Pharmacy500 Marketplace

USP 795 Non-Sterile Resources, Compliance, Technology

Leading Providers of Compounding Chemicals, Compounding Supplies, Pharmacist Training, Compound Formulas, Compounding Software, & Technology...

Aisle OVERVIEW

Non-sterile pharmacy compounding refers to the process of preparing customized medications in a pharmacy setting under conditions that do not require a sterile environment. This practice involves mixing, combining, altering, or assembling pharmaceutical ingredients to meet the specific needs of an individual patient when commercially available medications are not suitable. The primary focus of non-sterile compounding is to ensure that the compounded medication is safe, effective, and tailored to the patient’s requirements while adhering to established quality control practices.

Company Profiles

Request information from Pestle

Pestle is a compliance management platform designed for pharmacy organizations to document, manage, and maintain regulatory and internal compliance practices. The system provides clear, intuitive workflows that make it easy for staff to complete and document the compliance processes they are responsible for, without disrupting daily operations. 

Pestle gives pharmacy leadership real-time oversight into compliance activity, ensuring tasks are completed and documented on time and according to policy. When responsibilities are missed or noncompliance is identified, designated stakeholders are notified immediately, allowing management to investigate, document corrective actions, and course-correct with confidence. Centralized dashboards provide instant visibility into performance, trends, and exceptions, along with fast access to inspection-ready reports for accrediting bodies and inspectors. 

Pestle specializes in compliance for USP <795>, <797>, and <800>, while offering customizable tools to schedule, track, and manage virtually any pharmacy process—helping organizations stay organized, accountable, and audit-ready.

Informa Connect

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Driving Excellence in Compounding Compliance and Quality Standards: Year-End Update

Following the success of our Junel Compounding Pharmacy Compliance Summit, we’re back with a focused year-end update designed to address the most pressing regulatory developments and compliance challenges facing the industry today. The Compounding Pharmacy Compliance Year-End Update offers a concentrated dive into critical compliance areas and strategies to ensure inspection readiness as we navigate an increasingly complex regulatory landscape.

As GLP-1 regulations, FDA oversight, and state-level requirements continue to evolve rapidly, staying informed has never been more critical to maintaining high-quality compounding standards, improving patient safety, and ensuring compliance. This essential update conference is designed to help compounding professionals navigate the latest regulatory developments, address emerging compliance challenges, and optimize operational practices.

What’s Critical for Year-End 2025?
This focused 1.5-day program features live content from industry thought leaders, interactive speaker Q&A sessions, and targeted discussions specifically addressing the regulatory landscape changes since our June event. Including expert perspectives from the Strive Pharmaceuticals, Vios Compounding, Alliance for Pharmacy Compounding, Akina Pharmacy, Americare Pharmaceutical Services, Wells Pharmacy Network, Town & Country Compounding, and more, this year-end update is essential for compliance professionals.

This year-end program provides critical insights and the opportunity to:

  • Hear directly from Alliance for Pharmacy Compounding CEO Scott Brunner and Chief Advocacy Officer, Tenille Davis on navigating state compliance for GLP-1 compounding and strengthening industry trust and relationships
  • Deep dive into the most pressing hot topics that have emerged since June, Including: navigating the evolving GLP-1 regulatory landscape, state-level compliance requirements, reputation management, and building stronger healthcare provider relationships
  • Learn from case studies and real-world experiences from leading compounding professionals on implementing compliance strategies in today’s environment
  • Network in-person with colleagues and counterparts to expand your network and establish powerful partnerships during this critical time

Key Focus Areas Include:

  • GLP-1 Compliance Deep Dive – Navigate state-level requirements, federal guidelines, and enforcement priorities
  • Trust and Reputation Building – Clear up misconceptions and strengthen relationships with healthcare providers
  • Regulatory Updates – Latest Developments in FDA oversight and state board requirements
  • Operational Excellence – Streamlined strategies for maintaining compliance while serving patients

This year-end update serves as the essential follow-up to our June summit, ensuring you’re equipped with the latest regulatory insights and compliance strategies as we head into 2026.

For full program details and registration for you and your team, visit: https://informaconnect.com/compounding-pharmacy-compliance-year-end/

Willow Birch Pharma
Your Premier Supplier of Bulk APIs for Compounding Pharmacies

Request information from Willow Birch Pharma

Quality-verified APIs, reliable delivery, and documentation you can trust.

Willow Birch Pharma helps compounders ensure a quality and reliable supply of APIs. We are licensed as a drug wholesaler in all 50 states, DEA-registered, and NABP-accredited since 2007.

Who We Support:

  • 503A compounding pharmacies
  • 503B outsourcing facilities
  • Hospital & health-system pharmacies
  • Veterinary compounders
  • Compounders nationwide

We source exclusively from FDA-registered, cGMP-compliant manufacturers that are independently audited and continuously monitored to ensure quality and supply continuity.

Our team and manufacturing partners ensure seamless customs clearance, delivery, and regulatory documentation – with valid NDCs and complete COAs for each lot. DMFs are available for many products.

Why Supplier Choice Matters

FDA quality assurance inspections are returning to pre-pandemic levels with increased scrutiny of foreign manufacturing sites, especially for India and China.

The FDA’s latest Report on the State of Pharmaceutical Quality highlights quality concerns among API manufacturers that supply the compounding market.

Over the past five years, 72% of actions (warning letters/import alerts/regulatory meetings) were taken against API manufacturers that exclusively supply compounding pharmacies, even though these sites account for only 18% of API manufacturers in the FDA’s Site Catalog. As inspection frequency increases, the FDA has prioritized these higher-risk sites for future surveillance.

Are Your Top APIs De-Risked from Increasing FDA Scrutiny?

Ask our team for a no-cost supplier risk assessment on your top products. If you are not 100% confident your supplier will pass a quality assurance inspection from the FDA, your supply chain may be at risk.

Willow Birch can help you find a qualified source and de-risk your most important APIs.

Willow Birch Quality & Service Commitments

  • FDA-registered, cGMP manufacturers only
  • Valid NDCs on every API
  • COAs included, DMFs available
  • Independently audited, continuously monitored manufacturers
  • Pre-qualified alternative sources
  • Seamless customs clearance & dependable delivery
  • Experienced and proactive service with a single point of contact

Alliance for Pharmacy Compounding

Request information from Alliance for Pharmacy Compounding

The Voice for Pharmacy Compounding

APC represents compounding pharmacists and technicians in both 503A and 503B settings, as well as prescribers, educators, patients, and suppliers.

Our passion for compounding is fueled by our members’ passion for their patients — and the medications they create. APC is focused on strategies to assure that millions of patients can continue to access those compounded medications.

Our commitment — not only to our dues-paying members but also to their patients — is to lead, to influence, to speak, and to serve so that the practice of pharmacy compounding is not merely preserved but is elevated as a key component of health care delivery for millions of patients across America.

APC members subscribe to the Pharmacy Compounders Code of Ethics, comprised of 10 tenets that guide their professional, clinical, and business practices.

APC members play a vital role in the American healthcare system and in individual patients’ lives, preparing essential personalized medications for a range of issues, including autism, oncology, dermatology, ophthalmology, pediatrics, women’s health, and more.

Through its ally grassroots organization, the Partnership for Personalized Prescriptions, APC represents more than 150,000 patients, compounding professionals, prescribers, and others.

APC is committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare, and of patients to take personalized medication solutions to meet their unique health care needs.

LGM Pharma

Request information from LGM Pharma

Your Trusted Partner in Pharmaceutical Testing and Compliance

At LGM Pharma, we support pharmacies and pharmaceutical manufacturers with cGMP-compliant analytical testing services designed to ensure product quality, patient safety, and regulatory compliance.

LGM Pharma offers analytical testing on a contract basis with our FDA-inspected, ISO 9001 certified testing facility in Irvine, CA. With industry-leading responsiveness and deep regulatory expertise, we offer fast, reliable testing that pharmacies and manufacturers trust.

We tailor our services based on the unique regulatory requirements of various segments of the pharmaceutical industry:

  • 503A compounding pharmacies
  • 503B outsourcing facilities
  • Hospital pharmacies
  • Pharmaceutical manufacturers
  • Generic and branded pharmaceutical developers
  • API and excipient suppliers

Core Analytical Testing Capabilities

We offer a comprehensive suite of testing services, including:

Chemical and Physical Testing

  • Elemental impurities (USP <232>/<233> via ICP-MS)
  • Residual solvents (USP <467>)
  • Assay and impurity profiling
  • Stability testing (ICH-compliant, up to 180 days)
  • Physicochemical tests (e.g., ID, TOC, moisture/LOD, wet chemistry)

Microbiological Testing:

  • Microbial limits (USP <61>/<62>)
  • Antimicrobial effectiveness (USP <51>)
  • Bacterial endotoxin (USP <85>)
  • Sterility studies (USP <71>)
  • Rapid sterility, 5-day turnaround

Method Development & Validation

  • Custom method development and validation
  • Stability-indicating methods
  • Cleaning validation
  • Water system validation

Specialized Support for Compounding and Outsourcing Facilities

LGM Pharma understands the complex regulatory landscape and technical needs of 503A and 503B pharmacies, with specialty support including:

  • USP <795>, <797>, and <800> compliance
  • Batch release testing for compounded preparations
  • Method verification and validation for custom formulations
  • Testing for active ingredient concentration, content uniformity (USP <905>), sterility (USP <71>), and endotoxins (USP <85>)

Your Full-Service Pharmaceutical Partner

As part of our vertically integrated service model, we also offer:

  • API sourcing from a global network of pre-qualified, FDA-inspected manufacturers
  • U.S.-based drug product CDMO services for oral solids, topicals, suppositories, and solutions/suspensions

For compounding pharmacies and virtual drug development companies, outsourcing analytical services is an absolute necessity. In all cases, it’s essential to find a provider that meets your needs and your expectations for prompt turnaround, timely communication, and most of all, excellent quality.

Q.I. Medical

Request information from Q.I. Medical

Your source for products to support compliance with USP 797, USP 71, USP 800.

For over 20 years, Q.I. Medical has been a trusted provider of quality assurance products to compounding pharmacies throughout the world. Our focus is on developing
easy-to-use products for our customers to help them with their in-house testing needs. Whether it is a low, medium, or high risk facility, Q.I. Medical can help them to be in compliance with regulatory guidelines (USP <797>, USP <71>, 503a or 503b, etc.).

We offer unique products for pharmacists and nurses who handle sterile solutions. Our focus is on devices, test kits, and accessories that improve aseptic technique.

Applications include:

  • Environmental Monitoring
  • Technique and Process Validation
  • Microbial and Endotoxin Contamination Testing
  • Filtration
  • Needless Dispensing

Pharmacy500

Request information from Pharmacy500

The Pharmacy500 is awarded to 500 pharmacy supply chain businesses and associations that significantly impacted dispensing pharmacies in the U.S. over the past year.

Pharmacy500 Benefits

The following are complimentary benefits extended to Pharmacy500 companies and associations (coming this spring!)

  1. Company listings in the Platinum Pages Buyer’s Guide, 20Ways publications, and RXinsider website
  2. Company inclusion in the 20Ways themed Buyer’s Guide
  3. Unlimited job postings in the Pharmacy500 Career Center *Unlimited through 2025
  4. Tradeshow promotional resources including Pharmacy500 floor stickers and lanyards
  5. Two posts (annually) in RXinsider’s Pharmacy Market BUZZ news feed

Who are the Pharmacy500 and what are the selection criteria?

The Pharmacy500 includes:

  1. Companies within the Pharmacy Supply Chain
  2. National Pharmacy Trade Associations

The Pharmacy500 Selection Committee applies the following criteria to determine the list of 500:

  • Offers and actively markets at least one product or service to dispensing pharmacies
  • Dispensing pharmacies comprise at least 25% of their customer base
  • Has an estimated annual revenue exceeding $500,000
  • Has five or more full-time employees, and has been in business for more than two years
  • Has a national presence
  • Exhibited at one of the following national conferences in the previous year: APhA; ASCP Annual Meeting & Exhibition; Asembia’s Summit; ASHP Midyear Clinical Meetings & Exhibition; Cardinal Health RBC; McKesson ideaShare; NACDS Total Store Expo; NASP Annual Meeting & Expo; NCPA Annual Convention and Expo; Pharmacy Futures (ASHP Summer); ThoughtSpot.

The following supply chain segments are critical to pharmacy operations and patient care, but are excluded from the Pharmacy500 simply due to volume:

  • Manufacturers and Merchandisers of Pharmaceuticals
  • Manufacturers and Merchandisers of Devices and OTC Products
  • Colleges of Pharmacy
  • State Associations
  • Government Agencies and State Boards of Pharmacy
  • Pharmacy Fraternities & Sororities
  • Dispensing Pharmacies, Health Systems, Chains, Payors, and PBMs

International Journal of Pharmacy Compounding

Request information from IJPC

The International Journal of Pharmaceutical Compounding (IJPC) is a bi-monthly, scientific and professional digital journal emphasizing quality pharmaceutical compounding. IJPC is the only publication that covers pharmaceutical compounding topics relevant and necessary to empower pharmacists to meet the needs of today’s patients. No other publication features hands-on, how-to compounding techniques or the information that contemporary pharmacists need to provide individualized care.

Each issue includes peer-reviewed scientific articles, articles on pertinent topics, informational and professional articles, calculations, and other departments relevant to the practice of compounding. Articles and manuscripts are reviewed by pharmacy practitioners, academicians and scientists, as well as by others with expertise in various specialties.

The International Journal of Pharmaceutical Compounding is indexed by the International Pharmaceutical Abstracts,the Cumulative Index to Nursing & Allied Health Literature print index and database, the Chemical Abstracts Service, Elsevier Bibliographic Databases including EMBASE, EMNursing, Compendex, GEOBASE, Mosby Yearbooks and Scopus, the world’s largest abstract and indexing database of scientific and social sciences literature with more than 8 million users at more than 500 institutions worldwide.

Manuscripts published in the International Journal of Pharmaceutical Compounding are read and researched worldwide.

IJPC has been recognized with the following awards:

  • Houston International Association of Business
  • Communicators Award of Merit in Magazine Design
  • Houston Society for Technical Communication Distinguished Award for Technical Publications, Art & Online Competition
  • International Society for Technical Communication Excellence Award for Technical Publications, Art & Online Competition

Please contact us by phone at 800-757-4572 or click on the link below to visit our website.

CurifyLabs

Request information from CurifyLabs

CurifyLabs Compounding System Solution (CSS) is an automated pharmaceutical compounding platform for non-sterile dosage forms, including tablets, troches, liquids, suppositories, ovules, ointments, and capsules. It enables better treatments for patients and improved efficiency for pharmacies and hospital pharmacies. In addition to cost savings, it ensures high manufacturing standards at the point of care through in-process quality control. 

The CSS is a user-friendly platform consisting of: GMP-manufactured excipient bases, compounding robotics, integrated quality control tools, software, and a comprehensive formulation library to meet the versatile compounding needs of pharmacies. CurifyLabs’ CSS technology is in use for patients by customers in 10 different markets in Europe and the US.

Health Care Logistics

Request information from Health Care Logistics

Pharmacy Compounding Supplies
The HCL Compounding and Dispensing line features a diverse selection of products with a special focus on USP 797 & 795 supplies as well as those specially designed for precise medication measuring, mixing and filling. We’re committed to offering products that help you increase productivity, maximize efficiency and improve accuracy in all aspects of your business.

To eliminate hand fatigue when packaging liquid compounds, try our Liquid Unit Dose (LUD) Press. It has an aluminum base and rod that easily seals caps onto vials or cups. Choose a heavy-duty Holder for Vials or a Holder for Cups, each of which will hold up to eight items side by side to prevent spills. A raised notch on the LUD Press platform helps guide your holder into position to create a secure seal on every vial or cup, every time. You spend less time on alignment and improve productivity.

We create metal products to match your unique specifications so you can work more efficiently and produce better results. Could your facility benefit from stainless steel storage containers, lock boxes and utility trays to simplify USP <797> compliance? Do you have an existing product you’d like to upgrade with a specially sized metal adaptor such as a bracket, plate, clamp or hanger that is USP <797> friendly? Whatever solution you seek, HCL can deliver. Our designers use stainless steel and aluminum, dependent upon your needs, and our design consultation services are always FREE!

Product Highlight SHOWCASE

Subject Matter Expert & Thought Leader PROFILES

Pharmacy Educator
Children’s of Alabama

Educator for the department and educator on medication for the institution. Serve on Policy & Procedures committee, hospital-wide protocol committee, code committee, Order set review committee, pharmacy leadership, residency interview committee, and education forum for the hospital. Serve as residency preceptor and preceptor for students at 3 universities. Reviewer for hospital investigational protocols and hospital wide medication information for patient discharge teaching. Trainer for new pharmacists. Compliance trainer for USP 795 and 797. Trainer for Parenteral certification as required by ALBOP. Credentialed EPIC Willow Trainer.

Steve Postal is the Senior Director of Policy and Regulatory Affairs at the National Community Pharmacists Association (NCPA), as well as the Editorial Director of the American Society for Pharmacy Law (ASPL). His areas of expertise include Medicare Part D, compounding, and DSCSA. Before joining NCPA in April 2022, he worked for the American Physical Therapy Association (APTA) in federal regulatory affairs. Prior to that, he worked for the Pharmaceutical Research and Manufacturers of America (PhRMA) in state affairs, and for the law firm Powers Pyles Sutter & Verville in federal regulatory and legislative health policy.

Resources & Awareness

Learn more about compounding insights and Pharmacy500 companies behind the industry in our Pharmacy500 Platinum Pages 2026 publication!

The 2026 Pharmacy500 Companies Market Teardown report provides a concise snapshot of the 2026 companies, highlighting new additions, examining regional distributions, practice settings, supply chain categories, and key conferences attended.

RXinsider’s Pharmacy500 Careers Outlook report identifies key employment trends and workforce dynamics across Pharmacy500 companies. Check out this report to learn more about open position trends and the current state of the job market impacting the pharmacy supply chain!

Fortune Magazine’s annual Fortune 500 ranks the largest U.S. companies by revenue. Many leaders in healthcare and pharmaceuticals drive medication production, distribution, and patient access. This report highlights their impact on the pharmacy industry.

CurifyLabs enables pharmacies to deliver personalized, safe, and efficient treatments by transforming manual compounding into an automated, scalable process. Learn more in this issue of 20Ways!

This report examines key suppliers within the Pharmacy500 that support non-sterile pharmacy compounding through raw materials, chemicals, bases, and proprietary formulations. It highlights how these companies enable safe, compliant, and efficient compounding practices.

RXinsider’s Pharmacy500 Academy now offers training on non-sterile compounding and USP 795, along with company breakdowns and product comparisons. Visit the Pharmacy500 Academy to learn more about USP 795 Compounding.

October 2025 – PCCA today announced the launch of UniFlow™, a purpose-built powder excipient base that sets a new standard for compounding triturations…

Pharmacy500

COMPOUNDING 

Accu-Chart Plus Health Care Systems
Acute Care Pharmaceuticals (Hospeco Brands Group)
AirCare Automation
AirClean Systems
AIS Healthcare
Alliance for Pharmacy Compounding (APC) Allied Pharmacy Products
Allometrics
American College of Apothecaries (ACA)
ARL Bio Pharma
ARxIUM
Associates of Cape Cod, Inc
B. Braun Medical Inc.
Baxter
Berkshire Corporation
Blue Thunder Technologies
Bureau Veritas
Cardinal Health
Central Admixture Pharmacy Services, Inc. (CAPS)
ChemoGLO
CINTAS Corporation
Cleanetics
Cleanroom Connection
ConsortiEX Inc.
Contec, Inc.
Cordica Medical
CORMED
CPS Solutions, LLC
CurifyLabs
DiNovo Cleanroom Supplies and Packaging Solutions
Eagle Analytical Services
EMSL Analytical, Inc.
EQUASHIELD
Esco
Eurofins Analytics
Fagron
FLAVORx
Grifols
Hardy Diagnostics
Health Care Logistics, Inc.
Helmer Scientific
ICU Medical
Innovatix, LLC
Integrated Medical Systems, Inc. (IMS)
International Journal of Pharmaceutical Compounding (IJPC)
International Medical Industries Interphex
ISO-MED, Inc. (Hospeco Brands Group)
IsoTech Pharma
Lakeland Industries, Inc.
LGM Pharma
LifeFile
Medi-Dose, Inc./EPS, Inc.
Medical Technology Associates, LLC
Medisca Inc.
MediZap
MedSafety Solutions
MedXL Inc.
Modular Cleanrooms, Inc.
Modular Devices
MPS Pharma & Medical, Inc.
NuAire, Inc.
Nuvai Medical Technologies
P&C Pharma
PAAS National LLC
Parasol Medical, LLC
Particle Measuring Systems, Inc.
PCCA
Pestle (Accreditation Partners LLC)
Pharma Source Direct
Pharmacy Stars, LLC
Prudential Cleanroom Services
Pure Microbiology, LLC
Q.I. Medical Inc
QleanAir Scandinavia
Quality Solutions
QUESS 360 – Pharmacy Solutions
Rees Scientific
Samson Medical Technologies, LLC
Sharps Medical Waste Services
Shepard Medical Products | CareMates
SpecializedRx Products, LLC
Spectrum Pharmacy Products
Technical Safety Services
The Baker Company
TICKERWORKS
Total Pharmacy Supply, Inc.
Travis CleanAir, Inc.
TRC Healthcare
U.S. Micro-Solutions, Inc.
Vileda Professional
Visante LLC
Willow Birch Pharma, Inc.
Winfield Laboratories, Inc.
WM-PharmEcology
Wolters Kluwer
WorkingBuildings
Yukon Medical, LLC

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