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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and production, providing healthcare providers with a reliable source for patient-specific medications that are not commercially available.
The core function of 503B Compounding Pharmacy is the preparation of compounded medications in bulk for office use by healthcare practitioners. This means that physicians, surgeons, dermatologists, and other medical professionals serving patients from the 2160 W State Road 434, Longwood, FL 32779 location can access high-quality, pre-made medications for their practice needs. This service is distinct from traditional compounding, as it focuses on producing larger batches of medications without receiving individual patient prescriptions, thereby supporting the efficient operation of local clinics and medical offices.
Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy is subject to ongoing FDA oversight and must comply with Current Good Manufacturing Practices (cGMP). This ensures that every product leaving the facility meets strict standards for potency, purity, and sterility. For medical professionals at 2160 W State Road 434, Longwood, FL 32779, this provides a critical layer of assurance and patient safety, knowing the medications they use are produced under the highest level of regulatory scrutiny available for compounded drugs.
The services provided by 503B Compounding Pharmacy are essential for healthcare delivery. By supplying medications that are often on shortage or are not manufactured by large pharmaceutical companies, the facility at 2160 W State Road 434, Longwood, FL 32779 helps ensure continuity of care. Healthcare providers can depend on a consistent supply of vital medications, allowing them to focus on patient treatment without concerns about drug availability or quality.
To learn more about the specific medications and services available from this facility, healthcare providers are encouraged to contact 503B Compounding Pharmacy directly. The team is available to discuss needs and provide information on available formulations. You can reach them by phone at (407)993-1381 or visit their website for further details 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 the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. This registration requires us to comply with more rigorous federal standards, including Current Good Manufacturing Practices (cGMP), and subjects us to regular FDA inspections to ensure the quality, safety, and sterility of our compounded medications.
2. As a patient, can I order medication directly from 503B Compounding Pharmacy at 2160 W State Road 434?
No. 503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Patients must receive these medications through their doctor or healthcare provider, who will have ordered them from our facility for use in their practice at 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does 503B Compounding Pharmacy at this location provide?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding a wide range of sterile and non-sterile medications in bulk quantities. This includes, but is not limited to, injectables, ophthalmics, and topicals that are often on drug shortage lists or are not commercially available for healthcare providers to use.
4. How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly to establish an account and place orders. You can reach our team by calling (407)993-1381 to speak with a representative or visit our website at https://503bcompoundingpharmacy.com/ for more information on our ordering process.
5. Why should a local healthcare provider choose 503B Compounding Pharmacy?
Choosing our facility at 2160 W State Road 434, Longwood, FL 32779 ensures you are receiving medications produced under the strictest quality controls mandated by the FDA. Our status as a 503B outsourcing facility provides an added layer of safety and reliability for medications used in your practice, helping to protect your patients and your practice.