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 unwavering commitment to the highest standards of quality, safety, and consistency, providing healthcare providers and patients with medications they can trust implicitly.
The core function of 503B Compounding Pharmacy is the production of medications that are not commercially available. This includes creating specific strengths, altering dosage forms for easier administration, or removing non-essential allergens. All processes conducted at our Longwood facility are performed under rigorous quality control protocols that meet and exceed federal regulatory requirements. This ensures every preparation that leaves our location is of the utmost pharmaceutical grade.
Our services at 2160 W State Road 434 are integral to supporting local healthcare delivery. We provide physicians and clinics with access to essential medications that are critical for patient care but may be in short supply or discontinued by major manufacturers. By operating as a 503B outsourcing facility, we offer a reliable and compliant source for these vital medications, directly serving the needs of the medical community from our specific location.
Patients and healthcare professionals can be assured that the medications compounded at our Longwood facility are produced in a controlled environment. Our state-of-the-art cleanrooms and advanced equipment are designed to prevent contamination, ensuring sterility and potency. The team at 503B Compounding Pharmacy consists of highly skilled pharmacists and technicians who are experts in the science of compounding, adhering to precise formulations for optimal patient outcomes.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical practices. Healthcare providers can place orders directly with our facility to access a consistent supply of high-quality compounded medications for their office use. To learn more about our specific services or to initiate an order, please contact us directly. We are located at 2160 W State Road 434, Longwood, FL 32779. Reach out via our website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381.
FAQ
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with strict federal standards for compounding. This includes current Good Manufacturing Practices (cGMP) for higher volume production, ensuring consistent quality, strength, and purity in our medications.
Who can order medications from 503B Compounding Pharmacy?
Our medications are prepared for office use by licensed healthcare providers. Physicians and clinics can order compounded pharmaceuticals from our location to have on hand for patient treatments and procedures.
Are the medications from your Longwood facility sterile?
Yes, 503B Compounding Pharmacy compounds both sterile and non-sterile medications. Our sterile preparations are made in ISO-classified cleanrooms to ensure they are free from contaminants, making them suitable for injections, infusions, and ophthalmic use.
How does a 503B pharmacy differ from a traditional compounding pharmacy?
A 503B outsourcing facility, like ours at 2160 W State Road 434, Longwood, FL 32779, operates under federal oversight and produces larger batches of medications for office use without patient-specific prescriptions. A traditional compounding pharmacy typically compounds on a smaller, patient-specific basis under state board of pharmacy regulations.
How can I contact 503B Compounding Pharmacy?
You can contact our facility directly. We are located at 2160 W State Road 434, Longwood, FL 32779. Our website is https://503bcompoundingpharmacy.com/ and our phone number is (407)993-1381.