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D.C. Municipal Regulations (Last Updated: September 13, 2017) |
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Title 29. PUBLIC WELFARE |
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Chapter 29-23. [RESERVED] |
Section 29-2361. SPECIALITY SERVICES -- ADDITIONAL STANDARDS FOR NARCOTIC TREATMENT (OPIOID REPLACEMENT) PROGRAMS
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2361.1 In addition to the requirements of this section, programs providing narcotic treatment shall comply with standards for all facilities and program as specified in this chapter.
2361.2 Substance abuse treatment facilities or programs providing narcotic treatment with opioid replacement therapy shall comply with federal requirements for opioid treatment as specified in 21 C.F.R. Part 291 and shall comply with District and federal regulations for maintaining controlled substances as specified in Chapter 10, Title 22 of the District of Columbia Municipal Regulations, and 21 C.F.R. Part 1300, respectively.
2361.3 Each narcotic treatment program or service delivery site, whether providing inpatient or outpatient services shall submit applications to the Department and the U.S. Food and Drug Administration (FDA), respectively and shall require the approval of both agencies prior to its initial operation.
2361.4 A narcotic treatment program shall submit to the Department photocopies of all applications, reports and notifications required by federal laws and regulations.
2361.5 Narcotic treatment programs shall ensure the following:
(a) Access to electronic alarm areas where drug stock is maintained shall be limited to a minimum number of authorized licensed personnel. Each employee shall have his/her own individual code, which shall be erased upon termination.
(b) All stored drugs (liquid, powder, solid and reconstituted) including controlled substances, shall be clearly labeled with the following information:
(1) Name of substance;
(2) Strength of substance;
(3) Date of reconstitution or preparation;
(4) Manufacturer and lot number;
(5) Manufacturer’s expiration date; or
(6) Reconstituted/prepared drug’s expiration date according to the manufacturer’s expiration date, or one (1) year from the date of reconstitution or preparation, whichever is shorter.
(c) Take-home medications shall be labeled and packaged in accordance with Federal and District laws and shall include the following information:
(1) Treatment program’s name, address, and telephone number;
(2) Physician’s name;
(3) Patient’s name;
(4) Directions for ingestion;
(5) Name of medication;
(6) Dosage in milligrams;
(7) Date issued; and
(8) Cautionary labels as appropriate;
2361.6 Containers of drugs shall be kept covered and stored in the appropriate locked safe with access limited by an electronic alarm system that conforms to DEA and District requirements.
2361.7 The Department shall be notified of any theft, suspected theft or any significant loss of controlled substances, including spillage. Photocopies of DEA forms 106 and 41 shall be submitted to the Department.