1. (a) Definitions. As used in this part:

   1. (1)

      1. (A) “Administering” means giving a single dose of methadone, buprenorphine, or other approved medications to a patient to consume onsite.
      2. (B) A physician shall administer or supervise the administration of methadone and the clinic pharmacist shall retain appropriate methadone administration records;

   2. (2)

      1. (A) “Dispensing” means the:

2. (i) Preparation of one (1) or more doses of methadone, buprenorphine, or other approved medications in properly labeled, patient-specific containers; and

   1. (ii) Delivery of said drugs to the patient to consume away from the clinic.

      1. (B) Only a licensed pharmacist or physician holding a dispensing permit issued by the Arkansas State Medical Board shall dispense methadone; and
   2. (3) “Methadone clinic pharmacy” means the place in which a licensed professional prepares methadone, buprenorphine, or other approved medications to be administered and/or dispensed to a patient of the clinic.

3. (b) Permit.

   1. (1) Applications for methadone clinic permits shall be submitted pursuant to 17 CAR § 160-1201.

   2. (2) Any pharmacist shall notify the Arkansas State Board of Pharmacy in writing and ascertain that a methadone clinic pharmacy permit has been issued to the clinic before beginning practice in that clinic.

      1. (c) Pharmacy operations.
   3. (1) The pharmacist-in-charge shall provide written policies, procedures, and protocols for the operation of the pharmacy and shall obtain the approval of same by the Executive Director of the Arkansas State Board of Pharmacy prior to operation of said pharmacy.

   4. (2) A methadone clinic pharmacy shall stock and dispense methadone or buprenorphine only unless permission is obtained from the Arkansas State Board of Pharmacy to utilize other medications for research purposes.

      1. (d) Physical facilities.
   5. (1) The pharmacy shall be a controlled area for the storage, safeguarding, preparation, and dispensing of methadone, a Schedule II narcotic, buprenorphine, a Schedule III controlled substance, and any other medications approved by the Arkansas State Board of Pharmacy for research purposes, and shall have adequate facilities for pharmaceutical services including the procurement, storage, distribution, security, and control of said drug consistent with all federal and state laws and rules.

   6. (2)

      1. (A) The pharmacy shall have all equipment necessary to carry out the functions of the methadone clinic pharmacy and is otherwise exempt from 17 CAR § 160-1204.
      2. (B) The equipment must be identified in the policies and procedures of each methadone clinic specialty pharmacy.

4. (e) Licensed pharmacist personnel requirements.

   1. (1) A methadone pharmacy shall be open to serve its patients, with a pharmacist or pharmacists on duty, a minimum of ten (10) hours per week or, if necessary, a greater period of time in order to perform pharmacy duties necessary to ensure patient safety.
   2. (2) The pharmacy’s operating hours must be approved by the executive director.

Codification Notes: This section as promulgated prior to codification into the Code of Arkansas Rules provided as follows: “(Revised 11/15/2003, Amended 5/31/2014)"