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 at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the sterile and non-sterile compounding of medications. This designation signifies our commitment to the highest standards of quality, safety, and compliance, providing healthcare providers and patients with medications they can trust.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded medications. Unlike traditional compounding, our 503B status means we operate under current Good Manufacturing Practices (cGMP), which are the same rigorous quality standards required of major pharmaceutical manufacturers. This ensures every batch of medication produced at our Longwood facility meets stringent specifications for potency, purity, and sterility. We serve an important role in the healthcare ecosystem by providing medications that are often on shortage or are not available from conventional pharmaceutical companies.
Our location at 2160 W State Road 434, Longwood, FL 32779 is a state-of-the-art facility designed for precision and safety. The compounding processes undertaken here are critical for patient care, and we maintain a controlled environment to prevent contamination. The medications produced are distributed to healthcare facilities and practitioners for office use, ensuring they have the necessary supplies to treat their patients effectively. The work done within our facility is integral to supporting the local medical community.
As a 503B outsourcing facility, our operations are distinct. We are subject to FDA oversight, mandatory reporting of adverse events, and routine FDA inspections. This high level of regulatory scrutiny provides an additional layer of assurance for the healthcare professionals who utilize our services. Patients receiving medications compounded at our facility can be confident in their origin and quality. Our entire operation is focused on upholding the integrity of the compounding profession and fulfilling a vital need within the healthcare system.
For more information about the services provided by 503B Compounding Pharmacy, please contact us directly. We are available to answer questions from healthcare providers and their representatives regarding our processes and available medications. You can reach us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for further details. Our team at 2160 W State Road 434, Longwood, FL 32779 is dedicated to supporting the medical community with reliable compounded pharmaceutical products.
FAQ
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 complies with Section 503B of the Federal Food, Drug, and Cosmetic Act. This requires us to adhere to current Good Manufacturing Practices (cGMP) for the compounding of medications.
2. Who can receive medications from 503B Compounding Pharmacy?
Medications compounded at our facility on W State Road 434 are typically distributed to healthcare providers and facilities for "office use" in treating their patients. We do not compound patient-specific medications based on individual prescriptions; we produce batches for healthcare provider administration.
3. How does the 503B compounding process at your Longwood location ensure safety?
The compounding process at 2160 W State Road 434, Longwood, FL 32779 is conducted under strict cGMP standards. This includes rigorous testing of components, validated processes, environmental monitoring, and extensive quality control testing on finished medications to ensure sterility, potency, and purity.
4. Can I as an individual pick up a medication directly from your facility?
No. 503B Compounding Pharmacy operates as an outsourcing facility that supplies medications to licensed healthcare professionals and facilities. Individuals should receive their medications through their healthcare provider or clinic, not directly from our location.
5. How can a healthcare provider at a local clinic order from 503B Compounding Pharmacy?
Healthcare providers and facilities can contact 503B Compounding Pharmacy directly to inquire about ordering. Please call us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more information on our available medications and ordering procedures.