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 from its location at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act signifies a commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, an outsourcing facility like 503B Compounding Pharmacy prepares medications in large batches for office use, which are then distributed to healthcare providers for patient administration within their practice. This model is essential for physicians, surgeons, dermatologists, veterinarians, and other medical professionals who require access to a consistent, reliable, and sterile supply of medications for their procedures and treatments.
The core service of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile preparations. This includes a significant focus on producing injectable medications, such as hormone replacement therapies, vitamins, peptides, and other sterile solutions that are critical for clinics and surgical centers. All processes are conducted under stringent controlled environments with rigorous quality control testing, including sterility and endotoxin testing, to ensure every batch meets or exceeds USP standards. This level of quality assurance provides healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 with the confidence that the medications they use are of the utmost purity and potency.
Healthcare providers who source their medications from 503B Compounding Pharmacy benefit from a partnership built on reliability and expertise. The facility's operations are designed to alleviate the burdens of in-office compounding, allowing medical staff to focus on patient care. By outsourcing their compounding needs to this FDA-registered facility, practices mitigate risks associated with compounding, ensure regulatory compliance, and gain access to a broad formulary of consistently prepared medications. The team at 503B Compounding Pharmacy works closely with prescribers to support their specific patient treatment plans and practice requirements.
For medical practices and providers at 2160 W State Road 434, Longwood, FL 32779, engaging with 503B Compounding Pharmacy is a straightforward process. Orders are coordinated directly with the facility. The dedicated team is available to discuss specific compound formulations, batch sizes, and delivery schedules to seamlessly integrate this vital service into the daily operations of a healthcare practice. To learn more about the formulary or to initiate a partnership, providers are encouraged to contact 503B Compounding Pharmacy directly.
Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our 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 medications in large batches. This includes current Good Manufacturing Practices (cGMP) and rigorous testing protocols for sterility and potency, ensuring a higher level of quality control than is required of traditional pharmacies.
2. As a healthcare provider at 2160 W State Road 434, Longwood, FL 32779, can I order compounded medications for my office use?
Yes. 503B Compounding Pharmacy specifically provides compounded medications for office use. Healthcare practitioners can order these medications to have on hand for administering to patients during procedures, appointments, or treatments within their practice at 2160 W State Road 434, Longwood, FL 32779.
3. What types of compounded medications are available from your facility?
503B Compounding Pharmacy specializes in sterile injectable compounds, including but not limited to hormone replacement therapies (HRT), vitamins, peptides, and other customized solutions. The available formulations are designed to meet the needs of various medical specialties operating from 2160 W State Road 434, Longwood, FL 32779.
4. How does ordering work for a local healthcare practice?
Healthcare providers or their authorized staff can place orders directly with 503B Compounding Pharmacy by phone or through our website. Our team will work with you to determine your needs, and orders can be delivered to your practice at 2160 W State Road 434, Longwood, FL 32779.
5. Why should a practice at 2160 W State Road 434, Longwood, FL 32779 choose an outsourcing facility over other sources?
Choosing an FDA-registered outsourcing facility like 503B Compounding Pharmacy ensures you receive medications produced under the highest standards of quality and safety. It reduces the liability and resource burden of in-office compounding, guarantees compliance with federal regulations, and provides consistent, reliable medication for your patients.