NYS DOH Opioid Annual Technical Report and File Specifications. Version 1.4

This technical document is to be used by manufacturers/distributers of opioids to report the total morphine milligram equivalent amount and other required data elements for opioids sold into or within New York State for a given calendar year.

Definitions of terms used in this schema

DEA: - U.S. Drug Enforcement Agency
MME: - Morphine Milligram Equivalent
NYS: - New York State
DOH: - NYS Department of Health
SED: - New York State Education Department
Registrant: - The manufacturer/distributer selling opioids into or within NYS. A reporter is uniquely identified by its DEA registration number and/or SED registration number and/or its NYS Controlled Substance License number
NDC: - National Drug Code
Reportable: All transactions of opioids by the reporter as detailed in the ‘New York State Department of Health Opioid Annual Report Guidance’ document.

All information in this report is limited to opioid transactions (including sales, returns, credits, and cancellations) of a finished opioid unit by a registrant into or within NYS for the transaction year being reported.

Multiple Field Validation

The following validations rules are not enforced in within this XSD but will be enforced when a report is submitted.

The SellerTransactionId must be unique for every OpioidSale submitted in this report
An OpioidSale must have at least one of the following attributes filled: SellerDeaNumber, SellerCsLicenseNumber, SellerSedLicense
A SellerDeaNumber, SellerCsLicenseNumber, SellerSedLicense combination found in an OpioidSale must also appear in the RegistrantLicensesList
For 'S' (Sale) transactions, attributes Containers, TotalMetricQuantity and TotalNyMMEs must be greater than 0. TransactionGrossReceipt must be 0 or greater
For 'R' (Return/Credit/Cancellation) transactions, attributes Containers, TotalMetricQuantity and TotalNyMMEs must be less than 0. TransactionGrossReceipt must be 0 or less
The OpioidSale TransactionDate must be within the TransactionYear

NYS Opioid Tax Reporting Data NYS Opioid Tax Reporting Data NYS Opioid Tax Report by a Registrant for a reporting year Registrant. The taxable entity who is legally required to submit this report. Submitter Information. The person responsible for submitting the data and who should be contacted for any submission issues. List of license combinations (SED, DOH, DEA) used by the registrant. List of opioid transactions sold by or returned to the Registrant for the reporting year. Taxpayer Identification Number (FEIN or EIN assigned by the Internal Revenue Service) The year in which the transaction occurred (e.g. 2019) Corporate Name Associated with Taxpayer Identification Number (TIN) Corporate Address associated with TIN Corporate Address associated with TIN Corporate Address associated with TIN Corporate City associated with TIN Corporate State associated with TIN Corporate First 5 of the Zip Code associated with TIN Corporate Zip 4 associated with TIN Corporate Email associated with TIN Corporate Phone Number area code associated with TIN Corporate Phone Number (first 3 digits) associated with TIN Corporate Phone Number (last 4 digits) associated with TIN Corporate Phone Number (extension) associated with TIN First name of person to contact for questions related to the annual report Last name of person to contact for questions related to the annual report Address of person to contact regarding the annual report Address of person to contact regarding the annual report Address of person to contact regarding the annual report City of person to contact regarding the annual report State of person to contact regarding the annual report First 5 of the Zip Code of person to contact regarding the annual report Zip 4 of person to contact regarding the annual report Email of person to contact regarding the annual report Phone Number area code of person to contact regarding the annual report Phone Number (first 3 digits) of person to contact regarding the annual report Phone Number (last 4 digits) of person to contact regarding the annual report Phone Number (extension) of person to contact regarding the annual report Transaction ID assigned to each opioid transaction(must be a unique value per Reporting Year) Invoice number on sales transaction DEA registration number, if applicable, for the registrant that sold the opioid NYS DOH controlled substance license number, if applicable, for the registrant that sold the opioid State Education Department registration number, if applicable, for the registrant that sold the opioid DEA registration number of the buyer NYS DOH controlled substance license number, if applicable, of the buyer The name of the buyer as it appears on the DEA Registration Buyer's DEA Registered Address Buyer Classification: '32' - buyers operating pursuant to Article 32 of Mental Hygiene Law, '40' - buyers operating pursuant to Article 40 of Public Health Law, '99' - buyers located out of NYS, '49' - all other buyers Date transaction occurred S for Sale, R for Return/Credit/Cancellation. If the type is R, then you must supply the OriginalSaleDate and the OriginalSaleInvoice If the type is S, then OriginalSaleDate and OriginalSaleInvoice should not be supplied Gross receipt total for the opioid transaction (in US Dollars) Was this the first sale within or into New York State, 'Y' for yes, 'N' for no (A first sale is any transfer of title to an opioid unit for consideration where actual or constructive possession of such opioid unit is transferred by a registrant holding title to such opioid unit to a purchaser or its designee in this state for the first time.) 11-digit National Drug Code (NDC) identifying the opioid sold (include leading zeros’s) Name of the drug as registered with the Food and Drug Administration Amount of opioid in a unit, as measured by weight, volume, concentration or other measure Number of units in the saleable container as identified by the 11-digit NDC Code Number of containers in this transaction Units per container multiplied by the number of containers sold Reference standard of a particular opioid as it relates in potency to morphine as determined by the Commissioner of Health Total Morphine Milligram Equivalent's in transaction Is the wholesale acquisition cost equal to or greater than $0.50? 'Y' for yes, 'N' for no Information about a specific drug (idenfitied by an NDC number) involved in a sale/return transaction. If Transaction Type is a return, reference the transaction date of the original sale of opioid.
If Transaction Type is a sale, leave this field blank. If Transaction Type is a return, reference the invoice number of the original sale of opioid.
If Transaction Type is a sale, leave this field blank. S for Sale, R for Return/Credit/Cancellation The 1st line of the address of the buyer as it appears on the DEA Registration The 2nd line of the address of the buyer as it appears on the DEA Registration The 3rd line of the address of the buyer as it appears on the DEA Registration The city of the buyer as it appears on the DEA Registration The state of the buyer as it appears on the DEA Registration The first five digits of the zip code of the buyer as it appears on the DEA Registration The zip plus 4 of the buyer as it appears on the DEA Registration Combination of registrations/licenses (SED, CSL, DEA) for all registrants that operate under one Corporate Taxpayer Identification Number DEA registration number, if applicable, for each registrant included in the annual report NYS DOH controlled substance license number, if applicable, for each registrant included in the annual report NYS Education Department registration number, if applicable, for each registrant included in the annual report DEA registration name if available, otherwise, corporate name as displayed on license/registration certificate(CS or SED)