Beyond Regulation: Four PFAS Pressures Pharmaceutical Manufacturers Can’t Ignore
The biggest PFAS risk for pharmaceutical manufacturers may not come from regulation.
Even as regulators continue to debate definitions, exemptions and timelines, other pressures are moving much faster. Suppliers are exiting PFAS markets. Customers are asking harder questions about chemicals of concern. Investors are paying attention to potential financial exposure. And environmental liability can arise even when PFAS are considered an essential in manufacturing of the marketed drug product and/or present in the marketed drug product itself. As a result, the biggest single benefit of the marketed drug product, patient access to medicine, may become compromised.
For pharmaceutical leaders, waiting for regulatory certainty may be the riskiest strategy of all.
1. Supply Chain Vulnerability: When a Critical Material Disappears
Pharmaceutical manufacturers rely on fluorinated materials in tubing, seals, gaskets, filters, membranes, packaging components and drug delivery devices because they can withstand aggressive chemicals, repeated sterilization and other demanding conditions. That dependence becomes a business risk when supply changes faster than manufacturers can respond.
One prominent example is 3M, which completed its exit from PFAS manufacturing at the end of 2025. Changes like this can affect not only raw chemicals, but also finished components that incorporate fluorinated materials.
For pharmaceutical manufacturers, replacing those materials is rarely a simple procurement decision. A new process-contact material, packaging component or device material may require compatibility testing, extractables and leachables studies, supplier qualification, process validation, stability testing or regulatory change control.
That creates a critical mismatch: suppliers may discontinue a material much faster than a pharmaceutical manufacturer can qualify its replacement. An EFPIA analysis has also highlighted applications in pharmaceutical manufacturing, packaging and drug delivery where suitable alternatives remain difficult to identify.
The priority, therefore, is not immediate substitution across the board. It is visibility. Manufacturers need to know which critical products and processes depend on PFAS-containing inputs, where supplier options are limited and which materials would be hardest to replace.
2. Customer and Investor Expectations: PFAS Is Becoming a Market Issue
Regulators are not the only stakeholders asking harder questions about PFAS. Customers and investors are increasingly scrutinizing chemicals of concern, creating another source of pressure for pharmaceutical manufacturers.
Healthcare organizations have considerable purchasing power, and many are using procurement policies to encourage safer materials and greater transparency from suppliers. Practice Greenhealth, which works with more than 1,500 hospitals and health systems, has developed standardized environmental purchasing criteria that explicitly address PFAS in certain product categories. Its 2024 benchmarking data also show widespread adoption of purchasing policies designed to avoid chemicals of concern.
That does not mean hospitals are about to demand PFAS-free pharmaceuticals or combination devices. Many fluorinated chemistries and materials remain essential to active pharmaceutical ingredients (APIs), from the visible PFAS in the marketed drug product, contributing PFAS originating upstream from the drug manufacturing process, and invisible PFAS used in the manufacturing process but not present in the marketed drug product (Scotney et al, 2026). But it does signal a broader shift in expectations: manufacturers may increasingly be asked to explain what PFAS they use, where they are used and whether alternatives have been evaluated.
Investors are asking similar questions. A PFAS investor briefing from the First Sentier MUFG Sustainable Investment Institute identifies potential financial impacts for product manufacturers including increased R&D expenditures, operational changes, litigation exposure and changing customer preferences.
For manufacturers, transparency and a defensible PFAS strategy may increasingly become part of maintaining customer and investor confidence.
3. Legal and Environmental Liability: What Leaves the Facility Matters
For pharmaceutical manufacturers, PFAS liability is not limited to chemicals intentionally used in a product or process. PFAS can enter a facility through incoming water, raw materials or supplier components and ultimately leave through wastewater, solid waste or other release pathways.
That distinction matters because environmental obligations often focus on what is discharged or released, not simply where it originated.
There is currently no national PFAS-specific effluent limit for pharmaceutical manufacturing, but PFAS monitoring is already making its way into wastewater permitting and pretreatment programs. EPA provides guidance to NPDES permit writers and pretreatment authorities on PFAS monitoring, source identification and pollution-prevention measures, and recommends Methods 1633 or 1633A for monitoring PFAS in wastewater.
Liability can extend beyond wastewater as well. Terminal PFAS, such as PFOA and PFOS, are currently designated as hazardous substances under CERCLA, creating reporting requirements for qualifying releases and potential implications for contaminated sites and cleanup costs.
Pharmaceutical manufacturers have not been a primary target of PFAS litigation to date, and many sector uses have legitimate performance and patient-care justifications. But that does not eliminate environmental exposure. Understanding where PFAS enter a facility, where they concentrate and how they leave is therefore not just an analytical exercise. It is an important step in identifying and managing potential long-term liability.
4. Regulatory and Market Access Pressure: Exempt Doesn’t Mean Simple
For pharmaceutical manufacturers, the regulatory challenge around PFAS is more nuanced than an approaching ban. Many current PFAS laws carve out pharmaceuticals, medical devices and other FDA-regulated products, reflecting the essential role these materials can play in therapeutic efficacy and patient care. Those protections may remain in place for many uses in many regions.
The problem is that they are neither universal nor necessarily permanent.
In the US, while PFAS in pharmaceuticals is exempt at the federal level, manufacturers must pay attention to an increasingly complicated patchwork of state regulation. Maine, for example, exempts drugs, medical devices and certain equipment used to manufacture them from its PFAS product prohibitions. Minnesota also exempts FDA-regulated drugs and medical devices from its 2032 prohibition, but still requires manufacturers to report intentionally added PFAS in those products. This is a distinction manufacturers cannot afford to miss: permission to continue using PFAS does not necessarily eliminate requirements for disclosure, documentation or justification.
Europe adds another layer of uncertainty. The proposed EU-wide REACH restriction remains under development, and the future treatment of pharmaceutical uses, manufacturing material and packaging and delivery devices is still being debated. ECHA’s scientific committees have supported broad restriction with targeted derogations, while pharmaceutical groups continue to argue that stronger exemptions are needed to protect medicines manufacturing and patient access.
Regulatory readiness therefore means understanding not only whether a PFAS use is currently permitted, but how that use may result in an environmental release — and what product disclosure requirements apply — across every jurisdiction where a company manufactures, sources or sells its products.
The First Step: Know Where You’re Exposed
PFAS risk in pharmaceutical manufacturing is not one problem with one solution. Supply continuity, customer expectations, environmental liability and regulation all create different pressures, but they point to the same first step: manufacturers need a clear picture of where PFAS enter their operations, where they are essential and where they create avoidable exposure.
That means looking beyond visible APIs in the marketed drug product alone to contributing and invisible PFAS in manufacturing process materials, equipment, packaging, water systems, suppliers and waste streams. From there, companies can prioritize the risks that matter most, identify where alternatives are realistic and build a strategy that supports both near-term resilience and long-term readiness.
Battelle helps pharmaceutical manufacturers build that picture by combining deep pharmaceutical industry expertise with advanced PFAS analytics, treatment evaluation, regulatory strategy and materials expertise. With specialists spanning formulation, regulated manufacturing, product-contact materials, packaging, medical devices, toxicology and wastewater analysis, Battelle can help manufacturers understand PFAS exposure in the context of the full operation rather than treating it as an isolated environmental issue.
Waiting for regulatory certainty is unlikely to make the problem simpler. Building visibility now gives manufacturers more options later.
Download the white paper, Managing PFAS in Pharmaceutical Manufacturing: A Risk Management Approach for the Pharmaceutical Industry, to explore the full framework for assessing exposure, prioritizing risk and building a practical PFAS strategy.
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