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 at 2160 W State Road 434, Longwood, FL 32779
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 specifically designed and regulated to compound large quantities of sterile and non-sterile medications without patient-specific prescriptions. This designation signifies our unwavering commitment to the highest standards of quality, safety, and consistency in pharmaceutical compounding. We serve healthcare providers and facilities by providing them with access to essential medications that are often in shortage or are not commercially available, thereby playing a critical role in the local healthcare infrastructure.
The operational model of a 503B outsourcing facility is distinct from a traditional compounding pharmacy. Our processes at the Longwood location are subject to rigorous Current Good Manufacturing Practice (cGMP) regulations as enforced by the FDA. This includes extensive testing of raw materials, stringent environmental monitoring of our cleanrooms, validated sterilization processes, and thorough quality control checks on finished preparations. This level of oversight ensures that every batch of medication produced at 2160 W State Road 434 meets precise sterility, potency, and purity specifications before it is made available for office use or administration within clinical settings.
Our core service at 2160 W State Road 434, Longwood, FL 32779, is the production of compounded medications in bulk for office use by healthcare practitioners. This includes a significant focus on sterile injectable medications, which are essential for procedures and treatments in areas such as ophthalmology, dermatology, pain management, and rheumatology. By providing these vital medications, we enable local clinics and hospitals to maintain an inventory of drugs that are critical for patient care, especially during times of national drug shortages. Our team of experienced pharmacists and technicians utilizes state-of-the-art equipment within our modern facility to ensure every preparation is handled with the utmost precision and care.
Accessing the services of 503B Compounding Pharmacy is streamlined for medical professionals. Healthcare providers can contact our facility directly to inquire about our current product list, place orders, and discuss specific needs. We encourage all medical practices in need of reliable, high-quality compounded medications to reach out to us. You can visit our website at or call us at (407)993-1381 for more information on our available preparations and to establish an account. Our team is dedicated to supporting the local medical community from our location at 2160 W State Road 434, Longwood, FL 32779, with the consistent quality and reliability that defines a 503B outsourcing facility.
Frequently Asked Questions
1. What does it mean that this is a 503B Compounding Pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779, is registered with the FDA as an outsourcing facility under Section 503B of the FD&C Act. We compound medications in bulk for office use and are required to comply with stringent federal cGMP regulations for quality and safety, which are more comprehensive than the standards applied to traditional pharmacies.
2. Can I, as an individual patient, get a prescription filled at this location?
No. 503B Compounding Pharmacy provides medications for office use by healthcare providers and facilities. We do not compound patient-specific prescriptions for individual pick-up. Your healthcare provider will administer medications compounded at our facility within their practice setting.
3. What types of medications does this 503B facility compound?
Our primary focus at 2160 W State Road 434, Longwood, FL 32779, is on producing sterile injectable medications, including solutions and suspensions used in various therapeutic areas. We also compound certain non-sterile preparations. A current list of available products can be obtained by healthcare professionals by contacting us.
4. How can a medical practice at this location order from you?
Healthcare providers and facilities can establish an account with us by calling (407)993-1381. Our team will provide you with our current product availability and guide you through the ordering process to supply your practice with the necessary medications from our facility.
5. Why should a provider choose a 503B outsourcing facility over other compounders?
Choosing our 503B Compounding Pharmacy ensures you are receiving medications produced under the highest level of federal oversight. Our adherence to cGMP standards at 2160 W State Road 434, Longwood, FL 32779, provides an added layer of assurance regarding sterility, potency, and purity, which is critical for patient safety and effective treatment outcomes.