A Tower Of Medication Shortages: Leveraging Medication Repackaging Automation and Adaptive Staffing Strategies

Objective: Medication shortages disproportionately impact oncology practices due to reliance on high-risk therapies and limited therapeutic alternatives. This case study describes the operational and staffing strategies implemented to mitigate a prolonged unit-dose acetaminophen shortage and sustain oncology supportive care services.

Methods: From October 2023 through July 2024, pharmacy operations at Mayo Clinic in Rochester, Minnesota, managed a shortage of commercially available unit-dose acetaminophen 500-mg tablets. Pharmacy leaders implemented adaptive staffing models, including equitable overtime distribution, overnight and early-morning repackaging shifts, pharmacist batch verification, and staff feedback–driven workflow adjustments. Repackaging volume and overtime hours were tracked to assess operational impact and workforce sustainability.

Results: The shortage led to a near doubling of pharmacy repackaging workload, peaking in December 2023 with approximately 44,000 unit-dose tablets repackaged in a single month. Overtime hours increased substantially during peak shortage periods. Implementation of batch verification (1000-unit batches), staggered repackaging schedules, and equitable overtime assignment reduced workflow inefficiencies, minimized shift trading, and improved staff satisfaction. Pharmacy operations successfully maintained uninterrupted access to acetaminophen for oncology patients despite a concurrent 10% technician staffing deficit.

Conclusion: High-volume supportive care medication shortages place significant strain on oncology pharmacy operations. This case study demonstrates that adaptive staffing strategies, batching efficiencies, and frontline staff engagement can effectively mitigate operational burden and preserve patient access during prolonged shortages. Scalable, technology-enabled repackaging workflows and proactive workforce planning are essential for sustaining oncology pharmacy services amid ongoing medication shortages.

Medication shortages are a well-known challenge in the United States’ health care system, and the COVID-19 pandemic only exacerbated the issue. All types and forms of medications are affected by medication shortages, especially OTC medications used to treat a variety of ailments and indications. Results of a recent Vizient study showed that medication shortage-related activities cost hospitals nearly $900 million in 2025 in excess staffing needs and an additional $230 million in substitute medication purchases in 2019.^1,2

Oncology practices are uniquely vulnerable to medication shortages due to their reliance on high-risk, high-cost injectable therapies, narrow therapeutic alternatives, and supportive care medications essential for treatment tolerance and continuity. Shortages of chemotherapeutic agents, antiemetics, analgesics, and electrolyte replacements can directly disrupt cancer care delivery. Acetaminophen is a high-volume supportive care medication that can pose significant operational impacts to the oncology pharmacy practice when in short supply.

Acetaminophen is used for pain and fever relief in a wide range of patient populations. In cancer care specifically, acetaminophen is often utilized as an option within multimodal pain treatment plans for chemotherapy, tumor growth, surgical procedures, or mucositis. It is essential that oncology patients have access to all pain relief options. Access to acetaminophen is particularly important for patients experiencing drug-disease interactions such as thrombocytopenia or poor renal clearance. As such, these patients cannot often use standard nonsteroidal anti-inflammatory drugs and must take acetaminophen. These factors render oncology clinicians and pharmacists vulnerable to acetaminophen shortages. Unlike many nononcology medications, oncology therapies often lack clinically equivalent alternatives, requiring pharmacy operations to rapidly adapt dispensing, repackaging, and verification workflows during shortages.

Acetaminophen is a ubiquitously utilized medication, and seasonal respiratory conditions in demand can create a critical supply gap. Peaks in demand lead to intermittent supply gaps, posing a serious threat to the necessary access to acetaminophen in both inpatient and outpatient oncology settings. During medication shortages, health care institutions are forced to take a multifaceted approach to ensure that medications are reserved for the most vulnerable patients, such as the oncology population. For example, oncologists may restrict the use of acetaminophen in oncology patients who are opioid-intolerant or patients experiencing chemotherapy-induced fevers.³ It is vital for oncology clinicians to collaborate and communicate with pharmacy operations leaders to know the quantity of acetaminophen supply on hand and to recognize opportunities for maintaining a consistent supply. Pharmacy leaders are responsible for devising an operational strategy to ensure oncology patients continue to have access to acetaminophen during the medication shortage. Although this analysis focuses on a unit-dose acetaminophen shortage, the operational strategies described were intentionally designed to be scalable to other high-volume oncology and supportive care medication shortages. This scalable strategy includes having a dedicated, knowledgeable team to monitor existing supplies, research alternative therapies, and partner with clinician experts to ensure these therapies are available to other patient populations, thereby allowing acetaminophen supplies to be reserved for oncology patients.

Background

There are many types of acetaminophen formulations and commercially available medication options in the pharmaceutical supply chain. Two common options include unit-dose packaging and bulk container products.^4,5 The FDA defines medications packaged for unit dose dispensing as a single dose for a specific patient at the time of administration.⁴ Conversely, the FDA defines bulk drugs as finished dosage forms in bulk quantities (eg, 100 tablets) intended for further repackaging into unit-dose packaging.⁵ Purchasing unit-dose medications as opposed to bulk medications from pharmacy vendors when available improves medication safety from receipt of shipment to the point of administration because it offers a manufacturer product-specific barcode. This enhances barcode medication administration and minimizes unnecessary workload on pharmacy oncology operations and oncology staff, as these medications can be dispensed without further manipulation. During medication shortages, many unit-dose options become unavailable, creating a new workload for pharmacy oncology operations staff by requiring them to repack tablets from bulk containers into a single unit dose for patient use.

Oncology pharmacy practices perform a wide array of services, from infusion compounding to dispensing oral solid dosage forms. These pharmacy practice areas can manage medication shortages on a small scale, intermittent basis. In fall 2023, Mayo Clinic in Rochester, Minnesota, faced a long-term shortage of commercially available, unit-dosed 500-mg acetaminophen tablets. This shortage significantly increased the workload, as approximately 1 million doses are dispensed to patients annually, including oncology patients.

Given the supply shortage of the high-volume, unit-dose acetaminophen, pharmacy repackaging operations’ workload nearly doubled. It is not uncommon for pharmacies to repackage medication from bulk supply to unit doses, but the shortage of unit-dose acetaminophen immediately frustrated many pharmacy staff already stressed by staffing shortages. In the wake of medication shortages, this stress is compounded. At the time of the unit-dose acetaminophen shortage, Mayo Clinic Rochester pharmacy reported more than 20 technician openings, a 10% staffing deficit compared with normalized technician staffing plans. This staffing deficit placed a critical burden on the pharmacy operations staff to maintain adequate staffing levels and continue supporting the oncology pharmacy practice while navigating the new acetaminophen medication shortage. Although it is not ideal to place the burden of repackaging medications from bulk to unit dose on Pharmacy staff, it is at times the only alternative without drastically altering care practices. Because this shortage was not initially anticipated to last more than 60 days, reallocation of staff resources and voluntary overtime were elected as the best course of action. With that said, this particular shortage lasted longer than anticipated.

Study Design and Methods

Study Design

The project was conducted within the Mayo Clinic Rochester pharmacy repackaging area, which supports medication preparation and unit-dose packaging needs for patient care areas. During the acetaminophen shortage, commercially available unit-dose supply was insufficient to meet operational demand, requiring the department to rely more heavily on internal repackaging of bulk acetaminophen tablets.

This project used a retrospective, descriptive operational study design to evaluate the impact of the unit-dose acetaminophen tablet shortage on pharmacy repackaging workload, staffing resources, and overtime utilization. The evaluation focused on October 2023 through July 2024, when Mayo Clinic Rochester experienced sustained operational disruption related to the limited supply of commercially available unit-dose acetaminophen tablets.

The shortage led to a significant increase in internal repackaging demand and required the pharmacy department to implement additional staffing strategies, including overtime, modified shift coverage, and targeted repackaging support outside standard operating hours. The purpose of this analysis was to describe the operational burden associated with the shortage, quantify changes in repackaging workload and overtime hours, and evaluate staff-reported concerns related to workload sustainability and fatigue.

Intervention and Staffing Response

Pharmacy supervisors developed an overtime plan to support the increased workload of repackaging acetaminophen. Supervisors communicated the need for additional repackaging support by email and asked employees to volunteer for overtime shifts dedicated to acetaminophen repackaging.

Additional staffing strategies included offering partial shifts, using early morning and overnight hours, and coordinating volunteer support from both pharmacy technicians and pharmacists. Staffing coverage of up to 8 hours per shift could be accommodated when needed, although full-shift coverage was not always required. This flexible approach allowed staff to contribute based on availability while helping the department increase unit-dose acetaminophen inventory without significantly disrupting other pharmacy workflows.

To promote equitable access to overtime opportunities and reduce the risk of staff fatigue, supervisors reviewed technician overtime requests and distributed available overtime hours across staff members when possible. This approach was intended to balance workload demands, support staff engagement, minimize burnout, and maintain continuity of repackaging operations.

Supervisors followed up weekly on staffing schedules to ensure overtime was equitably dispersed among all employees who were interested. Supervisors would post shifts on a weekly basis for staff sign-up of shift preference, where supervisors would review, approve, or change the overtime staffing volunteers to ensure equitable and sustainable overtime repackaging staffing. The pharmacy technician and pharmacist approaches were similar, with most acetaminophen repackaging occurring on overnights or early morning shifts during expected pharmacy lulls. Pharmacists were also asked about opportunities to minimize workload-related burnout. One strategy implemented for the pharmacist team was batch verification and checking. This involved waiting until a repackaging batch quantity of 1000 units was reached before involving a pharmacist to check. This allowed the pharmacist supervisor to avoid requiring a dedicated pharmacist to be staffed in the repackaging work area throughout the repackaging process.

Data Collection

Data were collected from 2 primary sources: overtime logs and an internal repackaging database.

Overtime hours were recorded in a manual overtime log maintained in the dedicated pharmacy repackaging work area. Pharmacy technicians who worked additional hours specifically related to acetaminophen repackaging were instructed to document their overtime in the manual log. The log captured employee-specific overtime details, including the date, time worked, employee name, and number of overtime hours worked. These data were used to quantify the additional labor resources required to support acetaminophen unit-dose repackaging during the shortage period.

Repackaging workload data were obtained from the department’s internal repackaging database. This database captured repackaging work units of service and was used to measure changes in total repackaging workload over time. Acetaminophen-related repackaging volumes were reviewed alongside overall repackaging activity to assess the impact of the shortage and the resulting increase in operational demand on the repackaging area.

Data Analysis

Overtime log data were reviewed to calculate the total number of overtime hours worked in support of acetaminophen repackaging. The data were also used to evaluate patterns in overtime utilization, including the distribution of hours across employees and the timing of overtime shifts. Supervisors reviewed this data to assess staffing burden and to inform ongoing scheduling decisions.

Repackaging database data were analyzed descriptively to evaluate changes in workload volume during the shortage period. Work units of service were compared across time periods to identify changes in repackaging demand before and during the most operationally intense phase of the shortage. Particular attention was given to the increase in workload observed between September 2023 and December 2023, during which the repackaging workload increased by nearly 90%.

Although the burnout assessment was primarily qualitative, staff feedback consistently reflected concern about the volume of acetaminophen unit-dose repackaging required to meet patient care needs and the long-term sustainability of the manual repackaging response. Supervisors also monitored operational staffing behaviors during the shortage response. During this period, supervisors observed an increase in shift swapping among pharmacy technicians. This appeared to reflect an effort by some staff members to reduce the amount of time spent in the dedicated repackaging work area. These observations were considered alongside group discussion feedback as additional indicators of workload strain and staff fatigue.

Measures

The primary operational measures included as follows:

1. Total acetaminophen repackaging workload, measured through internal repackaging work units of service
2. Total overtime hours worked for acetaminophen repackaging, collected through the manual overtime log
3. Qualitative staff feedback regarding workload, burnout, fatigue, and process sustainability

Together, these measures provided a more complete view of the operational impact of the acetaminophen shortage, including both measurable workload burden and staff-reported experience.

FIGURE 1 HERE

FIGURE 2 HERE

Results

To successfully manage the high-volume acetaminophen shortage, supervisors need to recognize the importance of supporting a healthy work-life balance for pharmacy technicians and pharmacist staff. The 1000-unit batch strategy freed a pharmacist’s time for other work areas throughout the day while still allowing the pharmacist to finalize large quantities of acetaminophen for patient care needs. It was found that a pharmacist could reasonably check up to 3 batches of 1000 acetaminophen units within an 8-hour shift. Furthermore, a quarantine process was initiated for the repackaged unit-dose acetaminophen, with the batch quantities produced placed in a separate location for a pharmacist to check as time allowed. This provided space for both unit-dose acetaminophen checks while another pharmacist addressed general pharmacy repackaging needs.

Strategies such as equitable overtime staffing and batching enabled the pharmacy staff to manage the excessive acetaminophen volumes more effectively while minimizing ongoing strain on the team. Further discussions were held during routine staff huddles to gather feedback and input on how to proactively address and mitigate the excessive workload hours required to manage a high-volume medication shortage, such as the unit-dose acetaminophen. The suggestion that was brought forward and then implemented was to stagger the specific mediations shortage batch preparations so that each was processed every other day. The technician staff were very grateful that their voices were heard, which resulted in the technician staff refraining from trading assignments. Gathering direct feedback from staff and seeking their input throughout the process was the best way to gauge and measure the impact of the shortage and staff burnout. Leveraging an external repackaging company has since reduced the workload for highly repackaged medications. This, in itself, has greatly increased staff satisfaction, allowing them to devote greater concentration to enhancing the quality of their work.

FIGURE 3 HERE

As shown in Figure 1 and Figure 3, the overall workload and overtime hours peaked in December 2023 with the largest volume of unit-dose acetaminophen repackaging being as high as 44,000 doses within a single month.

The many measures identified and implemented by pharmacy supervisors to manage the high volume of the acetaminophen shortage resulted in reduced staff strain. This was apparent in the decrease in independent shift swapping and in the reduction in signs of staff frustration.

Discussion

The unit-dose acetaminophen tablet shortage created a high-impact operational stress test for pharmacy repackaging services and highlighted the significant labor burden that can result when commercially available unit-dose supply is disrupted. Although acetaminophen is a commonly used supportive care medication, the shortage created significant operational consequences due to the volume required to support routine inpatient and oncology practice needs. This experience is consistent with national data demonstrating that drug shortages are highly prevalent across health systems, frequently require operational management strategies, and can create substantial labor and budgetary burden for pharmacy departments.⁶ The experience demonstrated that medication shortages are not limited to procurement challenges; they can rapidly evolve into complex operational events requiring coordinated staffing, workload redistribution, inventory monitoring, communication, and leadership engagement.^6,7 American Society of Health‑System Pharmacists (ASHP) guidelines emphasize that drug shortages require structured operational and therapeutic assessment, defined team roles, inventory evaluation, communication planning, and mitigation strategies to reduce patient care and operational impact.⁷

A key intervention during the acetaminophen shortage was the development of a structured overtime staffing model to support increased repackaging demand. Overtime opportunities were communicated to pharmacy staff, and hours were documented using a manual log that captured the date, time, employee name, and overtime hours worked. This approach allowed department leaders to quantify the additional labor required to maintain unit-dose supply and to distribute overtime opportunities across available staff. By tracking overtime hours, supervisors were able to monitor the human resource impact of the shortage and identify when routine staffing models were insufficient to meet operational demand. This approach aligns with ASHP guidance that organizations should track drug and personnel costs related to shortages, as such accounting supports budget variance explanations, staffing requests, and resource planning.⁷

Supervisor involvement in the repackaging workload was another notable strategy. Work area supervisors assisted directly with repackaging activities to expand the available labor pool and reduce the burden on frontline pharmacy technicians. This intervention had several benefits. First, it redistributed work across a broader group of pharmacy personnel. Second, it reinforced visible leadership presence during a period of operational strain. Third, it created an opportunity for supervisors to gain a more immediate understanding of frontline workflow constraints, including the physical repetitiveness, time intensity, and competing demands associated with high-volume repackaging work. ASHP guidelines recognize that shortage response requires clearly defined roles, teamwork, and sufficient staffing to execute operational changes such as repackaging, inventory movement, system updates, and communication activities.⁷

The direct participation of supervisors appeared to have a positive cultural effect. Frontline staff and supervisors reported a greater sense of shared purpose when working together to address the shortage. This type of leadership engagement may strengthen workforce trust by demonstrating that leaders are willing to participate in the operational burden rather than delegating the response entirely to frontline staff. In this case, supervisor involvement may have contributed to stronger staff engagement, improved mutual understanding, and a greater sense of collective ownership over the shortage response. This is relevant because ASHP notes that drug shortages can create frustration and stress for purchasing agents, pharmacists, pharmacy technicians, nurses, physicians, and patients, underscoring the importance of visible leadership, communication, and coordinated team response.⁷

The increase in shift swapping among pharmacy technicians further underscored the strain of the repackaging workload. Staff appeared to trade assigned repackaging shifts to reduce the number of hours spent in the dedicated repackaging area. Although shift swapping may reflect peer-to-peer flexibility, in this context, it also served as an operational signal of fatigue and task burden. This finding is consistent with ASHP survey data showing that drug shortage management is labor-intensive and can divert pharmacy time and resources away from other clinical and operational responsibilities.⁶

Manual overtime logs and retrospective database review were useful for understanding the operational burden, but they may not provide the real-time visibility needed during rapidly evolving shortages. Future-state processes could include dashboards that integrate inventory levels, repackaging output, projected demand, overtime hours, staffing availability, and shortage duration estimates. Real-time visibility would allow leaders to identify when workload is exceeding internal capacity and when additional interventions are needed. ASHP guidelines recommend assessing inventory on hand, estimating duration of supply using historical utilization, evaluating alternative supply sources, and reassessing shortage status as availability changes.⁷ This type of infrastructure may be especially important for medications supporting oncology practice, where treatment continuity, symptom management, and supportive care needs are highly time-sensitive. ASHP’s 2023 survey found that antineoplastic shortages were among the most critically impactful shortage categories reported by respondents.⁶

Limitations

Several limitations should be considered when interpreting this experience. First, overtime data were collected through a manual log. Although the log captured important details, including date, time, employee name, and overtime hours worked, manual documentation is vulnerable to incomplete or delayed entries, transcription errors, and inconsistent interpretation of what should be counted as shortage-related overtime. Although ASHP recommends tracking personnel and drug costs associated with shortages, manual logs may be less reliable than standardized electronic tracking mechanisms for real-time shortage management and resource planning.⁷

Second, staff burnout and fatigue were assessed primarily through qualitative feedback through in-person discussion groups and supervisor observations. These sources provided valuable insight into staff experience but were not collected using a validated instrument. Therefore, conclusions about burnout should be interpreted as descriptive and experience-based rather than as a formal quantitative measurement. This limitation is important because drug shortages are known to create stress and frustration for pharmacy staff and other health care professionals, but formal measurement would be needed to quantify the magnitude of burnout or compare findings across settings.⁷

Third, redistributing the workload to supervisors does not eliminate the burden; it transfers part of it to another already-taxed workforce group. Although supervisor participation helped support frontline staff, it created a substantial workload impact for supervisors, who were simultaneously responsible for staffing coordination, operational decision-making, communication, inventory monitoring, and direct production support. Monthly overtime hours increased to an average of 24 hours for frontline staff in January 2024 and reached about 53 additional hours for a supervisor in December 2023 as a direct result of the shortage response. These data suggest that supervisor involvement can be an effective short-term mitigation strategy but may not be sustainable during prolonged shortages without additional leadership support, role coverage, or escalation pathways. ASHP guidelines emphasize that no single person can manage all shortage planning and response activities alone, reinforcing the need for defined team-based infrastructure and escalation processes.⁷

Finally, this analysis focused on operational response rather than clinical outcomes. Although the shortage response was designed to maintain medication availability and continuity of care, the analysis did not directly measure patient-level outcomes, medication administration delays, missed doses, substitution rates, or downstream clinical impact. ASHP guidelines identify patient safety, medication errors, delayed care, alternative therapy use, and effects across the medication-use process as key concerns during drug shortages, which should be considered in future evaluations.⁷

Generalizability to Other Practice Settings

Despite these limitations, the lessons from this shortage are broadly applicable to other hospital and health-system pharmacy settings. The operational principles identified in this experience—early workload identification and assessment, formal overtime tracking, flexible staffing, supervisor engagement, and staff feedback—can be adapted to a wide range of practice environments. ASHP guidelines provide a broad framework for shortage management in patient care settings, including infrastructure development, operational assessment, therapeutic assessment, final action planning, communication, and inventory system changes.⁷

For large hospital systems, the results of this study support the need for standardized shortage response playbooks that include repackaging capacity planning and workload visibility. For smaller hospitals, the findings may reinforce the importance of regional collaboration and a shared approach to mitigating medication shortages. For oncology-focused practice settings, the findings are particularly relevant because supportive care medications such as acetaminophen, antiemetics, and antimicrobials can have a significant operational impact when supply is disrupted. ASHP’s 2023 survey findings demonstrate that drug shortages are widespread across hospital and health system settings and that many organizations experience moderate or critical impacts on operations and patient care.⁶

This experience also has relevance beyond acetaminophen. Any high-volume medication shortage requiring internal unit-dose conversion can create similar stressors, especially when the product is used across multiple service lines or when alternative dosage forms are limited. ASHP specifically identifies repackaging into smaller dosage units, purchasing different strengths or package sizes, centralizing inventory, adjusting periodic automatic replenishment levels, and changing preparation or dispensing procedures as potential shortage mitigation strategies.⁷ Therefore, the framework developed from this shortage may be applicable to other tablet, capsule, oral liquid, or other high-volume supportive care medication shortages requiring significant operational intervention.⁷

Ultimately, this shortage demonstrated that successful medication shortage management requires more than acquiring additional quantities of medication from distributors; it requires a coordinated operational infrastructure that accounts for workload, staffing capacity, staff well-being, supervisor engagement, and patient care continuity. This conclusion aligns with ASHP guidance, which states that shortage management depends on effective information gathering, teamwork, rapid operational changes, and clear communication with providers, patients, and administrators.⁷

Conclusion

High-volume medication shortages, including those involving supportive care agents used in oncology practice, can create significant operational and staffing challenges for hospital pharmacies. The unit-dose acetaminophen tablet shortage placed substantial strain on pharmacy repackaging operations and required additional staffing resources, flexible scheduling strategies, supervisor engagement, and ongoing staff feedback to maintain adequate medication supply. National ASHP survey data reinforce that drug shortages commonly require operational management strategies and may increase both drug and labor budgets.⁶

This experience demonstrated that internal repackaging can serve as an effective bridge during medication shortages, but it may not be sustainable when demand is prolonged or when workload increases exceed baseline staffing capacity. Overtime utilization, shift swapping, supervisor workload, and staff-reported fatigue all served as important indicators that the existing process was under significant strain. ASHP guidance supports repackaging as one possible conservation or mitigation strategy, while emphasizing the need to evaluate personnel costs, operational feasibility, patient safety, and communication requirements during shortage response.⁷

Future shortage response models should include clear escalation thresholds, real-time workload monitoring, structured overtime tracking, staff well-being assessment, and consideration of qualified third-party repackaging vendors when internal capacity is exceeded. ASHP guidelines recommend that organizations develop shortage infrastructure before shortages occur, perform operational and therapeutic assessments, track costs, and establish final action plans that define roles, timing, communication, and required system changes.⁷

Institutions must remain adaptive and proactive in developing creative staffing plans while continuously soliciting staff feedback to ensure that pharmacy teams can meet patient care needs without compromising workforce sustainability. Effective internal and interdisciplinary communication is also essential to minimize care disruptions and maintain alignment between pharmacy operations and the clinical practice areas they support. ASHP emphasizes that communication should be timely, prospective, and multidisciplinary, including pharmacy staff, clinicians, administrators, and other affected stakeholders.⁷

By remaining vigilant, agile, and deliberate in shortage response planning, pharmacy teams can preserve safe and effective medication access for oncology patients and other vulnerable populations, even during periods of significant supply disruption. This approach is consistent with ASHP’s broader framework, which holds that proactive shortage planning can reduce adverse effects on patient care, mitigate health care organization costs, and prevent shortage-related operational issues from escalating into crises.⁷

References

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2. New Vizient survey finds drug shortages cost hospitals nearly $900M annually in labor expenses, Vizient. June 17, 2025. Accessed February 18, 2026. https://www.vizientinc.com/newsroom/news-releases/2025/new-vizient-survey-finds-drug-shortages-cost-hospitals-nearly-900m-annually-in-labor-expenses

3. Hantel A, Siegler M, Hlubocky F, Colgan K, Daugherty CK. Prevalence and severity of rationing during drug shortages: a national survey of health system pharmacists. JAMA Intern Med. 2019;179(5):710-711. doi:10.1001/jamainternmed.2018.8251

4. CPG Sec 430.100 unit dose labeling for solid and liquid oral dosage forms. FDA. February 1984. Accessed February 18, 2026. CPG Sec 430.100 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms | FDA

5. CPG Sec. 410.100 *Finished dosage form drug products in bulk containers-applications of current good manufacturing practice regulations. FDA. September 1987. CPG Sec. 410.100 *Finished Dosage Form Drug Products in Bulk Containers - Applications of Current Good Manufacturing Practice Regulations* | FDA

6. American Society of Health-System Pharmacists. Severity and impact of current drug shortages. June/July 2023. Accessed February 18, 2026. https://www.ashp.org/-/media/assets/drug-shortages/docs/ASHP-2023-Drug-Shortages-Survey-Report.pdf

7. Fox ER, McLaughlin MM. ASHP guidelines on managing drug product shortages. Am J Health Syst Pharm. 2018;75(21):1742-1750. doi:10.2146/ajhp180441