Section 12 AAC 52.995 - Definitions(a) In this chapter, unless the context requires otherwise, (1) "ACPE" means Accreditation Council for Pharmacy Education;(2) "approved program" means a continuing education activity that is a live program, home study, or other mediated instruction delivered by an approved or accredited provider;(3) "approved provider" means an individual, institution, organization, association, corporation, or agency offering an approved program under 12 AAC 52.340 and is not an accredited provider;(4) "authorized inspector" means a member of the board or an investigator with the division assigned occupational licensing functions in the department;(5) "blood" means whole blood collected from a single donor and processed either for transfusion or further manufacturing;(6) "blood component" means that part of blood separated by physical or mechanical means;(7) "board" means the Alaska Board of Pharmacy;(8) "care provider" means a person or organization that by the nature of experience and training is qualified, in the opinion of the board, to provide substance abuse counseling, rehabilitation, or related services to the public through established and recognized treatment programs;(9) "consultant pharmacist" means a licensed pharmacist retained by written agreement with an institutional facility to consult on a routine basis with an institutional facility about the practice of pharmacy as it relates to that facility;(10) "contact hour" means a unit of measure of educational credit that is equivalent to approximately 50 minutes of participation in an organized learning experience; a continuing education unit or "CEU" is equivalent to ten contact hours;(11) "DEA" means the United States Drug Enforcement Administration;(12) "department" means the Department of Commerce, Community, and Economic Development;(13) "direct supervision" means supervision that ensures adequate safety controls either by personal supervision or through a telepharmacy system;(14) "home study" and "other mediated instruction" mean continuing education activities that are not conducted as live programs, including audio tapes, video tapes, television, computer assisted instruction, journal articles, or monographs;(15) "institutional facility" means a (B) long-term care facility, including a nursing home, convalescent home, or other related facility;(C) mental health facility;(D) rehabilitation center;(F) developmental disability center;(G) drug abuse treatment center;(H) family planning clinic;(K) public health facility;(16) "institutional pharmacy" means a pharmacy located in an institutional facility;(17) "licensee" means a person who is licensed under AS 08.80 and this chapter;(18) "live program" means an on-site continuing education activity, including a lecture, symposium, live teleconference, or workshop;(19) "sterile pharmaceutical" means a drug dosage form free from living microorganisms (aseptic);(20) "wholesale distribution" (A) means distribution of prescription drugs to a person other than a consumer or patient;(B) does not include (i) an activity described in 12 AAC 52.695; or(ii) a manufacturer's distribution of the manufacturer's own manufactured drugs or devices;(21) "central pharmacy" means a pharmacy providing remote pharmacy services through a telepharmacy system;(22) "personal supervision" means supervision that includes visual or physical proximity to ensure adequate safety controls;(23) "pharmacy" includes a central pharmacy and a remote pharmacy;(24) "remote pharmacy" means a facility that provides pharmacy services, including the storage and distribution of prescription drugs, drug regimen review, and patient counseling through a telepharmacy system;(25) "still image capture" means a specific image captured electronically from a video or other image capture device;(26) "store and forward" means a video or still image record that is saved electronically for future review;(27) "telepharmacy system" means a system under the direct supervision of a licensed pharmacist that monitors the dispensing and distribution of prescription drugs and provides for related drug use review and patient counseling services through a computer link and a video link with sound;(28) "accredited provider" means an individual, institution, organization, association, corporation, or agency that is recognized by the ACPE as able to provide quality continuing education programs;(29) "filling pharmacist" means a pharmacist participating in shared pharmacy services that processes or fills a prescription order for a patient;(30) "filling pharmacy" means a pharmacy participating in shared pharmacy services that processes or fills a prescription order for a patient;(31) "requesting pharmacist" means a pharmacist participating in shared pharmacy services that forwards a prescription order to another participating pharmacy or pharmacist to be processed or filled;(32) "requesting pharmacy" means a pharmacy participating in shared pharmacy services that forwards a prescription order to another participating pharmacy to be processed or filled;(33) "shared pharmacy services" means a system allowing the processing by a participating pharmacist or a pharmacy of a request from another participating pharmacist or pharmacy to process or fill a prescription drug order, including dispensing, drug utilization review, claims adjudication, refill authorizations, therapeutic interventions, and institutional order review;(34) "dispenser" means a practitioner who delivers a controlled substance to an ultimate user or research subject under the lawful order of a practitioner; in this paragraph "delivers" includes the prescribing and administering of a controlled substance and the packaging, labeling, or compounding necessary to prepare the substance for delivery;(35) "profile" means a compilation of data concerning a patient, a dispenser, a practitioner, or a controlled substance.(36) "PDMP" means the prescription drug monitoring program's controlled substance prescription database.(37) "moral turpitude" includes conduct that is considered contrary to community standards of justice, honesty, or good morals.(38) "pharmacy technician who holds a national certification" means a pharmacy technician, licensed by the board, who obtains and maintains an active national certification through the Pharmacy Technician Certification Board (PTCB) or the National Healthcare Association (NHA).(39) "automated distribution kiosk" means a vending machine that stores and distributes prescription drugs or devices and maintains a record of transactions initiated or completed;(40) "manufacturer" means a person or entity, including a virtual manufacturer, engaged in the manufacturing of drugs or devices;(41) "virtual manufacturer" means a manufacturer that sells a prescription drug or device but never physically possesses the product;(42) "NAPLEX" means the North American Pharmacy Licensing Examination, administered by the National Association of Boards of Pharmacy.(43) "Internet-based pharmacy" means a person, entity, or Internet website that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense prescription drugs or devices by means of the Internet;(44) "standard of care" means care provided by a licensee that is within the accepted standard of care that would be provided in a similar setting by a reasonable and prudent licensee with similar education, training, and experience.(45) "NAPLEX" means the North American Pharmacy Licensing Examination, administered by the National Association of Boards of Pharmacy;(46) "owner", within the meaning given in AS 08.80.480, includes a person or entity who is the legal operator of a licensed pharmacy or facility and is assigned a unique federal employer identification number (EIN) for the transaction of business;(47) "change of ownership" (A) means a change in the federal employer identification number (EIN) at the parent level, or any transfer of a beneficial interest in a business entity licensed or registered by the board to any person or entity in which the transfer results in the transferee's holding 50 percent or more of the beneficial interest in that license or registration; a person or entity that engages in a change of ownership includes (i) an individual who sells a pharmacy or facility; (ii) an individual who enters into a partnership with others; (iii) an individual who becomes incorporated; (iv) a partnership who sells a pharmacy or facility; (v) a partnership whose membership changes and dissolves; (vi) a partnership who becomes incorporated; (vii) a corporation that sells or disposes all assets; (viii) a corporation that changes from a limited liability corporation to a corporation; or (ix) a corporation that merges into or consolidates with another corporation; (B) does not include (i) an individual incorporating only the individual incorporates only the individual, without other shareholders; (ii) an individual or entity that engages in a stock change of 20 percent or less; or (iii) a managing officer who transfers from or leaves the job position, and the change in managing officers does not result in a change described in (A) of this paragraph.(b) In AS 08.80.315(3), "other persons or governmental agencies" include investigators for the department who are assigned to conduct investigations under AS 08.(c) In AS 08.80.030(b)(7), "monitoring of drug therapy" means a review of the drug therapy regimen of patients by a pharmacist for the purpose of evaluating and rendering advice to the prescribing practitioner regarding adjustment of the regimen. "Monitoring of drug therapy" includes (1) collecting and reviewing records of patient drug use histories;(2) measuring and reviewing routine patient vital signs, including pulse, temperature, blood pressure, and respiration; and(3) ordering and evaluating the results of laboratory tests relating to drug therapy, including blood chemistries and cell counts, drug levels in blood, urine, tissue, or other body fluids, and culture and sensitivity tests that are performed in accordance with a written protocol under 12 AAC 52.240.(d) In AS l 7.30.200 and 12 AAC 52.855 - 12 AAC 52.895, "practitioner" has the meaning given in AS 11.71.900.(e) In 12 AAC 52.610 - 12 AAC 52.697, "designated representative" means the responsible manager who serves as the supervisor or manager and is responsible for ensuring that the third-party logistics provider, wholesale drug distributor, outsourcing facility, or manufacturer is in compliance with all state and federal laws and regulations pertaining to the operations.Eff. 1/16/98, Register 145; am 5/5/2000, Register 154; am 11/10/2001, Register 160; am 8/21/2002, Register 163; am 2/15/2006, Register 177; am 8/12/2007, Register 183; am 9/11/2010, Register 195; am 12/29/2011, Register 200; am 8/1/2014, Register 211, October 2014; am 6/7/2018, Register 226, July 2018; am 10/31/2019, Register 232, January 2020; am 4/3/2020, Register 234; am 8/30/2020, Register, 235; am 7/15/2023, Register 247, October 2023; am 1/19/2024, Register 249, April 2024; am 5/19/2024, Register 250, July 2024; am 9/28/2024, Register 251, October 2024Authority:AS 08.80.005
AS 08.80.030
AS 08.80.157
AS 08.80.159
AS 11.71.900
AS 17.30.200
AS 17.30.900