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 signifies our commitment to meeting the highest standards of quality, safety, and consistency, providing healthcare providers and patients with medications that are not commercially available.
The operations at 2160 W State Road 434, Longwood, FL 32779 are conducted under rigorous quality control protocols that exceed those of traditional compounding. As a 503B outsourcing facility, our processes are subject to current Good Manufacturing Practices (cGMP), ensuring every preparation is produced in a controlled environment with extensive documentation and testing. This focus on quality provides assurance to the medical community that the medications they rely on for their patients are produced with the utmost precision and care.
Our core service at this location is the production of medications in larger batches for office use by healthcare practitioners. This allows physicians, surgeons, veterinarians, and other medical professionals to have essential medications readily available for procedures and treatments without the need for in-office compounding. The 503B Compounding Pharmacy provides a critical supply chain component for clinics and hospitals, ensuring they have access to high-quality, reliable medications for patient care.
While we serve healthcare providers directly, patients benefit immensely from the work done at our Longwood facility. The medications compounded here are often vital for individuals with specific needs that cannot be met by mass-produced, commercially available drugs. This includes specific strengths, dosage forms, or formulations free of certain allergens or preservatives. By working through their prescribing healthcare provider, patients gain access to these tailored medications, all produced under the stringent oversight required of a 503B outsourcing facility.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical practices. Healthcare providers can place orders for the medications they need, confident that they will be produced and delivered with consistency and reliability. Our team is dedicated to supporting the local medical community from our facility at 2160 W State Road 434, Longwood, FL 32779. For more information or to initiate an order, please contact us via our website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381.
FAQ
1. What does it mean that this is a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered facility that compounds medications in accordance with strict federal standards, including current Good Manufacturing Practices (cGMP). This ensures a higher level of quality control and consistency compared to traditional compounding.
2. Can I, as a patient, order medication directly from your facility?
No. 503B Compounding Pharmacy provides medications for office use by healthcare providers. Patients must obtain a prescription from their doctor, who can then order the necessary medication from our facility at 2160 W State Road 434, Longwood, FL 32779 for administration or dispensing within their practice.
3. What types of medications do you compound at your Longwood location?
Our FDA-registered outsourcing facility at 2160 W State Road 434 compounds a wide range of sterile and non-sterile medications in batches for healthcare providers. This includes hormonal preparations, sterile injectables, ophthalmics, and other formulations that are not readily available from commercial manufacturers.
4. How do healthcare providers place an order with your pharmacy?
Healthcare providers can initiate orders by contacting 503B Compounding Pharmacy directly. The ordering process can be started by calling our facility at (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/ for more detailed information.
5. Why would a doctor choose your 503B pharmacy over other options?
Doctors choose our facility at 2160 W State Road 434, Longwood, FL 32779 because of our commitment to quality and compliance. As a 503B outsourcing facility, we provide the assurance of cGMP standards, rigorous testing, and batch consistency, which is essential for patient safety and effective treatment outcomes.