Sale of Controlled Substances Electronic Reporting Requirements Manual

Manufacturers and Distributors of Controlled Substances

New York State Department of Health
Bureau of Narcotic Enforcement
433 River Street, Room 303
Troy, New York 12180
Phone: 866-811-7957 Option 1
narcotic@health.ny.gov

December 15, 2009

I. Overview of Reporting Requirements for Sale of Controlled Substances

Section 80.23(f) of Title 10 New York State regulations requires manufacturers and distributors to electronically report information to the New York State Department of Health (NYSDOH) from the sale of all controlled substances in New York. A copy of the regulation is attached to this manual as Appendix A. The Department's Bureau of Narcotic Enforcement closely analyzes all reported sales information in carrying out its responsibilities under Article 33 of the Public Health Law to combat the diversion and illegal use of controlled substances.

Manufacturers and distributors of controlled substances must electronically transmit sales information as required by regulation and in the manner and format specified by the NYSDOH. Sales of all controlled substances in Schedules I through V must be reported.

Importers of controlled substances are authorized by their New York State license to distribute controlled substances. Importers that distribute controlled substances must comply with the sales reporting requirements stated in this manual.

The Transaction Codes required to be reported from the sale of a controlled substance to an Associate DEA Registrant are listed in Section VIII of this manual and correspond to a company's Bureau of Narcotic Enforcement license classification.

Important Note: Failure to submit required controlled substance sales information by the method, format and dates as specified in this manual is a violation of Title 10 regulations and may result in the commencement of an enforcement action and/or fines to be levied by the NYSDOH.

II. Additional Reporting Requirements and Guidance

  • Manufacturers and distributors located within New York State must transmit information from all controlled substances sales. Manufacturers and distributors located outside of New York State must transmit information only from controlled substances sales to DEA registrants located within New York State. Reverse distributors must transmit information from the return of controlled substances from DEA registrants located within New York State. See applicable 'sales transaction' codes in Section VIII.
  • Manufacturers and distributors that use a third-party to distribute all controlled substances are exempt from the requirement to report controlled substance sales. Such exemption is contingent upon approval by the NYSDOH.
  • The transaction code '7' must be transmitted in months where no sales of controlled substances occur.
  • Transfers of controlled substances between licensees authorized to distribute controlled substances are not required to be reported.
  • Importers of controlled substances: A company licensed in New York State as both an importer and a distributor of controlled substances must report required sales transaction information using the company's distributor DEA registration number only. A company licensed in New York State solely as an importer of controlled substances must report required sales transaction information under the company's importer DEA registration number only.

III. Internet Reporting Requirements

The NYSDOH uses a secure Web page, the Health Commerce System (HCS) located at https://commerce.health.state.ny.us, through which manufacturers and distributors must transmit required controlled substance sales information. An Internet browser, which provides 128 bit encryption Secure Socket Layer (SSL), must be used. Users are advised to review NYSDOH policy documents posted in the HCS section for manufacturers and distributors.

Electronic transmission must be done as a batch transmission at least once a month. Controlled substance sales information must be filed electronically not later than the 20th day of the month following the month in which the controlled substance was sold—meaning the date the controlled substance was shipped. Information must also be reported from the receipt of controlled substances from an Associate DEA registrant or from controlled substances determined to be lost in transit.

IV. Information to Establish an Online Internet Account

To establish a new account, manufacturers and distributors must complete appropriate application forms. These forms are included in the "NYSDOH Health Commerce System and Use Policy." Please refer to Appendix B for Application Instructions to Establish a New HCS Account.

Self Reporting

A self reporting manufacturer or distributor may only transmit controlled substance sales information conducted under their NYSDOH license.

Central Reporting

A central reporter may submit reports for one or more of its NYSDOH licensed locations by obtaining a central reporting identifier from the US Drug Enforcement Administration or as determined by NYSDOH. Online HCS accounts do not have to be obtained from a licensed manufacturer or distributor where a central reporting location is transmitting their information to the NYSDOH—only the central reporter is required to obtain an online HCS account.

V. Required Format for Electronic Submission of Sales Information

Electronic transmission must occur in the file format and manner approved by NYSDOH as described in this manual. The NYSDOH reporting format is the same format as required by the U.S. Department of Justice, Drug Enforcement Administration (DEA)—Automation of Reports and Consolidated Orders System (ARCOS) as of the release date of this document.

Important note: Reporting format revisions made by DEA may not be implemented by the NYSDOH.

Section VIII of this manual contains the listing of the fields for the Control Record and the Transaction Record as required by the NYSDOH.

VI. Certification and Rejection of Submitted Sales Information

Certification

All submissions of controlled substance sales information will be audited for compliance with the specified formats in this manual.

Rejection

Submissions of controlled substance sales information will be rejected as determined by the NYSDOH if they do not meet the data requirements specified herein. The submitting manufacturer or distributor will be notified of the reason for the rejection of information. In the event that a submission is rejected by the NYSDOH, the submitting manufacturer or distributor will be responsible for correcting the rejected submission and resubmitting the sales information within two weeks after notification by the NYSDOH.

Manufacturers and distributors should retain a back-up file for at least two months following transmission of controlled substance sales information.

VII. Assistance and Support

Assistance and information is available from the Bureau of Narcotic Enforcement between the hours of 8:30 a.m. and 4:45 p.m., Monday through Friday. The phone number is 1-866-811-7957 (select option 1). E-mail inquiries to narcotic@health.ny.gov

The DEA ARCOS Web page located at http://www.deadiversion.usdoj.gov/arcos/index.html contains the Arcos Registrant Handbook which provides detailed information regarding the formatting requirements.

Software for electronic transmission of controlled substance sales information will NOT be provided by the NYSDOH.

VIII. NYSDOH Electronic Data Interchange (EDI) Reporting Format

Listed on the following page are the required fields by the NYSDOH Bureau of Narcotic Enforcement.

New York State Department of Health EDI Reporting Format

Control Record
Example Data Field Name Column Position
AA1234567 Reporting Registrant 1-9
* Asterisk 10
01312006 Last day of the reporting period (mmddyyyy) 11-18
M Reporting Frequency 19
AB1234567 Central reporter's registration number 20-28
Transaction Record
Example Data Field Name Column Position
AA1234567 Registrant DEA Registration Number 1-9
S Transaction Code1 10
D Action Indicator 11
000543751** NDC Number 12-22
00000002 Quantity 23-30
4 Unit 31
BB1234567 Associate Registrant Number 32-40
00X453890 Order Form Number 41-49
01312006 Transaction Date (mmddyyyy) 50-57
91070022 Correction Number 58-65
0985 Strength 66-69
0000000088 Transaction ID 70-79
Leave Blank 80
000543751** NDC Number 81-91
0000002 Quantity 92-99
4 Unit 100
0985 Strength 101-104
End of Line Carriage Return 105

Footnote

  1. 1 Required Transaction Codes to transmit to NYSDOH: S, R, V, X, 7. [Reverse distributors only need to transmit R, V, 7.] [Other codes are not required but may be transmitted with a batch file.]
    • S - Sale, disposition, transfer
    • R - Return
    • V - Unsolicited Return
    • X - Lost in Transit
    • 7 - No activity during the period

Appendix A

Section 80.23(f) of Title 10 New York State Regulations

(f) Reports. Manufacturers and distributors shall report to the Department, in a manner approved by the Department, information of the sale of controlled substances. Such information shall be filed electronically with the Bureau of Narcotic Enforcement, utilizing a transmission format acceptable to the Department. The information filed with the Department shall include, but not be limited to:

  • (i) the manufacturer's or distributor's name, address, phone number, DEA registration number and controlled substance license number issued by the Department;
  • (ii) the name, address and DEA registration number of the entity to whom the controlled substance was sold;
  • (iii) the date of the sale of the controlled substance;
  • (iv) the name and National Drug Code (NDC) of the controlled substance sold; and
  • (v) the number of containers and the strength and metric quantity of controlled substance in each container of controlled substance sold.

Appendix B

An application form may be obtained by E-mailing a request to: narcotic@health.ny.gov. The e-mail must include the information as specified in 1-4 below:

Important Note: A registered central reporter (as specified in ARCOS) may report for its subsidiaries. If reporting for a subsidiary, only the central reporter should obtain an online account—not the subsidiary.

  1. In the e-mail subject heading state:
    • "HCS Application Request-Controlled Substances Sales Reporting"
  2. In the body of the E-mail include:
    • Company Name, Mailing Address
    • Telephone Number, Fax Number
    • Bureau of Narcotic Enforcement License Number
    • DEA Registration Number
    • DEA Central Reporter Identifier (if applicable) Note: A central reporter must provide information contained in this section for each of its subsidiaries. This is required for a central reporter submitting information on behalf a subsidiary.
  3. A "Director" for the online account must be designated. In the body of the e-mail include:
    • The full First name, Middle name, Last name
    • Title
    • Date of Birth
    • E-mail address
    • Telephone Number
  4. The Director may authorize other persons to establish separate HCS accounts. Such authorized person designated by the Director is considered a "Coordinator". Clearly specify proposed coordinator(s), and include in the body of the e-mail:
    • The full First name, Middle name, Last name
    • Date of Birth
    • E-mail address
    • Telephone Number

Once the Department has received your E-mail request, the necessary HCS application forms will be E-mailed to you. Follow the instructions provided and retain a copy for your records.

  • Each manufacturer/distributor must complete the "Participant Organization Security and Use Policy" within the packet (document 1 of the Security and Use Packet).
  • Each individual user must complete an "Individual User Security and Use Policy and Application" (document 2 of the packet). Once an account has been approved, individual confidential user IDs and passwords will be assigned.