(a) Any person, pharmacy, or facility located outside this state may apply to the board for a nonresident pharmacy permit which shall entitle the holder thereof to ship, mail, or deliver dispensed drugs, including but not limited to dangerous drugs and controlled substances, into this state. The board shall establish an application and require such information as the board deems reasonably necessary to carry out a background investigation of applicants and to ensure that the purposes of this Code section are met. Such application shall include:
(1) Proof of a valid, unexpired license, permit, or registration to operate a pharmacy in compliance with the laws and rules of each state in which the applicant receives and dispenses prescription drug orders, including but not limited to orders for prescription drugs, dangerous drugs, and controlled substances;
(2) Addresses, names, and titles of all principal corporate officers and the pharmacist in charge of dispensing drugs to residents of this state; and
(3) A statement of whether the applicant is in compliance with all lawful directions and requests for information from the regulatory or licensing agencies of each state in which the applicant is licensed as well as all requests for information made by the board pursuant to this Code section.
(b) The board shall establish by rule an application fee and the biennial renewal fee for a permit under this Code section.
(c) The board may only deny an application for a nonresident pharmacy permit for failure to comply with rules of the board or any requirements of this Code section or for good cause related to substantial evidence of misfeasance or malfeasance by the applicant. Applicants granted a permit under this Code section shall provide pharmacy care in a manner which does not endanger life and protects the health, safety, and welfare of the residents of this state. A pharmacy, facility, or entity licensed under Title 33 shall not be required to hold a nonresident pharmacy permit.
(d) After an effective date established by rule of the board for the enforcement of the nonresident pharmacy permits, it shall be unlawful for any person, pharmacy, or facility that is located outside this state and that does not possess a nonresident pharmacy permit to ship, mail, or deliver prescription drug orders or to advertise its services in this state, or for any person who is a resident of this state to advertise the services of such person, pharmacy, or facility with the knowledge that the advertisement will or is likely to induce residents of this state to use such person, pharmacy, or facility for pharmacy care. Nothing in this subsection shall be construed to limit or prohibit interstate commerce, including but not limited to the practice of pharmacy by mail.
(e) The board shall have the authority to promulgate rules and regulations governing the holder of a nonresident pharmacy permit under this Code section. Such rules and regulations shall minimally include the following requirements for nonresident pharmacy permit holders:
(1) A permit holder's pharmacist in charge of dispensing drugs to residents of this state shall be licensed in his or her state of location;
(2) A permit holder shall provide written notification to the board within ten days of any change of a permit holder's principal corporate officers or pharmacist in charge of dispensing drugs to residents of this state;
(3) A permit holder shall file a change of location application upon any change to the permit holder's state of registration in addition to proof of the license, permit, or registration from the permit holder's new state of registration and the United States Drug Enforcement Administration registration for such new location;
(4) A permit holder shall respond within ten calendar days to all communications from the board concerning emergency circumstances arising from errors in the dispensing of any drugs to residents of this state;
(5) A permit holder shall provide written notification to the board of each location at which the permit holder maintains its records for all prescription drug orders dispensed to patients in this state so that the records are readily retrievable from the business records of the permit holder; and
(6) A permit holder shall maintain a toll-free telephone number operational during the permit holder's regular hours of operation but not less than six days per week for a minimum of 60 hours per week that shall be used to provide and facilitate patient counseling. Such toll-free number shall be capable of receiving inbound calls from patients to the permit holder and shall be disclosed on the label affixed to each container of all dispensed and distributed drugs.
(f) The board may revoke, suspend, or refuse to renew a permit of a permit holder for failure to comply with rules of the board or with any requirement of this Code section or for conduct which causes serious bodily or psychological injury to a resident of this state, provided that the board has referred the matter involving the conduct to the regulatory or licensing agency in the state in which the permit holder is located and the regulatory or licensing agency fails to initiate an investigation into the matter within 180 days of such referral or fails, in the board's judgment, to render sufficient resolution.
(g) (1) As a prerequisite to registering or renewing a registration with the board, a nonresident pharmacy conducting sterile or nonsterile compounding for practitioners to use in patient care in the practitioner's office shall submit a copy of the most recent and current inspection report resulting from an inspection conducted by the regulatory or licensing agency of the jurisdiction in which it is located that indicates compliance with the requirements of this chapter, including compliance with USP-NF standards for pharmacies performing sterile and nonsterile compounding. The inspection report required by this subsection shall not be required if the compounding within the facility is done pursuant to a prescription. Such inspection report shall be deemed current for the purpose of this subsection if the inspection was conducted:
(A) No more than six months prior to the date of submission of an application for registration with the board; or
(B) No more than two years prior to the date of submission of an application for renewal of a registration with the board.
(2) If the nonresident pharmacy conducting sterile or nonsterile compounding has not been inspected by the regulatory or licensing agency of the jurisdiction in which it is located within the timeframes required in paragraph (1) of this subsection, the board may:
(A) Accept an inspection report or other documentation from another entity that is satisfactory to the board; or
(B) Make a request of the appropriate regulatory or licensing agency of the jurisdiction where the pharmacy is located to cause an inspection to be conducted by an agent duly authorized by the board.
A nonresident pharmacy shall be responsible for paying any inspection fee incurred pursuant to this paragraph.
Section: Previous 26-4-110 26-4-110.1 26-4-111 26-4-112 26-4-113 26-4-114 26-4-114.1 26-4-115 26-4-115.1 26-4-116 26-4-116.1 26-4-116.2 26-4-116.3 26-4-117 26-4-118 NextLast modified: October 14, 2016