Navigating Pharmacy Regulatory Compliance Challenges in Supply Chains
5 steps to strengthen compliance in a high-stakes regulatory landscape
From procurement and receipt to storage and dispensing, nearly every aspect of pharmacy supply chain operations is subject to regulatory oversight. Keeping up with regulatory compliance complexities while dealing with the daily demands of drug shortages, workforce challenges and rising costs can seem like an impossible feat.
A primary reason why pharmacies struggle to comply is the tangled web of disconnected systems, varied workflows (some automated, some manual) and siloed data that obscures visibility throughout the pharmacy supply chain. Then there are all the different people who handle drug products: Pharmacy technicians, clinicians, pharmacists, pharmacy supply chain staff members, etc.
This blog explores the evolving regulatory landscape impacting pharmacy supply chain operations, including key pharmacy regulatory compliance challenges presented by federal and state-level regulations.
It outlines how forward-thinking strategies, cross-functional collaboration and integrated technology can turn a compliance burden into a strategic supply chain strength.
DSCSA compliance: Safer drugs, stricter standards
Under the FDA’s Drug Supply Chain Security Act (DSCSA), pharmacies must electronically track prescription drugs by serial number, lot number, expiration date and National Drug Code (NDC). They can no longer rely solely on their wholesalers for compliance — they now bear direct responsibility for verifying drug legitimacy.
The prime purpose of the DSCSA is to keep illicit and counterfeit drugs out of the U.S. supply chain, and if they do enter, quickly detect and remove them to avoid patient harm. If a pharmacy team can’t verify a drug’s chain of custody, they are required to sequester it until they can confirm its legitimacy.
Pharmacy regulatory compliance challenges and implications:
- Receiving incomplete or inaccurate DSCSA data from wholesalers or vendors
- Failing to understand the sequester and reporting processes for suspect drugs
- Lacking the tools to provide full product pedigree during audits
- Staffing gaps — many operational employees are unaware of DSCSA requirements
- Running out of a sequestered drug while waiting to verify its chain of custody
340B program compliance: Critical discounts, complex rules
The CMS 340B Drug Pricing Program allows eligible hospitals, or “covered entities,” to purchase drugs at significantly discounted prices. The program is vital for hospitals — especially those serving vulnerable populations — because it helps offset the high and rising cost of medications. However, access to 340B discounts comes with stringent eligibility requirements and complex compliance rules.
To remain compliant, pharmacy teams must ensure medications are dispensed only to eligible patients by covered providers, accurately track drug movement from purchase to administration, and apply the correct eligible pricing (340B, WAC, GPO) based on a hospital’s varied care settings and patient populations.
Pharmacy regulatory compliance challenges and implications:
- Applying the wrong pricing, leading to overspending or lost savings
- Navigating varied care settings, complicating eligibility compliance
- Documenting manually, raising audit failure risks
- Managing with limited staff, overburdening pharmacy teams
Controlled and hazardous drugs: Regulated risks, rigid rules
Health system pharmacies are subject to strict regulations around the management and handling of controlled substances and those deemed hazardous under USP General Chapter <800> standards. These regulations are enforced on the federal and state level by the FDA, CMS, TJC and state boards of pharmacy.
Pharmacy regulatory compliance challenges and implications:
- Failing to maintain complete and accurate records of drugs purchased, received, stored, distributed, dispensed and disposed (chain of custody)
- Jeopardizing drug effectiveness and safety by storing temperature-sensitive hazardous drugs (HDs), such as chemotherapy agents, in the wrong storage conditions
- Risking drug diversion by failure to implement additional storage security for controlled substances
- Misidentifying HDs in the drug formulary, which poses the risk for mishandling and exposure to healthcare workers and patients
5 steps toward pharmacy regulatory compliance
Achieving full compliance with all the various regulations can’t happen overnight, especially with all the other challenges faced by pharmacy leaders and their teams today. And it can’t happen in a silo. It takes the right combination of people, processes and technologies to bridge gaps throughout the pharmacy supply chain.
Here are five steps to take on your pharmacy regulatory compliance journey.
1. Foster multidisciplinary collaboration
As pharmacy operations grow more complex — with specialized areas like IV admixture, kits and trays, mail order items and repackaging — pharmacy regulatory compliance can no longer rest solely on the shoulders of pharmacy leaders.
Today, effective regulatory compliance requires broad collaboration across disciplines. Nurses, physicians, clinical pharmacists and even radiology or lab teams must be engaged alongside pharmacy, supply chain and administrative leaders.
Breaking down silos ensures that compliance strategies are grounded in real-world workflows and frontline insights, rather than top-down decisions that may overlook operational challenges.
By bringing together key stakeholders — both decision-makers and those executing daily tasks — health systems can align on goals, improve communication, and make informed choices that support both safety and regulatory success.
2. Monitor evolving regulations
If regulations, standards and guidance were static, stakeholders would have a pretty good shot of quickly catching up on pharmacy regulatory compliance gaps in their supply chains. Unfortunately, like healthcare itself, the rules are constantly evolving.
Pharmacy leaders and their teams must stay informed to proactively get ahead of regulatory changes, and risk not falling behind. The American Society of Health-System Pharmacists (ASHP) has a wealth of online resources, including guidance documents, podcast recordings, and advocacy statements on key issues, including 340B pricing.
The FDA, CMS, TJC and state boards of pharmacy also regularly publish updates and insights on pharmacy regulatory compliance practices. For example, the FDA and the Partnership for DSCSA Governance (PDG) are hosting three virtual town hall sessions in 2025 for “interested parties to share information on continued implementation of DSCSA interoperability and areas of remaining concern.”
3. Educate and empower staff
Pharmacy regulatory compliance isn’t just a leadership responsibility — it requires educating and empowering staff at every level with the knowledge and ownership needed to meet complex requirements.
Designating pharmacy supply chain leads to oversee compliance is essential but so is training operational employees — such as buyers, pharmacists and receiving techs — who interact directly with inventory and systems.
When frontline staff understand their compliance roles and are involved in decisions that impact their daily workflows, hospitals gain more resilient, accountable and audit-ready pharmacy operations. Empowered teams are better equipped to spot risks, follow protocols and uphold the integrity of the pharmaceutical supply chain.
4. Demand IT system integration and interoperability
Disconnected systems are a major obstacle to pharmacy compliance, forcing staff to duplicate work, creating inefficiencies and increasing the risk of error.
While some vendors resist interoperability of their systems with other solutions, especially those deemed competitive, connectedness is critical to bridging pharmacy regulatory compliance gaps.
A seamless, connected pharmacy ecosystem ensures accurate data capture, fewer manual steps and stronger compliance across every touchpoint. If a technology vendor refuses to collaborate on connectivity, it’s time to find a new solution.
5. Implement an overarching inventory management solution
While interoperability between existing systems is important, what pharmacies need is an end-to-end automated inventory management solution with features and capabilities specifically designed for pharmacy regulatory compliance.
Tecsys’ Elite™ Pharmacy Inventory Management System (PIMS) enables hospitals to scan drugs once at receipt and maintain a digital chain of custody through to patient administration. It captures item-level data — such as serial number, lot number, expiration date and NDC — in compliance with DSCSA, and integrates with key systems to centralize data, support audit trails and automate tasks like 340B program documentation.
With real-time, accurate and complete item level data for all drug products residing in a single repository, pharmacy leaders have the data foundation required for advanced analytics, including the use of AI tools. With the right insights, pharmacy leaders can make decisions that strengthen clinical, operational and financial performance.
Want to see what real-time pharmacy visibility looks like in action? Learn how Parkview Health reduced manual work by over 50% while strengthening compliance.