(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.
Conviction: A judgement of guilt against a criminal defendant.
device: means an instrument, apparatus, implement, machine, contrivance, implant, or other similar or related article, including a component part or accessory, that is required under federal law to bear the label "Caution: Federal or state law requires dispensing by or on the order of a physician". See Alaska Statutes 08.80.480
dispensing: means the preparation and delivery of a drug or device to a patient or patient's agent under a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to, or use by, a patient. See Alaska Statutes 08.80.480
drug: means an article recognized as a drug in an official compendium, or supplement to an official compendium. See Alaska Statutes 08.80.480
Fraud: Intentional deception resulting in injury to another.
manufacturing: means the production, preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction from a substance of natural origin or independently by means of chemical or biological synthesis, and includes packaging or repackaging of a substance or labeling or relabeling of its container, and the promotion and marketing of drugs or devices. See Alaska Statutes 08.80.480
owner: means the owner of a place of business for wholesaling, retailing, compounding, or dispensing drugs, medicines, or poisons. See Alaska Statutes 08.80.480
pharmacist-in-charge: means a pharmacist who accepts responsibility for operation of a pharmacy in a manner that complies with laws and regulations applicable to the practice of pharmacy and the distribution of drugs and who is personally in charge of the pharmacy and the pharmacy's personnel. See Alaska Statutes 08.80.480
pharmacy: means a place in this state where drugs are dispensed and pharmaceutical care is provided and a place outside of this state that is subject to licensure or registration under Alaska Stat. See Alaska Statutes 08.80.480
practice of pharmacy: means the interpretation, evaluation, and dispensing of prescription drug orders in the patient's best interest. See Alaska Statutes 08.80.480
state: means the State of Alaska unless applied to the different parts of the United States and in the latter case it includes the District of Columbia and the territories. See Alaska Statutes 01.10.060
wholesale: means sale by a manufacturer, wholesale dealer, distributor, or jobber to a person who sells, or intends to sell, directly to the user. See Alaska Statutes 08.80.480
wholesale drug distributor: means anyone engaged in wholesale distribution of drugs, including manufacturers. See Alaska Statutes 08.80.480
(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
(1) permanent closing;(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;(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 Alaska Stat. § 08.80.390 than are set out in Alaska Stat. § 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 wholesale drug distributors, third-party logistics providers, and outsourcing facilities located outside the state under Alaska Stat. § 08.80.159.
