Alaska Administrative Code

An individual licensed under AS 08.80 may apply to the board for an alternative schedule of continuing education if the individual's failure to meet the continuing education requirements in 12 AAC 52.320 is due to illness or other extenuating circumstances. Notes 12 AAC 52.330 Ef…

(a) The following programs will be accepted by the board as continuing education for pharmacists and pharmacy technicians under 12 AAC 52.320 and 12 AAC 52.325: (1) any program presented by a provider accredited by the ACPE that results in a continuing education certificate showi…

(a) The board will randomly audit renewal applications for verification of reported continuing education contact hours. To conduct an audit under this section, the board will access and evaluate continuing pharmacy education data reported to the ACPE-NABP CPE Monitor Service duri…

A person that is required to be licensed by AS 08.80 and who has a license under AS 08.80 and this chapter shall adhere to the guidelines on facilities, reference material, equipment, supplies, and other guidelines established by the board in the pamphlet titled, "Facility Standa…

(a) A drug or device that has exceeded its expiration date shall be removed from stock and quarantined until properly disposed of in accordance with 12 AAC 52.560. (b) A pharmacist may not dispense a drug or device beyond the expiration date on the drug or device. (c) All drugs a…

(a) Each pharmacist, while on duty, is responsible for the security of the pharmacy, including effective control against theft or diversion of drugs. (b) The pharmacist-in-charge is responsible for compliance with all prescription department security requirements. (c) Excluding p…

(a) A central pharmacy that wishes to provide pharmacy services through a remote pharmacy in the state using a telepharmacy system as provided in 12 AAC 52.425 must apply to the board for a remote pharmacy license. The central pharmacy applying under this section for a remote pha…

(a) Only a pharmacist employed by a central pharmacy located in this state may provide pharmacy services to a remote pharmacy through a telepharmacy system. A telepharmacy system must be conducted under the direct supervision of a pharmacist located in this state. The pharmacist-…

A pharmacy or pharmacist that prepares or dispenses sterile pharmaceuticals shall adhere to the accented standard of care. Notes 12 AAC 52.430 Eff. 1/16/98, Register 145; am 10/9/2008, Register 188; am 9/28/2024, Register 251, October 2024 Authority: AS 08.80.030 AS 08.80.157 Sta…

A pharmacy or pharmacist that compounds drugs shall adhere to the guidelines established by the board in the pamphlet titled, "Compounding Practices,"dated February 2008, and incorporated by reference in this section. Notes 12 AAC 52.440 Eff. 1/16/98, Register 145; am 10/9/2008, …

(a) A requesting pharmacy in this state that seeks to participate in shared pharmacy services must apply to the board for approval on a form provided by the department. (b) The board will approve an application by a requesting pharmacy to participate in shared pharmacy services i…

(a) A requesting pharmacist in this state that seeks to participate in shared pharmacy services must apply to the board for approval on a form provided by the department. (b) The board will approve an application by a requesting pharmacist to participate in shared pharmacy servic…

(a) A pharmacy participating in shared pharmacy services, or a pharmacist acting independently of a pharmacy and participating in shared pharmacy services, shall use an identifier on the prescription container that identifies prescriptions to be filled at a filling pharmacy or by…

(a) Notwithstanding 12 AAC 52.445, during a disaster emergency declared by the governor, a pharmacy participating in shared pharmacy services, or a pharmacist acting independently of a pharmacy and participating in shared pharmacy services, shall do so in accordance with this sec…

(a) A pharmacy shall maintain prescription drug orders for a period of two years from the date of filling or the date of the last dispensed refill. The prescription drug orders shall be maintained in a manner that ensures they will remain legible for the required two-year period.…

(a) Before a pharmacist may fill a prescription drug order, the pharmacist shall obtain the following information: (1) name of the patient or, if the prescription drug order is for an animal, species of the animal and name of the owner; (2) address of the patient unless the presc…

A prescription drug order for a schedule II controlled substance may be partially filled if prescribed for (1) a terminally ill patient or a patient residing in a long term care facility, in accordance with 21C.F.R 1306.13; or (2) a patient who is not terminally ill or residing i…

(a) A pharmacist may dispense a refill of a prescription drug order only in accordance with the prescribing practitioner's authorization as indicated on the prescription drug order. If there are no refill instructions on the prescription drug order, or if all refills authorized o…

One or more labels containing the following information shall be affixed to every container in which a prescription drug order is dispensed: (1) name, address, and phone number of the dispensing pharmacy; (2) unique identification number of the prescription drug order; (3) date t…

(a) Legend drug and controlled substance prescriptions may be transmitted electronically under this section, consistent with state and federal laws. A pharmacist may dispense a prescription transmitted electronically under this section only if the prescribing practitioner include…

(a) For the purpose of dispensing a prescription drug order, original prescription drug order information may be transferred between pharmacies if the requirements of 12 AAC 52.460 and this section are met. (b) Original prescription drug order information for controlled substance…

(a) A pharmacist may dispense an equivalent drug product or interchangeable biological product instead of the prescribed drug if (1) the prescribing practitioner does not indicate on the prescription drug order that a specific brand must be dispensed, using language such as "bran…

(a) Instead of dispensing one or more prescribed drug products in separate containers, a pharmacist may, with the written consent of the patient, patient's caregiver, or prescribing practitioner, provide a customized patient medication package or patient med-pak. (b) A patient me…

(a) A pharmacy or pharmacist may accept a drug for return or exchange after the drug has been taken from the premises where the drug was sold, distributed, or dispensed if (1) the prescription was dispensed in a manner inconsistent with the original prescription drug order; or th…

If a pharmacy is required under 21 U.S.C. 801 - 904 (Controlled Substances Act) to complete DEA Form 106, "Report of Theft or Loss of Controlled Substances," the pharmacist-in-charge shall also send a copy of the completed form to the board. Notes 12 AAC 52.540 Eff. 1/16/98, Regi…

A pharmacy may advertise prescription drug prices if the advertisement contains all of the following information: (1) proprietary, trade, or generic name of the drug product; (2) name of the manufacturer or distributor of the drug product; (3) dosage form and strength of the drug…

(a) A licensed pharmacist may destroy noncontrolled prescription drugs if the drugs are destroyed in a manner that makes the drugs unfit for human consumption. (b) A drug that is a controlled substance shall be disposed of in accordance with federal statutes and regulations. Note…

(a) A pharmacist shall perform a drug regimen review, as defined in AS 08.80.480, for each prescription drug order. (b) If a pharmacist identifies any of the items listed in AS 08.80.480 during the drug regimen review, the pharmacist shall avoid or resolve the problem by consulti…

A pharmacy may use an automated data processing system to maintain the records required in AS 08.80 and this chapter if the system (1) is capable of on-line retrieval of all information required in 12 AAC 52.460, 12 AAC 52.470, and 21 C.F.R. 1306.22, as amended as of February 6, …

(a) Following the review of a patient's records, if considered necessary by the pharmacist, a pharmacist or pharmacist intern shall personally offer counseling to each patient or the patient's agent. (b) If a pharmacist or pharmacist intern provides counseling, the pharmacist or …

For the purpose of supplying drugs to a prescribing practitioner, drugs shall be prepackaged in child-resistant containers under the direct supervision of a pharmacist and bear a label that contains (1) the name, address, and telephone number of the pharmacy; (2) the name, streng…

(a) A licensed pharmacy in this state may install and use an automated distribution kiosk that is accessible to the patient or the patient's agent while the pharmacy is open or closed for the purpose of purchasing the patient's completed prescription drug orders if (1) the kiosk …

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 regi…

(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 …

(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,…

(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 b…

(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 ensur…

(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, b…

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 nationa…

(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 distri…

(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 principa…

(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 …

Notes 12 AAC 52.670 Eff. 1/16/98, Register 145; am 10/31/2019, Register 232, January 2020; repealed 7/15/2023, Register 247, October 2023 State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and t…

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'…

A wholesale drug distributor may not distribute a drug or preparation directly to a consumer or patient. Notes 12 AAC 52.685 Eff. 1/16/98, Register 145; am 10/31/2019, Register 232, January 2020 Authority:AS 08.80.005 AS 08.80.030 AS 08.80.157 AS 08.80.159 AS 08.80.261 State regu…

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. Notes 12 AAC …

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, pa…