DEA Reviews New Importer for Controlled Meds
Published Date: 2/13/2026
Notice
Summary
S&B Pharma LLC, also known as Norac Pharma, wants to become an official importer of certain controlled drugs. This means they’ll be allowed to bring in specific medicines that need special handling. If anyone has concerns or wants a hearing, they must speak up by March 16, 2026, so don’t miss the deadline!
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
Application to Import Two Schedule II Drugs
On January 13, 2026, S&B Pharma LLC DBA Norac Pharma applied to be registered to import ANPP (controlled substance code 8333, Schedule II) and Tapentadol (code 9780, Schedule II). The company plans to import intermediate forms of Tapentadol for further manufacturing and to import ANPP to bulk manufacture other controlled substances for distribution to its customers.
Finished Dosage Forms Not Authorized
The DEA notice states that authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale under this registration. The registration, if approved, is limited to the activities described in the application.
Deadline to Comment or Request Hearing
Registered bulk manufacturers of the affected drug classes and other applicants may submit comments or objections, or file a written request for a hearing, on or before March 16, 2026. Comments must be submitted electronically at https://www.regulations.gov and hearing requests must be sent to the DEA addresses listed in the notice.
Approval Conditional on Statutory Consistency
The notice states that approval of permit applications will occur only when the registrant's business activity is consistent with 21 U.S.C. 952(a)(2). That statutory consistency is a condition for authorization.
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: 2026-02913, Notice of OFAC Sanctions Action
The U.S. Treasury’s OFAC just blocked a Lebanese company called JOOD SARL and some related vessels because they support Hizballah. This means all their U.S.-related money and property are frozen, and Americans can’t do business with them. The action took effect on February 10, 2026, signaling serious financial consequences for those involved.
Next: 2026-02917, State of Wyoming: NRC Staff Assessment of a Proposed Amendment to the Agreement Between the Nuclear Regulatory Commission and the State of Wyoming
The Nuclear Regulatory Commission (NRC) is proposing changes to its agreement with Wyoming about how the state handles certain nuclear materials. This update affects Wyoming’s safety rules and staffing for managing these materials, aiming to keep everyone safe and sound. The public can share their thoughts by March 2, 2026, before any final decisions are made.