High urgency

Designation of P2P Methyl Glycidic Acid as a List I Chemical

Detected July 30, 2026 · in Pharmaceutical Manufacturing (FDA/DEA)

DEA finalizes designation of P2P methyl glycidic acid (BMK glycidic acid) and its esters, optical and geometric isomers as a List I chemical, imposing regulatory controls on handling, recordkeeping, and reporting.

Aforeworn detected this change in the Pharmaceutical Manufacturing (FDA/DEA) space on July 30, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated High urgency. Manufacturers, importers, exporters, and distributors of P2P methyl glycidic acid and its derivatives, including API and contract manufacturers. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Effective 30 days after publication in the Federal Register (April 3, 2026), so by May 3, 2026.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Pharmaceutical Manufacturing (FDA/DEA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.

What changed

The substance is now classified as a DEA List I chemical, subject to registration, recordkeeping, reporting, and security requirements under 21 CFR Parts 1309-1313.

Who it affects

Manufacturers, importers, exporters, and distributors of P2P methyl glycidic acid and its derivatives, including API and contract manufacturers.

What you must do

Review current operations involving this chemical; if not already registered as a List I chemical handler, apply for DEA registration; ensure compliance with recordkeeping and reporting obligations.

Deadline

Effective 30 days after publication in the Federal Register (April 3, 2026), so by May 3, 2026.

Source: https://www.federalregister.gov/documents/2026/04/03/2026-06523/designation-of-p2p-methyl-glycidic-acid-as-a-list-i-chemical

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