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.

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

Table of Contents

Elements

Complex Types

Simple Types

Element: OpioidTaxReportingData

Content Model

OpioidTaxReportingDataType

OpioidTaxReportingDataType

Elements
Element: RegistrantYearlyReport
 RegistrantYearlyReportType exactly 1

NYS Opioid Tax Report by a Registrant for a reporting year

RegistrantYearlyReportType

Attributes
Attribute: TIN
 tinType required

Taxpayer Identification Number (FEIN or EIN assigned by the Internal Revenue Service)

Attribute: TransactionYear
 transactionYearType required

The year in which the transaction occurred (e.g. 2019)

Elements
Element: Registrant
 RegistrantType exactly 1

Registrant. The taxable entity who is legally required to submit this report.

Element: Submitter
 SubmitterType exactly 1

Submitter Information. The person responsible for submitting the data and who should be contacted for any submission issues.

Element: RegistrantLicensesList
 RegistrantLicensesType exactly 1

List of license combinations (SED, DOH, DEA) used by the registrant.

Element: OpioidSales
 OpioidSalesType optional non-repeatable

List of opioid transactions sold by or returned to the Registrant for the reporting year.

RegistrantType

Attributes
Attribute: Name
 entityNameType required

Corporate Name Associated with Taxpayer Identification Number (TIN)

Attribute: AddressLine1
 addressLineType required

Corporate Address associated with TIN

Attribute: AddressLine2
 addressLineType optional

Corporate Address associated with TIN

Attribute: AddressLine3
 addressLineType optional

Corporate Address associated with TIN

Attribute: City
 cityType required

Corporate City associated with TIN

Attribute: State
 stateType required

Corporate State associated with TIN

Attribute: Zip5
 zip5Type required

Corporate First 5 of the Zip Code associated with TIN

Attribute: Zip4
 zip4Type optional

Corporate Zip 4 associated with TIN

Attribute: Email
 emailType optional

Corporate Email associated with TIN

Attribute: PhoneAreaCode
 phonePrefixType required

Corporate Phone Number area code associated with TIN

Attribute: PhonePrefix
 phonePrefixType required

Corporate Phone Number (first 3 digits) associated with TIN

Attribute: PhoneSuffix
 phoneSuffixType required

Corporate Phone Number (last 4 digits) associated with TIN

Attribute: PhoneExtension
 phoneExtType optional

Corporate Phone Number (extension) associated with TIN

SubmitterType

Attributes
Attribute: FirstName
 personNameType required

First name of person to contact for questions related to the annual report

Attribute: LastName
 personNameType required

Last name of person to contact for questions related to the annual report

Attribute: AddressLine1
 addressLineType required

Address of person to contact regarding the annual report

Attribute: AddressLine2
 addressLineType optional

Address of person to contact regarding the annual report

Attribute: AddressLine3
 addressLineType optional

Address of person to contact regarding the annual report

Attribute: City
 cityType required

City of person to contact regarding the annual report

Attribute: State
 stateType required

State of person to contact regarding the annual report

Attribute: Zip5
 zip5Type required

First 5 of the Zip Code of person to contact regarding the annual report

Attribute: Zip4
 zip4Type optional

Zip 4 of person to contact regarding the annual report

Attribute: Email
 emailType required

Email of person to contact regarding the annual report

Attribute: PhoneAreaCode
 phonePrefixType required

Phone Number area code of person to contact regarding the annual report

Attribute: PhonePrefix
 phonePrefixType required

Phone Number (first 3 digits) of person to contact regarding the annual report

Attribute: PhoneSuffix
 phoneSuffixType required

Phone Number (last 4 digits) of person to contact regarding the annual report

Attribute: PhoneExtension
 phoneExtType optional

Phone Number (extension) of person to contact regarding the annual report

OpioidSaleType

Elements
Element: SellerTransactionId
 maxLength4000Type exactly 1

Transaction ID assigned to each opioid transaction(must be a unique value per Reporting Year)

Element: SellerInvoice
 maxLength4000Type exactly 1

Invoice number on sales transaction

Element: SellerDeaNumber
 wholesaleDeaType optional non-repeatable

DEA registration number, if applicable, for the registrant that sold the opioid

Element: SellerCsLicenseNumber
 wholesaleCslType optional non-repeatable

NYS DOH controlled substance license number, if applicable, for the registrant that sold the opioid

Element: SellerSedLicense
 pharmNYSedType optional non-repeatable

State Education Department registration number, if applicable, for the registrant that sold the opioid

Element: BuyerDeaNumber
 allDeaType exactly 1

DEA registration number of the buyer

Element: BuyerCsLicenseNumber
 allCslType optional non-repeatable

NYS DOH controlled substance license number, if applicable, of the buyer

Element: BuyerDeaName
 deaNameAddrLineType exactly 1

The name of the buyer as it appears on the DEA Registration

Element: BuyerDeaAddress
 BuyerDeaAddressType exactly 1

Buyer's DEA Registered Address

Element: BuyerType
 buyerType exactly 1

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

Element: TransactionDate
 xsd:date exactly 1

Date transaction occurred

Element: TransactionType
 TransactionTypeType exactly 1

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

Element: TransactionGrossReceipt
 money10Type exactly 1

Gross receipt total for the opioid transaction (in US Dollars)

Element: IsFirstSale
 firstSaleTypeType exactly 1

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.)

Element: NdcCode
 ndcNumberType exactly 1

11-digit National Drug Code (NDC) identifying the opioid sold (include leading zeros’s)

Element: DrugName
 drugNameType exactly 1

Name of the drug as registered with the Food and Drug Administration

Element: StrengthPerUnit
 number10-4Type exactly 1

Amount of opioid in a unit, as measured by weight, volume, concentration or other measure

Element: UnitsPerContainer
 number10-4Type exactly 1

Number of units in the saleable container as identified by the 11-digit NDC Code

Element: Containers
 plusMinusNumber10-4Type exactly 1

Number of containers in this transaction

Element: TotalMetricQuantity
 plusMinusNumber10-4Type exactly 1

Units per container multiplied by the number of containers sold

Element: MmeConversionFactor
 number10-4Type exactly 1

Reference standard of a particular opioid as it relates in potency to morphine as determined by the Commissioner of Health

Element: TotalNyMMEs
 plusMinusNumber12-4Type exactly 1

Total Morphine Milligram Equivalent's in transaction

Element: IsOverWacThreshold
 isWacThresholdType exactly 1

Is the wholesale acquisition cost equal to or greater than $0.50? 'Y' for yes, 'N' for no

OpioidSalesType

Elements
Element: OpioidSale
 OpioidSaleType optional repeatable

Information about a specific drug (idenfitied by an NDC number) involved in a sale/return transaction.

TransactionTypeType

Attributes
Attribute: Type
 saleType required

S for Sale, R for Return/Credit/Cancellation

Elements
Element: OriginalSaleDate
 xsd:date optional non-repeatable

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.

Element: OriginalSaleInvoice
 maxLength4000Type optional non-repeatable

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.

BuyerDeaAddressType

Attributes
Attribute: Line1
 deaNameAddrLineType required

The 1st line of the address of the buyer as it appears on the DEA Registration

Attribute: Line2
 deaNameAddrLineType optional

The 2nd line of the address of the buyer as it appears on the DEA Registration

Attribute: Line3
 deaNameAddrLineType optional

The 3rd line of the address of the buyer as it appears on the DEA Registration

Attribute: City
 cityType required

The city of the buyer as it appears on the DEA Registration

Attribute: State
 stateType required

The state of the buyer as it appears on the DEA Registration

Attribute: Zip5
 usZip5Type required

The first five digits of the zip code of the buyer as it appears on the DEA Registration

Attribute: Zip4
 usZip4Type optional

The zip plus 4 of the buyer as it appears on the DEA Registration

RegistrantLicensesType

Elements
Element: RegistrantLicense
 RegistrantLicenseType 1 or more

Combination of registrations/licenses (SED, CSL, DEA) for all registrants that operate under one Corporate Taxpayer Identification Number

RegistrantLicenseType

Attributes
Attribute: DEANumber
 wholesaleDeaType optional

DEA registration number, if applicable, for each registrant included in the annual report

Attribute: CSLicense
 wholesaleCslType optional

NYS DOH controlled substance license number, if applicable, for each registrant included in the annual report

Attribute: SEDLicense
 pharmNYSedType optional

NYS Education Department registration number, if applicable, for each registrant included in the annual report

Attribute: LicenseeCorporateName
 licenseeCorporateName required

DEA registration name if available, otherwise, corporate name as displayed on license/registration certificate(CS or SED)

tinType

Pattern: [0-9,T,N][0-9,F,Y]\d{7}[0-9,A-Z]?[0-9,S]?

entityNameType

Minimum Length: 2

Maximum Length: 120

transactionYearType

Pattern: \d{4}

addressLineType

Minimum Length: 2

Maximum Length: 40

cityType

Minimum Length: 2

Maximum Length: 29

stateType

Length: 2

zip5Type

Length: 5

zip4Type

Pattern: \d{4}

Length: 4

usZip4Type

Pattern: \d{4}

Length: 4

emailType

Minimum Length: 0

Maximum Length: 320

personNameType

Minimum Length: 2

Maximum Length: 25

maxLength4000Type

Minimum Length: 1

Maximum Length: 4000

wholesaleDeaType

Pattern: [PR][A-Z9][0-9]{7}

wholesaleCslType

Pattern: (010|01A|020|02A|02B|02E|090)[0-9]{4}

pharmNYSedType

Pattern: [0-9]{6}

allDeaType

Pattern: [ABFGMPR][A-Z9][0-9]{7}

allCslType

Pattern: (010|01A|020|02A|02B|02E|030|03A|03B|03C|03D|03E|040|04A|050|060|06A|06B|070|080|090|09A|100|10A|110)[0-9]{4}

buyerType

Enumeration:

money10Type

Pattern: [-+]?\d{1,10}\.?\d{0,2}

ndcNumberType

Pattern: [0-9A-Z*]{11}

Length: 11

drugNameType

Minimum Length: 2

Maximum Length: 100

number10-4Type

Pattern: \d{1,10}\.?\d{0,4}

plusMinusNumber10-4Type

Pattern: [+-]?\d{1,10}\.?\d{0,4}

plusMinusNumber12-4Type

Pattern: [+-]?\d{1,12}\.?\d{0,4}

saleType

Enumeration:

Length: 1

phonePrefixType

Pattern: \d{3}

Length: 3

phoneSuffixType

Pattern: \d{4}

Length: 4

phoneExtType

Pattern: [A-Za-z0-9*_#]{0,10}

Minimum Length: 0

Maximum Length: 10

deaNameAddrLineType

Minimum Length: 2

Maximum Length: 40

usZip5Type

Pattern: \d{5}

Length: 5

licenseeCorporateName

Minimum Length: 1

Maximum Length: 150

firstSaleTypeType

Enumeration:

isWacThresholdType

Enumeration: