Arkansas Administrative Code
Agency 070 - Board of Pharmacy
Rule 070.00.02-001 - 04-03-0001 - Specialty Pharmacy Permits
Universal Citation: AR Admin Rules 070.00.02-001
Current through Register Vol. 49, No. 2, February 2024
The Board may issue a specialty pharmacy permit for a facility to provide unique aspects of pharmaceutical care to an identified patient population as provided in Regulation 04-03-0001et seq. Said specialty pharmacies and the pharmacists practicing therein shall comply with applicable federal and state law and regulations, including Arkansas Pharmacy Law, A.C.A. § 17-92-101 et seq., and Board Regulations, including without limitation regulations regarding Retail Pharmacies 04-02-0001et seq., which are not expressly superseded by the regulation applicable to the specific type of specialty pharmacy.
04-03-0002 METHADONE CLINIC SPECIALTY PHARMACY PERMIT
1.
DEFINITIONS:
a. "Methadone Clinic Pharmacy"
means the place in which a licensed professional prepares methadone to be
administered and/or dispensed to a patient of the clinic.
b. "Dispensing Methadone" means the
preparation of one or more doses of methadone in properly labeled, patient
specific containers and delivery of said drugs to the patient to consume away
from the clinic; only a licensed pharmacist or physician holding a dispensing
permit issued by the Arkansas State Medical Board shall dispense
methadone.
c. "Administering" means
giving a single dose of methadone to a patient to consume on-site; a physician
shall administer or supervise the administration of methadone and the clinic
pharmacist shall retain appropriate methadone administration records.
2. PERMIT
a. Applications for methadone clinic permits
shall be submitted pursuant to Regulation 04-02-0001.
b. Any pharmacist shall notify the 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.
3. PHARMACY OPERATIONS
a. 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 Pharmacy
Board prior to operation of said pharmacy.
b. A Methadone Clinic Pharmacy shall stock
and dispense methadone only.
4. PHYSICAL FACILITIES
a. The pharmacy shall be a controlled area
for the storage, safeguarding, preparation, and dispensing of methadone, a
Schedule II narcotic, 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
regulations.
b. The pharmacy shall
have all equipment necessary to carry out the functions of the Methadone Clinic
Pharmacy and is otherwise exempt from Regulation 02-02-0004; the equipment must
be identified in the policies and procedures of each Methadone Clinic specialty
Pharmacy.
5. LICENSED
PHARMACIST PERSONNEL REQUIREMENTS
a. A
methadone pharmacy shall be open to serve its patients, with a pharmacist or
pharmacists on duty, a minimum of 10 hours per week or, if necessary, a greater
period of time in order to perform pharmacy duties necessary to ensure patient
safety.
b. The pharmacy's operating
hours must be approved by the Executive Director of the Arkansas State Board of
Pharmacy.
Disclaimer: These regulations may not be the most recent version. Arkansas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
