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 large-scale compounding of sterile and non-sterile medications. This designation means we adhere to the highest federal standards for quality control, testing, and production, providing healthcare providers and patients with medications that are not commercially available. Our mission is to fulfill specific patient needs by preparing customized medication solutions that are essential for effective treatment plans.
The core function of 503B Compounding Pharmacy is the production of compounded medications in bulk for office use by healthcare practitioners. Physicians, dermatologists, veterinarians, and other medical professionals serving patients from our local community can rely on our facility for a consistent, high-quality supply of essential drugs. This allows these practitioners to have the necessary medications on hand for immediate administration during patient visits, ensuring timely and effective care. Our operations are pivotal in preventing drug shortages and providing access to critical therapies.
At our Longwood location, we maintain a state-of-the-art cleanroom environment that meets or exceeds all USP <797> and USP <800> standards for sterile and hazardous drug compounding. Every batch of medication produced within our facility undergoes rigorous analytical testing to verify potency, sterility, and purity before it is released. This unwavering commitment to quality and safety ensures that every preparation leaving 503B Compounding Pharmacy is of the highest integrity. Our highly trained pharmacists and technicians utilize advanced technology and precise processes to guarantee patient safety.
Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can access our comprehensive formulary, which includes a wide array of sterile preparations such as injections, ophthalmics, and inhalants, as well as non-sterile preparations like topical creams, capsules, and oral suspensions. We work directly with medical practices to supply these medications for their office use, supporting a broad spectrum of treatments from hormone therapy and pain management to dermatological applications and veterinary medicine. Our team is committed to supporting the local medical community with reliable service.
To learn more about our services or to place an order, healthcare entities can contact 503B Compounding Pharmacy directly. We are a vital resource for the medical community operating in and around our facility. You can reach us by phone at (407)993-1381 for immediate assistance or visit our website at https://503bcompoundingpharmacy.com/ for detailed information about our capabilities and compliance. Our team is dedicated to providing exceptional service and supporting the critical work of local healthcare providers.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with strict federal standards for compounding medications on a larger scale. This ensures a higher level of quality control, testing, and consistency compared to traditional compounding.
Who can order medications from 503B Compounding Pharmacy?
We supply medications exclusively to healthcare professionals and practices for office use. This includes physicians, clinics, hospitals, and veterinarians who administer medications directly to patients at their practice located near our facility at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility compounds a wide range of both sterile and non-sterile medications. This includes injectables, ophthalmics, nasal sprays, topical creams, gels, capsules, and oral suspensions that are not available commercially or are in shortage, serving the specific needs of local practitioners.
How does 503B Compounding Pharmacy ensure medication safety and quality?
We adhere to rigorous USP chapters <797> and <800> standards in our cleanroom environments. Every batch of medication is tested for potency, sterility, and endotoxins by an independent lab before being released, guaranteeing the highest level of safety for patients.
How can a healthcare practice at 2160 W State Road 434 place an order?
Healthcare practices can contact our pharmacy directly to establish an account and place orders. You can call us at (407)993-1381 to speak with our team or visit our website at https://503bcompoundingpharmacy.com/ for more information on our ordering process and formulary.