DURECT Corporation (DRRX): PESTLE Analysis [Nov-2025 Updated]

You are looking at DURECT Corporation, a biotech stock that just went through a major acquisition, and you defintely need to know if the remaining value is real or just paper. The September 2025 merger with Bausch Health fundamentally changed the risk profile, swapping a critical $6.7 million cash crisis for a potential $350 million in Contingent Value Rights (CVR) tied to larsucosterol, their drug for severe alcohol-associated hepatitis. This PESTLE analysis cuts through the noise to show you exactly where the regulatory tailwinds and economic pressures land now that they are part of a larger entity.

Political: The FDA Accelerator

Political factors, specifically FDA actions, are the primary near-term accelerator for DURECT Corporation's key asset, larsucosterol. The FDA Breakthrough Therapy Designation (BTD) already accelerates the review time, but increased FDA transparency on Complete Response Letters (CRLs) also helps Bausch Health refine their drug approval strategy. Still, you have to watch the downside: federal staffing reductions at the FDA could cause longer regulatory review timelines, slowing down that BTD advantage.

The FDA's pen stroke is the biggest variable here.

Also, look for movements on drug pricing equalization between the U.S. and other countries, which could create political will for even faster FDA review for life-saving drugs like this one.

Economic: From Crisis to Contingency

The economic picture shifted dramatically from a critical cash burn to a long-term, milestone-driven investment. Prior to the merger, DURECT Corporation's cash position was critically low at $6.7 million as of June 30, 2025, and Q1 2025 revenue was only $0.3 million. The acquisition by Bausch Health in September 2025 provided $63 million upfront cash, solving the immediate liquidity problem.

Here's the quick math: the real opportunity is the Contingent Value Rights (CVR), which offer up to $350 million in potential net sales milestones. What this estimate hides is that the payout is years away and entirely dependent on larsucosterol's Phase 3 success and commercial launch.

Zero revenue risk, but the payout is years away.

Sociological: Addressing a Public Health Crisis

The target market for larsucosterol is a high-need, high-visibility public health crisis, which creates a strong societal pull. Larsucosterol targets severe alcohol-associated hepatitis (AH), a life-threatening condition responsible for approximately 100 U.S. deaths daily. This high unmet medical need is a powerful driver for both regulatory support and market adoption.

The re-evaluation of POSIMIR for non-opioid pain management also aligns with public health crisis priorities, specifically the opioid epidemic. To be fair, growing demand for precision medicine means Bausch Health must focus on specific genetic subgroups in trials, adding complexity but potentially increasing efficacy in the most critical patients.

Saving 100 lives a day is a powerful market driver.

Technological: Differentiated Drug Platforms

DURECT Corporation holds valuable, differentiated technology that underpins its pipeline and delivery systems. Larsucosterol is a novel epigenetic modulator targeting DNA methyltransferases (DNMTs), a unique mechanism of action. Phase 2b data showed a compelling 90-day mortality reduction of up to 58% in U.S. AH patients, which is a strong technological signal.

Plus, they own the SABER drug delivery platform technology for controlled-release formulations, like POSIMIR. Anyway, the entire biotech industry is shifting toward leveraging Artificial Intelligence (AI) for clinical trial data management and compliance, a trend Bausch Health will need to fully implement to maximize efficiency.

Their core tech is a genuine differentiator.

Legal: Merger Obligations and Regulatory Hurdles

The new corporate structure and complex CVRs are the main legal focus now that the merger with Bausch Health was successfully completed on September 11, 2025. The company regained full commercial rights and data for the FDA-approved product POSIMIR in May 2025, simplifying the legal structure for that asset.

Still, the larsucosterol Phase 3 trial design must incorporate specific feedback from the FDA Type B meeting, which is a critical legal and regulatory hurdle. The CVR structure itself introduces complex, long-term contractual obligations and payment triggers that need constant legal oversight.

The devil is in the CVR details.

Environmental: Future Supply Chain Risk

Environmental factors are currently a low-priority risk but will grow as Bausch Health scales up manufacturing. While there is general pharmaceutical industry pressure to adopt ESG (Environmental, Social, and Governance) reporting, there is potential for reduced U.S. regulatory emphasis on non-financial ESG compliance in 2025.

The real environmental risk is the need for robust supply chain oversight for larsucosterol manufacturing, which directly impacts the carbon footprint and waste management. Compliance with global chemical and waste disposal regulations for R&D and manufacturing is mandatory, but it's a cost of doing business, not a core strategic challenge right now.

ESG is a future cost, not a current blocker.

Next Step: Finance: Draft a CVR probability model by the end of the month, using the 58% Phase 2b mortality reduction data as the initial success factor input.

DURECT Corporation (DRRX) - PESTLE Analysis: Political factors

The political and regulatory landscape for DURECT Corporation in 2025 is dominated by the U.S. Food and Drug Administration (FDA) policies and federal staffing dynamics, which directly impact the development timeline for its lead asset, larsucosterol. The company's political risk profile has also shifted significantly following the announced acquisition by Bausch Health.

Honestly, the regulatory environment is a double-edged sword right now: you have a fast-track ticket with larsucosterol, but the FDA itself is struggling to keep up with its own review mandates.

FDA Breakthrough Therapy Designation (BTD) for larsucosterol accelerates review time

DURECT Corporation's primary political tailwind is the Breakthrough Therapy Designation (BTD) granted by the FDA for larsucosterol in the treatment of severe alcohol-associated hepatitis (AH). This designation, secured in May 2024, is a formal political commitment to expedite the drug's development and review process.

The BTD ensures DURECT Corporation, and now Bausch Health, receives intensive guidance from senior FDA managers and an organizational commitment to an expedited review. A successful BTD-backed New Drug Application (NDA) typically moves faster than a standard review, which usually takes 10 months. This is crucial because the FDA has already agreed that a single Phase 3 trial, focused on the primary endpoint of 90-day survival, could be sufficient to support the NDA.

The importance of this designation is highlighted by the high mortality rate of AH, which is a significant public health issue. Mortality stands at approximately 26% at 28 days and 44% at 180 days, underscoring the political and humanitarian pressure for a first-approved therapy.

Increased FDA transparency on Complete Response Letters (CRLs) impacts drug approval strategy

A major shift in regulatory transparency occurred in 2025, affecting how DURECT Corporation and its new parent company, Bausch Health, must approach their regulatory filings. The FDA, as part of an effort to embrace 'radical transparency,' began publicly releasing redacted Complete Response Letters (CRLs)-the formal letters issued when an application cannot be approved in its current form.

This increased disclosure is a net positive for strategic planning, but it raises the stakes for public communications. The FDA published over 200 CRLs in July 2025, followed by another 89 in September 2025, and is now committed to promptly releasing newly issued CRLs.

This new level of transparency provides a massive, real-world database of common deficiencies-safety, efficacy, and manufacturing issues-that DURECT Corporation can use to de-risk its larsucosterol Phase 3 trial design and subsequent NDA submission. But, it also means any future CRL for larsucosterol would be quickly public, subjecting the company to immediate and intense market scrutiny.

Potential for faster FDA review if drug pricing is equalized between the U.S. and other countries

Federal policy is now directly linking drug pricing to regulatory speed, creating a unique opportunity for DURECT Corporation's lead asset. In 2025, the FDA unveiled a new Priority Voucher program that aims to accelerate reviews for companies that commit to setting lower prices for their drugs, specifically by equalizing the price between the U.S. and other comparably developed nations.

For a drug like larsucosterol, which has BTD and targets a high-mortality, unmet-need condition, this voucher is a powerful incentive. The potential benefit is staggering: a regulatory decision could be delivered in as little as 1-2 months, a massive reduction from the standard 10-12 month review period.

The decision for Bausch Health will be a clear trade-off: surrender some pricing power to gain a near-immediate market entry, or pursue maximum U.S. pricing at the risk of a significantly longer review timeline. This is a political decision with a tangible, quantifiable impact on the time-to-market and therefore, the net present value (NPV) of larsucosterol.

Federal staffing reductions at the FDA could cause longer regulatory review timelines

Despite the fast-track mechanisms in place, the operational capacity of the FDA is a major political risk in 2025. The agency has undergone significant workforce reductions, with expected layoffs of approximately 3,500 employees, including seasoned reviewers, as part of a wider restructuring. This is an estimated 20% cut in some areas.

This reduction has already caused a 'marked slowdown in drug review timelines,' procedural bottlenecks, and missed Prescription Drug User Fee Act (PDUFA) deadlines across the industry. The loss of senior staff has created a leadership vacuum that threatens regulatory clarity.

To mitigate this, the FDA announced in November 2025 a plan to hire over 1,000 new employees and launched a new communication pilot program to provide email responses to sponsors' questions within three business days.

The net effect is a high-volatility regulatory environment, as shown in the table below:

The risk of delay for the larsucosterol NDA is defintely real, even with BTD, because the agency's internal infrastructure is under immense strain. Bausch Health must factor in a minimum of a few months' buffer time for its Phase 3 timeline.

DURECT Corporation (DRRX) - PESTLE Analysis: Economic factors

The economic landscape for DURECT Corporation in 2025 is defined by a critical pre-acquisition financial state followed by a transformative acquisition by Bausch Health, all set against a backdrop of increasing US healthcare expenditure and a volatile biotech M&A market. The acquisition was a necessary financial lifeline, moving the company from a precarious cash position to a future model based on milestone payments.

The Acquisition as a Financial Inflection Point

DURECT's economic reality changed fundamentally on September 11, 2025, with the completed acquisition by Bausch Health. This transaction immediately stabilized the company's finances, which were at a critically low point. Prior to the merger, DURECT's cash, cash equivalents and investments stood at only $6.7 million as of June 30, 2025, a position that severely constrained its ability to fund the registrational Phase 3 trial for larsucosterol.

The deal provided an upfront, much-needed cash injection of approximately $63 million to DURECT shareholders. That's a clean break from the high cash burn of a pre-commercial biotech. The real long-term economic opportunity, however, is tied to the Contingent Value Rights (CVR) structure, which offers up to $350 million in potential aggregate net sales milestones.

Pre-Acquisition Financial Fragility (2025)

Before the Bausch Health deal, DURECT operated with minimal revenue, typical for a late-stage biopharmaceutical company focused on R&D. The quarterly financials clearly illustrate the financial pressure that necessitated a strategic transaction.

Here's the quick math on the pre-acquisition operating performance:

• Q1 2025 Total Revenues: $0.3 million
• Q1 2025 Net Loss: $4.2 million
• Q2 2025 Total Revenues: $447,000
• Q2 2025 Net Loss: $2.3 million

The minimal revenue stream and consistent net losses meant the company was heavily dependent on financing to continue development of its lead asset, larsucosterol. The acquisition effectively transferred the financial burden of the Phase 3 trial to Bausch Health, transforming DURECT's economic risk profile from high-burn R&D to performance-based payout.

Broader US Healthcare Spending and M&A Trends

The acquisition aligns perfectly with the broader economic trends in the US pharmaceutical sector in 2025. The overall market remains a massive growth engine, with national health spending projected to reach $5.6 trillion in 2025. More importantly, the growth rate for national health spending is estimated to be 7.1% in 2025, outpacing US GDP growth.

This massive spending pool fuels large pharmaceutical companies like Bausch Health to pursue strategic M&A, especially for late-stage assets like larsucosterol. Honestly, big pharma needs to refill their pipelines because over $300 billion in sales are at risk through 2030 due to the looming patent cliff.

The M&A environment is also being made more conducive by macroeconomic factors. The anticipation of Federal Reserve interest rate cuts in 2025, including a significant 50-basis-point reduction in September, makes debt financing for large acquisitions cheaper, which is a key catalyst for the expected increase in deal volume, with 76% of executives anticipating more deals than in 2024.

DURECT Corporation (DRRX) - PESTLE Analysis: Social factors

Sociological Factors: Addressing Public Health Crises

You're operating in a biopharma market where social needs often dictate regulatory priority and market demand. DURECT Corporation's pipeline is defintely well-aligned with two of the most pressing public health crises in the U.S.: the rising tide of severe alcohol-associated liver disease and the ongoing opioid epidemic. This alignment creates a compelling social tailwind for your lead programs, Larsucosterol and POSIMIR.

Larsucosterol targets severe alcohol-associated hepatitis (AH), a condition with a devastatingly high unmet medical need. Honestly, there are no FDA-approved therapies for AH right now, so patients rely on supportive care that often fails. A retrospective analysis shows that for hospitalized AH patients, the 90-day mortality rate is tragically close to 30%. This is a life-threatening condition, and the social toll is immense.

Here's the quick math on the scale of the alcohol-related liver disease crisis, which encompasses AH:

Non-Opioid Pain Management and POSIMIR

The re-evaluation of POSIMIR for non-opioid pain management is a direct response to the national opioid crisis. While provisional data for the 12 months ending September 2024 shows a predicted decline in overall drug overdose deaths to about 87,000, the crisis is far from over. In 2023, approximately 217 people died each day from an opioid overdose, with opioids involved in nearly 80,000 deaths. The demand for non-addictive alternatives for post-surgical pain is a core social priority, and it drives clinical adoption.

POSIMIR (bupivacaine solution) is a non-opioid, sustained-release local analgesic. Its approval for post-surgical analgesia following arthroscopic subacromial decompression demonstrated a clear social benefit, specifically a 67% reduction in I.V. morphine-equivalent rescue opioid use over the first 72 hours in a pivotal trial. That's a huge win for patients and a critical tool for surgeons trying to minimize opioid exposure.

Precision Medicine and Subgroup Focus

The growing demand for precision medicine-tailoring treatment to specific patient characteristics-is now a major societal expectation. This requires greater focus on specific genetic or demographic subgroups in trials, and DURECT Corporation is adapting. The Phase 2b AHFIRM trial for Larsucosterol showed a clear signal that the drug's efficacy varied by patient population.

Here's the key takeaway from the Phase 2b data, which is guiding the 2025 Phase 3 design:

• The overall reduction in 90-day mortality did not reach statistical significance.
• However, in the critical U.S. patient population subgroup, the reduction in 90-day mortality was pronounced, showing a 57% reduction with the 30 mg dose and a 58% reduction with the 90 mg dose compared with placebo.
• The planned Phase 3 registrational trial is now strategically focused on the U.S. patient population to capitalize on this subgroup data.

This move shows realism and a commitment to delivering a therapy where the data is strongest, which is exactly what the social trend toward personalized medicine demands.

Finance: Track the Phase 3 trial funding status, which is key to initiating the trial in 2025, as the social need for Larsucosterol is clear.

DURECT Corporation (DRRX) - PESTLE Analysis: Technological factors

Larsucosterol: Epigenetic Modulation and Clinical Data

The core of DURECT Corporation's pipeline technology is larsucosterol (DUR-928), a novel endogenous sulfated oxysterol that acts as an epigenetic modulator. This means it regulates gene expression patterns without changing the underlying DNA sequence, specifically by targeting DNA methyltransferases (DNMTs) to inhibit DNA methylation. This mechanism is key to its potential in treating severe alcohol-associated hepatitis (AH), a condition with no FDA-approved therapies.

The Phase 2b AHFIRM trial results, published in NEJM Evidence in January 2025, showed the drug did not meet the primary endpoint of 90-day mortality or liver transplant for the overall population. Still, a deeper look at the data reveals a compelling signal in the U.S. patient population, which represented a significant 76% of the total enrolled patients. This is the kind of technical detail that drives the next stage of development.

Here's the quick math on the most promising subgroup data:

Honestly, a mortality reduction of up to 58% in this high-risk patient group is a powerful signal, even if the overall trial didn't hit statistical significance. The company is now planning to initiate a registrational Phase 3 trial in 2025, focusing on 90-day survival as the primary endpoint, but this is contingent on securing sufficient funding. For context, the company's Research and development (R&D) expenses for Q1 2025 were $1.883 million.

Ownership of the SABER Drug Delivery Platform Technology

DURECT Corporation maintains a valuable, proven technological asset in its proprietary SABER (Supramolecular Bioerodible Delivery) drug delivery platform. This is a controlled-release formulation technology that allows for the sustained, local delivery of a drug over a period of days or weeks from a biodegradable depot. It's a smart way to improve patient compliance and efficacy while reducing systemic side effects.

The platform's lead commercial product, POSIMIR (bupivacaine solution), is FDA-approved for post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. The technical know-how for this product, including all data, was transferred back to DURECT in May 2025 following the termination of a licensing agreement with Innocoll Pharmaceuticals. This means DURECT now has full control over the asset.

The SABER platform offers clear technological advantages:

• Provides continuous, sustained drug delivery for up to 72 hours or more.
• Uses a biodegradable depot, eliminating the need for removal.
• Enables local delivery, minimizing systemic exposure and side effects.
• Applicable to small molecules and biologics, broadening its utility.

The immediate opportunity here is to find a new commercialization partner for POSIMIR, which is a defintely a high-value, approved asset in the non-opioid pain market.

Biotech Industry Shift Toward Leveraging AI for Clinical Trial Data Management and Compliance

The biotech industry is rapidly adopting Artificial Intelligence (AI) and smart automation, moving past the early hype to focus on practical applications that cut costs and time. For a company like DURECT, managing the complex data from a Phase 3 trial, especially one with a critical endpoint like 90-day survival, makes this trend an immediate technological risk and opportunity.

The global AI in pharmaceutical market is estimated to reach $1.94 billion in 2025, with overall AI spending in the pharmaceutical industry expected to hit $3 billion this year. This shows how serious the industry is about this shift. The technology is being used to optimize patient data flows, automate data quality review, and apply risk-based quality management (RBQM) approaches to trials.

Failing to integrate AI-driven solutions could put DURECT at a competitive disadvantage, especially in trial efficiency. AI-enabled workflows have been shown to reduce drug discovery costs by up to 40% and dramatically shorten development timelines. The technological imperative is clear: use smart automation to manage the massive datasets from the upcoming larsucosterol Phase 3 trial, ensuring higher data quality and faster time to database lock.

DURECT Corporation (DRRX) - PESTLE Analysis: Legal factors

Successful completion of the merger with Bausch Health on September 11, 2025, changes corporate structure.

You need to understand the new legal reality: DURECT Corporation is no longer an independent, publicly traded entity. The successful completion of the tender offer and subsequent merger with Bausch Health Companies Inc. on September 11, 2025, fundamentally changed the corporate structure. DURECT now operates as a wholly owned subsidiary of Bausch Health. This shift moves the legal and financial compliance burden from a small-cap public company structure to the established framework of a global, diversified pharmaceutical company. This is a massive de-risking event for the larsucosterol program.

The transaction was structured with an upfront cash payment of $1.75 per share, totaling approximately $63 million at closing. This structure immediately eliminates all the previous legal risks associated with DURECT's liquidity, such as the need for future dilutive equity financing to fund the Phase 3 trial, which was a significant concern in early 2025.

The company regained full commercial rights and data for the FDA-approved product POSIMIR in May 2025.

Regaining the rights to an FDA-approved product like POSIMIR (bupivacaine solution) creates a new legal and commercial opportunity, but also a new liability. On May 6, 2025, DURECT regained full control over the commercial rights, data, and know-how for POSIMIR following the termination of its licensing agreement with Innocoll Pharmaceuticals Limited.

This legal action means DURECT, now under Bausch Health, holds the full commercial risk and reward for this product in the U.S. They are actively seeking a new partner to commercialize POSIMIR, which requires drafting and executing a new, complex licensing and supply agreement. The previous agreement with Innocoll had potential milestone payments of up to $130 million and tiered, low to mid double-digit royalties on net product sales, setting a clear, if defintely high, benchmark for any new deal.

Larsucosterol's Phase 3 trial design must incorporate specific feedback from the FDA Type B meeting.

The regulatory pathway for larsucosterol, the lead asset, is legally defined by the U.S. Food and Drug Administration (FDA) requirements. The planned registrational Phase 3 trial design is not a guess; it incorporates specific feedback received from the FDA during a 2024 Type B meeting under Breakthrough Therapy Designation (BTD).

This FDA feedback is a critical legal de-risker because the agency confirmed that a single Phase 3 trial will be sufficient to support a New Drug Application (NDA) for larsucosterol in alcohol-associated hepatitis (AH). This clarity streamlines the regulatory timeline and minimizes the legal risk of needing an additional, costly Phase 3 trial. The core legal requirements for the trial are:

• Study Type: Randomized, double-blind, placebo-controlled, multi-center study.
• Primary Endpoint: 90-day survival.
• Location: Conducted in the U.S.

The CVR structure introduces complex, long-term contractual obligations and payment triggers.

The Contingent Value Rights (CVR) issued to former DURECT shareholders are a significant, long-term legal obligation for Bausch Health. This is where the complexity lies. The CVRs entitle holders to potential future payments of up to $350 million in the aggregate, contingent on achieving two specific net sales milestones for larsucosterol.

The legal documentation governing the CVR is dense, defining the exact payment triggers and the expiration date. The obligation to pay exists until the earlier of the 10-year anniversary of the first commercial sale in the United States or December 31, 2045. This 20-year-plus horizon means Bausch Health must maintain meticulous, auditable records of larsucosterol's net sales for decades to comply with the CVR agreement. This table shows the core financial and legal structure of the CVR:

DURECT Corporation (DRRX) - PESTLE Analysis: Environmental factors

General pharmaceutical industry pressure to adopt ESG (Environmental, Social, and Governance) reporting.

The environmental landscape for DURECT Corporation is now entirely defined by its new parent, Bausch Health Companies Inc., following the acquisition completion on September 11, 2025. You should stop thinking about DURECT Corporation as a small, independent R&D shop here; its environmental risk and compliance are now part of a much larger, global specialty pharmaceutical system. The industry-wide pressure to adopt formal ESG reporting is intense, with major pharmaceutical companies now dedicating an estimated $5.2 billion yearly to environmental programs, a massive 300% increase since 2020.

Bausch Health already operates a global EHS+S (Environmental, Health, Safety + Sustainability) organization embedded within its Global Manufacturing and Supply Chain division, which includes oversight for Research and Development. This means DURECT Corporation's Cupertino, California facility and its larsucosterol development program must now align with a more structured environmental policy that prioritizes minimizing waste generation and reducing consumption of fuel, energy, and water. This is a huge shift from an independent biotech with Q1 2025 revenues of just $0.3 million. That's the new reality.

Potential for reduced U.S. regulatory emphasis on non-financial ESG compliance in 2025.

To be fair, while the European Union's Corporate Sustainability Reporting Directive (CSRD) is driving mandatory, comprehensive ESG disclosure for thousands of companies, the U.S. federal regulatory environment for non-financial ESG has been a bit of a mixed bag in 2025. The Securities and Exchange Commission (SEC) Climate Disclosure Rule implementation began in Q1 2025 for Large Accelerated Filers, requiring them to start collecting climate-related data for the full fiscal year. Still, the overall federal tone has shown some pullback from climate-focused policies, creating a fragmented regulatory environment.

However, this federal uncertainty doesn't change the market's demand. Investors, including firms like Blackrock, still view climate risk as a fundamental financial consideration. Bausch Health's existing ESG framework, which has a net impact ratio of 55.5% and identifies GHG emissions as a negative impact area, shows they are already responding to this investor-led pressure, regardless of the political emphasis. You defintely can't ignore the market just because federal policy is in flux.

Need for robust supply chain oversight for larsucosterol manufacturing, impacting carbon footprint.

The biggest environmental risk for larsucosterol, DURECT Corporation's lead drug candidate, lies in its supply chain. For the pharmaceutical sector, Scope 3 emissions-those indirect emissions from the value chain, primarily from purchased goods, services, and manufacturing-account for a staggering 75% to 90% of the total environmental footprint. As larsucosterol moves toward a potential Phase 3 trial, the manufacturing scale-up will put this issue front and center.

Bausch Health addresses this with a 'Responsible Procurement' policy and by partnering with the Ecovadis platform to monitor supplier sustainability, including EHS and CO2 emissions. This oversight will now apply to the suppliers of the complex chemical components needed for larsucosterol. The entire supply chain needs to be transparent.

Here's the quick math on the focus:

Compliance with global chemical and waste disposal regulations for R&D and manufacturing.

For DURECT Corporation's R&D operations, the environmental risk is less about massive carbon emissions and more about strict compliance with hazardous chemical and waste disposal regulations. The regulatory environment got tighter in 2025, particularly in the U.S. [cite: 21 (from first search)]

The two major compliance shifts impacting the R&D lab and any small-scale manufacturing are:

• PFAS Reporting: New regulations under the Toxic Substances Control Act (TSCA) require reporting of Per- and Polyfluoroalkyl Substances (PFAS), effective July 11, 2025. [cite: 21 (from first search)] This affects any entity that manufactured or imported PFAS since 2011, which is common in complex chemical synthesis.
• RCRA e-Manifests: Changes to the Resource Conservation and Recovery Act (RCRA) e-manifest system take effect on December 1, 2025, requiring both small and large hazardous waste generators to register for the electronic manifest system to obtain final signed copies. [cite: 21 (from first search)]

The adoption of green chemistry principles, which can lead to a 19% reduction in waste and a 56% improvement in productivity, is the strategic opportunity here. Bausch Health's global EHS+S team is now responsible for ensuring DURECT Corporation's R&D processes meet these evolving, site-specific hazardous waste rules to avoid significant fines and operational delays.