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 at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act establishes a critical distinction, setting this facility apart from traditional compounding pharmacies. The 503B Compounding Pharmacy is held to the highest standards of pharmaceutical manufacturing, including Current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving the facility meets rigorous standards for sterility, potency, and purity. The core mission of the 503B Compounding Pharmacy is to provide healthcare practitioners serving the local community with access to high-quality, compounded medications that are often unavailable from standard commercial manufacturers.
The services provided by the 503B Compounding Pharmacy at its Longwood location are specifically tailored for office use by medical professionals. This means that the 503B Compounding Pharmacy primarily supplies medications to physicians, hospitals, clinics, and other healthcare providers for administration to their patients within a clinical setting. The 503B Compounding Pharmacy does not typically dispense medications directly to individual patients from this facility. Instead, it acts as a bulk manufacturer, producing large-scale batches of essential drugs that are critical for patient care but may be subject to national shortages or are simply not commercially available. This vital service supports the local medical community by ensuring a reliable supply of necessary medications.
Operating from 2160 W State Road 434, Longwood, FL 32779, the 503B Compounding Pharmacy specializes in sterile preparations. This includes a significant focus on injectable medications, such as hormone replacement therapy (HRT) injections, intravenous (IV) bags, and other parenteral formulations that require an aseptic environment to ensure patient safety. The facility's commitment to cGMP standards means that every step of the process, from ingredient sourcing to final packaging, is meticulously controlled and documented. This provides healthcare practitioners at local practices with the utmost confidence in the medications they use to treat their patients. The 503B Compounding Pharmacy is an essential partner in the local healthcare ecosystem.
For healthcare providers seeking a dependable source for compounded medications, the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a trusted resource. The facility's dedicated team of pharmacists and technicians leverages advanced technology and strict protocols to fulfill the specific needs of the medical community. To learn more about the services and capabilities of the 503B Compounding Pharmacy, or to inquire about becoming a client, healthcare professionals are encouraged to contact the facility directly. The 503B Compounding Pharmacy can be reached by phone at (407)993-1381 or through their official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this is a 503B Compounding Pharmacy?
Being a 503B Compounding Pharmacy means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA as an outsourcing facility. We operate under stricter federal regulations, including Current Good Manufacturing Practices (cGMP), which are the same standards required of major pharmaceutical manufacturers. This ensures a higher level of quality control for the sterile compounded medications we produce.
2. Can I, as an individual patient, pick up my prescription at your location?
No. The 503B Compounding Pharmacy primarily supplies medications for office use by licensed healthcare practitioners. Our services are designed for physicians, clinics, and hospitals in the area. Patients should receive their medications directly from their healthcare provider at the point of care.
3. What types of medications does the 503B Compounding Pharmacy specialize in?
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 specializes in producing large-scale batches of sterile injectable medications. This includes formulations like hormone therapy, vitamins, and other solutions that are administered by healthcare professionals, particularly those drugs that are currently in shortage or not available from commercial manufacturers.
4. How can my medical practice or clinic become a client?
Healthcare providers interested in utilizing our services can initiate the process by contacting the 503B Compounding Pharmacy directly. You can reach our team by calling (407)993-1381 to discuss your practice's specific needs and our onboarding procedures for new client accounts.
5. How do I verify the quality and safety standards of your facility?
As an FDA-registered 503B outsourcing facility, we adhere to stringent cGMP standards. Healthcare providers can request information about our quality control processes, and our registration status can be verified through the FDA's public database. Our commitment is to provide complete transparency and confidence in the medications we supply to the local medical community.