503A Compounding Pharmacy

Our Experts Are Here to Help

Eagle’s scientific experts excel at helping sterile and non-sterile facilities identify risks, challenges, and opportunities by suggesting and implementing cost-effective, science-based solutions. Through the experience and scientific mastery of our team, we serve 503A Compounding Pharmacies by testing routine samples, helping fine-tune formulations, providing feedback on techniques, and more while offering compliance solutions to meet your operational and regulatory requirements.

With Eagle’s guidance, regain confidence in your compliance.

“Our desire, dedication, and discipline to ensure that patient safety is at the forefront of everything we do and our holistic approach to resolving your compliance needs make Eagle a truly unique organization.”

— President and CEO, Ross A. Caputo, Ph.D.

503A Pharmacies

Service & Product Offerings

Through the experience and scientific mastery of our team, we serve Compounding Pharmacies by testing routine samples, helping fine-tune formulations, providing feedback on techniques, and more while offering compliance solutions to meet your operational and regulatory requirements. Browse our website to learn more about our team, laboratory capabilities, or to receive an initial consultation to discuss your operation’s specific needs. We look forward to assisting you!

Sterility Testing

ScanRDI® is a unique alternative technology that enables Eagle to deliver sterility testing results in 1 or 2 business days, allowing sterile compounding pharmacies to release product faster than when utilizing the compendial USP <71> method. ScanRDI® has revolutionized rapid microbial detection with its combination of speed and sensitivity, remaining unrivaled.

ScanRDI®

Ideal for aqueous and oil-based, filterable solutions.
Turnaround time: 1-day results

Celsis®

Suitable for various product types
Turnaround time: 5 to 7-day results

Bac/T Alert®

For testing LVP and SVP, ophthalmic, inhalation, cell-based, and tissue-derived products
Turnaround time: 7-day results

USP <71>

Filtration
Immersion
Fluid Path
16 to 18-day results

Sterility Test Method Suitability

The purpose of Method Suitability Testing in accordance with USP is to verify that the selected sterility test method is appropriate for detecting microbial contamination in a specific drug product formulation. This ensures that the test method does not inhibit microbial growth and that the media used can support the growth of specified microorganisms.

Key Points:

When Required: Method suitability must be performed prior to initiating routine sterility testing for each unique drug product formulation and for each sterility test method employed (e.g., membrane filtration, direct inoculation, or rapid methods such as BacT/ALERT, Celsis, ScanRDI).
Components of Method Suitability: Growth Promotion Test (Suitability of the Media): Confirms that the culture media (e.g., Fluid Thioglycollate Medium and Soybean-Casein Digest Medium) support the growth of specified microorganisms (e.g., Staphylococcus aureus, Bacillus subtilis, Candida albicans, etc.). Inhibitory Substances Test (Suitability of the Method): Demonstrates that the product being tested does not inhibit the growth of microorganisms when introduced into the test system.
Frequency: Method suitability is typically required once per formulation per method, unless there is a change in formulation, manufacturing process, or test method that could affect the outcome.

Product Release Testing

Finished Compounded Products

Finished Compounded Products are subjected to be tested for their chemical and microbial quality attributes at release to ensure their identity, strength, purity, and efficacy.

Potency (API/Preservative)

Appearance(color, clarity)

Sterility (USP <71>, ScanRDI®, BacT/Alert)

Bacterial Endotoxins Testing

Particulate Matter

Uniformity of Dosage Units

Microbial Examination of Nonsterile Products

- USP <60> - USP <61> - USP <62> Raw Materials & Consumables

USP/NF Monograph Testing

Growth Promotion Testing

Laboratory Testing Services and Pricing

Cleanroom

Design

CAD layout to meet USP // requirements

Commissioning

Commissioning support: ensuring cleanroom is built and certified to spec

Biannual certification

Ongoing monitoring and troubleshooting

Learn More

Consulting Services

Eagle’s consulting services specialize in providing compliance and safety solutions to help facilities minimize risks. These solutions are based on scientific research, pharmacy requirements, and industry best practices. With USP’s renewed focus on environmental monitoring frequencies, facility requirements, personnel competencies, garbing requirements, and more, it is essential for your facility to comply with local and federal regulations. Our expert guidance can help ensure your facility meets regulatory standards.

Let Our Experience Work For You
Our consultants have held positions at the Food and Drug Administration, pharmaceutical drug manufacturers including contract manufacturing organizations, 503A compounding pharmacies, and 503B outsourcing facilities.

Quality Systems Development
Cleaning Validation
Disinfectant Efficacy Testing (DET)
Due Diligence Analysis
Environmental Monitoring Program Development
Equipment Qualification
Facility Design Review
Gap analysis audit/Third-Party Audit
Mitigation, Remediation, & Regulatory Response Services
Process Validation
SOP Development & Implementation
Onsite Training
USP Compliance
SOP Media fills

Learn More

Environmental Monitoring Solutions

Tryptic Soy Agar Plates
Eagle offers TSA plates that are ideal for the recovery of a wide range of microorganisms, including bacteria, yeast, and fungi:

90 mm Tryptic Soy Agar (TSA) Plates

65 mm Tryptic Soy Agar (TSA) Plates

Features & benefits of our TSA plates include:

Supplemented with neutralizers, Lecithin and Tween 80, to inactivate disinfectants present in the environment.
Convenient room temperature storage to eliminate the need for refrigerated storage conditions.
Gamma-irradiation to ensure a high level of sterility and minimize the risk of false positive results.
Self-locking mechanism to ensure the integrity of the sample during handling and transportation.
Triple-wrapped for quicker movement through ISO-classified areas.
Include a certificate of growth promotion from the manufacturer and a verification of growth promotion testing performed by Eagle

SurfaceShield - Surface Wipe Sampling Kit

SurfaceShield is a ready-to-use wipe sampling kit to identify and quantify drug residue contamination on any surface of interest. To learn more about SurfaceShield and view the most up-to-date list of tested drugs, please visit our page. Sampling with SurfaceShield is a fast, easy, and convenient method for verifying the efficacy of decontamination and cleaning to support environmental monitoring per USP <800> Hazardous Drugs - Handling in Healthcare Settings.

SurfaceShield Wipe Sampling Kit |