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 dedicated to the preparation of sterile and non-sterile compounded medications. This designation signifies our commitment to the highest standards of quality, safety, and consistency, exceeding the requirements of a traditional compounding pharmacy. We serve healthcare providers and patients at our specific location by providing medications that are not commercially available, ensuring specific patient needs are met with precision and care.
The operations at our Longwood facility are governed by rigorous current good manufacturing practices (cGMP). This ensures every preparation, whether a complex sterile injectable or a specialized topical formulation, undergoes stringent quality control testing. Our team of highly trained pharmacists and technicians utilizes state-of-the-art equipment within our controlled environment to compound medications free of contaminants. For patients and prescribers utilizing our services at 2160 W State Road 434, this translates to an unparalleled level of confidence in the medications they rely on.
Our core service is the large-scale compounding of medications for office use by healthcare practitioners. Physicians and clinics can source essential medications directly from our 503B outsourcing facility, ensuring they have the necessary supplies for patient care. This includes a wide range of preparations, from hormone replacement therapies and ophthalmologic solutions to pain management formulations. By operating under Section 503B, we provide practitioners with access to medications that may be on shortage or are needed in specific strengths or formulations not offered by large pharmaceutical manufacturers.
While our primary function is supplying healthcare practitioners, we are a vital resource for individual patients with prescriptions for compounded medications. When a prescriber determines that a patient requires a medication that is not commercially available—due to a drug allergy, a needed dosage form, or a strength—they can specify 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779. Our facility then prepares that prescription with the same cGMP standards applied to all our preparations, ensuring patient safety and therapeutic efficacy.
Engaging with our pharmacy is a collaborative process that begins with the healthcare provider. Prescribers can contact our facility to discuss specific patient needs or formulary requirements. Patients with a valid prescription from their provider can have it filled at our location. We encourage open communication between the patient, their prescriber, and our pharmacists to achieve the best possible health outcomes. For more information or to speak with our team, please visit our website at or call us at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
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 an FDA-registered outsourcing facility. We compound medications on a larger scale under federal current good manufacturing practices (cGMP), which involve more rigorous quality control and testing standards than a traditional pharmacy.
2. Can I, as a patient, get my prescription filled directly at your location?
Yes, but only with a valid prescription from your healthcare provider. Your prescriber must determine that a compounded medication is medically necessary for you and will send the prescription directly to our facility at 2160 W State Road 434, Longwood, FL 32779 for our pharmacists to prepare.
3. Do you serve healthcare providers at your Longwood location?
Yes, a primary function of our 503B outsourcing facility is to supply compounded medications for office use to physicians and clinics. Healthcare providers can source medications from our location to administer to patients within their practice.
4. How are the medications from your facility different from those at a regular pharmacy?
Medications prepared at our 503B facility undergo stringent quality assurance testing and are produced in a controlled environment adhering to cGMP. This provides an extra layer of safety and consistency, especially for sterile injectables and other complex preparations.
5. How can I contact your pharmacy for more information?
You can learn more by visiting our website at or by calling us directly at (407)993-1381 to speak with a member of our team at our location on 2160 W State Road 434, Longwood, FL 32779.