Version 16.3 Office-Based Treatment Prescribing Only Application for Registration (Form DHHS 224-E) NC Department of Health and Human Services Division of Mental Health, Developmental Disabilities, and Substance Abuse Services – Drug Control Unit 3008 Mail Center Service Center Raleigh, North Carolina 27699-3008 (919) 733-1765 Application Instructions – PLEASE READ THESE INSTRUCTIONS CAREFULLY This application will be used by the North Carolina Department of Health and Human Services’ Drug Control Unit to initiate a registration for the applicant under the North Carolina Controlled Substances Act of 1971 as well as assist in determining whether or not the applicant is in compliance with State and Federal laws pertaining to controlled substances. Therefore, please fill out this application in its entirety. Do not leave any fields blank, rather indicate that a field is not applicable by typing “N/A” in the space provided. Failure to complete the entire form will result in the application being returned to the applicant along with a request for additional information. To submit this Application for Registration, e-mail both the completed electronic PDF and a signed PDF copy to [email protected] along with a signed PDF copy of an Applicant Disclosure of Loss, Diversion, or Destruction of Controlled Substances (Addendum to Forms DHHS 224 and 225). Attestation By signing below, you attest that the information provided on this form is true, accurate, and complete to the best of your knowledge. All responses are subject to verification by the North Carolina Department of Health and Human Services’ Drug Control Unit. Furthermore, you acknowledge that you have read and understand NC GS 90-101(a1): “(a1) Any physician who prescribes or dispenses Buprenorphine for the treatment of opiate dependence shall annually register with the Department, in accordance with rules adopted by the Commission. In the application for registration under this subsection, the applicant shall document plans to ensure that patients are directly engaged or referred to a qualified provider to receive counseling and case management, as appropriate, and shall acknowledge the application of federal confidentiality regulations to patient information. Applicant plans for referral to appropriate services shall be a written document and may include either an executed memorandum of agreement, contractual arrangement, or linkage agreement with qualified providers. The Department shall provide assistance upon request to physicians registered under this subsection to identify and establish linkages with qualified providers of counseling and case management. The Department shall provide the North Carolina Medical Board with any evidence of noncompliance with this subsection by a qualified physician prior to taking action to rescind the physician’s registration to prescribe or dispense Buprenorphine for the treatment of opiate dependency.” Signature Date Phone Number Name and Title E-Mail Address Section A - Applicant Information Applicant Name Facility’s Address Physical County Facility’s State, City, Zip Mailing Address Phone Number Mailing State, City, Zip Section B - Registration Classification B1. Check all applicable drug schedules in which you are applying for: ☐ Schedule III (Narcotic) B2. Are you currently authorized to manufacture, distribute, dispense, prescribe, conduct research, or otherwise handle controlled substances in the schedules for which you are applying under the laws of North Carolina or the Federal Government? ☐ Yes ☐ No B3. Has the applicant been convicted of a felony under State or Federal law relating to the manufacture, possession, distribution, or dispensing of controlled substances? ☐ Yes ☐ No B4. Has any previous registration held by the applicant, corporation, firm, partner, or officer of applicant under Federal CSA or NCCSA been surrendered, revoked, suspended, denied, or is it pending such action? ☐ Yes ☐ No
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Version 16.3
Office-Based Treatment Prescribing Only Application for Registration (Form DHHS 224-E)
NC Department of Health and Human Services Division of Mental Health, Developmental Disabilities, and Substance Abuse Services – Drug Control Unit
3008 Mail Center Service Center
Raleigh, North Carolina 27699-3008
(919) 733-1765
Application Instructions – PLEASE READ THESE INSTRUCTIONS CAREFULLY
This application will be used by the North Carolina Department of Health and Human Services’ Drug Control Unit to initiate a registration for the applicant under the North Carolina Controlled Substances Act of 1971 as well as assist in determining whether or not the applicant is in compliance with State and Federal laws pertaining to controlled substances. Therefore, please fill out this application in its entirety. Do not leave any fields blank, rather indicate that a field is not applicable by typing “N/A” in the space provided. Failure to complete the entire form will result in the application being returned to the applicant along with a request for additional information. To submit this Application for Registration, e-mail both the completed electronic PDF and a signed PDF copy to [email protected] along with a signed PDF copy of an Applicant Disclosure of Loss, Diversion, or Destruction of Controlled Substances (Addendum to Forms DHHS 224 and 225).
Attestation
By signing below, you attest that the information provided on this form is true, accurate, and complete to the best of your knowledge. All responses are subject to verification by the North Carolina Department of Health and Human Services’ Drug Control Unit. Furthermore, you acknowledge that you have read and understand NC GS 90-101(a1):
“(a1) Any physician who prescribes or dispenses Buprenorphine for the treatment of opiate dependence shall annually register with the Department, in accordance with rules adopted by the Commission. In the application for registration under this subsection, the applicant shall document plans to ensure that patients are directly engaged or referred to a qualified provider to receive counseling and case management, as appropriate, and shall acknowledge the application of federal confidentiality regulations to patient information. Applicant plans for referral to appropriate services shall be a written document and may include either an executed memorandum of agreement, contractual arrangement, or linkage agreement with qualified providers. The Department shall provide assistance upon request to physicians registered under this subsection to identify and establish linkages with qualified providers of counseling and case management. The Department shall provide the North Carolina Medical Board with any evidence of noncompliance with this subsection by a qualified physician prior to taking action to rescind the physician’s registration to prescribe or dispense Buprenorphine for the treatment of opiate dependency.”
Signature
Date
Phone Number
Name and Title E-Mail Address
Section A - Applicant Information
Applicant Name
Facility’s Address Physical County
Facility’s State, City, Zip
Mailing Address Phone Number
Mailing State, City, Zip
Section B - Registration Classification
B1. Check all applicable drug schedules in which you are applying for:
☐ Schedule III (Narcotic)
B2. Are you currently authorized to manufacture, distribute, dispense, prescribe, conduct research, or otherwise handle controlled substances in the schedules for which you are applying under the laws of North Carolina or the Federal Government?
☐ Yes ☐ No
B3. Has the applicant been convicted of a felony under State or Federal law relating to the manufacture, possession, distribution, or dispensing of controlled substances?
☐ Yes ☐ No
B4. Has any previous registration held by the applicant, corporation, firm, partner, or officer of applicant under Federal CSA or NCCSA been surrendered, revoked, suspended, denied, or is it pending such action?
☐ Yes ☐ No
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Version 16.3
Section C - State Registration History
C1. Please select the event below that best describes your reason for submitting an Application for Registration (Form DHHS 224) and provide an answer to each supporting question for that event (choose only one answer from below)
☐ The application is for a first time registrant ☐ The application reflects a name change for a registrant
Anticipated Opening Date: Name on Previous Registration:
Previous DHHS Registration No:
☐ The application reflects a change of location/address for a registrant
Name on Previous Registration: Previous DHHS Registration No:
Previous Address (Line 1): Previous City:
Previous Address (Line 2):
Section D - Please Answer the Following Questions
D1. Do you store Suboxone/Buprenorphine at your place of business or do you prescribe it only? If you store Suboxone/Buprenorphine please stop and fill out form 224G.
D2. What is your DEA number and when does it expire?
D3. How long have you been treating with Suboxone/Buprenorphine?
D4. How many clients are you currently treating with Suboxone/Buprenorphine? If more than 30, did you request the increase in number from the federal government?
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Version 16.3
D5. How are prescription pads secured at your facility?
D6. Do you provide in-house counseling? If no, does someone else provide in-house counseling?
D7. Do you refer counseling out into the community? Please provide credentials involved and submit along with this questionnaire.
D8. Is there a policy or agreement regarding referrals? If so, please provide a copy and submit along with this questionnaire.
D9. How do you handle federal confidentiality regulations regarding your clients? Do you provide the client with any documentation stating that you abide by federal confidentiality regulations? Please provide a copy and attach it to this questionnaire.
D10. Are you using the North Carolina Controlled Substances Reporting System? If you need information regarding CSRS, please refer to www.nccsrs.org or call 919-733-1765.
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Version 16.3
D11. If applicable, please indicate your method of reporting medical errors.
Section E - Supplemental Materials
The following documents are required as part of your Application for Registration:
1. Copy of the applicant’s current DEA Registration.
2. Credentials for counseling referred out into the community.
3. Copy of policy regarding referrals.
4. Copy of notice given to patients regarding confidentiality regulations and the applicant’s privacy practices.
5. For applicants treating more than 30 patients, a copy of the original notification that was submitted to SAMHSA/CSAT notifying them of the increased patient load as well as their response letter acknowledging your request.
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