Alaska Administrative Code

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…

(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 b…

(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…

(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)…

Notes 12 AAC 52.700 Eff. 1/16/98, Register 145; repealed 2/26/2000, Register 153 State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will…

(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 immedia…

(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 determin…

(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…

(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 …

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. Notes 12 AAC 52.810 Eff. 1/16/98, Register 145 Authority:AS 08.80.005 AS 08.80.030 AS…

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 ch…

(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 pat…

(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 neces…

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. Notes 12 AAC 52.850 Eff. 4/4/…

(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…

(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. Notes 12 AAC 5…

(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 d…

(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 …

(a) Unless excused from reporting under AS 17.30.200(t), a pharmacist-in-charge must submit information on behalf of the employing pharmacy required under AS 17.30.200(b) and other information required by the American Society of Automation in Pharmacy (ASAP), as specified in the …

(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 pu…

(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 par…

(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, an…