From Apothecaries to Innovation: DWK Supporting the Enduring Power of Compounding Pharmacies

Compounding pharmacies have been in existence since the early 1900s with pharmacists responsible for preparing nearly all prescriptions. Compounding services began to wane, and were reduced to a niche role, in the mid-20th century with the industrialization of drug manufacturing. Experiencing a resurgence driven by compounding personalized therapies, pediatric dosing, and in 2012 coming to the aid of drug shortages¹.

The global compounding pharmacy market is projected to grow from $13.3B in 2024 to over $21B by 2033, driven by the importance of preparing customized medications for patients when commercially available drugs do not meet specific needs inclusive of;

Converting dosage forms (tablet, liquid, injection)
Adjusting strengths (pediatric or geriatric patient body mass index)
Removing allergens or excipients (reduce side effects and address contraindications)
Combining multiple active ingredients (into one preparation to increase compliance and effectiveness)
Fulfilling Short Supply Demand (commonly sterile injectable dose forms)

North America is forecasted to hold ~46% share followed by Europe at ~24%².

Today, compound pharmacies remain indispensable despite haven taken divergent paths geographically influenced by significant reforms, training, and regulated frameworks.

The EU market is relatively small compared to the 7,500 compounding pharmacies in the US with a larger number of US-based compound pharmacies capable of preparing sterile injectable medicines under national 503 guidelines. The EU does not have a centralized 503B characterization and rather relies on stringent individual member state regulations for quality control, competency, and cleanroom requirements. Thus, in the EU hospital pharmacies handle most of the sterile product compounding with community pharmacies rarely focused on non-sterile magistral preparations. In both the US and EU, hospitals and clinics rely on compounding pharmacies to fill gaps when commercial drugs are unavailable. In the US, shortages are typically addressed by 503B pharmacies preparing oral, topical and injectable dose forms while in the UE by Hospital pharmacies having limited sterile injectable drug production capacity.

Governance in the US falls under the FDA, USP and State Boards of Pharmacy while compounding pharmacies in the EU are governed by the EU GMP Annex 1 and disparate guidelines from national competent authorities within each member state. Recent pharmaceutical legislation known as the EU Pharma Law Package included specific amendments to the provisions for pharmacy compounding with the goals of making medicines more available, accessible, and affordable across the EU³. While the Package doesn't specifically introduce new technical rules for sterility (which are covered by existing GMP Annex 1 guidelines), it expands and clarifies the scope for making limited stock preparations in advance, particularly within hospitals, to help alleviate drug shortages, including sterile injectables. Annex 1 establishes strict requirements related to access barriers, human-borne contamination controls, air quality, flow, and monitoring, and process validation. This requires hospital pharmacies to invest in the necessary infrastructure, technology, and quality systems to meet these stringent requirements limiting training and practice opportunities resulting in sterile compounding being less widely implemented in the EU.

In the US, the USP plays a significant role in compounding guidance. With 2023 revisions to USP <795> Nonsterile Compounding, USP <797> Sterile Compounding, and USP <800> Handling of Hazardous Drugs raising the bar on compliance, training and competency assessments, documentation, and ready to use (RTU) protocols. Sterile compounding under USP <797> covers injectable drugs, infusions, ophthalmic solutions, and inhalation therapies. Requiring aseptic techniques be applied in ISO classified cleanroom-controlled environments, equipped with environmental monitoring and laminar flow, using RTU packaging components, under strict sterility quality controls. Recently of keen interest with the packaging of GLP-1, personalized parenteral, and biologic therapeutics.

In June 2024, the U.S. Pharmacopeia (USP) released its inaugural Drug Shortage Report^4,5 citing, US drug shortages hit decade-high levels—with over half of new shortages attributed to generic sterile injectables—driving sustaining demand for ready-to-administer dosages in RTU packaging from Compound 503B outsourcing facilities and qualified hospital pharmacies.

Essential Labware and Packaging Standards for Compound Pharmacies

Compound pharmacies require robust, high-quality solutions to address the demands of personalized prescriptions, urgent clinical needs, and drug shortages—all while maintaining rigorous standards of reliability and regulatory compliance.

Their key requirements include:

Operational Efficiency: solutions must streamline technician workflows, minimize preparation time, and reduce operational risks, thereby optimizing productivity across the compounding process.
Regulatory Compliance: access to comprehensive, audit-ready documentation is essential to support regulatory inspections and ensure continuous adherence to industry standards.
Supply Continuity: reliable lead times and robust safety stock are critical to maintaining uninterrupted patient care and effectively mitigating the impact of drug shortages.
System Integration: compatibility with existing automated filling and sealing equipment, whether manually operated or automated, is necessary for seamless implementation, ensuring minimal disruption to established workflows.
Cost Efficiency: integrated product offerings that reduce total cost of ownership support both the financial and operational objectives of compound pharmacies.

In daily practice, compound pharmacies depend on calibrated labware for precise formulation and mixing, storage containers with superior chemical resistance and durability, and leak-proof primary packaging to safeguard drug integrity throughout preparation, storage, and transport.

The adoption of ready-to-use (RTU) packaging is rising, driven by the need to meet strict sterility and shelf-life standards, allowing for direct integration into production workflows enhancing operational efficiency and consistent compliance with sterility standards. RTU components—delivered with audit-ready documentation and engineered for compatibility with hand and automated filling equipment—enable streamlined processes, reduce contamination risk, and meet rigorous requirements for particulates, endotoxins, and sterility control.

Furthermore, RTU packaging solutions enhance traceability and when customizable barcoding and marking are addedenable positive identification, and support anticounterfeiting measures, strengthening the integrity of compounded medications.

Compounding pharmacies rely heavily on manufacturers of labware and primary packaging, especially those providing ready-to-use (RTU) sterile solutions and components, for several critical reasons related to safety, efficiency, and regulatory compliance. Showing a strong preference for working with comprehensive, single-source providers, like DWK Life Sciences, who can supply a full range of labware, primary packaging, and ready-to-use (RTU) solutions supported by traceable regulatory documentation.

Learn more about DWK’s commitment to Compounder at https://www.dwk.com/primary-packaging/markets-and-applications/compound-pharmacy

*Images used in this article have been created using generative AI