21st Century
2001: Pediatric patients fall ill as a result of a hospital pharmacy
Four patients in Missouri developed an infection after receiving IV ranitidine that had been mixed with Automated Compounding Devices. Poor employee hand hygiene and garbing were thought to be the causes of the issue.
2002: Five patients receive contaminated steroids, one dies
In South Carolina, five patients were given contaminated injectable steroids, resulting in one death. Researchers identified exophiala as the primary issue, and the incidents occurred up to 152 days following the injections. In this instance, untrained compounding personnel were deemed the main cause.
2004: Contaminated radioisotope equipment causes hepatitis C
Sixteen patients in Maryland contracted hepatitis C infections after being exposed to a Tc 99m radioisotope used during their cardiac stress tests. At the pharmacy responsible for preparing the radioisotopes, breaks in aseptic technique were cited.
Sterile compounding standards evolve
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On January 1, 2004, USP <797> Pharmaceutical Compounding – Sterile Preparations became an official chapter, replacing <1206>.
- Included BUD storage limits for the first time.
2007: Study reveals lack of prepared pharmaceutical graduates
A study conducted in 2007 regarding the extent of sterile compounding training at U.S. pharmaceutical schools revealed a lack of prepared graduates. About 13 percent of the school's deans claimed that their students were adequately trained in sterile compounding before graduation.
2008: USP revises <797>
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USP proposed a revision to Chapter <797> on November 27, 2007, placing an emphasis on individual training and evaluation of sterile compounding standards, and this revision became official on June 1, 2008.
Despite the fact that USP 797 was first introduced in 2004, its adoption and compliance was slow. A compliance survey of compounding pharmacists conducted in 2011 revealed that financial constraints and budget limitations were holding many compounders back from complying with the regulations.
2010: Pediatric patient dies in hospital due to compounding error
The child died after receiving a sodium chloride concentrate that was not compounded properly prior to administration.
2011: Multiple patients blinded due to Avastin contamination
Patients in California, Florida, and Tennessee were blinded after receiving compounded Avastin intravitreal injections. The injections had been contaminated during repackaging from large vials into single dose syringes. Additionally, one patient suffered permanent brain damage.
2012: New England Compounding Center (NECC) fungal meningitis outbreak
A widespread fungal meningitis outbreak was linked to contaminated preservative-free methylprednisolone acetate injections, compounded at a pharmacy that was not in compliance with USP 797 standards. The U.S. Centers for Disease Control and Prevention found 751 cases and 64 deaths across 20 states, primarily from Exserohilum rostratum fungus. The New England Compounding Center meningitis outbreak led to the closure of the facility, criminal charges, and new legislation to improve oversight of compounding pharmacies.
2013: A Connecticut hospital identifies contaminated magnesium sulfate
Yale-New Haven Hospital identified visible mold in 5 bags of IV Magnesium Sulfate, which were prepared and repackaged by a repackaging pharmacy in New Jersey. Upon investigation of the New Jersey pharmacy, the FDA found multiple contaminated products and risky compounding practices that were far below industry standards, including contaminated non-sterile equipment in the cleanroom, compounding personnel with an active eczema condition, and mislabeled preparations, both in drug and strength. The pharmacy has since been shutdown.
2013: A Georgia pharmacy recalls 79 lots of products
Products intended for retinal injections were recalled due to a risk of eye infection.
2013: 15 patients are infected in Texas, 2 die
Patients are infected and two individuals die due to a batch of compounded IV calcium gluconate.
2013: The Drug Quality and Security Act (DQSA) becomes law
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Congress passes the DQSA, Title I of which is the Compounding Quality Act.
- This act amended section 503a of the Food, Drug and Cosmetic Act (FD&C), to increased FDA authority to regulate compounding pharmacies.
- It created a new entity, outsourcing facilities, under section 503b, and revised 503a to require that traditional compounded preparations must comply with USP chapters on compounding.
- This law requires the FDA to engage in two-way communication with regulators—state boards of pharmacy must inform the FDA when they send a warning letter or impose sanctions in regards to compounding medications.
2014: Patient dies after receiving the wrong drug
An Oregon patient dies after receiving rocuronium instead of fosphenytoin. The labeling was correct, but the rocuronium went unnoticed.
2015: Voluntary recalls continue across the U.S.
Recalls impacting compounded drugs continue across the U.S.
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The FDA announced in Sept. 2015 that U.S. Compounding, Inc., had issued a voluntary recall of all sterile compounded products.
- Downing Labs, Inc., issues a voluntary recall of compounded materials in Oct. 2015.
- Hospira begins a recall in March 2015 due to mold contamination in its compounded drugs.
2015: USP releases revisions to <797> for public comment
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In 2014, USP met with FDA and CDC to prepare for revisions to <797>. The proposed revisions were released for public comment in 2015.
- The revisions received over 8,000 public comments from stakeholders, so the draft was further revised by USP.
- Between 2015 and 2020, extensive stakeholder engagement events were held.
2016: CDC and New Mexico Health Department link unsafe compounding and injection practices to multiple abscesses and osteomyelitis in patient
Multidose vials at an outpatient facility were found to be contaminated, resulting in abscesses at an injection site and osteomyelitis requiring surgery. Investigations cited lapses in infection control, environmental monitoring, compounding, and safe injection practices.
2016: 17 reported cases of fungal bloodstream infections and 2 deaths linked to contaminated compounded IV flush solutions
An outpatient oncology clinic in New York City had administered compounded saline, heparin, vancomycin, and ceftazidime IV flush bags that did not meet <797> and <800> standards, nor CDC infection control and FDA guidelines. They were improperly stored and used for multiple patients far beyond the BUDs allowed by <797>.
2017: Contaminated pharmacy bulk packaged products (PBP) result in 41 cases of septic arthritis
41 cases of septic arthritis at a NJ outpatient knee clinic were linked to contaminated intraarticular injections. An investigation identified multiple breaches of sterile compounding and infection-control standards, including inadequate hand hygiene, improper garbing, substandard injection techniques, and improper handling of pharmacy bulk packages (PBPs). Injections were prepared several days in advance, outside of appropriate compounding environments, not in compliance with sterile compounding requirements, and were used for multiple patients.
2018: CDC releases report on compounding related outbreaks
The report highlighted the frequency of non–patient-specific compounding from non-sterile ingredients and the repackaging of products as a source of contamination. The report also cited failures in aseptic technique and weaknesses in sterilization methods, as well as in sterility and endotoxin testing.
2018: USP releases second <797> draft revision
This draft considered all the stakeholder feedback on the 2015 draft, as well the available scientific evidence, including the 2018 CDC report. Public comments indicated further stakeholder feedback and additional revisions were required.
2019: USP publishes <797> revision in USP-NF
Upon publication of the chapters, USP received appeals, in accordance with USP By-laws, to the chapters from stakeholders regarding key provisions. An appeals panel determined that further dialogue and consideration was warranted, and <797> was remanded to the Compounding Expert Committee for further revision.
2021: USP proposes fourth draft revision to <797> for public comment
On September 1, 2021, after extensive deliberation and stakeholder engagement, and a review of over 14,000 public comments, USP proposes a fourth draft for public comment. This public comment lasted until beyond the typical 90 days to March 2022. This draft received 1400 public comments, which were reviewed and a final draft was published 6 months later.
2022: USP publishes final revision of <797> in USP-NF
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After nearly a decade of revision, public comments, and stakeholder engagement, USP publishes the final revisions to <797> on November 1, 2022. This revision becomes official and enforceable on November 1, 2023.
2023: USP <797> 2022 revisions become official and enforceable
Recent developments and emerging concerns (2019–present)
The long-awaited revision of USP <797>, completed after nearly a decade of work, reflects meaningful advances in science, technology, and best practices for sterile compounding. The hope is that these updated standards will reduce the frequency of preventable compounding-related incidents. Yet, the impact of <797> is ultimately dependent on compliance and enforcement. USP itself has no enforcement authority, and implementation depends on state adoption and oversight. Alarmingly, not all states have incorporated the standard fully into their regulatory codes, and a 2015 survey found that only 30% of states required reporting of serious adverse events, leaving significant gaps in surveillance and accountability.
Against this backdrop, the FDA continues to document insanitary conditions and issue Safety Alerts for compounded medications. These recurring findings underscore a persistent truth: USP <797> provides only the foundation from which compounders must build a robust quality-driven practice. The reality of ongoing risks is reflected in a 2020 ISMP survey in which 74% of respondents reported awareness of at least one compounding error in the previous year.
As compounding practices evolve, new challenges continue to emerge. The rise of compounded GLP-1 agonists, for example, has prompted significant concern; as of December 2024, the FDA had identified over 900 adverse events linked to compounded GLP-1 products, including 17 deaths. Similarly, the growth of IV infusion services in medspas—often staffed by individuals without medical training and operating without clear regulatory oversight—has led to additional injuries and fatalities linked to contaminated infusions.
Taken together, these contemporary developments illustrate that while standards continue to evolve, the core issue is not the absence of guidance, but rather inconsistent adherence to the standards already in place. Nearly all of these incidents are preventable. A sustained commitment to implementing USP <797> as the minimum standard, coupled with facility-specific SOPs and robust quality assurance systems, is essential. Strengthening compliance, reporting, and regulatory harmonization will be critical to reducing avoidable harm and improving patient safety in sterile compounding pharmacy practice in the years ahead.
