Florida is home to one of the largest healthcare markets in the United States, driven by a rapidly growing and aging population. With major hospital systems and medical centers in Miami, Orlando, Tampa, Jacksonville, and Fort Lauderdale, the demand for reliable, high-quality compounded medications is substantial. For hospitals, clinics, and physician practices across the state, 503B outsourcing facilities provide a critical supply of sterile and non-sterile compounded drugs produced under FDA oversight and Current Good Manufacturing Practices (cGMP).
This page provides a comprehensive, up-to-date directory of all FDA-registered 503B outsourcing facilities located in Florida. Each facility listed below is registered with the FDA and subject to federal inspection standards.
Official List of FDA-Registered 503B Facilities in Florida
503B Outsourcing Facility One, LLC
An FDA-registered 503B outsourcing facility located in West Palm Beach, serving the South Florida healthcare market. FDA registration in February 2025.
View Full Profile →Ajenat Pharmaceuticals, LLC
A Largo-based 503B outsourcing facility registered with the FDA since March 2025. Provides sterile compounding services for the Tampa Bay area healthcare market.
View Full Profile →Assure Infusions, Inc.
An FDA-registered 503B outsourcing facility (non-sterile) located in Bartow, in the Central Florida region. Registered with the FDA since November 2024. Does not intend to compound sterile drugs from bulk substances.
View Full Profile →Aveva Drug Delivery Systems, Inc
A Tamarac-based 503B outsourcing facility in the Fort Lauderdale metropolitan area. FDA-registered since November 2024, offering sterile compounding services.
View Full Profile →BayCare Integrated Service Center, LLC dba BayCare Central Pharmacy
Operating as BayCare Central Pharmacy in Temple Terrace, part of the Tampa Bay metropolitan area. FDA-registered since June 2019. Non-sterile compounding facility. FMD-145 Letter issued 9/18/2023.
View Full Profile →BPI Labs LLC
A Largo-based 503B outsourcing facility in the Tampa Bay area, FDA-registered since March 2019. Provides sterile compounding services. Form 483 issued during most recent inspection. FMD-145 issued 7/28/2025.
View Full Profile →Bravado Pharmaceuticals, LLC
A newly registered 503B outsourcing facility in Lutz, north of Tampa. FDA-registered since February 2025, offering sterile compounding services.
View Full Profile →GenoGenix LLC
A Boca Raton-based 503B outsourcing facility in the South Florida market. FDA-registered since February 2025. Form 483 issued during most recent inspection.
View Full Profile →Hybrid Pharma, LLC
One of the longer-operating 503B outsourcing facilities in Florida, Hybrid Pharma has been FDA-registered since January 2015. Located in Deerfield Beach, serving the South Florida healthcare market. Form 483 issued during most recent inspection.
View Full Profile →Leesar Inc.
One of the earliest-registered 503B outsourcing facilities in Florida, Leesar has been FDA-registered since April 2014. A non-sterile compounding facility located in Fort Myers, serving the Southwest Florida healthcare market. Form 483 issued during most recent inspection.
View Full Profile →Olympia Pharmaceuticals
A well-established 503B outsourcing facility in Orlando, FDA-registered since March 2014. One of the longest-operating 503B facilities in Florida. Form 483 issued during most recent inspection.
View Full Profile →PQ Pharmacy LLC
A Brooksville-based 503B outsourcing facility in the Nature Coast region, between Tampa and Ocala. FDA-registered since October 2020. Form 483 issued during most recent inspection.
View Full Profile →Rapha Pharmaceuticals, Inc.
A Tampa-based 503B outsourcing facility registered with the FDA since December 2024. Provides sterile compounding services for the Tampa Bay healthcare market.
View Full Profile →Signature Rx
A Delray Beach-based 503B outsourcing facility in the Palm Beach County area. FDA-registered since October 2023. Provides sterile compounding services for the South Florida healthcare market.
View Full Profile →SKNV formerly registered as Sincerus Florida, LLC
Located in Pompano Beach, this 503B outsourcing facility has been FDA-registered since March 2016. Provides sterile compounding services. Untitled Letter issued 9/16/2025 following most recent inspection.
View Full Profile →Wesley Pharmaceuticals
A newly registered 503B outsourcing facility in Orlando. FDA-registered since July 2025, offering sterile compounding services for the Central Florida healthcare market.
View Full Profile →Why Partner with a Florida-Based 503B Facility?
For hospitals, clinics, and health systems operating in Florida, sourcing compounded medications from an in-state 503B outsourcing facility offers several key advantages:
- Logistical Efficiency: Shorter shipping distances mean faster delivery times and reduced shipping costs, especially for temperature-sensitive sterile preparations that require cold-chain management. Given Florida's warm climate, minimizing transit time for cold-chain products is particularly important.
- Regional Expertise: Florida-based facilities understand the unique needs of the state's healthcare market, including the high-volume demands driven by one of the nation's largest senior populations and a robust network of hospitals, ambulatory surgery centers, and specialty clinics.
- Simplified Audits: Many healthcare systems conduct on-site vendor audits before adding a 503B facility to their approved supplier list. Partnering with a local facility makes these audits more practical and cost-effective, without requiring expensive out-of-state travel.
- Supporting the Local Economy: Partnering with Florida-based compounding facilities keeps healthcare dollars within the state and supports the growth of the local pharmaceutical manufacturing sector.
Navigating Compounding Regulations in Florida
503B outsourcing facilities in Florida operate under a dual regulatory framework. At the federal level, they are overseen by the FDA and must comply with Current Good Manufacturing Practices (cGMP). At the state level, they must also maintain licensure and good standing with the Florida Board of Pharmacy.
The Florida Board of Pharmacy, operating under the Florida Department of Health, oversees all pharmacy operations in the state, including licensing, inspections, and enforcement of state pharmacy laws. While the FDA is the primary regulatory authority for 503B facilities with respect to cGMP compliance and product quality, the Board ensures that these facilities also meet state-level requirements for pharmacy operations, pharmacist oversight, and record-keeping.
Healthcare providers in Florida should verify that any 503B facility they partner with is both FDA-registered and in good standing with the Florida Board of Pharmacy. For more on the differences between federal and state oversight of compounding pharmacies, see our guide to 503A vs. 503B pharmacies.
Find a 503B Pharmacy Near You
South Florida / Miami-Fort Lauderdale Area 503B Facilities
The South Florida tri-county area (Miami-Dade, Broward, and Palm Beach counties) has the highest concentration of 503B outsourcing facilities in the state, with 7 registered facilities serving one of the most densely populated healthcare markets in the country.
- 503B Outsourcing Facility One, LLC — West Palm Beach
- Aveva Drug Delivery Systems, Inc — Tamarac
- GenoGenix LLC — Boca Raton
- Hybrid Pharma, LLC — Deerfield Beach
- Signature Rx — Delray Beach
- SKNV formerly registered as Sincerus Florida, LLC — Pompano Beach
- Leesar Inc. — Fort Myers
Tampa Bay Area 503B Facilities
The Tampa Bay metropolitan area is home to 6 FDA-registered 503B outsourcing facilities, supporting a major regional healthcare market that includes several large hospital systems.
- Ajenat Pharmaceuticals, LLC — Largo
- BayCare Integrated Service Center, LLC dba BayCare Central Pharmacy — Temple Terrace
- BPI Labs LLC — Largo
- Bravado Pharmaceuticals, LLC — Lutz
- Rapha Pharmaceuticals, Inc. — Tampa
- PQ Pharmacy LLC — Brooksville
Orlando & Central Florida Area 503B Facilities
The Central Florida corridor is served by 3 registered 503B outsourcing facilities, supporting a growing healthcare market anchored by Orlando's expanding hospital systems.
- Olympia Pharmaceuticals — Orlando
- Wesley Pharmaceuticals — Orlando
- Assure Infusions, Inc. — Bartow
Your Trusted Source for 503B Information in Florida
View detailed profiles for each Florida-based facility, including FDA inspection histories, compliance status, and contact information. Or let us help you find the right compounding partner for your specific needs.
Browse All 503B FacilitiesNew to 503B outsourcing facilities? Read our comprehensive guide: What is a 503B Pharmacy? Or learn about the key differences between traditional compounding and outsourcing facilities in our 503A vs. 503B comparison guide.