Section 08.80.157 - Licensing of facilities(a) A facility engaged in the practice of pharmacy or in the manufacture, production, or wholesale distribution of drugs or devices, and a pharmacy where drugs or devices are dispensed, shall be licensed by the board, and shall renew the license at intervals determined by the board. If operations are conducted at more than one location, each location shall be licensed by the board.(b) The board may by regulation determine the licensure classifications of facilities and establish minimum standards for the facilities.(c) The board shall establish by regulation the criteria that a facility must meet to qualify for licensure in each classification. The board may issue licenses with varying restrictions to facilities when the board considers it necessary to protect the public interest.(d) The board may deny or refuse to renew a license if it determines that the granting or renewing of the license would not be in the public interest.(e) Licenses issued by the board are not transferable or assignable.(f) The board shall specify by regulation the minimum standards for responsibility of a facility or pharmacy that has employees or personnel engaged in the practice of pharmacy or engaged in the manufacture, wholesale distribution, production, or use of drugs or devices in the conduct of its business.(g) A licensed facility shall report to the board(2) change of ownership; management, location, or pharmacist-in-charge of a pharmacy;(3) theft or loss of drugs or devices as defined by regulations of the board;(4) conviction of an employee of violation of a state or federal drug law;(5) disasters, accidents, theft, destruction, or loss relating to records required to be maintained by state or federal law;(6) occurrences of significant adverse drug reactions as defined by regulations of the board;(7) other matters and occurrences the board may require by regulation.(h) The board may suspend, revoke, deny, or refuse to renew the license of a facility or pharmacy on the following grounds: (1) the finding by the board of violations of a federal, state, or local law relating to the practice of pharmacy, drug samples, wholesale or retail drug or device distribution, or distribution of controlled substances;(2) a felony conviction under federal, state, or local law of an owner of the facility or pharmacy or of an employee of the facility or pharmacy;(3) the furnishing of false or fraudulent material in an application made in connection with drug or device manufacturing or distribution;(4) suspension or revocation by federal, state, or local government of a license currently or previously held by the applicant for the manufacture or distribution of drugs or devices, including controlled substances;(5) obtaining remuneration by fraud, misrepresentation, or deception;(6) dealing with drugs or devices that are known or should have been known to be stolen drugs or devices;(7) dispensing or distributing drugs or devices directly to patients by a wholesale drug distributor other than a pharmacy unless (A) the drug or device is a dialysate, drug composed solely of fluids, electrolytes, and sugars, or device that is (i) necessary to perform home dialysis;(ii) approved by the United States Food and Drug Administration, as required by federal law; and(iii) delivered in its original, sealed, and labeled packaging only upon the receipt of a physician's order;(B) the wholesale drug distributor (i) delivers the dialysate drug or device directly to a patient with end-stage renal disease, or to the patient's designee, for the patient's self-administration of dialysis therapy;(ii) uses a barcode scanning and verification system confirming that the dialysate drug or device selected to fill the patient-specific order matches the information on the patient-specific label; and(iii) has additional secondary accuracy and delivery checks in place; and(C) a licensed pharmacist serves as a consultant to the wholesale drug distributor to (i) conduct a retrospective audit of 10 percent of the dialysate drug and device orders provided directly to patients processed by the wholesale drug distributor every month; and(ii) perform assessments at least twice monthly to ensure quality of product storage, handling, and distribution by the wholesale drug distributor and to ensure product expiration dates are later than three months after the date of assessment;(8) violation of this chapter or a regulation adopted under this chapter.(i) The board's regulations under (b) - (d) and (f) of this section may not establish more stringent licensing requirements for the facilities governed by AS 08.80.390 than are set out in AS 08.80.390.(j) This section does not apply to the offices of physicians, osteopaths, podiatrists, physician assistants, advanced nurse practitioners, dentists, veterinarians, dispensing opticians, or optometrists.(k) This section applies to pharmacies, manufacturers, wholesale drug distributors, third-party logistics providers, and outsourcing facilities located outside the state under AS 08.80.159.Amended by SLA 2023, ch. 15,sec. 5, eff. 11/26/2023.Amended by SLA 2023, ch. 15,sec. 4, eff. 7/7/2023.Amended by SLA 2018, ch. 66,sec. 4, eff. 7/1/2019.