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§ 17-95-102. Legend drugs

AR Code § 17-95-102 (2018) (N/A)
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(a) A dispensing physician is a physician licensed under the Arkansas Medical Practices Act, § 17-95-201 et seq., § 17-95-301 et seq., and § 17-95-401 et seq., who purchases legend drugs to be dispensed to his or her patients for the patients' personal use and administration outside the physician's office.

(b) This section shall not apply to physicians who only dispense drugs in injectable form unless they are controlled substances, in which case the section shall fully apply.

(c) The dispensing physician shall:

(1) Personally dispense legend drugs, and the dispensing of such drugs may not be delegated;

(2) Keep records of all receipts and distributions of legend drugs. The records shall be subject to inspection by the proper enforcement authority and shall be readily accessible for inspection and maintained in a central registry; and

(3) Label legend drugs with the following information:

(A) Patient's name and address;

(B) Prescribing physician's address and narcotic registry number issued by the Drug Enforcement Administration of the United States Department of Justice;

(C) Date of dispensing; and

(D) Directions and cautionary statements, if any, as required by law.

(d)

(1) A physician licensed under the Arkansas Medical Practices Act, § 17-95-201 et seq., § 17-95-301 et seq., and § 17-95-401 et seq., shall not dispense legend drugs without prior approval by the Arkansas State Medical Board after application to the board and on the showing of need.

(2) Licensed physicians who were dispensing in the ordinary course of their practice before April 12, 2013, shall be exempt from the requirements of this subsection.

(3) The board shall determine whether need exists for a physician to dispense a specific legend drug to the physician's patient for a patient's personal use and administration outside of the physician's office based on such information as is necessary for the board to determine:

(A) The legend drug or drugs that the physician requests to dispense;

(B) The ability of a physician's patient to obtain the legend drug from other medical professionals;

(C) The availability of the legend drug to be prescribed by the physician;

(D) The hours at which the legend drug may be obtained from other medical professionals;

(E) The distance the physician's patient must travel to obtain the legend drug from other medical professionals;

(F) Whether the physician has been investigated by the board concerning the improper prescribing or use of a legend drug;

(G) Whether the physician has a financial relationship with the manufacturer of a legend drug that would create the appearance of a conflict of interest;

(H) Whether the physician dispensing a legend drug will foster cost containment through improved efficiency and productivity; and

(I) The procedures the physician has implemented to:

(i) Assure compliance with the requirements of subsection (c) of this section;

(ii) Monitor and guard against potential drug interactions;

(iii) Store and safeguard the legend drugs; and

(iv) Comply with the Prescription Drug Monitoring Program Act, § 20-7-601 et seq., concerning the reporting requirements to the Prescription Drug Monitoring Program.

(4) A prescription for a topical medication, Naloxone, or contraceptives is exempt from subdivision (d)(3) of this section.

(e) The board shall enforce the provisions of this section and is authorized and directed to adopt regulations to carry out its purpose.

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§ 17-95-102. Legend drugs