MN Opiate Product Reporting FAQ

  • How frequently must data be reported?

    Data must be reported at least annually prior to March 1st for the preceding year.
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  • What data/products must be reported?

    All sales, deliveries, or other distributions of opiates, as defined in Minnesota Statutes Section, 152.02, Subd. 3-5, made to an MN-located practitioner, pharmacy, hospital, veterinary hospital, or other person permitted to possess controlled substances for administration or dispensing to patients must be reported.

    Please note, this includes codeine-containing preparations that are classed as Schedule-III controlled substances in Minnesota, as well as butorphanol and pentazocine.

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  • What is the statutory definition for “units”? (i.e. per pill, per bottle, etc.)

    Per Minnesota Statute Section, 151.066, a "unit means the individual dosage form of the particular drug product that is prescribed to the patient".

    "One unit" equals one tablet, capsule, patch, syringe, milliliter, or gram.

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  • What format must the data be reported in?

    The Automation of Reports and Consolidated Orders System (ARCOS) format. Acceptable file extensions are .dat or .txt with a maximum size limitation of 100MB.

    Required naming convention:

    • File name begins with "MN_" (without quotes)
    • Extension of .dat or .txt

    Suggested naming conventions:

    • DEA number of reporting manufacturer or distributor
    • Year of reporting period

    For example: MN_AB9876543_2023.txt

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  • How are reportable opiates identified? (by base code, NDC list, DEA ARCOS list)

    Those defined in MN Stat. 152.02 Subd. 3-5.

    Please note, codeine-containing preparations that are classified as Schedule-III controlled substances in Minnesota, as well as butorphanol and pentazocine, must be reported.

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  • What ARCOS Transaction codes are acceptable to report?

    The MNOPR system may accept the following status codes:
    • ARCOS Disposition Transaction Codes (Decreases to Inventory)
    • S ‐ Sale, Disposition, or Transfer
    Miscellaneous Transaction Codes (zero reports):
    • 7 ‐ No ARCOS Activity for the Current Reporting Period
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  • If a licensee/DEA registrant has no transactions to report for the reporting period (previous calendar year) is a report required?

    A zero report is required. With a zero report on record, it will confirm that no activity in or within MN took place and save all parties from unnecessary inquires. The ‘zero report’ contains a header record identifying the reporting facility and a single transaction record with a transaction code of ‘7’ (per DEA ARCOS coding) which indicates there were no transactions to report during the previous calendar year.
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  • Do granted exemptions from reporting expire and need to be renewed annually?

    If the facility was previously granted an exemption, the facility should have received an exemption approval email or letter. Exemptions do not require annual renewal. However, if your facility is issued a new MN License Number, then re-applying for an exemption is necessary. 

    If at any point the facility no longer qualifies for an exemption, you must notify the MN Opiate Product Registration Fee Program and report any qualifying transactions or submit a zero report, as applicable. 

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  • How should we correct submission errors?

    If any data element submitted does not pass validation, you will be required to resubmit the entire file once you have resolved the errors. The corrected file must be given the SAME name as the original file that was submitted. Additionally, if during the final processing of the data, it is determined there are other issues with the data, you would also be required to resubmit the entire file once the errors have been resolved. Failure to submit the updated file prior to March 1, 2024, may result in being assessed a $500 a day penalty for late reporting.

    In order to delete a valid entry that was submitted in error, enter zero for the quantity and resubmit the file using the same file name as the original. Please note, the Action Indicator is not used.

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  • Will I be notified if a submission is successful or contains errors?

    Yes, it will be sent to the email address as provided in the data reporter’s account profile.
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