# Eagle

> Meeting the Needs of Pharmacies, 503B & CGMP Manufacturers

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## Sitemaps

- [XML Sitemap](https://eagleanalytical.com/sitemap.xml): Contains all public & indexable URLs for this website.

## Posts

- [Eagle Blog](https://eagleanalytical.com/blog/)
- [Environmental Monitoring in Sterile Compounding: What USP <797> Requires and How to Get It Right](https://eagleanalytical.com/eagle-news/environmental-monitoring-in-sterile-compounding-what-usp-requires-and-how-to-get-it-right/): Learn how environmental monitoring supports USP compliance and how Eagle Analytical's 90mm TSA plates and 65mm contact plates support cleanroom monitoring.
- [SurfaceShield Demonstration Video](https://eagleanalytical.com/eagle-news/surfaceshielddemovideo/): Eagle's SurfaceShield USP Wipe Sampling and Cleaning Verification Kit Demonstration Instructions. Visit Our Shop to order a SurfaceShield Kit.
- [Protein Characterization](https://eagleanalytical.com/eagle-news/protein-characterization/): Advanced LC-MS Protein Characterization Services Eagle Analytical provides advanced LC-MS protein characterization services to support biologic development, ensure product quality, and accelerate regulatory compliance. Our team combines deep scientific expertise with state-of-the-art instrumentation to deliver reliable data, actionable insights, and faster project timelines. Whether you are developing monoclonal antibodies, peptide therapeutics, or complex biologics, Eagle is your partner for high-resolution protein analysis and
- [USA May Have Had COVID-19 Cases Earlier Than We Think](https://eagleanalytical.com/eagle-news/usa-may-have-had-covid-19-cases-earlier-than-we-think/): UCLA researchers analyzed over 10 million records studying visits to hospitals in Los Angeles between the months of December and February.
- [USP <800> is Now Official](https://eagleanalytical.com/eagle-news/usp-is-now-official/): Eagle brings together experts in chemistry, microbiology, engineering, CGMP, quality control, and quality assurance.
- [Stability-Indicating Assays: The Complete Science-Based Guide for Pharmaceutical Manufacturers and Compounding Pharmacies](https://eagleanalytical.com/eagle-news/what-is-a-stability-indicating-assay/): Learn what a Stability-Indicating Assay is, how it differs from a potency assay, and why it's essential for stability studies and BUD determination
- [What We Know About the COVID-19 Vaccines](https://eagleanalytical.com/eagle-news/what-we-know-about-the-covid-19-vaccines/): What are the key differences between the Pfizer, Moderna, and AstraZeneca vaccines? How will these products work in our bodies, and when will we have more information on their efficacy?
- [Dangerous Hand Sanitizers on the Market - FDA Recalls](https://eagleanalytical.com/eagle-news/dangerous-hand-sanitizers-on-the-market-fda-recalls/): Dangerous Hand Sanitizers on the Market What should protect you may now hurt you, as hundreds of hand sanitizer products have been recalled by the Food & Drug Administration, and labeled potentially harmful. FDA is warning consumers and health care professionals about certain products that have been tested and found to contain Methanol and other
- [Lessons Learned from USP <795> and USP <797> Updates](https://eagleanalytical.com/eagle-news/cpc-boston-2025-ross-speaker/): the summary of Dr.Caputo presentation about updated requirements in USP 795 and USP 797 he gave at the CPC conference in Boston.
- [Covid-19 Q&A | Answering Client, Employee & Viewer Questions](https://eagleanalytical.com/eagle-news/covid19-qa/): Dr. Ross Caputo, PhD. of Microbiology and Immunology, and Dr. David Hussong, PhD. of Microbiology, discuss ​questions about the e Covid-19 virus
- [COVID-19 Vaccine Timeline: When Will It Be Your Turn?](https://eagleanalytical.com/eagle-news/covid-19-vaccine-timeline-when-will-it-be-your-turn/): COVID-19 Vaccine Timeline As the distribution of the COVID-19 vaccine has begun among priority groups including healthcare workers, and other frontline workers, it may be a while before the general public begins receiving doses. In this episode of EagleTV, Dr. Ross Caputo and Dr. David Hussong discuss a recent timeline published in the Business Insider
- [Cost of Quality and the Price of Nonconformance](https://eagleanalytical.com/eagle-news/cost-of-quality-and-the-price-of-nonconformance/): Recalling and disposing of products, enduring lengthy litigation proceedings, processing reimbursements, and repairing a damaged reputation are among the daunting tasks that no compounding business ever wants to face.
- [Coffee with Ross Podcast | Grab a cup & lend an ear.   ????☕️](https://eagleanalytical.com/eagle-news/coffee-with-ross-podcast-grab-a-cup-📻☕️/): Coffee with Ross Podcast Coffee with Ross is an Eagle Analytical Services podcast for all those who are interested in the pharmacy compounding world. Whether you are a pharmacy owner, staff pharmacist, technician, part of a 503B, or a patient using personalized medicine, this is the podcast for you. Hosted by Ross Caputo, Ph.D. Microbiological
- [Beyond-Use Dates | USP 795 & 797 Revisions](https://eagleanalytical.com/eagle-news/beyond-use-dates-usp-795-797-revisions/): Beyond-Use Dates | USP 795 & 797 Revisions The USP published updates to the USP General Chapters on compounding nonsterile (USP 795) and sterile (USP 797) preparations. Included in these revisions were updates to the beyond-use dates (BUDs) to clarify topics that were not consistently understood. Most of the revisions involved guidance on stability and
- [Appropriateness of ScanRDI® as a Validated Alternative Rapid Microbiological Method](https://eagleanalytical.com/eagle-news/appropriateness-of-scanrdi-as-a-validated-alternative-rapid-microbiological-method/): Discover how ScanRDI® helps accelerate microbiological testing with validated rapid detection methods designed for pharmaceutical and cleanroom applications.
- [Antimicrobial Effectiveness | USP 795 & 797 Revisions](https://eagleanalytical.com/eagle-news/antimicrobial-effectiveness-usp-795-797-revisions/): In the video we discuss the changes introduced with USP 795 and USP 797 revisions
- [Analytical Testing Outsourcing: Growth Trends & Outlook](https://eagleanalytical.com/eagle-news/analytical-testing-outsourcing-growth-trends-outlook/): CDMOs and CROs weigh in on today’s analytical testing outsourcing trends, including growth trends, challenges and more. Visit our website for more information.
- [ACHC Partnership Announcement](https://eagleanalytical.com/eagle-news/achc-partnership-announcement/): ACHC Partnership Announcement Eagle Analytical Services is pleased to announce its partnership with ACHC, The Accreditation Commission for Health Care. Through this partnership, ACHC-accredited pharmacies and facilities have access to Eagle’s full range of laboratory, consulting, and engineering services, with special terms and pricing available for compliance audits.Eagle Analytical supports the pharmaceutical compounding industry and
- [Groundwater Microorganisms in Pharmaceutical Products](https://eagleanalytical.com/eagle-news/a-comparative-metagenomic-analysis-of-specified-microorganisms-in-groundwater-for-non-sterilized-pharmaceutical-products/): Microbial safety is essential in pharma. Culture-based tests are slow; metagenomic analysis offers a faster, more sensitive alternative for detection.
- [9 Vaccine Makers Pledge, Myocarditis Issue, and More](https://eagleanalytical.com/eagle-news/9-vaccine-makers-pledge-myocarditis-issue-and-more/): 9 Vaccine Makers Pledge, Myocarditis Issue, and More Dr. David Hussong discusses recent vaccine-related news and other topics including Myocarditis and Herd Immunity. Related Articles: 9 Drug Companies Pledge to ‘Stand With Science’ on Coronavirus Vaccines https://www.nytimes.com/2020/09/08/health/9-drug-companies-pledge-coronavirus-vaccine.html The Real Reason Post-COVID Myocarditis Is a Worry https://www.medpagetoday.com/infectiousdisease/covid19/88487?xid=nl_mpt_investigative2020-09-09&eun=g1490905d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=InvestigativeMD_090920&utm_term=NL_Gen_Int_InvestigateMD_Active
- [A New Era for Endotoxin Testing: USP <86> Introduces Sustainable Recombinant Alternatives to LAL](https://eagleanalytical.com/eagle-news/usp-86-endotoxin-testing/): USP 86 Endotoxin Testing introduces rCR and rFC recombinant reagents, offering sustainable, non-animal alternatives to traditional LAL-based BET methods.
- [Sterility Testing: Why It Matters and How USP <71>, <72>, and <73> Methods Compare](https://eagleanalytical.com/eagle-news/sterility-testing-why-it-matters-and-how-usp-and-methods-compare/): Learn about Sterility Testing, USP , and , and how each method supports pharmaceutical sterility assurance.
- [Welcome to Eagle! | Video Tour](https://eagleanalytical.com/updates/eagle-tour/): Welcome to Eagle, an FDA and DEA-registered A2LA ISO 17025 accredited laboratory founded in 2003 that provides analytical chemistry and microbiological testing.
- [Surface Wipe Sampling Technique](https://eagleanalytical.com/eagle-news/eagletv-wipe_-sampling_technique/): SurfaceShield is an all-in-one kit for the detection of HDs on surfaces. It helps you to evaluate/reduce the risk of exposure while achieving USP800 standards.
- [Dr. David Hussong published in Microorganisms](https://eagleanalytical.com/updates/david-hussong-published-microorganisms/): Dr. David Hussong, Ph.D., is part of a distinguished group of microbiologists who published a recent article in MDPI’s journal Microorganisms.
- [Here's What We Know About COVID-19 Vaccines](https://eagleanalytical.com/eagle-news/heres-what-we-know-about-covid-19-vaccines/): Since the beginning of the coronavirus pandemic, companies and universities have been rushing to develop a COVID-19 vaccine.
- [CPHi North America, 05/07 – 05/09](https://eagleanalytical.com/upcoming-events/cphi_na_2024/): The CPhI NA (Convention on Pharmaceutical Ingredients of North America) is coming to Philadelphia, the City of Brotherly Love! This event brings together industry leaders, pharmaceutical professionals, and businesses of all sizes. Don't miss out; CPhI NA is happening from May 7th to May 9th at the Pennsylvania Convention Center in Philadelphia. We hope to
- [FDA Issues Clarification on Compounding Policies](https://eagleanalytical.com/eagle-news/fda-issues-clarification-on-compounding-policies/): In case you missed it, the FDA sent an email clarifying several compounding policies in response to questions from stakeholders. Of particular importance to compounding pharmacies and outsourcing facilities is the FDA’s position that a compounded drug identical to a commercially available drug is not considered to be “essentially a copy” if the commercially available
- [Currently No Closures. No Delays. We're Here for You](https://eagleanalytical.com/updates/currently-no-closures-no-delays-were-here-for-you/): At Eagle, we have been closely monitoring the COVID-19 situation and are taking it very seriously.
- [Health Connect Partners 2023, 05/22 – 05/24](https://eagleanalytical.com/upcoming-events/hcp_2023/): Eagle is heading to Indianapolis for Health Connect Partners #HCP23!
- [FDA Issues Temporary Policy on PPE for Compounders](https://eagleanalytical.com/eagle-news/fda-issues-temporary-policy-on-ppe-in-compounding/): FDA has issued a guidance document that addresses the Sterile Compounding Industry’s concerns regarding PPE in light of current shortages during the COVID-19 pandemic. The document entitled “Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities during the COVID-19 Public Health Emergency” was released on Friday, April
- [Unsung Heroes of the Fight Against COVID-19](https://eagleanalytical.com/updates/unsung-heroes-of-the-fight-against-covid-19/): “While the world stayed home to wait out the storm, you stepped forward to face the beast"
- [Stability Studies in the Pharmaceutical Industry](https://eagleanalytical.com/eagle-news/stability-studies-in-the-pharmaceutical-industry/): Learn how pharmaceutical stability studies support shelf life, regulatory compliance, and product quality. Explore study types, ICH guidelines, and testing.
- [ScanRDI® Rapid Sterility Testing for 503A Compounding Pharmacies](https://eagleanalytical.com/eagle-news/scanrdi-rapid-sterility-testing-for-503a-compounding-pharmacies/): Learn how ScanRDI® rapid sterility testing supports faster release timelines, USP compliance, and workflow efficiency for 503A pharmacies.
- [What It Means When Your Sample is Out-Of-Specification](https://eagleanalytical.com/updates/what-it-means-when-your-sample-is-out-of-specification/): When sending samples for testing at third-party facilities, most clients want to ensure that results are both accurate and provided in a timely manner. This article intends to summarize the Out-of-Specification process.What Does OOS Mean?Out-of-Specification (OOS) means that the test results for your sample do not meet the accepted established criteria. These criteria may be
- [Environmental Monitoring Analyses: Early Warning Opportunities for Sterile Compounders](https://eagleanalytical.com/updates/environmental-monitoring/): Environmental monitoring analyses help sterile compounders identify early contamination risks and strengthen compliance through proactive monitoring strategies.
- [Updates to FDA’s Purple Book: Database of Licensed Biological Products](https://eagleanalytical.com/eagle-news/updates-to-fdas-purple-book-database-of-licensed-biological-products/): Learn about the latest FDA Purple Book update for licensed biological products. Discover enhancements improving access, usability, and public awareness.
- [FDA Updates Guidance On Adverse Reporting During a Pandemic](https://eagleanalytical.com/eagle-news/fda-updates-guidance-on-adverse-reporting-during-a-pandemic/): The FDA made an update to their final guidance, "Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic". The guidance document now includes information for compounded drugs in Table 1: Type of Product or Application Type of Report(s)/Statutory or Regulatory Timeframes(s) FDA Recommended Reporting During a Pandemic With High Employee Absenteeism
- [Proper Environmental Surface Sampling with Agar Plates](https://eagleanalytical.com/eagle-news/surface-sampling-agar-plates/): Environmental monitoring (EM) is a key element in ensuring that aseptic processing areas are maintained in an adequate state of control.
- [FDA Updates Temporary Policy Regarding PPE for Compounders](https://eagleanalytical.com/eagle-news/fda-updates-temporary-policy/): The FDA has issued an update to its Temporary Policy Regarding Non-Standard PPE Practices for Pharmacy Compounders During the COVID-19 Pandemic.
- [FDA Announces Update on MOU for Compounding Pharmacies](https://eagleanalytical.com/eagle-news/fda-announces-update-on-mou-for-compounding-pharmacies/): FDA Announces Latest Step Toward Finalizing Memorandum of Understanding with States Addressing Compounded Drug Distribution.
- [Dexamethasone Added to Temporary Compounding List](https://eagleanalytical.com/eagle-news/dexamethasone-sodium-phosphate-added-to-the-list-of-drugs-for-temporary-compounding/): Learn about the addition of dexamethasone sodium phosphate to the temporary compounding list and what it means for compounding pharmacies.
- [EagleTrax Sample Management System](https://eagleanalytical.com/updates/eagletrax-sample-management-system/): EagleTrax is our new full-featured system that allows you to track your samples, print reports at the click of a button, and much more.
- [USP Issues a Decision on: 795, 797, and 825](https://eagleanalytical.com/eagle-news/usp-issues-a-decision-on-795-and-797/): USP has published a notice communicating the final decisions from the Appeals Panel in relation to USP , , and .
- [Pharmaceutical Supply Chain Infiltrated with Methanol](https://eagleanalytical.com/eagle-news/pharmaceutical-supply-chain-infiltrated-with-methanol/): According to FDA, the pharmaceutical supply chain has been penetrated with ethanol that is contaminated and sometimes substituted with methanol.
- [Facility Design and Construction Requirements | USP 795 & 797 Revisions](https://eagleanalytical.com/eagle-news/facility-design-video/): Explore USP & facility design and construction requirements. Learn compliance expectations for sterile and non-sterile compounding environments.
- [FDA Investigator’s Manual](https://eagleanalytical.com/eagle-news/fda-handbook-2025/): The Investigations Operations Manual (IOM) is the primary operational reference for FDA employees who perform field investigational activities.
- [Traditional USP <71> vs Alternative Sterility Testing Methods](https://eagleanalytical.com/eagle-news/traditional-usp-vs-alternative-sterility-testing-methods/): Compare traditional USP and rapid sterility testing methods. Understand compliance, turnaround times, and product-specific requirements | Eagle Analytical
- [Peptide Mapping for Protein Characterization](https://eagleanalytical.com/eagle-news/peptide-mapping-for-protein-characterization/): Understanding Peptide Mapping in Protein Characterization Peptide mapping is one of the most powerful analytical techniques used in protein characterization and biopharmaceutical analysis. It helps scientists confirm a protein’s identity, primary sequence, and structure. It does this by enzymatically digesting the protein into peptide fragments, which are then separated and analyzed in detail. Peptide mapping is vital for biotherapeutic development, quality control, and regulatory compliance. It helps ensure
- [Exploring Alternative Sterility Testing Methods: A Q&A with Eagle Experts.](https://eagleanalytical.com/eagle-news/exploring-alternative-sterility-testing-methods-a-qa-with-eagle-experts/): A discussion on alternative sterility testing methods: insights from our team on evolving sterility testing approaches and future industry trends.
- [The Essentials of Surface Wipe Sampling for Pharmacies](https://eagleanalytical.com/updates/essentials-of-surface-wipe-sampling/): wipe sampling is essential tool for minimizing the risk of drug exposure by healthcare personnel and patients, and avoiding cross-contamination of the product.
- [The Importance of Sterility Testing in Pharmacy and Pharmaceuticals](https://eagleanalytical.com/eagle-news/the-importance-of-sterility-testing-in-pharmacy-and-pharmaceuticals/): Sterility testing is a critical part of quality control. It verifies that products are free from microbial contamination and safe for patient use.
- [COVID-19 Tips for Compounding Pharmacists](https://eagleanalytical.com/eagle-news/covid-19-tips-for-compounding-pharmacists/): Watch this week’s Episode of Eagle TV, where our expert scientist tackles some of the questions we received through our “Coronavirus Fact Check Form.”
- [Isopropyl Alcohol Effectiveness Against Coronavirus](https://eagleanalytical.com/eagle-news/why-70-isopropyl-alcohol-is-more-effective-than-99-against-coronavirus/): Many people believe that the higher the percentage of alcohol in a disinfectant, the more effective it will be against bacteria and viruses.
- [UTHealth - COVID-19 Vaccine Comparison Chart](https://eagleanalytical.com/eagle-news/uthealth-covid-19-vaccine-comparison-chart/): The University of Texas Health Science Center (UTHealth) recently published an infographic that compares the Pfizer/BioNTech and Moderna COVID-19 vaccines. The comparison chart details the vaccine age eligibility requirements, the number of shots required, days between shots, as well as side effects.View the chart below, and click for a larger view.Additional resources: Your Local Epidemiologist
- [More on Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients](https://eagleanalytical.com/updates/more-on-temporary-policy-for-compounding-of-certain-drugs-for-hospitalized-patients/): The policy allows compounding pharmacies to dispense certain compounded medications under particular conditions without first receiving a patient-specific prescription order.
- [The Appropriateness of the ScanRDI® Sterility Testing Method](https://eagleanalytical.com/eagle-news/the-appropriateness-of-the-scanrdi-sterility-testing-method/): Introduction Mandated by regulatory requirements such as USP Pharmaceutical Compounding – Sterile Preparations and Current Good Manufacturing Practices (CGMP), sterility testing is a quality control measure for aseptically produced pharmaceutical products. However, the compendial testing method outlined in USP Sterility Tests presents significant statistical, microbiological, and time limitations. The implementation of a robust
- [Eagle Virtual Compliance Seminar - Edutainment at its Best](https://eagleanalytical.com/updates/seminar2020/): Registration for this Session is Now Closed We will be posting information on upcoming seminars and compliance-related films soon! Want to be notified of upcoming events? Contact us and request to be added to our email list! The Most Unique Compounding Seminar You'll Ever Attend! Come experience "edutainment" as we premiere "The Inspection,"
- [ASHP Summer, 06/08 – 06/10](https://eagleanalytical.com/upcoming-events/ashp-summer-2025/): Pharmacy Futures 2025 Transforming Pharmacy Practice Today and Tomorrow Eagle hopes to see you at ASHP Summer in Charlotte, NC! This event brings together pharmacy practitioners and practice leaders to collaborate and innovate to shape the practice's future. Event Information
- [AzPA Convention, 06/12-06/15](https://eagleanalytical.com/upcoming-events/azpa-convention-2025/): Be in the room for candid conversations and hear about the trends shaping the next decade of pharmacy. Eagle would love to see you there! From capsules to curriculum, reimagined and resilient, AzPA’s Annual Convention will debut a new fearless experience for every professional in pharmacy. Event Information
- [IVT/Health Informa (CPC), 06/02-06/03](https://eagleanalytical.com/upcoming-events/ivt-cpc2025/): Eagle is going to Boston 2025! Come attend the presentation by 2021 IVT Speaker of the Year, Dr.Ross A. Caputo, Ph.D. at the Compounding Pharmacy Compliance Congress, where he discusses Interpreting and Operationalizing USP 795 and 797 Updated Requirements. If you have questions about any of the updated 795 and 797 requirements, make sure to visit
- [EAGLE Seminar Conference 2021 🦅  EVENT NOTICE](https://eagleanalytical.com/updates/eagle-seminar-2021/): "Compliance Readiness Is a Mindset" Wednesday, October 20, 2021 │ In-Person Attendance Only Industry experts Ross A. Caputo, PhD, and David Hussong, PhD, will discuss how having the mindset to stay compliant is a key factor in protecting your business. Topics include: Preparing for a Regulatory Inspection Quality Systems (Environmental Monitoring & Swab Kit) Stability Studies/BUDs Insanitary
- [Eagle’s ScanRDI® - Industry's Fastest Rapid Sterility Test!](https://eagleanalytical.com/updates/eagles-scanrdi-rapid-sterility-test/): Get sterility test results in as little as 1 business day with Eagle’s ScanRDI® rapid sterility test! The ScanRDI® rapid sterility test is a proven method that detects viable microbial cells down to one microorganism without the need for growth or cell multiplication, removing the 14-day incubation period required for the USP test method.
- [Safety for Pharmacists & Others Working During COVID-19](https://eagleanalytical.com/eagle-news/safety-for-pharmacists-others-working-during-covid-19/): In this week's episode of Eagle TV, the current Chairman of the USP Microbiology Expert Committee who is also Eagle’s Chief Technical Officer, Dr. David Hussong, Ph.D., details various ways that essential workers can protect themselves while continuing to work during the COVID-19 pandemic. Dr. Hussong summarizes a recent article from the Journal of Hospital
- [Our New Social Distancing Lab Hours](https://eagleanalytical.com/updates/our-new-social-distancing-lab-hours/): At Eagle, we’re implementing measures to help our laboratories and staff maintain safety during the COVID-19 pandemic. Health officials have instructed the public to practice social distancing, and in response we’re taking strides towards limiting employee interaction and proximity, while still maintaining efficiency as we serve you. As of Sunday, April 5th, our lab is
- [More on FDA's EUA for Hydroxychloroquine](https://eagleanalytical.com/eagle-news/more-on-fdas-eua-for-hydroxychloroquine-sulfate-and-chloroquine-phosphate/): More on FDA’s EUA for Hydroxychloroquine Sulfate and Chloroquine Phosphate Here’s what Eagle's Chief Technical Officer and the current Chairman of the USP Microbiology Expert Committee, Dr. David Hussong says about the Emergency Use Authorization (EUA) of hydroxychloroquine sulfate and chloroquine phosphate issued by the FDA on March 29, 2020. More details on the EUA
- [Links: FDA & USP Guides on Compounding of Hand Sanitizer](https://eagleanalytical.com/eagle-news/links-fda-usp-guides-on-compounding-of-hand-sanitizer/): To address shortages of hand sanitizer due to the rapidly evolving COVID-19 pandemic, the FDA issued a guidance document on compounding and labeling alcohol-based hand sanitizer, which can be accessed here: https://www.fda.gov/media/136118/download?fbclid=IwAR2rXBUHHk-xob8pCQ8i84VE2sGCeU5S0YXB_Sl6HutSpbhkrR3SdMIOcFk The FDA guidance document provides two formulations that compounders can follow to prepare alcohol-based hand sanitizers. In addition, the USP Compounding Expert Committee
- [FDA Issues EUA for the Use of Hydroxychloroquine and Chloroquine](https://eagleanalytical.com/eagle-news/fda-issues-eua-for-the-use-of-hydroxychloroquine-and-chloroquine/): On Sunday March 29, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to permit the emergency use of hydroxychloroquine sulfate and chloroquine phosphate. The drugs, which have been used to treat Malaria for decades, have been observed to perform positively in COVID-19 patients. “The EUA requires that fact sheets (which)
- [A Scientific Response to the SARS-CoV-2 Coronavirus: Covid-19 Disease](https://eagleanalytical.com/updates/a-scientific-response-to-the-sars-cov-2-coronavirus-covid-19-disease/): As Eagle Scientists, we want you to know that we understand the position you’re in today as a healthcare professional, and as a member of society. Whether you’re a Compounding Pharmacy, Outsourcing Facility, GMP Manufacturer, Doctor, Nurse, or even a consumer, you are part of a global community that is faced with uncertainty and fear.
- [Testing Alone is not Enough](https://eagleanalytical.com/eagle-news/testing-alone-is-not-enough/): A common misconception is the belief that finished product testing is sufficient to demonstrate quality. However, facilities that perform routine tests on their products can still face unfavorable inspection outcomes. Regulatory agents are examining with scrutiny the processes, methods, and environments under which sterile and non-sterile compounds are produced. Therefore, implementing Quality Systems must now
- [Take a Tour of Our New Facility](https://eagleanalytical.com/updates/take-a-tour-of-our-new-facility/): Eagle’s state-of-the-art 35,000 square foot facility and laboratory feature innovative technologies and more lab space so we can increase our efficiency and have faster turnaround times for our clients. This behind-the-scenes video gives you a tour of our laboratory and a chance to see testing as it is occurring.
- [Tracking Your Sample's Progress Just Became Possible.](https://eagleanalytical.com/updates/tracking-your-samples-progress-just-became-possible/): We’re pleased to announce EagleTrax™ EagleTrax is our new customer portal that allows you to track your sample as it moves through analysis. Its fast and easy to use, and allows you to see real-time updates regarding your samples at our facility. With EagleTrax, you can print reports at the click of a button. Our
- [FDA Inspections of Compounding Pharmacies](https://eagleanalytical.com/updates/fda-inspections-of-compounding-pharmacies/): The U.S. Food and Drug Administration (FDA) inspects both 503A and 503B compounding pharmacies to assess if procedures, practices, and controls exist for the preparation of products in compliance with FDA requirements. Are you prepared? Join Eagle Analytical Services General Manager and Chief Technical Officer Ross Caputo, Ph.D., for this FREE webinar, which will help
- [The Mindset of Quality Operations | Award Winning Presentation](https://eagleanalytical.com/eagle-news/the-mindset-of-quality-operations/): Update: Congratulations to our very own Eagle President & CEO Ross Caputo, Ph.D. for being the recipient of the 2021 IVT Speaker of the Year Award! ???????? This video and his presentation on Preparing for Regulatory Inspections led to him being nominated and ultimately receiving this honor. The annual Compounding Pharmacy Compliance conference assembles a
- [Sterility Testing | USP 795 & 797 Revisions](https://eagleanalytical.com/eagle-news/sterility-testing-video/): The quality attribute “sterile” attribute describes a condition that “cannot be applied to actual items labeled as sterile because of irresolvable limitations in testing” (USP Sterility Assurance). These irresolvable limitations are statistical and biological. While the attribute “sterile” applies to a complete absence of living organisms (an absolute condition), there is no test that
- [Water Activity | USP 795 & 797 Revisions](https://eagleanalytical.com/eagle-news/eagletv-water_activity/): The new practice of using water activity as a tool for establishing the BUD of a CNSP is described in Section 10.3 of the to-be-official USP chapter. Water activity testing in accordance with USP is not required but is highly recommended to support the established BUD of the CNSP. Water activity testing should
- [Cleanroom Certification | USP 795 & 797 Revisions](https://eagleanalytical.com/eagle-news/eagletv-cleanroom_certification/): A cleanroom certification shall be performed prior to initiating sterile operations and must be repeated at least every six months and/or after any changes to the classified area including construction, replacement, or relocation of any primary engineering control (PEC), and any reconfiguration of the room and major equipment. Classified areas and engineering controls are certified
- [Safeguard Your Compounding Pharmacy Business](https://eagleanalytical.com/eagle-news/safeguard-your-compounding-pharmacy-business/): Does your pharmacy need help with USP , , and compliance? Do you need assistance with PCAB® accreditation? Or are you unsure of where you stand in matters of compliance? Let our experts conduct a Gap Analysis at your facility to determine compliance with compounding regulations and standards.
- [FDA Warns Against Compounded Moxifloxacin Injections](https://eagleanalytical.com/eagle-news/fda-warns-against-compounded-moxifloxacin-injections/): Dr. David Hussong explains the FDA's recent alert to health care professionals of risks associated with intraocular use of compounded moxifloxacin.
- [Potential Treatment for COVID-19: Convalescent Plasma Therapy](https://eagleanalytical.com/eagle-news/potential-treatment-for-covid-19-convalescent-plasma-therapy/): One investigational treatment that is being explored for COVID-19 is the use of convalescent plasma from individuals who have recovered from the virus. Recovered COVID-19 individuals now have antibodies, which are proteins the body uses to fight off the infection, for the virus in their blood. Convalescent plasma is the liquid part of the blood
- [The Phases of Developing a Vaccine](https://eagleanalytical.com/eagle-news/the-phases-of-developing-a-vaccine/): How much longer should we expect to wait before a vaccine is available? This is a question many have been asking throughout the COVID-19 pandemic. Potential vaccines must undergo certain processes prior to their release for use. These processes include clinical trials comprising 4 phases that can take months, and in some cases even years
- [CDC Reports Adults Drinking & Misusing Disinfectants During Pandemic](https://eagleanalytical.com/eagle-news/cdc-reports-adults-drinking-misusing-disinfectants-during-pandemic/): According to a recent report from the Centers for Disease Control and Prevention (CDC) more than one-third of survey respondents misused household cleaning products in an effort to prevent Coronavirus infection. Rinsing food with bleach and gargling with disinfectants are among the improper practices some Americans are reportedly engaging in. In this episode, Dr. David
- [Mask Wearing - It's the Right Thing to Do](https://eagleanalytical.com/eagle-news/covid19-mask-wearing/): We are living in a new world. Dr. Ross Caputo, Ph,D., shares some important words on what wearing a mask means in this new Covid-19 environment. Masking is more than an opinion. It is the right thing to do in order to protect others and be part of minimizing the potential spread of COVID-19. Speaker
- [COVID-19 Exposure Action Plan for Eagle Employees](https://eagleanalytical.com/updates/covid-19-exposure-action-plan-for-eagle-employees/): We take the health and safety of our employees very seriously and want to assure you that we are continuing to monitor available US Centers for Disease Control and Prevention (CDC) and Occupational Safety and Health Administration (OSHA) guidance on the Coronavirus pandemic. We have implemented the following Exposure Action Plan (Plan) to minimize COVID-19
- [The Science Behind Antibody Tests](https://eagleanalytical.com/eagle-news/the-science-behind-antibody-tests/): Since the COVID-19 pandemic, many have been wondering if they had the virus in the past or maybe even had it without even knowing, meaning they were asymptomatic. One way to figure out is to take an antibody test, which will show if you have the antibodies for the virus. Scientists are saying that antibody
- [Face Masks Now Required in Harris County](https://eagleanalytical.com/eagle-news/face-masks-now-required-in-harris-county/): As COVID-19 continues to spread across the country, many states and counties have issued face mask orders to help stop the spread. According to CDC, face coverings “may slow the spread of the virus and help people who may have the virus and do not know it from transmitting it to others.”(a) Face masks limit
- [Shhh! Study Shows Talking May Spread COVID-19](https://eagleanalytical.com/eagle-news/shhh-study-shows-talking-may-spread-covid-19/): Shhh! Study Shows Talking May Spread COVID-19 A recent study conducted by the National Institute of Health (NIH) found that talking could present a risk for exposure to respiratory viruses, including the coronavirus. Droplets emitted when a person speaks can potentially linger in the air for minutes. In this week’s episode, Dr. David Hussong breaks
- [Keeping Homes, Schools, etc... Clean During COVID-19](https://eagleanalytical.com/eagle-news/cdc-covid19-guidance/): How to Keep Schools, Businesses, and Homes Clean During COVID-19 As parts of the country start to reopen, the CDC issued a guidance document discussing the importance of disinfecting and cleaning different areas to help reduce the risk of exposure to the coronavirus. Dr. David Hussong. Ph.D. gives us a brief summary of what is
- [COVID-19: Is There Another Possible Spike? Where Did It Originate From?](https://eagleanalytical.com/eagle-news/covid-19-spike/): Do you know where the coronavirus came from? Is there really another spike in the coronavirus coming? When's the vaccine expected to be ready? Dr. David Hussong, Ph.D. touches on these topics in this episode. Have a question for our experts? Visit our COVID-19 resource page and access our fact check form to get science-based
- [Morphine Sulfate & Epinephrine added to COVID-19 Compounding List](https://eagleanalytical.com/eagle-news/morphine-sulfate-epinephrine-added-to-covid-19-compounding-list/): FDA has updated two guidance documents that describe temporary policies for the compounding of certain human drugs during the COVID-19 public health emergency. The updates add morphine sulfate and epinephrine to the list of drugs covered by the guidance documents that are being issued to address shortages and access concerns affecting some drugs urgently needed
- [Microbiological Showdown: Plastic Bags vs. Paper Bags](https://eagleanalytical.com/eagle-news/microbiological-showdown-plastic-bags-vs-paper-bags/): When visiting the supermarket, which type of grocery bags do you prefer? Our microbiology department conducted an experiment to compare the levels of microbial contamination on plastic bags versus paper bags. You’ll be surprised at the results! Watch this video to hear our Microbiology Supervisor discuss the findings and Dr. David Hussong detail the scientific
- [MUST READ: Cleaning and Disinfection During COVID-19](https://eagleanalytical.com/eagle-news/must-read-cleaning-and-disinfection-during-covid-19/): The CDC has published a detailed document as well as an infographic outlining effective cleaning and disinfection methods. The document subtitled “Interim Recommendations for U.S. Households with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19)” provides recommendations on the cleaning and disinfection of households where persons under investigation or those with confirmed COVID-19 are residing. The
- [No Script Required but Conditions Apply](https://eagleanalytical.com/eagle-news/no-script-required-but-conditions-apply/): A Summary of FDA’s Guidance for 503A Compounding of COVID-19 Meds On April 20, 2020, the FDA issued a guidance document outlining temporary policies to allow 503A compounding pharmacies to prepare certain compounded medications for hospitalized patients during the COVID-19 public health emergency. This comes after a similar guidance document was issued on April 16,
- [Cleaning And Disinfecting Your Home](https://eagleanalytical.com/eagle-news/cleaning-and-disinfecting-your-home/): The CDC (Centers for Disease Control and Prevention) recently published a helpful document that provides tips and details on how to effectively disinfect your home, along with extra steps to take if someone inside your home is sick. The document recommends using EPA-registered disinfectants that have been found effective against COVID-19 and links to the
- [FDA’s Guidance for 503A Compounding of COVID-19](https://eagleanalytical.com/eagle-news/fda-503a-covid19-compounding-guidance/): Following our previous posts on FDA’s guidance released this week, Dr. David Hussong discusses the terms stipulated by the temporary policy which allows 503A pharmacies to compound certain drugs for COVID-19 without patient-specific prescriptions. Watch this episode of Eagle TV to hear more! Have a question for our experts? Visit our COVID-19 resource page and
- [Updates to FDA's Policy for Compounding of Hand Sanitizer](https://eagleanalytical.com/eagle-news/updates-to-fdas-policy-for-compounding-of-hand-sanitizer/): On April 15, FDA updated the Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products during the COVID-19 public health emergency.
- [COVID-19: Reusing 3-Layer Masks & Detecting the Coronavirus](https://eagleanalytical.com/eagle-news/covid-19-reusing-3-layer-masks-detecting-the-coronavirus/): In this week’s episode of Eagle TV, our Chief Technical Officer, Dr. David Hussong discusses how long a surgical mask can be worn and if it is possible to detect the coronavirus through a USP sterility test.
- [503A's Can Temporarily Compound Certain Drugs](https://eagleanalytical.com/eagle-news/503as-can-compound-certain-commercial-drugs-for-covid-19/): The FDA has issued a temporary guidance which enables 503A compounding pharmacies to compound certain medications without the requirement of a patient-specific prescription during the COVID-19 public health emergency. The new guidance comes days after FDA issued a similar temporary policy for 503B outsourcing facilities. According to the document published Monday April 20th, “many hospitals
- [FDA Relaxes Restrictions on 503Bs for COVID-19](https://eagleanalytical.com/eagle-news/fda-relaxes-restrictions-on-503bs-for-covid-19/): On April 16, 2020, the FDA issued the guidance document “Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency”. The guidance intends to address reports that the FDA has received from hospitals regarding difficulties in sourcing FDA-approved drugs due to increased demand and supply chain
- [Reusing N95 Masks, COVID-19 in Pets, & More](https://eagleanalytical.com/eagle-news/reusing-n95-masks-covid-19-in-pets-more/): In this week’s episode of Eagle TV, our Chief Technical Officer, Dr. David Hussong responds regarding the reuse of N95 respirator masks in an emergency situation. He also discusses the issue of potential transmission of the Coronavirus to and from household pets, as well as the intriguing topic of asymptomatic carriers. Have a question related
- [What to Test – When to Test – Why to Test](https://eagleanalytical.com/eagle-news/what-to-test-when-to-test-why-to-test/): Join Eagle CEO, Dr. Ross Caputo as he shares the testing requirements for your compounding facility: helping you navigate the “what, when & the why’s” of testing.
- [The Compounder's Crash Course to FDA and 503A Exemption Audits](https://eagleanalytical.com/eagle-news/the-compounders-crash-course-to-fda-and-503a-exemption-audits/): The Compounder's Crash Course to FDA and 503A Exemption Audits Hosted by Eagle Analytical Services If your pharmacy were inspected by the FDA, would you be prepared?
- [Insanitary Conditions in Compounding Pharmacies: The Regulatory Framework](https://eagleanalytical.com/eagle-news/insanitary-conditions-in-compounding-pharmacies-the-regulatory-framework/): In the wake of the 2012 tragedy caused by contaminated drugs produced at the New England Compounding Center, Congress passed the Drug Quality and Security Act, which amended the federal Food, Drug, and Cosmetic (FD&C) Act and more clearly defined the FDA’s authority to regulate compounding pharmacies. Under Section 503A of the FD&C Act, compounding
- [Important Considerations For Cleanroom Design](https://eagleanalytical.com/updates/important-considerations-for-clean-room-design/): When designing a cleanroom, there are many aspects to take into consideration. While regulations and guidelines such as USP chapters outline the minimum requirements for cleanroom design, they do not address all important elements. Many compounding pharmacies use the requirements stated in USP chapters and as the template for designing their cleanroom—often at
- [A Summary of Proposed Changes to USP 797](https://eagleanalytical.com/eagle-news/proposed-changes-to-usp-797/): Some of the changes are significant and will require major adjustments in pharmacy systems and processes, while other changes will be easier to accommodate.
- [EagleTrax Tutorial Video](https://eagleanalytical.com/updates/eagletrax-tutorial-video/): EagleTrax is our new full-featured system which allows you to track your samples, print reports at the click of a button, and much more. Our user-friendly interface and filters enable you to quickly search for anything pertaining to your sample submission. Once tests are completed, EagleTrax can send your results to you via email and
- [Dr. Scott Gottlieb Tours the New Eagle Facility](https://eagleanalytical.com/updates/scott-gottlieb-visits-eagle/): Former FDA Commissioner Dr. Scott Gottlieb visited the Eagle Facility on Thursday, October 10th, 2019. Eagle President and CEO Dr. Ross Caputo took the opportunity to share our mission...
- [Helpful Q&A Regarding COVID-19 and Pets](https://eagleanalytical.com/eagle-news/helpful-questions-and-answers-regarding-covid-19-and-pets/): The FDA released a document regarding the coronavirus and animals, particularly household pets. It provides questions and answers to help keep your pets safe during the pandemic. The document touches on if you can pick up the coronavirus from your pet or even transfer the virus to your pet if you get sick. The FDA
- [What Do FDA Investigators Look For At Compounding Facilities?](https://eagleanalytical.com/eagle-news/what-do-fda-investigators-look-for-at-compounding-facilities/): Recent FDA-483’s and Warning Letters reveal patterns of common observations by the FDA at compounding facilities.
- [The Woodlands Compounding Pharmacy Recommends Eagle Plates](https://eagleanalytical.com/eagle-news/the-woodlands-compounding-pharmacy-recommends-eagle-plates/): Keisha Lovoi, Rph. says "I highly recommend ordering plates through Eagle to any compounding pharmacy...."
- [Central Drug Compounding & Wellness Recommends Eagle Plates](https://eagleanalytical.com/eagle-news/central-drug-compounding-recommends-eagle-plates/): Steve Branch R.Ph says "I heard that Eagle was selling environmental plates, so I decided to give them a shot. First of all, it’s quick and easy! It’s convenient to be able to order the plates online. The process is simple and streamlined...."
- [PCCA’s Advisory Council #8 visits Eagle, 02/06](https://eagleanalytical.com/updates/pcca-advisory-concil-8/): Last Friday Eagle had the opportunity to host PCCA’s Advisory Council #8. It was our pleasure to offer a tour of our lab and demonstrate our newest equipment, explain our workflow, answer any questions, and interact with individuals who prioritize patient care. Eagle is always open for visits from healthcare providers who are interested in exploring our
- [PCCA Sterility Assurance Training cohort visits Eagle, 05/11](https://eagleanalytical.com/updates/pcca_sat_visit_0511/): Today, it was our honor to host a group of dedicated pharmacists who are attending the PCCA Sterility Assurance Training in Houston. At Eagle, we value those who continuously strive to expand their knowledge and skills. It was our pleasure to provide a laboratory tour, discuss our extensive testing and service capabilities, and answer any questions. Thank
- [APC 2023, 03/26 – 03/28](https://eagleanalytical.com/upcoming-events/apc_2023/): We are in Point Clear, Alabama for the Alliance for Pharmacy Compounding Owner (APC) 2023 Compounding Pharmacy Owner Summit 2023! Don't miss out on the chance to connect with Eagle President & CEO Ross A. Caputo, Ph.D. Caputo, and Vice President of Marketing & Business Development Lisa Johnson at APC and learn more about how
- [PDA Annual, 04/03 – 04/05](https://eagleanalytical.com/upcoming-events/pda_2023/): Join Eagle at the Parenteral Drug Association (PDA) annual meeting. booth #115, in New Orleans, Louisiana! This year’s PDA theme, Back to the Future: Learning from The Past in A Patient-Centric World, spotlights the critical connection between patients and the manufacturing process and enabling a patient-focused mindset on the manufacturing floor. Event Information Event Images
- [USP 3rd Annual Compounding Implementation Workshop, 02/07 – 02/08](https://eagleanalytical.com/upcoming-events/usp-workship-2023/): Eagle is excited to join USP volunteers and other esteemed compounding colleagues in a deeper discussion on the implementation of USP compounding standards. Please join our Eagle colleagues in attending the upcoming Compounding Implementation Workshop on Feb 7 - 8, 2023 to be part of this important and informative dialogue. Event Information
- [ashp Summer Meeting & Exhibition, 06/10 – 06/14](https://eagleanalytical.com/upcoming-events/ashp_2023/): If you're looking for a chance to meet Eagle in person, you're in luck! The Eagle team will be exhibiting at the ashp Summer Meeting and Exhibition in Baltimore from June 10th – 14th. This is an excellent opportunity to speak with us face-to-face and discuss any questions or concerns you may have. If you're
- [OPA Annual Conference, 04/14 – 04/16](https://eagleanalytical.com/upcoming-events/opa_2023/): Eagle in flight to Ohio! Eagle is on the move and is attending the OPA Annual Conference and Trade Show! Our President, Ross A. Caputo, Ph.D. will be presenting on the requirements for terminal sterilization cycle validation in support of Category 3 beyond-use dating per the new USP revisions! Event Information Event Image Set 1
- [2023 PDA/FDA Joint Regulatory Conference, 09/18 – 09/20](https://eagleanalytical.com/upcoming-events/pda-fda_2023/): Eagle attended the 2023 PDA/FDA Joint Regulatory Conference in the nation's capital. This year's topic was CGMP: Quality Through Science and Innovation. A lot of great information was discussed, and ideas were exchanged. We look forward to 2024's conference and hope to see you there. Event Information | Images
- [APC: Compounders on Capitol Hill, 09/19 – 09/20](https://eagleanalytical.com/upcoming-events/apc_dc_2023/): APC's Compounders on Capitol Hill was a great event. Eagle would like to thank everyone who was able to make it out to make it such a success. We hope to you at next year's DC event! Event Information | Images
- [PCCA International Seminar 2023, 10/26 – 10/28](https://eagleanalytical.com/upcoming-events/pcca-int-2023/): It was an honor to participate as both an exhibitor and educator at this year's PCCA International Seminar that took place in Woodland, Texas. It was great getting to see so many and we really enjoyed our conversations with you. We eagerly look forward to ISTX24!! Event Information | Event Images
- [Compounding Pharmacy Compliance, 08/17 – 08/18](https://eagleanalytical.com/upcoming-events/cpc-2023/): Eagle went to Boston! Did you attend the presentation by Dr. Ross A. Caputo, Ph.D. at the Compounding Pharmacy Compliance Congress, where he discussed achieving Category 3 Beyond-Use Dates? If you have questions about any of the Category 3 BUD requirements, make sure to visit our Eagle Team representatives: Lisa Johnson, Jacqueline Esqueda, PharmD, BCSCP, RPh,
- [2023 PDA Pharmaceutical Microbiology Conference, 10/02 – 10/04](https://eagleanalytical.com/upcoming-events/pda-micro-2023/): Eagle attended the 2023 PDA Pharmaceutical Microbiology Conference taking place this October 2nd – 4th in Washington DC. The conference addressed the most relevant opportunities and challenges to the future of microbiology in our global market. Professionals from all facets of the global industry, academia, and regulatory authorities, shared insights on how to best prepare
- [HCP Hospital Pharmacy Fall Conference, 10/23 – 10/25](https://eagleanalytical.com/upcoming-events/hcp-2023/): Thank you, Health Connect Partners (HCP), for organizing this worthwhile event! It was our pleasure to be part of #HCP2023 and we hope it was as profitable for everyone as it was for us. Event Information | Image
- [ashp Midyear Clinical Meeting 2023, 12/03 – 12/07](https://eagleanalytical.com/upcoming-events/ashp-midyear-2023/): What a week it's been @ #ASHP2023 Midyear! As we reflect on the highlights of Midyear, we're filled with gratitude for the opportunities ASHP2023 presented. Here's to leveraging these experiences for future achievements and continued excellence! Event Information | Event Images 1 | Event Images 2
- [HRT Functional Medicine Symposium, 02/15 – 02/17](https://eagleanalytical.com/upcoming-events/hrt-02-15-2024/): Eagle went to its first show in 2024, an enlightened 3-day exploration at the HRT Functional Medicine Symposium in Vegas! Thank you, PCCA, for creating an event to showcase the latest advancements in health and wellness. We look forward to seeing you! #HRTVegas2024 #eagleanalytical | PCCA Event Information | Image 1
- [APhA, 03/22 – 03/25](https://eagleanalytical.com/upcoming-events/apha2024/): This year's APhA Annual Meeting and Exposition in Orlando was a good experience. Eagle CEO and President Ross Caputo, Ph.D.'s presentation was well received, and we had the opportunity to meet pharmacists from various levels and practice settings. We are eagerly looking forward to meeting everyone again at upcoming events. #APhA2024 Event Information
- [PDA Annual, 03/25 – 03/27](https://eagleanalytical.com/upcoming-events/pda2024/): 2024's PDA Annual Meeting was a unique event that united pharmacists from all levels and practice settings. We gained new knowledge, made new connections, and caught up with some of our clients. Thank you to PDA and the LBC for a fantastic SoCali experience! #2024PDA Annual Meeting Event Information Event Images 1 | Event Images
- [APC Owner Summit, 04/04 – 04/06](https://eagleanalytical.com/upcoming-events/owner-summit-2024/): This year's APC (Alliance for Pharmacy Compounding) Compounding Pharmacy Owner Summit will occur in April (4th - 6th) at the Hilton Torrey Pines in beautiful La Jolla, California. The Owner Summit is a great event, and we hope to see you there. Event Information Note: Register by February 15th to save $300.
- [HCP Spring, 04/08 – 04/10](https://eagleanalytical.com/upcoming-events/hcp-spring-2024/): Don't miss the Health Connect Partners Spring event in Dallas, TX from April 8-10! It's the perfect opportunity to gain valuable education, forge new connections, and discover innovative solutions for hospital pharmacies. Be sure to join Eagle and other industry leaders at this gold-standard healthcare leadership event. Event Information
- [Western Pharmacy Exchange, 04/18 – 04/21](https://eagleanalytical.com/upcoming-events/wpe_2024/): Don't miss the Westen Pharmacy Exchange presented by the California Pharmacists Association at Planet Hollywood in Las Vegas, Nevada! The WPE takes place April 19-21 and is the largest premier West Coast experience for all pharmacy professionals. Event Information
- [ashp Summer, 06/08 – 06/12](https://eagleanalytical.com/upcoming-events/ashp-summer-24/): Eagle hopes to see you at ASHP Summer in Portland, OR. This event brings together pharmacy practitioners and practice leaders to collaborate and innovate to shape the practice's future. Event Information
- [APC EduCon Virtual 2024, 06/20 & 21](https://eagleanalytical.com/upcoming-events/educon2024/): The Alliance for Pharmacy Compounding EduCon 2024 is a live continuing pharmacy education (CPE) activity that will be streamed on June 20th & 21st. APC event calander & infromation page
- [Compounding Pharmacy Compliance - IVT/Health Infroma, 06/18 & 19](https://eagleanalytical.com/upcoming-events/ivt-cpc2024/): Join us in Boston, MA, this June for Compounding Pharmacy Compliance (CPC) 2024, the premier event for compounding professionals. The event will occur on June 18th and 19th at the Reserve Hotel Boston Common. Ross Caputo, Ph.D., President and CEO of Eagle, and the 2021 IVT Speaker of the Year award recipient, will be one
- [PCCA International Seminar, 10/17 - 10/19](https://eagleanalytical.com/upcoming-events/isx2024/): Don't miss out on the compounding event of 2024! PCCA's "Think NEXT" International Seminar will focus on new and emerging research in compounded therapies, formulations, products, equipment, and technology. The ISX conference will occur in Houston, Texas, from October 17th to 19th. While you're in Houston, take a tour of our facility. Contact our Client
- [Compounders on Capital Hill (CCH), 09/18 & 19](https://eagleanalytical.com/upcoming-events/cch2024/): The Alliance for Pharmacy Compounding hosts the annual Compounders on Capital Hill (CCH) event, which brings pharmacy compounders from all over the country to meet with their congressional representatives in Washington, DC. APC Event calendar and information page
- [Health Connect Fall, 09/30 - 10/02](https://eagleanalytical.com/upcoming-events/hcpfall2024/): Health Connect Fall will take place in Columbus, Ohio, from September 3 to October 2nd. This autumn event will feature providers and suppliers for hospitals, health systems, imaging centers, surgery centers, and more. Eagle will be in attendance, and we look forward to speaking with you there. Health Connect Partners conference schedule & event information
- [ASHP Midyear, 12/08 - 12/12](https://eagleanalytical.com/upcoming-events/ashp-midyear20234/): The ASHP Midyear Clinical Meeting is in New Orleans, LA, from December 8 to 12. We look forward to ending the year off right, and what better way to do so than being in New Orleans with amazing pharmacists advancing healthcare? We can't wait to see you! ASHP Upcoming Meetings Schedule
- [Eagle President & CEO named the 2021 IVT Speaker Of The Year](https://eagleanalytical.com/eagle-news/eagle-president-ivt-speaker-of-the-year/): Congratulations to our very own Eagle President & CEO Ross Caputo, Ph.D. for being the recipient of the 2021 IVT Speaker of the Year award! Since 1994, the Institute of Validation Technology (IVT) has been dedicated to expanding the global knowledge base for validation and compliance professionals in FDA-regulated industries.⁠ Dr. Caputo delivered captivating presentations

## Pages

- [Meeting the Needs of Pharmacies, 503B & CGMP Manufacturers](https://eagleanalytical.com/): Analytical testing, sterility testing, calibration, consulting, and compliance services for pharmacies, 503B outsourcing facilities, and CGMP companies.
- [Laboratory Testing Services](https://eagleanalytical.com/testing/): Let Our Experience Work For You Cutting-Edge Our Laboratories Eagle’s cutting-edge 80,000-square-foot facility and laboratory are equipped with advanced technologies and specialized segregated laboratory spaces to meet the diverse needs of our clients. This behind-the-scenes video provides you with an opportunity to witness testing while touring our laboratory. Laboratory Testing Services & Turnaround Testing Services &
- [Engineering Services](https://eagleanalytical.com/engineering/): Eagle Analytical provides certification, calibration, qualification, and cleanroom design & review services to support regulatory compliance.
- [503B Outsourcing Facility](https://eagleanalytical.com/503b-outsourcing-facilities/): Analytical Testing Services for 503B Outsourcing Facilities Services and Solutions Eagle offers comprehensive services to CGMP facilities, including those that are sterile or non-sterile. Our solutions are designed to help identify potential risks, challenges, and opportunities, all while remaining grounded in scientific principles. We understand the importance of regulatory compliance, and our expert guidance can
- [EagleTrax App is Here!](https://eagleanalytical.com/eagletrax-app-is-here/): Real-Time Sample Updates, Results & More! Introducing EagleTrax Portal & Mobile App Our new EagleTrax app puts the power of managing your samples right in the palm of your hand. You can now complete many of the tasks which you perform in the EagleTrax portal right from your mobile device. As an industry leader in
- [Environmental Monitoring Services](https://eagleanalytical.com/em/): USP revisions, effective November 1, 2023, increased the monitoring requirements of air and surfaces for microbial contamination. Environmental Monitoring Solutions for Controlled Environments Eagle offers comprehensive environmental monitoring (EM) solutions that assist pharmaceutical facilities, including 503B outsourcing facilities, and 503A compounding pharmacies, achieve regulatory compliance with relevant industry standards. Environmental monitoring is a key element in
- [Facility Design Considerations For Updated USP 795 & 797](https://eagleanalytical.com/facility-design/): Pharmaceutical Facility Design Services Facilities need to keep up with the changes in USP Chapters Pharmaceutical Compounding – Nonsterile Preparations and Pharmaceutical Compounding – Sterile Preparations. Both chapters have undergone significant updates, and to remain compliant, it is essential to understand the revised requirements. This webpage serves as an overview of the major changes related to facility design
- [Frequently Asked Question about EagleTrax](https://eagleanalytical.com/faq-eagletrax/): Find answers to common EagleTrax® Portal questions, including account setup, sample submissions, tracking, and managing laboratory testing requests.
- [Gap Analysis Audit Services](https://eagleanalytical.com/gap-analysis-audit/): Take Flight With Eagle Close The Gaps In Your Facility ​Let our experts conduct a Gap Analysis Audit of your facility to determine compliance with regulations and standards. Our audit will identify areas where your operation needs improvement in order to achieve compliance. Take the guesswork out of compliance. Be prepared for regulatory inspections. What
- [Hospital Pharmacies Consulting & Compliance Services](https://eagleanalytical.com/hospitals/): Experience Matters Eagle excels at helping sterile and nonsterile hospital compounding facilities identify risks, challenges, and opportunities by suggesting and helping you implement cost-effective, science-based solutions. Our personnel’s experience spans the compounding and pharmaceutical industry with expertise in USP Pharmaceutical Compounding – Nonsterile Preparations, USP Pharmaceutical Compounding – Sterile Preparations, USP Hazardous
- [Stability Indicating Method Development & Validation](https://eagleanalytical.com/mdmv/): Stability Indicating Method Development & Validation Method Validation Parameters The FDA requires that all CGMP facilities perform potency testing utilizing methods that are stability-indicating, specific, accurate, and precise.Validation of an analytical procedure is the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for the intended analytical
- [Microbiological Services](https://eagleanalytical.com/micro/): Take Flight With Eagle Excellence Throughout Our vast knowledge and experience in Microbiological Testing provide our customers with an extensive portfolio of compendial testing that accommodates product development, product validation, and product compliance to regulatory requirements. The microbiology department comprises three laboratories: Sterile Laboratory, Bacteriology Laboratory, and Biotechnology Laboratory. Below list the test services offered
- [EagleTrax New Client Registration](https://eagleanalytical.com/new-client-registration/): New client registration for Eagle Analytical’s EagleTrax portal - begin tracking samples, accessing results, and managing your account today.
- [Peptide Mapping](https://eagleanalytical.com/peptide-mapping/): Eagle Analytical provides precise peptide mapping and LC‑MS protein analysis to confirm sequence, structure, and modifications for biotherapeutics.
- [Shield Analysis - Process Control Charts](https://eagleanalytical.com/process-control-charts/): Process Control Charts -Harness the Power of Trending Learn More The new Shield Analysis feature of EagleTrax provides a comprehensive and retrospective review of personnel and environmental monitoring data as well as critical quality attributes of the compounded preparation, enabling users to analyze trends over time. By examining data points collectively, Shield Analysis can assist in interpreting the overall state of microbial and
- [Protein Analysis Services](https://eagleanalytical.com/protein-characterization-services/): Eagle Analytical provides Protein Analysis Services including peptide mapping, protein ID, quantitation, and PTM analysis to support biotherapeutic development.
- [Add User to EagleTrax](https://eagleanalytical.com/register-for-eagletrax/): Get started with EagleTrax from Eagle Analytical. Register today for secure sample tracking, result access, and simplified lab management.
- [Research and Development Services](https://eagleanalytical.com/rnd/): Take Flight With Eagle Developing Excellence The Research and Development Team members have a combined 40 plus years of experience in industrial and academic settings. Their combined knowledge allows us to find solutions to your complex problems in a proficient manner.The Research and Development team has the technical skills and experience to develop a customized
- [Australia](https://eagleanalytical.com/australia/): Eagle Analytical Services Australia Eagle thanks you for trusting us with your business. Your support has played a significant role in Eagle’s growth. That support has enabled us to expand our services to the Commonwealth of Australia. Eagle Australia is proud to offer Active Ingredient Potency testing. We look forward to serving you.The Eagle Team –
- [Australia FAQ's](https://eagleanalytical.com/australia-faqs/): WE TEST, WE CERTIFY, WE CONSULT Frequently Asked Questions - Eagle Analytical Services Australia Below are common questions we receive. Contact us at 02-9316-1500 if you have additional questions or require further assistance. What samples can I get tested by Eagle Australia? Available Sample TestingMelatoninEstriol Fluoxetine HCLLow Dose Naltrexone (LDN)Amitriptyline KetoprofenT3 DilutionTestosteroneOmeprazoleT4 DilutionTrilostaneTrazadoneDHEAMinoxidilEstradiol (E2)ProgesteroneMethimazoleDiltiazem Where do I
- [Antimicrobial Effectiveness](https://eagleanalytical.com/antimicrobial/): Antimicrobial Effectiveness Testing Antimicrobial preservatives are substances added to sterile and nonsterile dosage forms to inhibit the growth of microorganisms in multiple–dose products. Antimicrobial effectiveness should be demonstrated for all products containing preservatives including injections and other aqueous-based, multiple–dose products not limited to ophthalmics, topicals, and oral dosage forms. USP Revisions Antimicrobial Effectiveness Revisions to USP compounding chapters Pharmaceutical Compounding – Nonsterile Preparation and Pharmaceutical Compounding
- [Consulting Services & Compliance Solutions](https://eagleanalytical.com/consulting/): Discover the Benefits of EagleShield Our Consulting Team is composed of professionals spanning the pharmaceutical industry with expertise in Current Good Manufacturing Practice (CGMP), Quality Control and Quality Assurance, USP Pharmaceutical Compounding – Sterile Preparations, USP Pharmaceutical Compounding – Nonsterile Preparations, and USP Hazardous Drugs – Handling in Healthcare Settings. Prior to starting with
- [Cleanroom Certification](https://eagleanalytical.com/cleanroom-certification/): Committed to Quality Cleanroom certification shall be performed prior to initiating sterile operations and must be repeated at least every six months and/or after any changes to the classified area including construction, replacement, or relocation of any primary engineering control (PEC), and any reconfiguration of the room and major equipment. USP Revisions Cleanroom Certification Despite
- [Cleaning Validation](https://eagleanalytical.com/cleaning-validation/): Ensure Your Facility Meets the Highest Standards with GMP & CFR 21-Compliant Cleaning Validation Solutions. Specialized Services for Pharmaceutical, Biotech, Hospital and Outsourcing Facilities to Guarantee Safety, Compliance, and Efficiency. Protect Your Products, Patients, and Business​ In the pharmaceutical and biotech industries, maintaining cleanliness isn’t just a best practice — it’s a regulatory requirement. Our
- [Chemistry Services](https://eagleanalytical.com/chem/): Take Flight With Eagle Committed To Quality Our laboratory is equipped with high-technology instruments and equipment that allow us to deliver high accuracy and precision in our test results, including HPLC and UPLC equipped with UV-VIS, PDA, QDA, CAD, fluorescence detectors as well as GC-MS, ICP-OES, and TOC capabilities.Our Chemistry Team is composed of knowledgeable
- [CGMP](https://eagleanalytical.com/cgmp/): Eagle Analytical provides CGMP-focused QA, QC, regulatory, and lab services to regulated manufacturers, helping ensure safe, compliant, high‑quality products.
- [Cleanroom & Cleanroom Facility Services](https://eagleanalytical.com/cert/): Optimize your operations and meet industry standards with Eagle’s certified calibration, qualification, and facility design solutions tailored to your needs.
- [Careers in Eagle](https://eagleanalytical.com/careers/): Explore careers at Eagle Analytical in lab testing, cleanroom certification, and regulatory compliance for pharma and biotech industries.
- [Beyond-Use Dating Revisions](https://eagleanalytical.com/bud-revisions/): Committed to Quality BUDs are defined as the date or time after which a compounded nonsterile preparation (CNSP) or compounded sterile preparation (CSP) may not be stored, used, or transported. These dates are calculated from the date or time of the compounding.BUDs are necessary to help decrease the risks to patients by identifying the end
- [Establishing Beyond-Use Dates](https://eagleanalytical.com/bud/): Beyond-Use Dating A beyond-use date, also known as BUD, is the date, or hour and date, beyond which a compounded preparation, sterile or nonsterile, cannot be used and should be set based on the date or date and time of compounding. Get BUD Initial Quote Establishing BUDs for Compounded Nonsterile Preparations (CNSPs) Table 1 defines the
- [Eagle Canada](https://eagleanalytical.com/canada/): Trusted analytical chemistry and microbiology testing services in Canada for compounded preparations and pharmacy operations.
- [Sample Management and Client Care Team](https://eagleanalytical.com/sample-management-client-care-team/): Prioritizing Quality, Safety & Compliance Service Driven Success The Sample Management and Client Care team focus on all aspects of receiving, inspecting, documenting, processing, and returning the samples submitted to Eagle for testing. Whether it is a small sample request or a large volume of bulk samples, it is the Sample Management and Client Care
- [ScanRDI® Rapid Microbial Method](https://eagleanalytical.com/scanrdi/): ScanRDI®: The World’s Fastest Sterility Test A Faster Way to Comply The ScanRDI® is a unique alternative technology that enables Eagle to deliver sterility testing results in 1 or 2 business days, allowing sterile compounding facilities to release product faster than when utilizing the compendial USP method. ScanRDI® has revolutionized rapid microbial detection and
- [Sterility Testing Updates](https://eagleanalytical.com/sterility-testing/): Sterility Testing The updated revisions to USP Chapters Pharmaceutical Compounding – Nonsterile Preparations and Pharmaceutical Compounding – Sterile Preparations became official on November 1st, 2023 and the conditions established are enforceable by regulatory bodies. Both chapters underwent significant changes making it important for compounders to understand the quality control expectations to ensure they remain compliant.
- [Sterility Testing Methods](https://eagleanalytical.com/sterility/): Comparision of different alternative sterility testing methods with traditional USP 71.
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- [Australia Testing Services](https://eagleanalytical.com/testing-au/): Ensure your compounded medicines meet safety standards with Eagle Australia's precise testing services designed for Australian compounding pharmacies.
- [Environmental Swab Test](https://eagleanalytical.com/environmental-swab-test/): Environmental swab testing detects hazardous drug residue on surfaces. Panel and targeted swab test methods using validated LC-MS/MS analysis
- [SurfaceShield Kit](https://eagleanalytical.com/surfaceshield/): Order SurfaceShield, a hazardous drug wipe sampling kit that detects and quantifies drug residue on any surface. Supports USP compliance.
- [Cleaning Validation Services](https://eagleanalytical.com/cleaning-validation-services/): GMP and CFR 21 compliant cleaning validation for pharmaceutical, 503B, biotech, medical device, and cosmetics facilities, for product and patient safety.
- [SurfaceShield Wipe Sampling Kit](https://eagleanalytical.com/surfaceshield-1/): Detect hazardous drug residue on surfaces with the Wipe Sampling Kit. Simple sampling, fast lab analysis, and reliable USP compliance support.
- [Sample Submission](https://eagleanalytical.com/submissions/): New to Eagle? Welcome! Send a Sample To Eagle So that we can better meet your needs, if you have not sent a sample within the last six months, please call us at (800) 745-8916 prior to sending samples. We look forward to working together with you! Existing Client Login New Client Registration Sample Submission
- [503A Compounding Pharmacy](https://eagleanalytical.com/503a-pharmacy/): Ensure patient safety and meet regulatory standards with Eagle’s science-based testing, formulation support, and compliance services.
- [SurfaceShield Demo Video](https://eagleanalytical.com/surfaceshielddemovideo/): How to Use Your SurfaceShield® Kit Watch The Surface Wipe Sampling Technique This video demonstrates the recommended sampling technique and provides guidance on using the SurfaceShield® Kit for environmental wipe sampling.
- [About Eagle](https://eagleanalytical.com/about-eagle/): Eagle provides analytical & microbiological testing & consulting services for compounding pharmacies, 503B outsourcing facilities & CGMP manufacturers.
- [USP <800> Consulting & Compliance Services](https://eagleanalytical.com/usp-800/): Prioritizing Quality, Safety & Compliance Facility & Engineering Controls At Eagle, we offer services that aid in meeting the USP requirements for facility and equipment compliance. Our services include certifying Containment Primary Engineering Controls (C-PECs) and Containment Secondary Engineering controls (C-SECs) and conducting extensive reviews of your facility design and workflow. Our environmental quality and control
- [Chief Technical Officer](https://eagleanalytical.com/david-hussong-ph-d/): David Hussong, Ph.D. Dr. David Hussong is the Chief Technical Officer at Eagle. He also served as the chair of the USP Microbiology Expert Committee for the 2015– 2020 cycle. He has been active with USP for over 20-years in various roles. David retired after a 30-year career at the Food and Drug Administration (FDA), where he had
- [Vice President of Marketing & Business Development](https://eagleanalytical.com/consulting-team/lisa-johnson/): Lisa Johnson, BS Lisa Johnson joined the Eagle team in November 2017 with over 25 years of experience in competitive and technical industries, she is known for her customer-centric approach and exceptional interpersonal skills. She specializes in building and nurturing key accounts and relationships, driving clients to achieve their revenue goals while supporting broader business
- [Vice President of Scientific Affairs](https://eagleanalytical.com/consulting/robert-e-byrne-phd/): Robert E. Byrne, Ph.D. Robert earned his Ph.D. from the Department of Chemistry at the University of Notre Dame in 1980. He continued his academic studies as a Post-Doctoral Research Fellow in Biochemistry and as a Research Associate/Assistant Professor at the University of Chicago.He has built an extensive industrial background in R&D and Operations. He
- [Quality Department](https://eagleanalytical.com/quality/): Prioritizing Quality, Safety & Compliance Developing Excellence The quality team has the responsibility of managing a multitude of priorities to meet the compliance expectations of both internal and external customers. In pursuit of continuous improvement, these personnel employ data analysis tools to evaluate procedures, closely monitor and furnish process information, and execute preventive measures.Our top
- [Marketing and Business Development](https://eagleanalytical.com/marketing-business-development-department/): Prioritizing Quality, Safety & Compliance Committed To Your Success From understanding and resolving the needs of our clients to communicating ideas, the Marketing and Business Development Team play an important role in promoting Eagle’s business and mission. These professionals work to build public awareness of Eagle’s service offerings and increase Eagle’s market share within the
- [Celsis® Rapid Sterility Method](https://eagleanalytical.com/celsis/): Celsis®, alternative rapid sterility method, delivers sterility results in 7 days—50% faster comparing to USP . Trusted for compliance and patient safety.
- [Bacterial Endotoxins Test](https://eagleanalytical.com/bet/): Ensuring Safety Through USP ​ Bacterial endotoxins pose serious health risks, particularly when introduced into sterile environments such as the bloodstream or spinal fluid. To mitigate these risks, the United States Pharmacopeia (USP) mandates endotoxin testing for sterile injectable products. Specifically, USP outlines the acceptable endotoxin limits and provides standardized methods for detection and
- [USP Revisions](https://eagleanalytical.com/usp-revisions/): Keeping You Current with USP 〈795〉 & 〈797〉 Published Revisions USP Published Revisions - Whats Changed? On November 1st, 2023, the United States Pharmacopeia (USP) published its new compounding standards for Pharmaceutical Compounding – Nonsterile Preparations and Pharmaceutical Compounding – Sterile Preparations. These published chapters make USP General Chapter Hazardous Drugs – Handling in
- [Senior Business Development](https://eagleanalytical.com/jacqueline-esqueda/): Jacqueline Esqueda , PharmD, BCSCP, RPh Dr. Jacqueline Esqueda received a Bachelor of Science in Chemistry and a Doctor of Pharmacy from the Feik School of Pharmacy in San Antonio. Since joining Eagle in 2021, Jacqueline Esqueda has now accepted the role as Vice President of Regulatory and Quality Compliance. Over the past four years, Jackie has
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- [Eagle Blog](https://eagleanalytical.com/eagle-blog/): ARTICLES, PUBLICATIONS, INFORMATION, EVENTS, UPDATES & MORE Here you will find articles, publications, information, events, and more for people interested in the pharmacy compounding world. From pharmacist to patient, this news is for you. It is our commitment to provide your organization with the tools to operate and maintain compliance within a highly regulated environment.
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- [Thank You - Eagle ScanRDI® Rapid Sterility Testing Request](https://eagleanalytical.com/thank-you-eagle-scanrdi-request/): Thank You for Your Interest! We look forward to helping you. One of our Client Care Team members will contact you. For immediate assistance during business hours, please contact us at 800-745-8916.Thank you and have a great day.— Eagle Care Team Eagle is a U.S. Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) registered
- [Thank you - ScanRDI Registration](https://eagleanalytical.com/thank-you-scanrdi-registration/): Thank You for Your Interest! We’re looking forward to helping you get started with the ScanRDI® Rapid Sterility Test. We appreciate your interest, and a member of our team will contact you with more information. At Eagle, our goal is to be your one-stop-shop for compliance and patient safety. We look forward to helping you.
- [Thank You - New Customer Registration](https://eagleanalytical.com/thank-you-new-customer-registration-2/): Thank You for Your Interest! We look forward to helping you. One of our Client Care Team members will contact you. For immediate assistance during business hours, please contact us at 800-745-8916.Thank you and have a great day.— Eagle Care Team
- [Water Activity](https://eagleanalytical.com/water-activity/): Committed to Quality In the past, pharmacists were tasked with combing through multiple sources of literature and previous studies to determine an appropriate BUD for a specific formulation. However, revisions to USP that will take effect on November 1, 2023, introduce the use of a dosage forms’ water activity as the basis for establishing a BUD
- [Eagle's Holiday Closure Schedule](https://eagleanalytical.com/holiday-schedule/): Eagle's Holiday Closure Schedule Eagle will be closed on the specified dates in observance of the holiday.Note: Friday, November 29th, limited staffing will be on hand to receive packages from 7 a.m. to 2 p.m. Please contact the Eagle Client Care team if you have any questions about Eagle’s holiday schedule.
- [Josie Gonzalez, AAS](https://eagleanalytical.com/josie-gonzalez-aas/): Josie Gonzalez, AAS Josie Gonzalez joined Eagle in February of 2022 as a Sample Submission Specialist and later became a member of the Client Care Team. In November of 2022, she was offered and accepted a new role as the CEO and President’s Executive Assistant, as well as the Human Resources Liaison between Eagle and its sistercompany PCCA.
- [Seth Carbajal, BS](https://eagleanalytical.com/seth-carbajal/): Seth Carbajal, BS Seth Carbajal joined Eagle in 2020 as a member of the Sample Management team and later transitioned to the Chemistry Department as an Analytical Chemist.Seth now works as a Market Development Supervisor in the Marketing and Bussiness Development team and Sample Management and Client Care team.Prior to joining Eagle, in 2019 Seth graduated from the
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- [Miguel Hernandez](https://eagleanalytical.com/consulting-team/miguel-hernandez/): Miguel is a pharmacist who received his education at Santa Maria University in Caracas, Venezuela. After graduating, Miguel continued his education and received a Master of Science in Industrial Engineering from the Universidad Nacional Experimental Politécnica (UNEXPO) in Caracas. Miguel has worked in the GMP pharmaceutical field since 2006. During this time, he worked at companies like Sanofi and Merck KGaA, performing various roles in operations such as quality control, validating manufacturing processes – cleaning validation analyst, being the Production Supervisor of the Solid, Liquid, and Semisolid Manufacturing Department. As the Production Supervisor, he oversaw the wet/dry granulation process, tableting/encapsulation, film/sugar coating, syrups/solution manufacturing, and bottling. After moving to Texas in 2016, he worked for Nutraceutical as the Solid Dose Production Supervisor, managing the mixing, tableting/encapsulation, coating, and inspection operations for the company.
- [Vice President of Analytical Sciences](https://eagleanalytical.com/team-jay-patel/): Jay Patel, Ph.D. Dr. Jay Patel joined the Eagle team in 2021 and has extensive experience in analytical chemistry and synthetic organic chemistry. Previously, he was the Manager of Research & Development and Quality Control at WDPrx, where he has successfully managed multiple NDA/ANDA projects from their inception to commercial launch by navigating them through the
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- [President & CEO](https://eagleanalytical.com/ross/): Ross A. Caputo, Ph.D. Dr. Ross Caputo earned his Ph.D. in Microbiological Physiology and Immunology from Miami University in 1976 and has over 30 years of experience in the FDA-regulated pharmaceutical industry on sterilization research and aseptic processing focusing on process optimization and control.He has authored more than 50 publications and owns 15 patents, all related to

## Products

- [SurfaceShield Wipe Sampling Kit](https://eagleanalytical.com/shop/surfaceshield/): Identify hazardous drug contamination fast with the Surface Wipe Sampling Kit. Easy sampling, expert lab testing, and USP compliance support.
- [65 mm TSA (Tryptic Soy Agar) Contact Plates - 10 plates per pack](https://eagleanalytical.com/shop/65mm-tsa-plate/): 65 mm TSA contact plates for environmental monitoring and microbial surface sampling in controlled environments. Explore Eagle Analytical's products.
- [90 mm TSA (Tryptic Soy Agar) Settle Plates - 10 plates per pack](https://eagleanalytical.com/shop/90mm-tsa-plate/): 90 mm plates used for personnel monitoring are supplemented with neutralizers to minimize the effect of any antimicrobial agents used in the cleanroom.

## Portoflio

- [Accounting Advisory](https://eagleanalytical.com/portfolio/accounting-advisory/): Dut perspiciatis unde omnis iste natus error sit accusantium doloremqu laudan tiums ut, totams se aperiam, eaque ipsa quae ab illo inventore veritatis et quasi architecto beatae duis autems vell eums iriure dolors in hendrerit saep. Lorem ipsum dolor sit amet, consectetuer adipiscing elit. Aenean commodo ligula eget dolor. Aenean massa. Cum sociis natoque penatibus
- [Digital Startup Agency](https://eagleanalytical.com/portfolio/digital-startup-agency/): Dut perspiciatis unde omnis iste natus error sit accusantium doloremqu laudan tiums ut, totams se aperiam, eaque ipsa quae ab illo inventore veritatis et quasi architecto beatae duis autems vell eums iriure dolors in hendrerit saep. Lorem ipsum dolor sit amet, consectetuer adipiscing elit. Aenean commodo ligula eget dolor. Aenean massa. Cum sociis natoque penatibus
- [Business Growth Check](https://eagleanalytical.com/portfolio/business-growth-check/): Dut perspiciatis unde omnis iste natus error sit accusantium doloremqu laudan tiums ut, totams se aperiam, eaque ipsa quae ab illo inventore veritatis et quasi architecto beatae duis autems vell eums iriure dolors in hendrerit saep. Lorem ipsum dolor sit amet, consectetuer adipiscing elit. Aenean commodo ligula eget dolor. Aenean massa. Cum sociis natoque penatibus
- [Digital Business Path](https://eagleanalytical.com/portfolio/digital-business-path/): Dut perspiciatis unde omnis iste natus error sit accusantium doloremqu laudan tiums ut, totams se aperiam, eaque ipsa quae ab illo inventore veritatis et quasi architecto beatae duis autems vell eums iriure dolors in hendrerit saep. Lorem ipsum dolor sit amet, consectetuer adipiscing elit. Aenean commodo ligula eget dolor. Aenean massa. Cum sociis natoque penatibus
- [Business Growth Model](https://eagleanalytical.com/portfolio/business-growth-model/): Dut perspiciatis unde omnis iste natus error sit accusantium doloremqu laudan tiums ut, totams se aperiam, eaque ipsa quae ab illo inventore veritatis et quasi architecto beatae duis autems vell eums iriure dolors in hendrerit saep. Lorem ipsum dolor sit amet, consectetuer adipiscing elit. Aenean commodo ligula eget dolor. Aenean massa. Cum sociis natoque penatibus
- [Strategy Growth Check](https://eagleanalytical.com/portfolio/strategy-growth-check/): Dut perspiciatis unde omnis iste natus error sit accusantium doloremqu laudan tiums ut, totams se aperiam, eaque ipsa quae ab illo inventore veritatis et quasi architecto beatae duis autems vell eums iriure dolors in hendrerit saep. Lorem ipsum dolor sit amet, consectetuer adipiscing elit. Aenean commodo ligula eget dolor. Aenean massa. Cum sociis natoque penatibus
- [Marketing Solution](https://eagleanalytical.com/portfolio/marketing-solution/): Dut perspiciatis unde omnis iste natus error sit accusantium doloremqu laudan tiums ut, totams se aperiam, eaque ipsa quae ab illo inventore veritatis et quasi architecto beatae duis autems vell eums iriure dolors in hendrerit saep. Lorem ipsum dolor sit amet, consectetuer adipiscing elit. Aenean commodo ligula eget dolor. Aenean massa. Cum sociis natoque penatibus
- [Artboard Studio](https://eagleanalytical.com/portfolio/artboard-studio/): Dut perspiciatis unde omnis iste natus error sit accusantium doloremqu laudan tiums ut, totams se aperiam, eaque ipsa quae ab illo inventore veritatis et quasi architecto beatae duis autems vell eums iriure dolors in hendrerit saep. Lorem ipsum dolor sit amet, consectetuer adipiscing elit. Aenean commodo ligula eget dolor. Aenean massa. Cum sociis natoque penatibus
- [Startup Funding](https://eagleanalytical.com/portfolio/startup-funding/): Dut perspiciatis unde omnis iste natus error sit accusantium doloremqu laudan tiums ut, totams se aperiam, eaque ipsa quae ab illo inventore veritatis et quasi architecto beatae duis autems vell eums iriure dolors in hendrerit saep. Lorem ipsum dolor sit amet, consectetuer adipiscing elit. Aenean commodo ligula eget dolor. Aenean massa. Cum sociis natoque penatibus

## Pricing

- [Standard Plan](https://eagleanalytical.com/pricing/standard-plan-2/): Curabitur nullam dis nibh nisi nascetur vestibulum proin mi morbi.
- [Agency Plan](https://eagleanalytical.com/pricing/agency-plan-2/): Curabitur nullam dis nibh nisi nascetur vestibulum proin mi morbi.
- [Basic Plan](https://eagleanalytical.com/pricing/basic-plan-2/): Curabitur nullam dis nibh nisi nascetur vestibulum proin mi morbi.
- [Agency  Plan](https://eagleanalytical.com/pricing/agency-plan/): Curabitur nullam dis nibh nisi nascetur vestibulum proin mi morbi.
- [Standard Plan](https://eagleanalytical.com/pricing/standard-plan/): Curabitur nullam dis nibh nisi nascetur vestibulum proin mi morbi.
- [Basic Plan](https://eagleanalytical.com/pricing/basic-plan/): Curabitur nullam dis nibh nisi nascetur vestibulum proin mi morbi.

## Categories

- [Eagle Updates](https://eagleanalytical.com/blog/updates/)
- [All Eagle News](https://eagleanalytical.com/blog/eagle-news/): Stay up to date with Eagle Analytical news, company updates, industry insights, new services, events, regulatory changes, and scientific advancements.
- [COVID-19](https://eagleanalytical.com/blog/covid19/): Updates related to the COVID-19 outbreak
- [Eagle TV](https://eagleanalytical.com/blog/eagle-tv/)
- [FDA](https://eagleanalytical.com/blog/regulations/fda-updates/)
- [USP](https://eagleanalytical.com/blog/regulations/usp-updates/): Updates and articles concerning USP , , , and other chapters related to pharmaceutical compounding
- [Regulatory Info & Updates](https://eagleanalytical.com/blog/regulations/): Explore the latest pharmaceutical regulations, USP updates, compliance guidance, and industry news to help maintain quality and regulatory compliance.
- [EagleTrax](https://eagleanalytical.com/blog/eagletrax/)
- [Quality](https://eagleanalytical.com/blog/regulations/quality-compliance/)
- [Environmental Monitoring](https://eagleanalytical.com/blog/regulations/environmental-control-monitoring/): Environmental control and monitoring insights for cleanrooms, contamination control, and USP compliance in pharmaceutical and compounding environments.
- [Demo Videos](https://eagleanalytical.com/blog/demo-videos/)
- [FAQ](https://eagleanalytical.com/blog/faq/)
- [Trade Shows](https://eagleanalytical.com/blog/upcoming-events/)

## Tags

- [Environmental Monitoring](https://eagleanalytical.com/tag/environmental-monitoring/): Explore environmental monitoring insights, cleanroom testing, microbial control, contamination prevention, and regulatory compliance resources
- [USP](https://eagleanalytical.com/tag/usp/)
- [contact plates](https://eagleanalytical.com/tag/contact-plates/)
- [compounded sterile preparation](https://eagleanalytical.com/tag/compounded-sterile-preparation/): Read expert insights on compounded sterile preparations, USP , sterility testing, quality assurance, and regulatory compliance
- [United States Pharmacopeia](https://eagleanalytical.com/tag/united-states-pharmacopeia/)
- [settle plates](https://eagleanalytical.com/tag/settle-plates/)
- [OOS](https://eagleanalytical.com/tag/oos/)
- [Out-Of-Specification](https://eagleanalytical.com/tag/out-of-specification/)
- [Out of Spec](https://eagleanalytical.com/tag/out-of-spec/)
- [TSA plates](https://eagleanalytical.com/tag/tsa-plates/)
- [Tryptic Soy Agar plates](https://eagleanalytical.com/tag/tryptic-soy-agar-plates/)
- [swabs](https://eagleanalytical.com/tag/swabs/)
- [Endotoxin Testing](https://eagleanalytical.com/tag/endotoxin-testing/): Discover articles about bacterial endotoxin testing, USP , pharmaceutical quality control, regulatory compliance, and laboratory testing
- [Bacterial Endotoxins](https://eagleanalytical.com/tag/bacterial-endotoxins/)
- [Recombinant Reagents](https://eagleanalytical.com/tag/recombinant-reagents/)
- [rCR](https://eagleanalytical.com/tag/rcr/)
- [rFC](https://eagleanalytical.com/tag/rfc/)
- [Limulus Amebocyte Lysate](https://eagleanalytical.com/tag/limulus-amebocyte-lysate/)
- [LAL Alternatives](https://eagleanalytical.com/tag/lal-alternatives/)
- [FDA](https://eagleanalytical.com/tag/fda/)
- [investigation](https://eagleanalytical.com/tag/investigation/)
- [investigational activities](https://eagleanalytical.com/tag/investigational-activities/)
- [field operations](https://eagleanalytical.com/tag/field-operations/)
- [quality](https://eagleanalytical.com/tag/quality/)
- [compliance](https://eagleanalytical.com/tag/compliance/): Learn about pharmaceutical compliance, regulatory requirements, USP standards, quality systems, and best practices for maintaining compliant operations.
- [compounding](https://eagleanalytical.com/tag/compounding/): Explore articles on pharmaceutical compounding, USP standards, sterility, analytical testing, quality assurance, and industry best practices
- [USP797](https://eagleanalytical.com/tag/usp797/)
- [inspection](https://eagleanalytical.com/tag/inspection/)
- [pharmaceutical](https://eagleanalytical.com/tag/pharmaceutical/)
- [CMDO](https://eagleanalytical.com/tag/cmdo/)
- [analytical testing](https://eagleanalytical.com/tag/analytical-testing/): Explore Eagle Analytical’s analytical testing services, including chemistry, microbiology, protein characterization, sterility testing, and regulatory support.
- [trends](https://eagleanalytical.com/tag/trends/)
- [safety](https://eagleanalytical.com/tag/safety/)
- [sterility testing](https://eagleanalytical.com/tag/sterility-testing/)

## Product categories

- [Environmental Monitoring](https://eagleanalytical.com/product-category/environmental-monitoring/): Environmental Monitoring Plates
- [EAGLESHIELD](https://eagleanalytical.com/product-category/eagleshield/): EAGLESHIELD All-Products

## Portoflio Categories

- [All](https://eagleanalytical.com/portfolio_category/all/): Default Category
- [Business](https://eagleanalytical.com/portfolio_category/business/)
- [Consulting](https://eagleanalytical.com/portfolio_category/consulting/)
- [Finance](https://eagleanalytical.com/portfolio_category/finance/)
- [Marketing](https://eagleanalytical.com/portfolio_category/marketing/)
- [Solution](https://eagleanalytical.com/portfolio_category/solution/)
- [Strategy](https://eagleanalytical.com/portfolio_category/strategy/)

## Pricing Categories

- [Monthly](https://eagleanalytical.com/pricing_category/monthly/)
- [Yearly](https://eagleanalytical.com/pricing_category/yearly/)