Are pharmaceutical products exempt from Tier II?

Substances regulated by FDA as drugs are exempt. The exemption generally doesn't reach active ingredients still in process, or the solvents and reagents used to make them.

Does the research laboratory exemption cover our R&D site?

It covers chemicals used in a research laboratory under the direct supervision of a technically qualified individual. Pilot plants, scale-up and production don't qualify, and neither does bulk storage feeding production. Document how you apply it.

Does recovered solvent count?

Yes, solvent recovered for reuse is inventory. Spent solvent managed as RCRA hazardous waste is generally excluded from Tier II.

Does ethylene oxide sterilization need to be reported?

Ethylene oxide is an extremely hazardous substance with a low threshold, so check it at every site that sterilizes on site.

How do we handle a constantly changing SDS library?

Keep SDSs current as suppliers update them, and review hazard classifications when you do. NeoTech's AI extraction re-indexes updated SDSs so your inventory reflects the latest hazard data.

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Pharmaceuticals

Tier II reporting for pharmaceuticals: know what's exempt and what isn't

Pharmaceutical sites sit on the line between exempt and reportable. Finished drugs and lab work can qualify for exemptions, but the solvents, reagents and utilities around them usually don't. NeoTech helps you draw that line correctly and file accurate Tier II reports for every site.

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Where the chemicals are in pharmaceutical facilities

API and production

Bulk solvents such as methanol, acetone, isopropyl alcohol, toluene, heptane and acetonitrile
Acids, bases and reagents
Raw materials and intermediates
Recovered solvent

Clean utilities and cleanrooms

Purified water system regeneration chemicals (acid and caustic)
Disinfectants and sporicides, including hydrogen peroxide and peracetic acid
Isopropyl alcohol for cleanroom wipe-down

R&D and quality labs

Solvents, reagents and standards
Liquid nitrogen and other cryogens

Sterilization and support

Ethylene oxide sterilization
Compressed gases
Boiler, cooling tower and generator chemicals and fuel

Four places pharmaceutical reports go wrong

Stretching the drug exemption

FDA-regulated drugs are exempt, but active ingredients in process, bulk solvents and reagents generally are not.

Stretching the lab exemption

The research laboratory exemption covers chemicals used in the lab under a technically qualified person's supervision. It doesn't cover pilot plants, production or bulk solvent tanks.

Forgetting recovered solvent

Solvent that's recovered and reused is still inventory and counts toward the facility total.

Missing extremely hazardous substances

Ethylene oxide and some reagents have low thresholds and also trigger Section 302 notifications.

How NeoTech handles it

Every site in one place. Production plants, R&D campuses and distribution sites, each set up once and tracked together.

State requirements, checked for you. NeoTech checks each site against its state's Tier II rules and submission system.

SDS extraction at scale. NeoTech's AI extracts and indexes hazard data from the large, frequently changing SDS libraries pharma sites manage.

Totals combined by chemical. Inventory is combined by CAS number across products and locations, then compared against the correct threshold, including extremely hazardous substance thresholds.

Deadlines on the calendar. Reminders for Section 302 notifications, Section 311 SDS submissions and the March 1 Tier II deadline.

Reports in your state's format. Submission-ready .t2s packages for Tier2 Submit, E-Plan exports and more.

Or let us file for you. NeoTech can submit on your behalf to the SERC, LEPC and fire department.

Minnesota facilities: we'll walk the site with you

NeoTech is based in Minneapolis. For Minnesota facilities, our team can collect your chemical inventory on site and load it straight into the platform.

Schedule an on-site inventory

State rules

Tier II requirements differ by state. See our state guides below, or browse every state we cover.

See every state's Tier II requirements →

Frequently asked questions

Are pharmaceutical products exempt from Tier II?: Substances regulated by FDA as drugs are exempt. The exemption generally doesn't reach active ingredients still in process, or the solvents and reagents used to make them.
Does the research laboratory exemption cover our R&D site?: It covers chemicals used in a research laboratory under the direct supervision of a technically qualified individual. Pilot plants, scale-up and production don't qualify, and neither does bulk storage feeding production. Document how you apply it.
Does recovered solvent count?: Yes, solvent recovered for reuse is inventory. Spent solvent managed as RCRA hazardous waste is generally excluded from Tier II.
Does ethylene oxide sterilization need to be reported?: Ethylene oxide is an extremely hazardous substance with a low threshold, so check it at every site that sterilizes on site.
How do we handle a constantly changing SDS library?: Keep SDSs current as suppliers update them, and review hazard classifications when you do. NeoTech's AI extraction re-indexes updated SDSs so your inventory reflects the latest hazard data.

Exempt where it's allowed, reported where it's required

Tell us about your sites and we'll show you how NeoTech takes each one from inventory to filed report.

Talk to us about your sites