Sterile compounding oversight in the U.S. has been moving toward uniform, USP-aligned inspection evidence, especially for nonresident pharmacies shipping compounded sterile preparations across state lines. The National Association of Boards of Pharmacy (NABP) now provides two common frameworks boards lean on - VPP accreditation and their Blueprint inspection form. Even as the U.S. remains a patchwork of requirements, state regulatory frameworks tend to fall into three categories.
Read MoreFor more than two decades, the United States has navigated a recurring tension between two legitimate public-health aims: safeguarding the integrity of FDA-approved medicines and preserving access to individualized therapies prepared by licensed compounders. The flashpoints change—bioidentical hormones yesterday, GLP-1 receptor agonists today—but the core pattern remains strikingly similar. This article traces the parallels—factually and even-handedly—between (1) Wyeth’s mid-2000s campaign concerning compounded bioidentical hormone therapy (cBHT) and (2) current actions by Novo Nordisk and Eli Lilly involving compounded versions of semaglutide and tirzepatide.
Read MoreAs scrutiny sharpens around sterile drug compounding, 503A pharmacies are facing increasing pressure to ensure that every component used in compounded sterile preparations (CSPs)—from APIs and excipients to glassware and stir bars—meets the quality and documentation requirements set forth in USP <797> Section 9.3.1 and related FDA guidance.
Read MoreAs scrutiny intensifies around popular compounded medications like GLP-1 receptor agonists, some 503A pharmacies and 503B outsourcing facilities are recalibrating their strategies—shifting their focus toward underserved patient populations, orphan diseases, and non-commercially viable dosage forms.
Read MoreThe Shift from Stick-Built to Smart-Built: A New Era in Cleanroom Design
Read MoreFor organizations that already live in cGMP—generics firms, CDMOs, and late-stage biotech—standing up a 503B outsourcing facility is a credible way to (1) generate revenue, (2) validate commercial assumptions, and (3) sharpen operational excellence in parallel with an ANDA or 505(b)(2) program. Done right, a 503B business becomes a near-term, compliant go-to-market channel that builds hospital relationships, hardens your aseptic capability, and creates data that de-risks launch plans—without waiting for approval.
Read MoreThe compounding industry is undergoing a significant transformation. With the recent resolutions of the semaglutide and tirzepatide shortages, along with increased FDA scrutiny and legal challenges (such as the OFA vs. FDA tirzepatide case), many 503A and 503B facilities that relied on GLP-1 compounding are now at a crossroads. While some may see these changes as the end of an era, the reality is that compounding is evolving, and new opportunities are emerging for those willing to adapt.
Read MoreThe FDA has implemented strict oversight procedures that include regular inspections of 503Bs. The guidance document emphasizes that the FDA’s approach is risk-based, meaning that the scope and intensity of an inspection will depend on a facility’s compliance history, the complexity of its operations, and its overall risk profile. This article explores the six systems FDA inspects at 503B outsourcing facilities and provides a practical gap analysis checklist that can help facilities identify potential areas for improvement.
Read MoreIn today’s highly regulated environment, 503B outsourcing facilities must be prepared for all eventualities—including the possibility of a product recall. This article provides a detailed roadmap for implementing a robust recall readiness program, drawing on current FDA guidance and best practices.
Read MoreBio/pharmaceutical, advanced therapy, and 503B manufacturing facilities often face the decision of hiring in-house validation personnel or engaging third-party consultants for facility and equipment IQOQPQ. While both approaches have merits, outsourcing validation activities to specialized consultants frequently emerges as a more cost-effective and efficient GMP validation solution.
Read MoreCompounding animal drugs is a valuable practice in veterinary medicine, filling gaps when approved drugs are unavailable or unsuitable. However, it operates within a complex regulatory framework outlined by FDA Guidance #256. This Q&A explores key aspects of compounding, including shortage situations, to provide clarity for practitioners.
Read MoreStarting a 503B outsourcing facility is a significant undertaking, requiring careful planning, investment in infrastructure, and a deep commitment to quality. By thoughtfully considering your capabilities, designing a compliant facility, investing in proper equipment, adhering to cGMPs, and hiring well-trained personnel, you will set the foundation for a successful operation.
Read MoreIn August 2024, the FDA held its annual Compounding Quality Center of Excellence Conference, where the agency provided key insights into the most common Form 483 observations for 503B outsourcing facilities. These observations highlight compliance issues that outsourcing facilities must address to ensure regulatory adherence and maintain patient safety. In this article, we’ll examine the top Form 483 observations shared at the conference and discuss best practices for addressing these compliance issues.
Read MoreA recent FDA draft guidance was issued to permit 503B facilities to sell compounded drugs to 503A pharmacies, which can then dispense these products directly to patients pursuant to a valid prescription. This guidance has significant implications for the regulatory landscape, operational practices, and business strategies of 503A compounding and traditional community pharmacies.
Read MoreFor 503B outsourcing facilities, scaling up production and reducing costs is essential for maintaining competitiveness in this niche industry. By applying principles of production volume and economies of scale, 503B facilities can achieve greater efficiencies, streamline workflows, and lower operational costs while ensuring compliance with FDA regulations. Here’s an in-depth approach to achieving this goal.
Read MoreThis article explores why investing in quality within 503A and 503B facilities is not only necessary but also the key to thriving in a highly regulated and scrutinized environment. In the 503A and 503B pharmaceutical compounding industry, poor quality is not an option. From the risks of regulatory penalties to the potential for patient harm, the consequences of inadequate quality management can be devastating. But by making strategic investments in quality systems, fostering a culture of quality, and leveraging regulatory incentives, compounding facilities can reduce risks, improve efficiency, and, most importantly, protect patient safety.
Read MoreThe FDA's proposed rule on drugs deemed difficult to compound marks a significant shift in regulatory oversight. This rule targets three specific categories: oral solid modified-release drug products with coated systems (MRCs), liposome drug products (LDPs), and drug products made via hot melt extrusion (HME). The FDA uses six criteria to assess difficulty: complexity in formulation, drug delivery mechanisms, dosage forms, bioavailability, compounding processes, and testing requirements. If implemented, this rule could significantly impact the compounding industry, limiting the ability to produce certain complex medications and potentially affecting patient access to customized treatments.
Read MoreThe compounding industry is complex, and success requires more than just meeting minimum regulatory standards—it requires a commitment to quality, operational efficiency, and proactive planning. For 503A and 503B drug companies, partnering with a specialized consultant like Restore Health Consulting LLC can make the difference between compliance struggles and long-term success.
Read MoreRisk assessment is a critical component of the cleaning validation process in the compounding industry. It helps identify potential hazards, assess their impact, and prioritize efforts to mitigate risks associated with contamination. Conducting a thorough risk assessment ensures that the cleaning processes are robust, effective, and safeguard patient safety. This article describes a detailed example of how a risk assessment for cleaning validation might be conducted.
Read MoreCleaning validation is an essential process in the pharmaceutical compounding industry. Its primary goal is to ensure that compounding equipment is free of contaminants before it is used for production. This article explores the key concepts in developing a sound cleaning validation protocol.
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