APR 2025
SUPPLY CHAIN TEARDOWN
503B OUTSOURCING
FACILITIES
©2025 RXinsider | RXinsider Market Intelligence Group | 2025
Alexa DiLuca
Marketing Manager
Michael McEwen
Pharmacy500 Market Analyst
michael.mcewen@rxinsider.com
Gregory Cianfarani, RPh
Founder & CEO
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Jeff Rackliff
Pharmacy500 Market Analyst
jeff.rackliff@rxinsider.com
Emma Cidade
Pharmacy500 Market Analyst
emma.cidade@rxinsider.com
Lexi Cianfarani
Pharmacy500 Market Analyst
lexi.cianfarani@rxinsider.com
Report Lead
Emma Cidade
©2025 RXinsider | RXinsider Market Intelligence Group | 2025
A 2025 Breakdown of 503B Outsourcing Facilities
Table of Contents
• Introduction .............................................................2-3
• 503B Outsourcing Executive Snapshot .................4
• 503B Outsourcing Overview .................................5-7
• 503B History and Timeline .......................................8
• Registered 503B Outsourcing Facilities ...........9-12
• Conferences, Trade Shows & Meetings .............. 13
• References .......................................................... 14-15
• Pharmacy500 Companies ............................... 16-19
The objective of this report is to educate Pharmacy500
professionals, pharmacy leadership, and other stakeholders on
the 503B compounding sector. 503B outsourcing facilities are
vital in addressing drug shortages and ensuring the timely delivery
of sterile and non-sterile medications while adhering to strict FDA
regulations.
©2025 RXinsider | RXinsider Market Intelligence Group | 2025
89
FDA-registered 503B
facilities in the U.S.
12
503B facilities are listed on the
Pharmacy500.
50+%
of shortages are due
to manufacturing and
supply chain issues.
99%
of U.S. hospitals report
drug shortages.
60%
of shortages involve
injectable medications.
6,093
hospitals in the
U.S. as of 2025
The Drug Quality and Security Act (DQSA) was signed into law in 2013.
Source: U.S. Senate Homeland Security Report
on Drug Shortages
SCA Pharmaceuticals
became the first registered
503B company
Source: FDA
Source: American Hospital
Association
Source: RXinsider
Source: FDA
EXECUTIVE SNAPSHOT
503B
OUTSOURCING
FACILITIES
Source: FDA
271
drug shortages reported
as of December 2024.
Source: FDA
503B Outsourcing Overview
©2025 RXinsider | RXinsider Market Intelligence Group | 2025
Pharmacy 503B Outsourcing refers to a specific type of pharmaceutical
outsourcing facility regulated under Section 503B of the Federal Food,
Drug, and Cosmetic Act (FDCA). It involves the outsourcing of compounded
medications by a pharmacy facility that is registered with the U.S. Food
and Drug Administration (FDA). These pharmacies are authorized to
produce large quantities of compounded drugs for hospitals, clinics, and
other healthcare providers, primarily for office use and without requiring
individual prescriptions for each patient.
Pharmacy 503B outsourcing provides a crucial role in the healthcare
system by producing bulk compounded medications that are safe,
effective, and in compliance with FDA standards, ensuring that healthcare
providers have the necessary medications to treat their patients in a timely
and cost-effective manner.
Key Components of Pharmacy 503B Outsourcing
1. FDA Registration and Compliance:
A 503B outsourcing facility is required to register with the FDA, adhere to Current Good Manufacturing Practices
(CGMPs), and comply with strict quality control standards. These facilities are distinct from traditional compounding
pharmacies (which are regulated under Section 503A of the FDCA), which only compound drugs for individual patients
based on prescriptions.
Outsourcing facilities are required to follow more stringent manufacturing practices, ensuring that the compounded
drugs meet the same high standards as FDA-approved medications.
2. Compounding Medications for OfÏce Use:
503B outsourcing facilities primarily compound medications in bulk and sell them to healthcare providers, such as
hospitals, surgical centers, and physicians’ offices. These medications are not dispensed directly to patients but are
intended for use in clinical settings.
Common types of compounded medications produced include injectable drugs, sterile preparations (e.g., IV solutions),
and other treatments needed for various medical procedures or patient care.
3. Sterile and Non-Sterile Compounding:
503B outsourcing facilities may compound both sterile and non-sterile medications, though sterile compounding (such
as injectables and IV bags) is often the focus due to its critical role in clinical settings.
They must adhere to USP <797> standards for sterile compounding, ensuring that the drugs are prepared in sterile
environments to prevent contamination.
©2025 RXinsider | RXinsider Market Intelligence Group | 2025
4. Bulk Production and Distribution:
Unlike traditional pharmacies, which only compound drugs based on individual prescriptions, 503B facilities may produce
large batches of compounded medications in advance. These medications are distributed in bulk to healthcare providers
for use in multiple patients.
The facility must meet all requirements for large-scale production, including detailed labeling, lot tracking, and
documentation for each batch.
5. Quality Assurance and Safety:
503B facilities are subject to FDA inspections and must comply with rigorous quality assurance protocols to ensure that
the compounded medications are safe, effective, and meet regulatory standards.
These facilities must perform routine stability and potency testing, maintain proper documentation of the compounding
process, and provide patients with products that are free from contaminants or errors.
6. Traceability and Recall Procedures:
Outsourcing facilities must have robust systems in place for tracing medications to ensure that they can quickly identify
and recall products if there are safety concerns or if a product is found to be defective.
This is a critical feature to safeguard patient health, especially since 503B facilities supply large quantities of compounded
drugs to healthcare systems.
Key Differences Between 503A and 503B Pharmacies
Focus on compounding medications
for individual patients based on
prescriptions. They are subject to state
pharmacy laws and are not required to
follow CGMPs.
503A PHARMACIES
Can produce medications in bulk for
office use and are subject to FDA
oversight and CGMPs. They are
permitted to distribute compounded
medications to healthcare providers
without individual patient prescriptions.
503B PHARMACIES
©2025 RXinsider | RXinsider Market Intelligence Group | 2025
Examples of Medications Compounded by 503B
Outsourcing Facilities
• Injectables: Antibiotics, pain management drugs, and anesthetics administered intravenously
or via injection.
• Sterile IV Solutions: Fluids for hydration or the delivery of medications in a sterile
environment.
• Custom Doses: Medications that are required in specific dosages for treatment but are
not commercially available.
• Oncology Drugs: Chemotherapy drugs and supportive medications compounded for
cancer treatment.
• Hormone Therapies: Medications for hormone replacement therapy (HRT) or specific
hormone-based treatments used in clinical practice.
Benefits of 503B Outsourcing
• Increased Access to Medications: 503B outsourcing facilities help healthcare providers
access needed compounded medications that are not commercially available, often in
critical or emergency situations.
• Quality Control: The requirement to follow CGMPs ensures that products from outsourcing
facilities meet high standards of safety, purity, and potency.
• Cost EfÏciency: Bulk compounding and distribution can provide hospitals and clinics
with medications at a lower cost compared to sourcing small quantities from individual
compounding pharmacies or purchasing FDA-approved commercial drugs.
Challenges of 503B Outsourcing
• Regulatory Complexity: Compliance with FDA regulations and CGMPs is complex and
costly, which can create barriers for smaller facilities.
• Inventory Management: Bulk compounding requires careful inventory management to
ensure medications are produced in the correct quantities and distributed efficiently.
• Recalls and Safety Concerns: As bulk compounding involves larger production scales,
any issues with the quality of a product can potentially affect a larger group of patients,
requiring prompt recall procedures and quality checks.
©2025 RXinsider | RXinsider Market Intelligence Group | 2025
503B History and Timeline
The Drug Quality and Security Act, signed into law on
November 27, 2013, created a new section 503B in the
Federal Food, Drug, and Cosmetic Act. Under section 503B,
a compounder can become an outsourcing facility.
SCA Pharmaceuticals became the first FDA
registered 503B compounding facility.
753 patients in 20 states were diagnosed with
a fungal infection after receiving contaminated
methylprednisolone acetate from New England
Compounding Center. The CDC reported 64 deaths,
with a total of 793 patients affected nationwide.
2013
2012
2016
2018
Prescription Requirement is added under Section
503A of the Federal Food, Drug, and Cosmetic Act.
2019
Industry guidelines are created by registered
outsourcing facilities on the Compounding and
Redistribution of Radiopharmaceuticals.
Section 503A Bulks List Final Rule Questions and
Answers; Small Entity Compliance Guide is established.
2023
Prohibition on Wholesaling is added under Section
503B of the Federal Food, Drug, and Cosmetic Act.
2020
Biological products that were approved under
the Federal Food, Drug, and Cosmetic (FD&C)
Act transitioned to being licensed under
the Public Health Service (PHS) Act.
2024
FDA established Modernization Initiatives to
create a unified human foods program, revamp
field operations, and introduce additional reforms.
2025
Interim Policy on Compounding Using Bulk
Drug Substances is added under Section 503A
of the Federal Food, Drug, and Cosmetic Act
As of March 31, 2025, a total of 89 503B
companies are registered.
©2025 RXinsider | RXinsider Market Intelligence Group | 2025
©2025 RXinsider | RXinsider Market Intelligence Group | 2025
Registered 503B Outsourcing Facilities
503B Outsourcing Facility One, LLC
West Palm Beach
FL
2/18/2025
2/18/2025
Not yet Inspected
AnazaoHealth Corporation
Las Vegas
NV
9/23/2014
12/10/2024
9/23/2024
Annovex Pharma, Inc.
Lorton
VA
10/14/2021
11/22/2024
9/6/2024
Apocus, Inc.
San Antonio
TX
10/17/2023
2/6/2025
Not yet inspected
Apollo Care
Columbia
MO
9/14/2017
12/16/2024
4/5/2023
Apothecary Pharma, LLC
Cary
NC
9/7/2024
1/11/2025
Not yet inspected
Arc Compounding Pharmacy LLC
Waco
TX
6/22/2024
2/3/2025
Not yet inspected
Aspire Compounding Pharmacy
Sugar Land
TX
3/21/2025
3/21/2025
Not yet inspected
Assure Infusions, Inc.
Bartow
FL
11/22/2024
11/22/2024
Not yet inspected
Atilar Pharma Corporation
Houston
TX
2/20/2025
2/20/2025
Not yet inspected
Aveva Drug Delivery Systems, Inc
Tamarac
FL
11/4/2024
11/4/2024
Not yet inspected
BayCare Integrated Service Center, LLC dba
BayCare Central Pharmacy
Temple Terrace
FL
6/4/2019
10/25/2024
6/2/2023
Bennett Pharmaceuticals of America LLC
Hudson
WI
4/19/2022
1/23/2025
Not yet inspected
BPI Labs LLC
Largo
FL
3/4/2019
10/17/2024
2/21/2025
Bravado Pharmaceuticals, LLC
Lutz
FL
2/28/2025
2/28/2025
Not yet Inspected
Brookfield Medical/Surgical Supply, Inc.
Brookfield
CT
1/12/2015
1/10/2025
5/10/2024
BSO LLC
Golden
CO
1/24/2024
10/18/2024
Not yet inspected
BSO LLC
Lakewood
CO
11/24/2015
10/31/2024
7/3/2024
Central Admixture Pharmacy Services, Inc.
Allentown
PA
2/28/2014
10/22/2024
3/30/2023
Central Admixture Pharmacy Services
Phoenix
AZ
3/29/2018
10/22/2024
7/31/2023
Delta Pharma, Inc.
Ripley
MS
8/6/2014
12/31/2024
4/12/2024
Denver Solutions, LLC, dba Leiters Health
Buena
NJ
7/1/2022
11/18/2024
Not yet inspected
Denver Solutions, LLC, dba Leiters Health
Englewood
CO
3/24/2017
11/18/2024
4/5/2024
Eagle Pharma
Birmingham
AL
6/16/2015
10/23/2024
2/27/2025
Echo Health LLC dba Nova Specialty
Pharmacy
Mansfield
TX
5/20/2024
2/18/2025
Not yet inspected
Empower Clinic Services New Jersey
East Windsor
NJ
6/10/2024
11/20/2024
Not yet inspected
Empower Pharma
Houston
TX
7/16/2016
12/6/2024
8/28/2024
Excite Pharma Services, LLC
Tonganoxie
KS
6/1/2021
1/28/2025
Not yet inspected
F.H. Investments, Inc., dba Asteria Health
Birmingham
AL
5/18/2017
10/17/2024
11/8/2024
Fagron Compounding Services dba Fagron
Sterile Services
Wichita
KS
10/2/2015
10/18/2024
6/28/2024
Farmakeio Outsourcing LLC
Southlake
TX
12/12/2018
12/6/2024
6/10/2022
Fresenius Kabi Compounding LLC dba
Fagron Sterile Services
Canton
MA
4/21/2017
10/18/2024
03/06/2023
GenoGenix LLC
Boca Raton
FL
2/4/2025
2/4/2025
Not yet inspected
FACILITY NAME
CITY
STATE
INITIAL
REGISTRATION
DATE
MOST RECENT
REGISTRATION
DATE
LAST
INSPECTION
DATE
10
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GFC Pharma, LLC
Westminster
MD
12/16/2024
12/16/2024
Not yet inspected
Hikma Injectables USA Inc.
Dayton
NJ
9/15/2021
12/20/2024
6/25/2024
Hikma Pharmaceuticals USA Inc.
Cherry Hill
NJ
9/15/2021
12/20/2024
6/12/2024
Hybrid Pharma, LLC
Deerfield Beach
FL
1/14/2015
1/8/2025
11/9/2023
Imprimis NJOF, LLC
Ledgewood
NJ
11/12/2016
10/23/2024
4/3/2024
IntegraDose Compounding Services, LLC
Minneapolis
MN
5/8/2018
12/13/2024
3/1/2024
Leesar Inc.
Fort Myers
FL
4/30/2014
12/19/2024
10/29/2021
Mark Cuban Cost Plus Manufacturing and
Compounding, LLC
Dallas
TX
11/2/2022
12/14/2024
9/6/2024
McGuff Pharmaceuticals, Inc. dba McGuff
Outsourcing Solutions
Santa Ana
CA
1/11/2023
11/21/2024
Not yet inspected
Medi-Fare Drug
Blacksburg
SC
12/17/2013
12/24/2024
5/26/2023
MedisourceRx
Los Alamitos
CA
2/14/2017
12/31/2024
11/10/2022
Molecular PharmaGroup
New Providence
NJ
5/8/2018
12/10/2024
12/11/2023
Nephron Sterile Compounding Center, LLC
(NSCC)
West Columbia
SC
7/15/2014
11/25/2024
9/25/2024
Nubratori, Inc.
Torrance
CA
2/24/2017
10/22/2024
7/26/2024
Olympia Pharmaceuticals
Orlando
FL
3/10/2014
10/18/2024
5/29/2024
OSRX, Inc.
Missoula
MT
10/28/2023
10/25/2024
10/25/2024
OurPharma LLC
Fayetteville
AR
3/15/2019
11/14/2024
9/27/2024
Park Avenue Compounding
St. Louis
MO
12/23/2023
11/8/2024
Not yet inspected
PGRrx LLC
Exton
PA
12/10/2024
12/10/2024
Not yet inspected
Pine Pharmaceuticals, LLC
Tonawanda
NY
3/9/2018
10/16/2024
9/30/2024
PQ Pharmacy LLC
Brooksville
FL
10/29/2020
11/26/2024
10/27/2022
ProRx LLC
Exton
PA
4/27/2022
11/22/2024
8/2/2024
Qualgen LLC
Edmond
OK
5/23/2014
11/15/2024
3/19/2024
Quantum Pharmaceuticals, LLC
Mounds
OK
5/30/2024
2/15/2025
Not yet inspected
Quva Pharma, Inc.
Bloomsbury
NJ
9/15/2017
11/22/2024
10/14/2022
Quva Pharma, Inc.
Sugar Land
TX
9/10/2015
12/92024
10/28/2024
Rapha Pharmaceuticals, Inc.
Tampa
FL
12/23/2024
12/23/2024
Not yet inspected
RC Outsourcing, LLC
Lowellville
OH
10/6/2015
11/22/2024
9/27/2024
Right Value Drug Stores, LLC, dba Carie
Boyd’s Prescription Shop
Irving
TX
7/3/2019
12/23/2024
6/21/2024
Sankav Pharmaceuticals, LLC
Hackettstown
NJ
3/21/2025
3/21/2025
Not yet inspected
SCA Pharmaceuticals
Little Rock
AR
12/13/2013
12/23/2024
5/17/2023
SCA Pharmaceuticals
Windsor
CT
8/3/2017
12/9/2024
12/20/2024
Signature Rx
Delray Beach
FL
10/13/2023
1/9/2025
Not yet inspected
SKNV formerly registered as Sincerus
Florida, LLC
Pompano Beach
FL
3/10/2016
11/22/2024
5/23/2024
FACILITY NAME
CITY
STATE
INITIAL
REGISTRATION
DATE
MOST RECENT
REGISTRATION
DATE
LAST
INSPECTION
DATE