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. This designation is a critical distinction that sets our operation apart, ensuring the medications we prepare meet the highest standards of quality, safety, and purity for the patients and healthcare providers we serve at our facility located at 2160 W State Road 434, Longwood, FL 32779. Our mission is to provide essential medications that are not commercially available, directly supporting the specific needs of the local medical community.
As a 503B outsourcing facility, our primary function is the large-scale compounding of sterile injectable medications. This process is conducted within our state-of-the-art cleanroom environment at 2160 W State Road 434, Longwood, FL 32779, which is meticulously controlled and monitored to prevent microbial contamination. Our highly trained pharmacists and technicians adhere to rigorous sterile compounding protocols, including beyond-use date assignment based on validated stability data and comprehensive testing. We provide these medications to healthcare practitioners for office use, ensuring they have the necessary supplies to treat their patients effectively and without delay.
The services provided by 503B Compounding Pharmacy are fundamentally different from a traditional retail pharmacy. We do not compound based on individual patient-specific prescriptions presented by the public. Instead, we work directly with physicians, hospitals, and clinics, supplying them with medications they can administer on-site. This model is vital for drugs that are in shortage, have been discontinued by large manufacturers, or are needed for office-based procedures. Our presence at 2160 W State Road 434, Longwood, FL 32779, provides a reliable, local source for these critical medications, enhancing the capabilities of healthcare professionals in our community.
Quality assurance is the cornerstone of our operation at 503B Compounding Pharmacy. Every batch of medication is produced under a system of strict controls. This includes environmental monitoring, personnel training and competency evaluations, endotoxin testing, sterility testing, and stability studies. By operating as an FDA-registered 503B outsourcing facility, we are subject to regular inspections by the U.S. Food and Drug Administration, providing an additional layer of oversight and assurance for the healthcare providers who depend on our products. Our commitment is to uncompromising quality for every preparation that leaves our facility.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, and the patients under their care, 503B Compounding Pharmacy represents a trusted partner in health. We understand the critical nature of the medications we produce and the profound responsibility we carry. To learn more about our current product offerings or to discuss your facility's needs, we encourage you to contact us directly. You can reach our team by phone at (407)993-1381 or visit our website for more detailed information 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 and inspected by the U.S. Food and Drug Administration. We compound medications in large batches for office use by healthcare practitioners under the federal regulations outlined in Section 503B, which mandates compliance with Current Good Manufacturing Practices (cGMP) for superior quality control and patient safety.
2. Can I, as an individual patient, bring my prescription to 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy does not compound patient-specific medications from individual prescriptions. We supply compounded sterile preparations in larger quantities directly to healthcare providers, hospitals, and clinics for them to have on hand and administer to patients within their practice at 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does 503B Compounding Pharmacy typically provide?
Our facility specializes in compounding sterile injectable medications, which often include hormones, vitamins, electrolytes, and other solutions used in therapeutic treatments. We frequently compound medications that are on the FDA drug shortage list or are no longer available from conventional manufacturers, serving the specific needs of local healthcare providers.
4. How does a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from you?
Healthcare providers can contact 503B Compounding Pharmacy directly to establish an account and place orders. Our team can be reached by phone at (407)993-1381 to discuss specific medication needs, availability, and ordering procedures for our office-use compounded preparations.
5. Why should a provider choose a 503B outsourcing facility over other compounders?
Choosing an FDA-registered 503B outsourcing facility like ours ensures the medications are produced under the most stringent quality and safety standards, including cGMP, rigorous sterility testing, and stability studies. This provides healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with a higher level of confidence in the medications they administer to patients.