reglab/statecodes huggingface dataset:
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 5 - Pharmacy Practice Standards › 12 AAC 52.596 - Remodeling

Current through May 31, 2024
Not later than 30 days after starting the structural
					 remodeling of a pharmacy or a prescription department within the premises of a
					 licensed or registered pharmacy that would result in a change in layout, square
					 footage, plumbing, or additional storage areas, the licensee or registrant
					 shall notify the board in writing.
Authority:
AS
						08.80.005
AS 08.80.030
AS
						08.80.157
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 6 - Wholesale Drug Distributors and Facilities › 12 AAC 52.610 - Wholesale drug distributor license

Current through May 31, 2024
(a) An applicant for
				  a wholesale drug distributor license shall submit the items required in (b) of
				  this section for review and approval by the executive administrator. An
				  application that does not clearly demonstrate qualifications for licensure must
				  be reviewed and approved by the board.
(b) A wholesale drug distributor license will be issued to an
				  applicant who
(1) submits a completed
				  application on a form provided by the department;
(2) pays the applicable fees required in
				  12 AAC 02.310;
(3) provides the name of the designated
				  representative who will manage the wholesale distribution of drugs or devices
				  for the wholesale drug facility;
(4) submits an attestation that
(A) a self-inspection of the premises using the form provided by
				  the department was completed within the last two years; or
(B) a Verification Accredited Wholesale
				  Distributors (VAWD) inspection has been completed; and
(5) submits a copy of a current valid
				  license, permit, or registration to conduct operations in the jurisdiction in
				  which it is located, as applicable.
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 6 - Wholesale Drug Distributors and Facilities › 12 AAC 52.620 - Wholesale drug facilities

Current through May 31, 2024
(a) A wholesale
				  drug facility in which drugs or devices are stored, repacked, or sold to
				  persons, businesses, or government agencies that may legally purchase drugs or
				  devices must
(1) have storage areas that
				  ensure proper lighting, ventilation, temperature, sanitation, humidity, space,
				  equipment, and security conditions;
(2) be of suitable size, construction, and
				  location to facilitate cleaning, maintenance, and proper operations;
(3) be equipped with an alarm system to
				  detect entry into the wholesale drug facility after business hours;
(4) meet all applicable federal, state, and
				  local building standards;
(5) be
				  secure from unauthorized entry from outside the facility, including having
				  exterior lighting along the outside perimeter of the facility;
(6) restrict entry into areas inside the
				  facility where drugs or devices are stored; entry must be open to authorized
				  personnel only;
(7) have a
				  quarantine area for storage of drugs or devices that are outdated, damaged,
				  deteriorated, misbranded, or adulterated, or that are in a secondary container
				  that has been opened or the seal of which has been broken;
(8) be maintained in a clean and orderly
				  condition; and
(9) be free from
				  infestation by insects, rodents, birds, or vermin of any kind.
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 6 - Wholesale Drug Distributors and Facilities › 12 AAC 52.625 - Personnel requirements; grounds for denial or other disciplinary action

Current through May 31, 2024
(a) A
				  wholesale drug distributor shall maintain a roster of all officers, directors,
				  and managers responsible for wholesale drug distribution, storage, and
				  handling. The roster shall include a description of each person's duties and a
				  summary of the person's experience.
(b) The board will not approve an application
				  for a wholesale drug distributor license unless the designated representative
				  in charge of the drug facility documents having a basic knowledge of federal
				  and state laws related to the wholesale distribution of drugs.
Authority:
AS
						08.80.005
AS 08.80.030
AS 08.80.157
AS 08.80.159
AS 08.80.261
AS
						08.80.480
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 6 - Wholesale Drug Distributors and Facilities › 12 AAC 52.630 - Drug storage

Current through May 31, 2024
(a) A wholesale drug distributor shall ensure
				  that all drugs are stored at appropriate temperatures in accordance with label
				  requirements to help ensure that the identity, strength, quality, and purity of
				  the products are not affected.
(b)
				  A wholesale drug distributor shall ensure that a separate quarantine storage
				  area is provided for drugs that are deteriorated, outdated, damaged,
				  misbranded, adulterated, or are in a secondary container that has been opened
				  or the seal of which has been broken.
(c) A wholesale drug distributor shall ensure
				  that appropriate manual, electromechanical, or electronic temperature and
				  humidity recording equipment or handwritten logs are used to document how drugs
				  have been stored.
Authority:
AS
						08.80.005
AS
						08.80.030
AS
						08.80.157
AS
						08.80.159
AS
						08.80.480
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 6 - Wholesale Drug Distributors and Facilities › 12 AAC 52.635 - Designated representative

Current through May 31, 2024
(a) A designated
				  representative of a wholesale drug distributor, outsourcing facility,
				  third-party logistics provider, or manufacturer designated to replace an
				  outgoing designated representative of a facility shall notify the board not
				  later than 30 days after that designation, by submitting a completed change of
				  designated representative notice in writing. The outgoing designated
				  representative shall also notify the board in writing not later than 30 days
				  after departure.
(b) A designated
				  representative may be in charge of more than one location and may be designated
				  as the designated representative for multiple facilities
				  simultaneously.
Authority:
AS
						08.80.005
AS 08.80.030
AS 08.80.157
AS 08.80.159
AS
						08.80.480
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 6 - Wholesale Drug Distributors and Facilities › 12 AAC 52.640 - Written policies and procedures

Current through May 31, 2024
A wholesale drug distributor shall prepare and follow a
					 written procedure to
(1) handle crisis
				  situations that affect the security or operation of the wholesale drug
				  facility, including fire, flood, earthquake or other natural disasters, and
				  situations of local, state, or national emergency;
(2) identify, record, report to the board,
				  and correct any error found in an inventory;
(3) ensure that any outdated drug or any drug
				  with an expiration date that, in the wholesale drug distributor's view, does
				  not allow sufficient time for repacking or resale, is segregated from other
				  stock, is documented as a drug that has a characteristic described in this
				  paragraph, and is prepared for timely return to the manufacturer or is
				  destroyed;
(4) ensure that the
				  wholesale drug distributor exercises control over the shipping and receiving of
				  all drugs within the wholesale drug distribution operation;
(5) ensure the proper handling and disposal
				  of returned drugs; and
(6) ensure
				  that the oldest approved stock of a drug is distributed first and that any
				  deviation from this requirement is only temporary.
Authority:
AS
						08.80.005
AS 08.80.030
AS 08.80.157
AS 08.80.159
AS
						08.80.480
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 6 - Wholesale Drug Distributors and Facilities › 12 AAC 52.645 - Examination of drug shipments

Current through May 31, 2024
(a) A wholesale
				  drug distributor shall ensure that upon receipt of a drug shipment, each
				  outside shipping container is visually examined for identity and damage in
				  order to reduce the acceptance of drugs that are contaminated or unfit for
				  distribution.
(b) A wholesale drug
				  distributor shall ensure that each outgoing shipment of drugs is inspected for
				  identity of the contents and the integrity of the shipping container in order
				  to ensure that the drugs to be shipped were not damaged in storage, held under
				  improper conditions, or likely to receive damage in shipment.
Authority:
AS
						08.80.005
AS
						08.80.030
AS
						08.80.157
AS
						08.80.159
AS
						08.80.480
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 6 - Wholesale Drug Distributors and Facilities › 12 AAC 52.650 - Records and inventories

Current through May 31, 2024
(a) A wholesale
				  drug distributor shall establish and maintain records and inventories of all
				  transactions regarding the receipt, distribution, or disposition of a drug. The
				  records must include the following information:
(1) the source of the drug, including the
				  name and principal address of the seller or transferor and the address of the
				  location from which the drug was shipped;
(2) the identity and quantity of the drug
				  received, distributed, or disposed of; and
(3) the date of receipt and of distribution
				  or other disposition.
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 6 - Wholesale Drug Distributors and Facilities › 12 AAC 52.660 - Returned, damaged, and outdated drugs

Current through May 31, 2024
(a) A wholesale
				  drug distributor shall ensure that a drug that is outdated, damaged,
				  deteriorated, misbranded, or adulterated is quarantined and physically
				  separated from other drugs until it is either destroyed or returned to the
				  supplier.
(b) A wholesale drug
				  distributor shall ensure that a drug that has a secondary container that has
				  been opened or used is identified as such, and is quarantined and physically
				  separated from other drugs until the drug is either destroyed or returned to
				  the supplier.
(c) A wholesale drug
				  distributor shall ensure that if the conditions under which a drug has been
				  returned, shipped, or stored cast doubt on the drug's safety, identity,
				  strength, quality, or purity, the drug is destroyed or returned to the
				  supplier, unless examination, testing, or other investigation proves that the
				  drug meets appropriate standards of safety, identity, strength, quality, and
				  purity.
Authority:
AS
						08.80.005
AS
						08.80.030
AS
						08.80.157
AS
						08.80.159
AS
						08.80.480
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 6 - Wholesale Drug Distributors and Facilities › 12 AAC 52.680 - Inspections

Current through May 31, 2024
A wholesale drug distributor shall permit an authorized
					 inspector or law enforcement official, who shows proper identification, to
					 enter and inspect that distributor's facilities and deliver vehicles at
					 reasonable times and in a reasonable manner, and to inspect that distributor's
					 records and written operating procedures.
Authority:
AS
						08.80.005
AS
						08.80.030
AS
						08.80.157
AS
						08.80.159
AS
						08.80.480
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 6 - Wholesale Drug Distributors and Facilities › 12 AAC 52.685 - Prohibition against direct distribution

Current through May 31, 2024
A wholesale drug distributor may not distribute a drug or
					 preparation directly to a consumer or patient.
Authority:
AS
						08.80.005
AS
						08.80.030
AS
						08.80.157
AS
						08.80.159
AS
						08.80.261
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 6 - Wholesale Drug Distributors and Facilities › 12 AAC 52.690 - Salvage and reprocessing

Current through May 31, 2024
A wholesale drug distributor is subject to the provisions
					 of all applicable federal and state statutes and regulations and local
					 ordinances that relate to drug salvaging or reprocessing, including 21 C.F.R.
					 Parts 207, 210, and 211, as amended as of February 6, 1997.
Authority:
AS
						08.80.005
AS
						08.80.030
AS
						08.80.157
AS
						08.80.159
AS
						08.80.480
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 6 - Wholesale Drug Distributors and Facilities › 12 AAC 52.695 - Provisions not applicable

Current through May 31, 2024
The following activities do not constitute wholesale
					 distribution of prescription drugs for which a wholesale drug distributor
					 license is required by
					 12 AAC 52.610 -
					 12 AAC 52.690:
(1) intracompany sales, defined as any
				  transaction or transfer between any division, subsidiary, parent, and an
				  affiliated or related company under the common ownership and control of a
				  corporate entity;
(2) the purchase
				  or acquisition, by a hospital or other health care entity that is a member of a
				  group purchasing organization, of a drug, for its own use, from the group
				  purchasing organization or from another hospital or health care entity that is
				  a member of the group purchasing organization;
(3) the sale, purchase, or trade of a drug or
				  an offer to sell, purchase, or trade a drug by a charitable organization
				  described in
				  26 U.S.C.
				  501(c)(3) (Internal Revenue
				  Code of 1954), as amended as of February 6, 1997, to a nonprofit affiliate of
				  the organization to the extent otherwise permitted by the law;
(4) the sale, purchase, or trade of a drug or
				  an offer to sell, purchase, or trade a drug among hospitals or other health
				  care entities that are under common control; for purposes of this paragraph,
				  "common control" means the power to direct or cause the direction of the
				  management and policies of a person or an organization, whether by ownership of
				  stock, by voting rights, by contract, or otherwise;
(5) any of the following transfers of a drug,
				  if the gross dollar value of the transfer does not exceed five percent of the
				  total prescription drug sales revenue of either the transferor or transferee
				  during any 12-consecutive-month period:
(A)
				  the sale of a drug by a retail pharmacy to another retail pharmacy or to a
				  practitioner, or the offer by a retail pharmacy to sell a drug to another
				  retail pharmacy or to a practitioner;
(B) the purchase of a drug by a retail
				  pharmacy or by a practitioner from another retail pharmacy, or the offer by a
				  retail pharmacy or by a practitioner to purchase a drug from another retail
				  pharmacy;
(C) the trade of a drug
				  by a retail pharmacy with another retail pharmacy, or the offer by a retail
				  pharmacy to trade a drug with another retail pharmacy;
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 6 - Wholesale Drug Distributors and Facilities › 12 AAC 52.696 - Outsourcing facilities

Current through May 31, 2024
(a) An applicant for an outsourcing facility
				  license shall submit the items required in (b) of this section for review and
				  approval by the executive administrator. An application that does not clearly
				  demonstrate qualifications for licensure must be reviewed and approved by the
				  board.
(b) An outsourcing facility
				  license will be issued to an applicant who
(1) submits a complete application on a form provided by the
				  department;
(2) pays the
				  applicable fees required in
				  12 AAC 02.310;
(3) provides the name of the designated
				  representative;
(4) submits an
				  attestation that the applicant holds a license as an outsourcing facility in
				  another jurisdiction and that the license is in good standing, if
				  applicable;
(5) submits an
				  attestation that a self-inspection of the premises using the form provided by
				  the department was completed within the last two years; and
(6) submits the results of the most recent
				  Good Manufacturing Practice (GMP) inspection by the United States Food and Drug
				  Administration.
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 6 - Wholesale Drug Distributors and Facilities › 12 AAC 52.697 - Third-party logistics providers

Current through May 31, 2024
(a) An applicant for
				  a third-party logistics provider license shall submit the items required in (b)
				  of this section for review and approval by the executive administrator. An
				  application that does not clearly demonstrate qualifications for licensure must
				  be reviewed and approved by the board.
(b) A third-party logistics provider license will be issued to an
				  applicant who
(1) submits a complete
				  application on a form provided by the department;
(2) pays the fees required in
				  12 AAC 02.310;
(3) provides the name of the designated
				  representative;
(4) submits an
				  attestation that the applicant holds a license as a third-party logistics
				  provider in another jurisdiction and that the license is in good standing, if
				  in applicable; and
(5) submits an
				  attestation that a self-inspection of the premises using the form provided by
				  the department was completed within the last two years.
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 6 - Wholesale Drug Distributors and Facilities › 12 AAC 52.698 - Manufacturer license

Current through May 31, 2024
(a) An applicant for a manufacturer license
				  shall submit the items required in (b) of this section for review and approval
				  by the executive administrator. An application that does not clearly
				  demonstrate qualifications for licensure must be reviewed and approved by the
				  board.
(b) A manufacturer license
				  will be issued to an applicant who
(1)
				  submits a complete application on a form provided by the department;
(2) pays the applicable fees required in
				  12 AAC 02.310;
(3) provides the name of the designated
				  representative who will manage the manufacture of drugs or devices for the
				  wholesale drug facility;
(4)
				  submits an attestation that
(A) a
				  self-inspection of the premises using the form provided by the department was
				  completed within the last two years; or
(B) an inspection of the premises by a third
				  party was completed within the last two years; and
(5) submits an attestation that the applicant
				  holds a license as a manufacturer in another jurisdiction and that the license
				  is in good standing, if applicable.
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 7 - Institutional Pharmacies › 12 AAC 52.710 - Absence of a pharmacist from an institutional pharmacy

Current through May 31, 2024
(a) When an
				  institutional pharmacy will be unattended by a pharmacist, the
				  pharmacist-in-charge shall arrange in advance for providing drugs for use
				  within the institutional facility.
(b) When an institutional pharmacy is closed
				  and a drug is required to treat a patient's immediate need and is not available
				  from the drug stock outside of the pharmacy, a person designated by the
				  pharmacist-in-charge and licensed to handle drugs may obtain the drug from the
				  institutional pharmacy. The pharmacist-in-charge is responsible
(1) to record on a suitable form the removal
				  of any drug from the institutional pharmacy by the person designated; the
				  record must show the
(A) patient's name and
				  room number;
(B) name, strength,
				  and amount of the drug;
(C) date
				  and time of removal; and
(D)
				  initials or signature of the person designated who removed the drug from the
				  pharmacy;
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 7 - Institutional Pharmacies › 12 AAC 52.720 - Emergency room outpatient medications

Current through May 31, 2024
(a) The
				  pharmacist-in-charge of an institutional pharmacy, in cooperation with the
				  appropriate committee of the institutional facility's medical staff, shall
				  prepare a list of prescription drugs that may be delivered to outpatients
				  receiving emergency treatment and shall determine appropriate quantities for
				  unit-of-use packaging and prepackaging of the prescription drug.
(b) A licensed health care provider on
				  emergency room staff may deliver the medications identified on the list of
				  prescription drugs prepared under (a) of this section to a patient receiving
				  emergency outpatient treatment if
(1) the
				  drug is ordered by an authorized prescribing practitioner either in writing or
				  verbally; a verbal order must be transcribed into writing on the patient's
				  record;
(2) the medication is
				  prepackaged in a child-resistant container under the direct supervision of a
				  pharmacist;
(3) the medication
				  bears a label that contains the
(A) name,
				  address, and telephone number of the institutional facility;
(B) name, strength, and quantity of the
				  drug;
(C) cautionary information
				  required for patient safety and information;
(D) lot number and expiration date if not
				  already contained on the unit-of-use packaging or prepackaging; and
(E) initials of the pharmacist;
(4) no more than one prepackaged
				  container of a drug is delivered to a patient unless more than one package is
				  required to sustain the patient until a retail pharmacist is on duty in the
				  community; however, the amount of the controlled substance delivered may not
				  exceed a 72 hour supply; and
(5)
				  labeling of the container is completed by the licensed health care provider
				  before the container is presented to the patient; the container label must
				  include the
(A) name of the
				  patient;
(B) directions for use by
				  the patient;
(C) date of
				  delivery;
(D) identifying number
				  unique to the patient;
(E) name of
				  the prescribing practitioner; and
(F) initials of the licensed health care
				  provider delivering the prepackaged medication.
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 7 - Institutional Pharmacies › 12 AAC 52.730 - Drug distribution and control

Current through May 31, 2024
(a) The
				  pharmacist-in-charge of an institutional pharmacy is responsible for the
				  storage, preparation, distribution, and control of the institutional facility's
				  drug supply and for ensuring that these activities are carried out in
				  conformance with established policies, procedures, and accepted
				  standards.
(b) The
				  pharmacist-in-charge of an institutional pharmacy shall establish written
				  procedures for the distribution and control of drugs and for the provision of
				  pharmacy services. The procedures must be consistent with
				  12 AAC 52.710 and
				  12 AAC 52.720. The
				  pharmacist-in-charge shall make an annual updated copy of the policies and
				  procedures available for inspection by the board.
(c) Persons employed at an institutional
				  pharmacy who are licensed under AS 08.80 and this chapter shall provide drug
				  information to the staff and practitioners of the institutional
				  facility.
(d) Persons employed at
				  an institutional pharmacy who are licensed under AS 08.80 and this chapter may
				  assist in the planning of and participate in the institutional facility's
				  education and staff development programs relating to drugs.
Authority:
AS
						08.80.005
AS 08.80.030
AS 08.80.157
AS
						08.80.390
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 8 - Drug Rooms and Facilities Without a Pharmacy › 12 AAC 52.800 - Drug room license

Current through May 31, 2024
(a) An
				  institutional facility that does not maintain a pharmacy but prepares and
				  administers prescription drugs from bulk supplies for patients receiving
				  treatment within the facility must be licensed by the board as a drug room
				  under 12 AAC 52.020.
(b) An institutional facility that does not
				  maintain a pharmacy but stores and administers prescription drugs that are
				  labeled and dispensed for specific patients by a pharmacy does not require a
				  drug room or pharmacy license.
(c)
				  A drug room that has changed its name, physical address, or ownership must
				  notify the board on a form or in writing not later than 30 days after the
				  change. The notification must include an attestation that a new self-inspection
				  will be completed not later than 30 days after the start of business.
(d) An applicant for renewal of a drug room
				  license must comply with the requirements of
				  12 AAC 52.300.
Authority:
AS
						08.80.005
AS 08.80.030
AS 08.80.157
AS 08.80.390
AS
						08.80.480
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 8 - Drug Rooms and Facilities Without a Pharmacy › 12 AAC 52.810 - Pharmacist required

Current through May 31, 2024
An institutional facility described in
					 12 AAC 52.800(a)
					 must continuously employ a pharmacist or have a written agreement with a
					 pharmacy or pharmacist to provide consultant pharmacist
					 services.
Authority:
AS
						08.80.005
AS 08.80.030
AS 08.80.157
AS
						08.80.390
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 8 - Drug Rooms and Facilities Without a Pharmacy › 12 AAC 52.820 - Responsibilities of the consultant pharmacist

Current through May 31, 2024
A pharmacist who, under
					 12 AAC 52.810, provides consultant
					 pharmacy services shall
(1) provide
				  evaluations and recommendations concerning drug distribution, control, and
				  use;
(2) complete on-site reviews
				  to ensure that drug handling and use procedures conform to AS 08.80, this
				  chapter, and recognized standards of practice;
(3) provide drug information to facility
				  staff and physicians;
(4) plan and
				  participate in the facility's staff development program relating to drug
				  distribution, control, and use;
(5)
				  assist in establishing policies and procedures to control the distribution and
				  administration of drugs; and
(6)
				  document pharmacy services that are provided and maintain the documentation for
				  a period of at least two years.
Authority:
AS
						08.80.005
AS 08.80.030
AS 08.80.157
AS 08.80.390
AS
						08.80.480
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 8 - Drug Rooms and Facilities Without a Pharmacy › 12 AAC 52.830 - Emergency drug kits

Current through May 31, 2024
(a) An institutional facility described in
				  12 AAC 52.800(b)
				  may have a limited supply of drugs provided by a pharmacist licensed under this
				  chapter and AS 08.80 in emergency drug kits on-site. An emergency drug kit is
				  for use by personnel authorized to administer the drugs to patients receiving
				  treatment within the institutional facility.
(b) The pharmacist who provides or supplies
				  drugs in emergency drug kits shall cooperate with the prescribing practitioners
				  on staff at the institutional facility to determine the identity and quantity
				  of the drugs to be included in the emergency drug kits.
(c) An emergency drug kit must
(1) only contain drugs that are not available
				  from any other source in sufficient time to prevent risk of harm to
				  patients;
(2) only contain drugs
				  that are provided and sealed by a pharmacist;
(3) be stored in a secured area to prevent
				  unauthorized access;
(4) be labeled
				  on the exterior to indicate it is for use only in emergencies as described in
				  this section; and
(5) have a list
				  of the kit's contents posted on or near the kit.
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 8 - Drug Rooms and Facilities Without a Pharmacy › 12 AAC 52.840 - First dose kits

Current through May 31, 2024
(a) In addition to the emergency drug kit
				  described in
				  12 AAC 52.830, an institutional
				  facility described in
				  12 AAC 52.800 may maintain a first
				  dose kit for the initiation of nonemergency drug therapy to a patient receiving
				  treatment within the institutional facility if the necessary drug is not
				  available from a pharmacy in time to prevent risk of harm to a
				  patient.
(b) The dispensing or
				  consultant pharmacy for the institutional facility and the medical staff of the
				  institutional facility are responsible for the proper storage, security, and
				  accountability of the first dose kit.
(c) The staff of the dispensing or consultant
				  pharmacy for the institutional facility shall determine jointly with the
				  medical staff of the institutional facility the content and quantity of drugs
				  to be included in the first dose kit.
Authority:
AS
						08.80.005
AS 08.80.030
AS 08.80.157
AS
						08.80.390
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 8 - Drug Rooms and Facilities Without a Pharmacy › 12 AAC 52.850 - Emergency distribution

Current through May 31, 2024
In an emergency, if a drug is not otherwise available, a
					 drug room may distribute the drug from bulk supplies to a practitioner or a
					 pharmacist for use by a patient outside the facility, under a prescription,
					 until the drug can be otherwise obtained.
Authority:
AS
						08.80.005
AS 08.80.030
AS 08.80.157
AS 08.80.390
AS
						08.80.480
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 9 - Controlled Substance Prescription Database › 12 AAC 52.855 - Registration with the prescription drug monitoring program

Current through May 31, 2024
(a) A prescriber
				  shall register with the prescription drug monitoring program's controlled
				  substance prescription database (PDMP) not later than 30 days initial licensure
				  or the date of registration with the federal Drug Enforcement Administration
				  (DEA), whichever is later.
(b) A
				  licensed pharmacist practicing in this state shall register with the PDMP.
				  Registration must be completed not later than 30 days after initial licensure
				  if the pharmacist's practice is expected to involve dispensing a schedule II,
				  III, or IV controlled substance under federal law. A pharmacist who was not
				  dispensing a schedule II, III, or IV controlled substance under federal law at
				  the time of initial licensure but plans to begin dispensing a schedule II, III,
				  or IV controlled substance under federal law shall register with the PDMP
				  before dispensing a schedule II, III, or IV controlled substance under federal
				  law in this state.
(c) Except as
				  provided in (a) of this section, before dispensing, prescribing, or
				  administering a schedule II, III, or IV controlled substance under federal law,
				  a pharmacist or practitioner required to register with the PDMP must
(1) register online on the PDMP database by
				  providing
A an electronic mail address
				  corresponding to an electronic mail account accessible to and utilized
				  exclusively by the registering pharmacist or practitioners;
B a password created by the Registrant at the
				  time of registration just meets the minimum requirements set by the PDMP
				  database;
C a user role selected
				  from the options provided by the PDMP database that meets closely corresponds
				  to the registrant's professional role;
D the registrant's healthcare specialty;
E the DEA number issued to the
				  registrants or, if a pharmacist, the employer's DEA number;
				  and
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 9 - Controlled Substance Prescription Database › 12 AAC 52.856 - PDMP designation renewal

Current through May 31, 2024
(a) A PDMP
				  designation expires on the same date as the pharmacist's or practitioner's
				  corresponding professional license.
(b) To renew a PDMP designation, a licensee
				  must submit the fee established in
				  12 AAC 02.107 on or before the
				  PDMP designation expiration date.
Authority:
AS
						08.80.005
AS 08.80.030
AS
						17.30.200
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 9 - Controlled Substance Prescription Database › 12 AAC 52.857 - Change in dispensing or distributing of controlled substances

Current through May 31, 2024
(a) A pharmacist
				  with a PDMP registration under
				  12 AAC 52.855 must notify the
				  board on a form provided by the department when the pharmacist changes their
				  PDMP status to no longer dispense controlled substances in this state not later
				  than 10 days from the date of the change in dispensing status.
(b) A pharmacist who is not required to
				  register with the PDMP and who has met the requirements in
				  12 AAC 52.855(b)
				  must comply with the requirements in
				  12 AAC 52.855(c)
				  not later than 10 days from the date of a change in practice that requires the
				  pharmacist to register with the PDMP.
(c) A pharmacy required to report to the PDMP
				  that no longer dispenses or distributes controlled substances in or to this
				  state must notify the board on a form provided by the department not later than
				  10 days from the date of the change in dispensing or distributing
				  status.
(d) A pharmacy that obtains
				  a DEA registration after its license is initially granted by the board must
				  notify the board on a form provided by the department not later than 10 days
				  from the date the DEA registration is issued to the pharmacy.
Authority:
AS
						08.80.005
AS 08.80.030
AS
						17.30.200
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 9 - Controlled Substance Prescription Database › 12 AAC 52.860 - Access to and conditions for use of the prescription drug monitoring program

Current through May 31, 2024
(a) Access to the PDMP is limited as
				  described in
				  AS
				  17.30.200(d).
(b) For the purposes in
				  AS
				  17.30.200(d)(1) of an
				  inquiry under a search warrant, subpoena, or order issued by an administrative
				  law judge or a court,
(1) "personnel of the
				  board" means employees of the Department of Commerce, Community, and Economic
				  Development assigned to the Board of Pharmacy; and
(2) "personnel of another board or agency"
				  mean an employee of this state who is assigned to a board or agency that
				  requires a practitioner to register with the PDMP
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 9 - Controlled Substance Prescription Database › 12 AAC 52.870 - Waiver of electronic submission requirement by pharmacist or practitioner

Current through May 31, 2024
(a) The department shall waive the electronic
				  submission requirements of
				  12 AAC 52.865(g)
				  for good cause. The pharmacist or practitioner requesting the waiver is
				  responsible for establishing the basis for the requested waiver under this
				  section.
(b) To establish good
				  cause for purposes of this section, a pharmacist or practitioner must submit an
				  application and sworn statement showing that
(1) a natural disaster or other emergency
				  beyond the control of the pharmacist or practitioner prevents the pharmacist or
				  practitioner from complying with
				  12 AAC 52.865(g);
(2) the pharmacist or practitioner will only
				  dispense controlled substances as part of a controlled research project
				  approved by an accredited institution of higher education or under the
				  supervision of a government agency;
(3) the pharmacist's or practitioner's
				  business is located in an area that lacks access to the telecommunication
				  services needed to comply with
				  12 AAC 52.865(g);
				  or
(4) the pharmacist or
				  practitioner's will suffer financial hardship if required to acquire the
				  technology necessary to comply with
				  12 AAC 52.865(g).
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 9 - Controlled Substance Prescription Database › 12 AAC 52.875 - Solicited requests for information from non-registered persons

Current through May 31, 2024
(a) A patient
				  authorized under
				  AS
				  17.30.200(d)(6) to receive
				  information from the controlled substance prescription database, the patient's
				  authorized agent, or in the case of a unemancipated minor unable to give
				  consent for medical services under
				  AS
				  25.20.025(a), the minor's
				  parent or legal guardian, may request profile information from the controlled
				  substance prescription database concerning the patient if the person requesting
				  the information
(1) submits the request on a
				  form provided by the board;
(2)
				  pays a $10 fee; and
(3) does one of
				  the following:
(A) if a patient, presents to
				  the department, in person, government-issued photographic identification
				  confirming the patient's identity as the same person on whom profile
				  information is sought;
(B) if a
				  patient, submits a signed and notarized request
(i) verifying that the patient is the same
				  person on whom profile information is sought; and
(ii) providing the patient's full name,
				  address, and date of birth;
(C) presents a valid power of attorney
				  concerning the patient, or presents
(i)
				  verification that the person requesting the information is the parent, legal
				  guardian, or legal administrator of a minor, incapacitated person, or deceased
				  person on whom profile information is sought; and
(ii) if the person is a parent or legal
				  guardian of a patient who is a minor, verification that the patient is not an
				  emancipated minor legally able to consent to medical treatment under
				  AS
				  25.20.025.
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 9 - Controlled Substance Prescription Database › 12 AAC 52.880 - Reports

Current through May 31, 2024
(a) The board will maintain a register for
				  patient profile requests solicited under
				  12 AAC 52.875. The register
				  includes the following information:
(1) the
				  date on which the request was received;
(2) the name of the patient and the patient's
				  date of birth;
(3) the name, title,
				  and address of the individual requesting the profile;
(4) the date on which the information was
				  disseminated, mailed, or sent by facsimile transmission.
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 9 - Controlled Substance Prescription Database › 12 AAC 52.885 - Purged database records

Current through May 31, 2024
The following information will be purged from the PDMP
					 database after two years have elapsed from the date the prescription was
					 dispensed:
(1) the name of the
				  prescribing practitioner and the practitioner's federal Drug Enforcement
				  Administration registration number or other appropriate identifier;
(2) the date of the prescription;
(3) the date the prescription was filled and
				  the method of payment;
(4) the
				  name, address, and date of birth of the person for whom the prescription was
				  written;
(5) the name and national
				  drug code of the controlled substance;
(6) the quantity and strength of the
				  controlled substance dispensed;
(7)
				  the name of the drug outlet dispensing the controlled substance; and
(8) the name of the pharmacist or
				  practitioner dispensing the controlled substance and other appropriate
				  identifying information.
Authority:
AS
						08.80.005
AS
						08.80.030
AS
						17.30.200
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 9 - Controlled Substance Prescription Database › 12 AAC 52.890 - Grounds for discipline

Current through May 31, 2024
A violation of
					 12 AAC 52.855 -
					 12 AAC 52.855 by a pharmacist is
					 grounds for the imposition of disciplinary sanctions under AS 08 .01.075 and
					 AS
					 08.80.261. A violation of
					 12 AAC 52.855 - 12 AAC 52.885 by a
					 practitioner not licensed by this board shall be reported to the practitioner's
					 licensing board.
Authority:
AS
						08.80.005
AS
						08.80.030
AS
						17.30.200
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 9 - Controlled Substance Prescription Database › 12 AAC 52.895 - Correcting information in database

Current through May 31, 2024
(a) To request a
				  correction under
				  AS
				  17.30.200(k)(2) to
				  information in the controlled substance prescription database concerning a
				  person, that person must submit to the board
(1) on a form or in a format prescribed by
				  the board,
(A) a description of the
				  information asserted to be incorrect, and the correction requested;
(B) the mailing and physical address and
				  telephone number of the requester; and
(C) a signed, sworn statement attesting to
				  the truth of the corrected information;
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 10 - Disciplinary Guidelines › 12 AAC 52.900 - Purpose of disciplinary guidelines

Current through May 31, 2024
The disciplinary guidelines in
					 12 AAC 52.900 -
					 12 AAC 52.980 are established to
					 ensure the board's disciplinary policies are known and are administered
					 consistently and fairly.
Authority:
AS
						08.80.005
AS 08.80.030
AS 08.80.261
AS
						08.80.450
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 10 - Disciplinary Guidelines › 12 AAC 52.910 - Violations

Current through May 31, 2024
(a) A person who is licensed under AS 08.80
				  and this chapter who, after a hearing under AS 44.62 (Administrative Procedure
				  Act), is found to have violated a provision of AS 08.80 or this chapter is
				  subject to the disciplinary penalties listed in
				  AS
				  08.01.075, including public notice of the
				  violation and penalty in appropriate publications.
(b) Nothing in the guidelines set out in
				  12 AAC 52.920 prohibits the board
				  from imposing greater or lesser penalties than those described in
				  12 AAC 52.920 or restricting the
				  practice of a licensee depending upon the circumstances of a particular
				  case.
Authority:
AS
						08.80.005
AS 08.80.030
AS 08.80.261
AS
						08.80.450
Alaska Administrative Code › Title 12 - Professional Regulations › Part 1 - Boards and Commissions Subject to Centralized Licensing › Chapter 52 - Board of Pharmacy › Article 10 - Disciplinary Guidelines › 12 AAC 52.925 - Grounds for denial or discipline for criminal history

Current through May 31, 2024
(a) As used in AS
				  08.80.261 and this chapter, crimes that affect the applicant's or licensee's
				  ability to practice competently and safely include
(1) murder;
(2) manslaughter;
(3) criminally negligent homicide;
(4) assault;
(5) sexual assault;
(6) sexual abuse of a minor;
(7) unlawful exploitation of a minor,
				  including possession or distribution of child pornography;
(8) incest;
(9) indecent exposure;
(10) robbery;
(11) extortion;
(12) stalking;
(13) kidnapping;
(14) theft;
(15) burglary;
(16) forgery;
(17) endangering the welfare of a
				  child;
(18) endangering the welfare
				  of a vulnerable adult;
(19)
				  unlawful distribution or possession for distribution of a controlled substance;
				  for purposes of this paragraph, "controlled substance" has the meaning given in
				  AS 11.71.900;
(20) reckless
				  endangerment.