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D.C. Municipal Regulations (Last Updated: September 13, 2017) |
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Title 22. HEALTH |
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SubTilte 22-A. MENTAL HEALTH |
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Chapter 22-A63. CERTIFICATION STANDARDS FOR SUBSTANCE USE DISORDER TREATMENT AND RECOVERY PROVIDERS |
Section 22-A6325. PROVIDER REQUIREMENTS FOR MEDICATION ASSISTED TREATMENT
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6325 PROVIDER REQUIREMENTS FOR MEDICATION ASSISTED TREATMENT
6325.1 In accordance with 42 C.F.R. part 8, Certification of Opioid Treatment Programs, Medication Assisted Treatment (MAT) providers must also be certified by the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) and accredited by a national accreditation body that has been approved by SAMHSA.
6325.2 SUD treatment programs providing MAT with opioid replacement therapy shall comply with Federal requirements for opioid treatment, as specified in 42 C.F.R. part 8, and shall comply with District and Federal regulations for maintaining controlled substances as specified in Chapter 10, Title 22 DCMR and 21 C.F.R. part 1300, respectively.
6325.3 Each MAT program, whether providing inpatient or outpatient services, shall submit applications to the Department and to the U.S. Food and Drug Administration (FDA), respectively, and shall require the approval of both agencies prior to its initial operation.
6325.4 MAT programs shall submit to the Department photocopies of all applications, reports, and notifications required by Federal laws and regulations.
6325.5 MAT programs shall ensure the following:
(a) That access to electronic alarm areas where drug stock is maintained shall be limited to a minimum number of authorized, licensed personnel;
(b) That each employee shall have his or her own individual code to access alarmed stock areas, which shall be erased upon termination;
(c) That 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, if applicable; and
(6) If applicable, 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;
(d) Take-home medications shall be labeled and packaged in accordance with Federal and District laws and regulations and shall include the following information:
(1) Treatment program’s name, address, and telephone number;
(2) Physician’s name;
(3) Client’s name;
(4) Directions for ingestion;
(5) Name of medication;
(6) Dosage in milligrams;
(7) Date issued; and
(8) Cautionary labels, as appropriate.
6325.6 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 the U.S. Drug Enforcement Administration (DEA) and District requirements.
6325.7 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.