By Elizabeth Akiwowo Hoffner, MS | VP, Head of Business Development and Marketing, Pharmatech Associates, a USP company

On December 18, 2025, the BIOSECURE Act was signed into law. With it came a new reality for every biopharmaceutical company that depends on federal contracts: certain biotechnology equipment and services sourced from designated “biotechnology companies of concern” are now restricted. The clock is ticking, and the supply chain map that most organizations have been working from is no longer good enough.

The more pressing question is not simply whether your supply chain touches a restricted source. It is: where are your highest-risk exposures, which products warrant the most urgent attention, and how do you build an execution plan that is technically credible and regulatorily sound before the compliance window closes? USP’s Medicine Supply Map provides the ingredient-level supply chain visibility that makes a targeted, defensible response possible.

What is USP’s Medicine Supply Map?

The Medicine Supply Map is a tool developed by the U.S. Pharmacopeia (USP), a nonprofit standards-setting organization that has played a central role in U.S. drug quality and safety for over two centuries. The Map was built in direct response to the supply chain vulnerabilities exposed during the COVID-19 pandemic, when the absence of reliable, ingredient-level sourcing data made it nearly impossible for policymakers and industry to identify where the system was most exposed.

At its core, the Map traces the supply chain for U.S.-approved drug products from finished dosage form back through active pharmaceutical ingredients (APIs) and the key starting materials (KSMs) used to synthesize them. It draws on FDA regulatory submissions, facility registration data, and other public sources to link specific products to the manufacturers and geographies that produce their upstream inputs. The result is a layered, facility-level picture of where medicines actually come from: not where companies report their headquarters, but where the chemistry happens.

For the purposes of a BIOSECURE compliance analysis, that distinction matters enormously. A drug product may be formulated domestically by a U.S.-based contract manufacturer, while its API is synthesized in Europe, from a KSM produced exclusively in China. Without ingredient-level supply chain visibility, that exposure is invisible. The Medicine Supply Map makes it traceable, and in the current regulatory environment, traceable is the starting point for defensible.

The Supply Chain Problem Is Bigger Than BIOSECURE

Even before BIOSECURE, the U.S. pharmaceutical supply chain was showing serious strain. According to USP’s Annual Report on Drug Shortages, the number of active shortages reached a 10-year high of 125 in 2023 before declining to 98 in 2024, yet the duration of those shortages grew dramatically. The average length of an ongoing shortage at year-end 2024 was 1,585 days, more than double the figure recorded five years earlier. Fewer shortages, but ones that last significantly longer.

The structural vulnerabilities driving this are well documented. Injectables are particularly exposed: nearly 70% of active shortages involve injectable drugs. Low-margin generic products face the sharpest pricing pressure, and price compression is itself correlated with reduced investment, which leads to decreased inventory and eventually to shortages. It is a reinforcing cycle that BIOSECURE could accelerate if companies cannot pivot quickly to compliant alternative sources.

Critically, the sourcing concentration risk is concentrated in a small number of geographies. USP’s Medicine Supply Map data reveals that 58% of key starting materials (KSMs) used in U.S.-approved APIs are sole-sourced from a single country, with 41% coming exclusively from China. Another 16% are sole-sourced from India. For the subset of APIs most critical to the U.S. market, 12% rely on China for all of their KSMs and 5% rely entirely on India. These are not abstract geopolitical risks. They are specific, quantifiable vulnerabilities that the BIOSECURE Act makes legally actionable.

Visibility Is a Start. Prioritization Is the Game.

Many organizations responded to early supply chain warnings by investing in visibility tools: knowing where their ingredients come from, which facilities are involved, and which suppliers sit in high-risk regions. Visibility is necessary but not sufficient.

The USP Medicine Supply Map goes well beyond mapping. Developed by USP, Pharmatech’s parent company and one of the most trusted scientific organizations in global pharmaceutical standards, the platform delivers AI-driven vulnerability scores backed by analysis of over 100 risk factors, back-tested against actual shortage records from the FDA and ASHP. Its current coverage includes 96% of finished dosage forms at the U.S. Rx label level, 85% of API volume mapped to specific manufacturing facilities, and 85% of active NDCs by country of origin. The platform identifies injectable shortages up to four months before they occur with 94% predictive accuracy.

The platform tracks four risk categories, each independently validated as a predictor of shortage:

• Geographic concentration of API and KSM sourcing
• Quality concerns flagged at the facility or country level
• Low pricing dynamics that suppress investment and reduce resilience
• Manufacturing complexity that limits the pool of qualified alternative suppliers

For companies navigating BIOSECURE compliance, these four factors translate directly into a triage framework. Not every product in your portfolio carries the same risk exposure. The Medicine Supply Map gives you a scored, ranked view of where concentration and shortage vulnerability are highest, so you can direct your reshoring investments where they will have the greatest impact rather than reacting across the board.

From Insight to Execution: Where Pharmatech Comes In

Supply chain intelligence is only as useful as the execution framework it informs. Identifying that a product has high BIOSECURE exposure is step one. The harder work is determining what to do about it, and doing so within a timeline that keeps regulatory submissions defensible and market supply uninterrupted.

Once the Medicine Supply Map identifies your highest-priority products and the suppliers or geographies of concern, Pharmatech’s CMC strategy and tech transfer teams translate that intelligence into an executable plan. That means evaluating alternative API sources against your chemistry, manufacturing, and controls requirements; developing the technical package needed to qualify a new supplier; and designing a tech transfer pathway that keeps development timelines realistic and regulatory submissions defensible.

Tech transfer in a reshoring or supplier-diversification context is not simply moving a process from one site to another. It requires confirming that the new site’s capabilities match the process requirements, that analytical methods are transferred and validated appropriately, and that any changes are positioned correctly within the existing regulatory filing. Pharmatech has deep experience navigating these steps, including managing the CMC implications of sourcing changes that may trigger comparability assessments or prior approval supplements.

The connection between USP and Pharmatech is not incidental: the vulnerability intelligence informing your prioritization decisions comes from the same trusted scientific institution whose standards underpin FDA-regulated pharmaceutical quality globally. And it means that as the Medicine Supply Map’s active flags surface emerging disruptions or quality concerns in real time, Pharmatech can help you respond with technically sound, regulatory-ready plans rather than reactive workarounds.

What “Winning” Looks Like Under BIOSECURE

The companies that will navigate BIOSECURE most successfully are not necessarily those with the largest budgets or the most suppliers. They are the ones that move from reactive to proactive: identifying the right products to prioritize, building technically credible alternative supply options, and doing so on a timeline that preserves market position and patient access.

Concretely, that means:

• Using vulnerability scores from the Medicine Supply Map to rank your product portfolio by BIOSECURE exposure and shortage risk, well before a crisis forces your hand
• Identifying alternative API and KSM sources in compliant geographies with the highest feasibility for your specific chemistry and dosage forms
• Executing tech transfers with disciplined CMC planning so that regulatory submissions reflect the change accurately and timelines hold
• Monitoring ongoing supply chain flags in the Medicine Supply Map to catch emerging risks before they become shortages or compliance events

The cost of inaction is real and measurable. Drug shortages generate more than $359 million in additional annual labor costs for healthcare systems, drive 16% average price increases for affected drugs, and can affect over 500,000 patients per shortage event. BIOSECURE adds a legal and contractual dimension to what was previously a business and patient-care risk. The urgency is no longer theoretical.

The Window Is Open. The Clock Is Running.

BIOSECURE compliance is not a one-time audit. It is an ongoing operational capability: the ability to know where your vulnerabilities are, act on the highest-priority ones first, and keep pace with a supply chain environment that will continue to shift. The companies that build that capability now, grounded in real data and executed with technical rigor, will be better positioned not just for BIOSECURE, but for every supply disruption that follows.

The Medicine Supply Map gives you the visibility to know where to start. The execution work, including qualifying alternative sources, managing tech transfer, and ensuring regulatory submissions hold, requires the same level of rigor applied at the project level, product by product. That is where the difference between a compliance plan and a compliance outcome is made.

Pharmatech Associates has supported companies through each stage of this process, from initial portfolio triage through regulatory submission. If you are working through the prioritization and execution questions that BIOSECURE raises for your portfolio, we are glad to think through them with you.

Reach out to Pharmatech Associates at contact@pai-qbd.com.

Data references: USP Annual Report on Drug Shortages, 2025; USP Medicine Supply Map, 2024-2025; ASPE; ASHP (Vizient). Pharmatech Associates is a USP company.