D.C. Mun. Regs. tit. 22, r. 22-A6327

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-A6327 - PROVIDER REQUIREMENTS FOR OPIOID TREATMENT PROGRAMS

6327.1

In accordance with 42 CFR Part 8, Certification of Opioid Treatment Programs ("OTPs"), all OTPs must be certified by the U.S. Substance Abuse and Mental Health Services Administration ("SAMHSA"), the Drug Enforcement Administration ("DEA"), and accredited by a national accreditation body that has been approved by SAMHSA.

6327.2

OTPs shall comply with Federal requirements for opioid treatment, as specified in 42 CFR Part 8, and shall comply with Federal and District laws and regulations for maintaining controlled substances as specified in Chapter 10, Title 22-B DCMR and 21 CFR Part 1300, respectively.

6327.3

OTPs shall submit to the Department photocopies of all applications, reports, and notifications required by Federal laws and regulations.

6327.4

OTPs 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 separation from the provider;

(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.

6327.5

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 DEA requirements and District laws and regulations.

6327.6

The Department shall be notified of any theft, suspected theft, or any significant loss of controlled substances, including spillage. Copies of DEA forms 106 and 41 shall be submitted to the Department.

D.C. Mun. Regs. tit. 22, r. 22-A6327

Final Rulemaking published at 62 DCR 12056 (9/4/2015); amended by Final Rulemaking published at 67 DCR 11585 ( 10/9/2020 ).