DEA Approves New Exempt Chemical Mixtures
Published Date: 5/20/2026
Notice
Summary
The Drug Enforcement Administration (DEA) reviewed and decided on applications for special chemical mixtures that don’t fall under strict drug rules, covering requests from July 2025 to March 2026. Some mixtures got approved, others denied, and a few listings were fixed from earlier notices. If you’re involved with these chemicals, you’ve got until July 20, 2026, to share your thoughts—no fees or big costs involved, just your voice!
Analyzed Economic Effects
5 provisions identified: 1 benefits, 4 costs, 0 mixed.
Certain lab mixtures exempted from parts of CSA
DEA approved specific chemical preparations listed in Chart I (applications received July 1, 2025 through March 31, 2026) as exempt from application of sections 302, 303, 305, 306, 307, 308, 309, 1002, 1003, and 1004 (21 U.S.C. 822-823, 825-829, and 952-954) of the Controlled Substances Act and from 21 CFR 1301.74, effective as of the dates in the approval letters. The exemptions apply only to the exact preparations and forms described in the applications.
Some applications denied — products remain regulated
DEA determined that the chemical preparations listed in Chart II (applications received July 1, 2025 through March 31, 2026) are not exempt, so those specific products remain subject to all parts of the Controlled Substances Act and related regulations as of the dates in the determination letters. Companies listed in Chart II must comply with CSA and CFR requirements for those products.
Bulk-exempt products limited to in-house use
For exempted bulk products listed in this order, DEA determined they may only be used in-house by the manufacturer and may not be distributed for any purpose or transported to other facilities. This restriction is intended to limit diversion from larger bulk quantities.
Exemptions limited to exact formulation — changes need refile
The exemptions apply only to the precise composition, form, and trade name described in each application; any change in quantitative or qualitative composition or in the trade name after the application date requires a new application under 21 CFR 1308.24(h).
Other CSA requirements still apply (importer registration)
DEA states that the exemptions are limited to the specific CSA/CFR sections identified in 21 CFR 1308.24(a); all other CSA and CFR requirements remain in force, including registration as an importer as required by 21 U.S.C. 957. Affected entities must still meet those other obligations.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-11526, Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment
Starting July 9, 2026, new rules make it easier for doctors and pharmacies to provide medicine that helps people recover from opioid addiction. These changes affect healthcare providers by expanding who can give medication-assisted treatment and how pharmacies can deliver these medicines. The goal? Faster, safer access to treatment with clear rules that save time and support recovery.
2026-10128, Revision of Applications for Manufacturing and Procurement Quotas
The DEA wants to update how companies apply for permission to make and buy certain controlled drugs and chemicals. These changes will make the rules clearer, help prevent drug shortages, and ensure enough supply for medical and scientific needs. If you’re a manufacturer or involved in this process, get ready to follow new steps and share your thoughts by July 20, 2026.
2026-16665, Exempt Chemical Preparations Under the Controlled Substances Act
The applications for exempt chemical preparations received by the Drug Enforcement Administration between March 1, 2026, and June 30, 2026, as listed below, were accepted for filing and have been approved or denied as indicated. This publication addresses preparations through June 30, 2026, that were not included in previous Federal Register notices, and it does not affect preparations that have been previously published.
2026-16413, Schedules of Controlled Substances: Temporary Placement of O-Desmethyltramadol in Schedule I
The Drug Enforcement Administration issues this temporary order to schedule O-desmethyltramadol (other names: O-DSMT; desmetramadol; 3-[(1R,2R)-2-[(dimethylamino)methyl]-1- hydroxycyclohexyl]phenol), including its isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act. DEA bases this action on a finding that placing O-DSMT in schedule I is necessary to avoid an imminent hazard to public safety. This order imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle O-DSMT.
2026-16375, Schedules of Controlled Substances: Rescheduling of Suvorexant, Lemborexant, and Daridorexant From Schedule IV Into Schedule V
The Drug Enforcement Administration proposes to transfer suvorexant ([(7R)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4- diazepan-1-yl]-[5-methyl-2-(triazol-2-yl)phenyl]methanone), lemborexant ((1R,2S)-2-[(2,4-dimethylpyrimidin-5-yl)oxymethyl]-2-(3-fluorophenyl)- N-(5-fluoropyridin-2-yl)cyclopropane-1-carboxamide), and daridorexant ([(2S)-2-(5-chloro-4-methyl-1H-benzimidazol-2-yl)-2-methylpyrrolidin-1- yl]-[5-methoxy-2-(triazol-2-yl)phenyl]methanone) from schedule IV to schedule V of the Controlled Substances Act. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule V controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle suvorexant, lemborexant, and daridorexant.
2026-15624, Amendment to 3,4-MDP-2-P Methyl Glycidic Acid, a List I Chemical
The Drug Enforcement Administration is proposing to modify the listing of the list I chemical 3,4-MDP-2-P methyl glycidic acid (also known as PMK glycidic acid) to include esters of 3,4-MDP-2-P methyl glycidic acid, not listed elsewhere in the Controlled Substances Act (CSA), as list I chemicals under the CSA. The current listing of 3,4- MDP-2-P methyl glycidic acid includes its salts, optical and geometric isomers, and salts of isomers. DEA proposes the new listing to read as follows: 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid) and its esters, not listed elsewhere in the CSA, its optical and geometric isomers, its salts, salts of its optical and geometric isomers, salts of its esters, not listed elsewhere in the CSA, and any combination thereof, whenever the existence of such is possible.
Previous / Next Documents
Previous: 2026-10089, Importer of Controlled Substances Application: Amneal Pharmaceuticals, LLC
Amneal Pharmaceuticals wants to become an official importer of a strong painkiller called Remifentanil. This means they’ll be allowed to bring this controlled drug into the U.S. People who make or use these drugs can share their thoughts or ask for a hearing by June 22, 2026. No direct money changes yet, but this move could affect drug availability and business in the future.
Next: 2026-10091, Commission Information Collection Activities (FERC-919); Comment Request; Extension
FERC is extending its current info collection rules for another three years without any changes. This affects public utilities that sell electricity at market-based rates, making sure their prices stay fair. If you want to share your thoughts, you’ve got until July 20, 2026, to comment—no extra costs or new paperwork coming your way!