-1381 or by visiting the website at .