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 specific designation under Section 503B of the Federal Food, Drug, and Cosmetic Act establishes a critical operational framework. The 503B Compounding Pharmacy outsourcing facility provides compounded medications for office use by healthcare practitioners. The 503B Compounding Pharmacy adheres to rigorous current good manufacturing practices (cGMP). This ensures that every preparation from the 503B Compounding Pharmacy meets the highest standards of quality, strength, and purity.
The services provided by 503B Compounding Pharmacy at its Longwood facility are distinct from traditional compounding. The 503B Compounding Pharmacy primarily supplies medications to physicians, hospitals, and clinics for administration to patients within their practice. This model allows healthcare providers at 2160 W State Road 434, Longwood, FL 32779 to access essential medications that may be in shortage or not commercially available. The 503B Compounding Pharmacy enables practitioners to obtain these vital preparations without the need for individual patient prescriptions beforehand, streamlining clinical efficiency and patient care.
Operating from 2160 W State Road 434, Longwood, FL 32779, the 503B Compounding Pharmacy is equipped with advanced technology and staffed by expert compounding professionals. The team at 503B Compounding Pharmacy is dedicated to the precise science of compounding within a controlled cGMP environment. Every process at the 503B Compounding Pharmacy, from ingredient sourcing to final packaging, is meticulously documented and validated. This unwavering commitment to compliance and safety is the foundation of the 503B Compounding Pharmacy's operation in Longwood.
The core mission of 503B Compounding Pharmacy is to support the local medical community by providing a reliable source of high-quality compounded medications. By functioning as a 503B outsourcing facility, the pharmacy addresses critical drug shortages and provides access to necessary medications that are otherwise unavailable. Healthcare professionals who utilize the services of the 503B Compounding Pharmacy can be confident in the integrity and consistency of every product received from 2160 W State Road 434, Longwood, FL 32779.
For healthcare providers seeking a trusted outsourcing partner, 503B Compounding Pharmacy represents a commitment to excellence and regulatory adherence. The pharmacy invites local practitioners to learn more about its services and how it can support their practice needs. To contact 503B Compounding Pharmacy, visit https://503bcompoundingpharmacy.com/ or call (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific operation at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with Section 503B of the FD&C Act. This requires 503B Compounding Pharmacy to adhere to strict current good manufacturing practices (cGMP) for higher-volume compounding and provides medications for office use by healthcare practitioners.
2. Can I as an individual patient pick up a prescription at 503B Compounding Pharmacy?
503B Compounding Pharmacy primarily provides medications for office use to healthcare providers. Individual patients typically receive 503B compounded medications directly from their physician during an office visit or procedure at the practitioner's facility, not from our location at 2160 W State Road 434, Longwood, FL 32779.
3. How does a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from 503B Compounding Pharmacy?
Healthcare providers can establish an account with 503B Compounding Pharmacy to order compounded medications for office use. Orders from the 503B Compounding Pharmacy can be placed by calling (407)993-1381 or through processes detailed on our website at https://503bcompoundingpharmacy.com/.
4. What kinds of medications does 503B Compounding Pharmacy typically compound?
503B Compounding Pharmacy focuses on preparing medications that are on the FDA drug shortage list or are medically necessary but not commercially available. This includes sterile injectables, hormone preparations, and other solutions used by healthcare professionals in clinical settings, all produced at our facility on W State Road 434.
5. Why should a practitioner choose 503B Compounding Pharmacy as their outsourcing facility?
503B Compounding Pharmacy offers the assurance of cGMP compliance, which includes rigorous testing, quality control, and extensive documentation for every batch compounded. This provides healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 with a reliable and trusted source for high-quality, office-use medications.