Elevating Quality, Safety, and Trust in Telehealth and Compounding

What drew me here was the company’s approach to telehealth and pharmaceutical compounding by providing innovative, high-quality solutions that empower individuals to live healthier, happier lives along with its unwavering commitment to quality, excellence, and safety through continuous improvement. It was an exciting opportunity to bring my experience in health and pharmaceutical operations and quality assurance to a company dedicated to raising the bar on safety and quality all while redefining access to care. 

Hims & Hers customers value convenience and the discretion that telehealth brings them, especially when addressing conditions that carry a stigma in our society. We know our customers want seamless, connected, and on-demand care rather than the traditional  months-long waits for in-person appointments - not to mention any required follow-up visits- many Americans have come to expect when taking care of their health. Most of all, our customers care about trust. One of the reasons I joined Hims & Hers is because of how seriously our team takes trust, and truly believes that every patient deserves confidence that the care and medications they receive are safe, effective, and held to the highest standards. 

At Hims & Hers, excellence in everything we do isn’t an option—it’s our commitment. Quality and safety are not static; they require continuous improvement, adaptation, and, most importantly, transparency. And health care is personal and subjective, that is why we listen—really listen—to our customers, the providers on our platform, and industry experts. In this spirit of excellence and transparency, I want to share a few key initiatives that Hims & Hers will be implementing that will further our mission and improve health care.

Establishing the Quality & Safety Advisory Council (QSAC) to Drive Transparency, Access, and Affordability

Hims & Hers is forming an independent Quality & Safety Advisory Council (QSAC) to build on our deep commitment to quality and safety and continue leveraging the highest levels of expertise to help inform our approach. The QSAC will work to advise Hims & Hers on important policies, processes, and best practices for our platform and products, including identifying additional opportunities for enhancing safety while also championing affordability and access.  We will also tap into this group to advise on our efforts to work with regulators and industry to combat bad actors providing counterfeit and illegal medications that not only put individual patients at risk, but undermine legitimate compounding and telehealth operations such as Hims & Hers.

As we hear too often from consumers, quality should not come at the expense of affordability and accessibility, and affordability and accessibility should never mean sacrificing quality and safety. The QSAC will help us navigate this balance, ensuring that we are not only meeting but exceeding expectations for what high-quality, cost-effective, and accessible telehealth care should look like. Only by taking this approach of integrating affordability and accessibility with quality and safety can we truly start to address the imbalanced health system that has left too many Americans in the lurch without access to affordable quality health care.

Earning Consumer Trust: Making Public Our Compounding Pharmacy Framework for Safety, Quality, and Transparency 

503A compounding pharmacies and 503B outsourcing facilities—whether your local neighborhood pharmacy that has served a community for generations or the affiliated pharmacies and outsourcing facilities of a telehealth provider like Hims & Hers—adhere to a strict set of laws and other requirements to operate legally. For 503A compounding pharmacies that means complying with state and Boards of Pharmacy regulations. 503B outsourcing facilities are directly regulated by the FDA. These are non-negotiable laws and regulations that distinguish between legitimate compounding pharmacies and bad actors.

At Hims & Hers, we believe that meeting regulatory requirements should be the starting point, not the benchmark for quality and safety. We believe companies like ours should be open with customers about how we ensure safety and follow the rules. This includes, clear practices for supply chain and sourcing, testing, labeling, employee training, ethical standards, handling issues, and product safety.

Our intent is that this framework serve as a trusted marker, not only for Hims & Hers, but for compounders and telehealth providers generally who are willing to commit to safety, quality, and transparency. By being transparent with our principles, we want to make it easier for patients and providers to identify and trust pharmacies and companies who prioritize integrity and patient care—ensuring confidence in every prescription filled. We invite others in the industry to join us in adhering to these principles.

When patients receive a compounded medication, they should never have to question its safety or quality. By making this framework public, we’re providing clarity and confidence, reinforcing trust in legitimate compounding operations. Here’s what that framework looks like:

• Delivering Access to Trusted Care with Qualified and Expert Teams: Our commitment to quality and safety begins with our team. Pharmacists and technicians involved in compounding are trusted experts at the core of our model. As a best-in-class workforce, they undergo rigorous and ongoing training in aseptic technique, process validation, hazardous drug handling, and other critical practices. We require continuing education, qualification assessments, and adherence to applicable Food and Drug Administration (FDA) and state pharmacy requirements, including US Pharmacopoeia (USP) standards and applicable current good manufacturing practices (cGMP) requirements. By investing in our team’s development and expertise, we ensure that every step of care is grounded in professionalism, precision, and trust. ‍
• Sourcing Pharmaceutical-Grade Ingredients to Ensure Purity and Potency: We require that all active pharmaceutical ingredients (APIs) used in compounded medications available through our platform be sourced from FDA-registered facilities and accompanied by Certificates of Analysis (COAs) to confirm identity, potency, and purity.  Ingredients must meet relevant USP standards and applicable state board regulations and have been manufactured in accordance with cGMP, as applicable. All raw materials, particularly APIs, undergo rigorous testing for potency, identity, and acceptability using validated analytical methods. This approach upholds product integrity and ensures alignment with regulatory and quality standards from the outset.‍
• Adhering to cGMP, USP, and Regulatory Standards: We require that all sterile, non-sterile, and hazardous compounding processes follow all relevant regulatory requirements, including USP standards and, in the case of any outsourcing facility, applicable cGMP, supported by documentation. We also follow applicable state pharmacy board requirements and FDA guidance.‍
• Maintaining Controlled Environments & Facility Standards: We require that all sterile compounding take place in cleanroom and controlled environments that meet relevant regulatory requirements, including USP standards, and in the case of any outsourcing facility, applicable cGMP.  This includes HEPA filtration, environmental monitoring, and fully validated aseptic processing areas. For both sterile and non-sterile products, we apply beyond-use dating (BUD) based on stability studies and USP standards to ensure appropriate shelf life and safety.‍
• Implementing Testing Protocols and Quality Controls for Sterile Compounding: We require that all sterile compounded products undergo routine potency and sterility testing in accordance with applicable USP standards, using risk-based protocols and batch verification to support compliance and patient safety. As appropriate, mandatory lot release testing—including sterility, endotoxin, and particulate matter testing—is conducted prior to distribution, with full documentation, quarantine procedures, and FDA-audited quality assurance systems. ‍
• Documenting Compounding Processes and Ensuring Label Accuracy: We require that medication labels comply with applicable FDA requirements and state pharmacy board requirements and, as applicable, include such information as active ingredients, concentration, lot or batch numbers, beyond-use date (BUD), and storage conditions to support traceability and distribution. We maintain documentation of compounding processes, including formula validation, weighing logs, and technician sign-offs.  ‍
• Maintaining Ethical Practices and Transparent Communications: We require adherence to applicable marketing and promotional regulations.  Communications must include appropriate disclosures and risk information to help customers understand the nature of compounded medications, including that FDA does not approve compounded drugs or evaluate them for safety or efficacy. This commitment reflects our focus on transparency, ethical conduct, and consumer trust.‍
• Monitoring Adverse Events, Handling Complaints, and Managing Recalls: We maintain FDA-compliant pharmacovigilance programs, as applicable, that require timely reporting of adverse events and rapid recall protocols when necessary. We also have formal complaint handling procedures in place to document, investigate, and resolve product-related concerns. In the event of a recall, we ensure prompt notification to regulatory authorities, patients, and providers regarding any affected lots, in alignment with applicable reporting requirements and patient safety protocols.‍
• Committing to Safe Handling, Storage, and Disposal Practices: We strive to meet all applicable environmental, cGMP, and USP standards for the handling, storage, and disposal of hazardous materials and controlled substances. This includes validated cleaning protocols, secure disposal methods, and safeguards designed to protect both staff and patients. We are committed to using proper disposal practices to prevent environmental contamination and to align with all relevant regulatory expectations.‍
• Implementing Quality Assurance Initiatives for Operational Excellence: We are committed to implementing robust Quality Assurance programs that foster continuous improvement and operational excellence. These include regular internal audits, proactive process improvement initiatives, and timely updates based on evolving USP standards and appropriate FDA protocols. Where relevant and appropriate, we incorporate Corrective and Preventive Action (CAPA) procedures and maintain alignment with cGMP reflected in FDA guidance and inspection findings, and industry best practices to strengthen our systems and improve care delivery.

The Path Forward: A Commitment to Continuous Improvement 

At Hims & Hers, we sit at the intersection of innovation and quality. As we define the next generation of health care we are developing and delivering access to the services and products that promote holistic health, well-being, and quality of life by committing to raise the bar for safety and quality in everything we do. As I look ahead, I am proud of the standards we’ve set for ourselves and even more excited about how we’ll continue to raise those standards even more, for ourselves and the industry. The work of quality and safety is never done, but with a commitment to listening, learning, and leading, we can continue to build a stronger, more transparent, and more trusted future for telehealth, pharmaceutical compounding and all of health care.