Utah Admin. Code 156-17b-614a

Current through Bulletin 2024-20, October 15, 2024

Section R156-17b-614a - Operating Standards - Class A or Class B Pharmacy - General Operating Standards

In accordance with Subsection 58-17b-601(1), the following operating standards apply to Class A and Class B pharmacies, and may be supplemented or amended by additional standards in this rule applicable to specific types of Class A and B pharmacies.

(1) The general operating standards include:

(a) A facility shall be well lighted, well ventilated, clean and sanitary.

(b) A facility that transfers a drug from a manufacturer's or distributor's original container to another container shall have a sink with hot and cold culinary water separate and apart from restroom facilities. This sink requirement does not apply to clean rooms where sterile products are prepared. Clean rooms may not have sinks or floor drains.

(c) Required equipment shall be clean and in good operating condition.

(d) A facility shall be equipped to store prescription drugs and durable medical equipment:

(i) in an orderly manner that permits clear identification, separation, and easy retrieval of products; and

(ii) in an environment necessary to maintain the integrity of the product inventory.

(e) A facility shall be equipped to permit practice within the standards and ethics of the profession as dictated by the usual and ordinary scope of practice conducted within that facility.

(f) A facility shall be stocked with the quality and quantity of product necessary for the facility to meet its scope of practice in a manner consistent with the public safety.

(g) A facility that dispenses controlled substances shall be equipped with a security system that:

(i) permits detection of entry at all times when the facility is closed; and

(ii) provides notice of unauthorized entry to an individual.

(h) A pharmacy department shall:

(i) be equipped with a lock where drugs are stored; and

(ii) be securely locked when the pharmacy department is closed.

(i) A facility shall have a counseling area to allow for confidential patient counseling, if applicable.

(2)

(a) Prescription labels for compounded sterile and non-sterile medications, when dispensed to the patient or patient's agent, shall include:

(i) the minimum information required under Section 58-17b-602;

(ii) generic name;

(iii) quantity or concentration of each active ingredient; and

(iv) labeling for sterile preparation for parenteral use shall include:

(A) the name of the diluent;

(B) assigned compounding record or lot number; and

(C) the phrase "compounded preparation."

(b) The requirements described in Subsections (2)(a)(i) and (2)(a)(iv) shall not apply to a label on the container of a drug that a health care provider administers to a patient at:

(i) a pharmaceutical administration facility; or

(ii) a hospital licensed under Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.

(3) The temperature of the pharmacy shall be maintained within a range compatible with the proper storage of drugs. If a refrigerator or freezer is necessary to properly store drugs at the pharmacy, the pharmacy shall keep a daily written or electronic log of the temperature of the refrigerator or freezer on days of operation. The pharmacy shall retain each log entry for at least three years.

(4) A facility shall have current editions of the following reference publications in print or electronic format, that are readily available to and retrievable by facility personnel:

(a) Title 58, Chapter 1, Division of Occupational and Professional Licensing Act;

(b) Rule R156-1, General Rule of the Division of Occupational and Professional Licensing;

(c) Title 58, Chapter 17b, Pharmacy Practice Act;

(d) Rule R156-17b, Utah Pharmacy Practice Act Rule;

(e) Title 58, Chapter 37, Utah Controlled Substances Act;

(f) Rule R156-37, Utah Controlled Substances Act Rule;

(g) Title 58, Chapter 37f, Controlled Substance Database Act;

(h) R156-37f, Controlled Substance Database Act Rule;

(i)21 CFR 1300 et seq. (2021) or equivalent such as the USP DI Drug Reference Guides;

(j) current FDA-Approved Drug Products; and

(k) any other general drug references necessary to permit practice, as dictated by the usual and ordinary scope of practice conducted within that facility.

(5)

(a) A facility shall maintain a current list of licensed employees involved in the practice of pharmacy at the facility, that includes:

(i) individual licensee names;

(ii) license classifications;

(iii) license numbers; and

(iv) license expiration dates.

(b) The list shall be readily retrievable for inspection by the Division, and may be maintained in paper or electronic form.

(6) A pharmacy may not dispense a prescription drug or device to a patient unless a pharmacist or DMP is physically present and immediately available in the facility, or, for a remote dispensing pharmacy, physically present and immediately available in the facility or supervising through a telepharmacy system.

(7) Only a licensed Utah pharmacist, DMP, or authorized personnel shall have access to the pharmacy when the pharmacy is closed.

(8) The facility or parent company shall maintain a record for at least five years of the initials or identification codes that identify each dispensing pharmacist or DMP by name. The initials or identification code shall be unique to ensure that each pharmacist or DMP can be identified; therefore identical initials or identification codes may not be used.

(9) The pharmacy facility shall maintain:

(a) copy 3 of DEA order form 222 that has been properly dated, initialed, and filed;

(b) copies of each unaccepted or defective order form; and

(c) any attached statements or other documents.

(10) If applicable, a hard copy of a power of attorney authorizing a pharmacist, DMP, or DMP designee to sign DEA order form 222 shall be available to the Division upon request.

(11) A pharmacist, DMP, or other responsible individual shall verify that controlled substances are listed on the suppliers' invoices and were actually received, by clearly recording their initials and the actual date of receipt of the controlled substances.

(12) The facility shall maintain a record of suppliers' credit memos for controlled substances.

(13) A copy of the inventories required under Section R156-17b-605 shall be made available to the Division when requested.

(14) The facility shall maintain hard copy reports of surrender or destruction of controlled substances and legend drugs submitted to appropriate state or federal agencies.

(15) If the pharmacy does not store drugs in a locked cabinet and has a drop or false ceiling, the pharmacy's perimeter walls shall extend to the hard deck, or the pharmacy shall take other measures to prevent unauthorized entry into the pharmacy.

Utah Admin. Code R156-17b-614a

Amended by Utah State Bulletin Number 2015-6, effective 2/24/2015

Amended by Utah State Bulletin Number 2016-10, effective 4/21/2016

Amended by Utah State Bulletin Number 2016-15, effective 7/11/2016

Amended by Utah State Bulletin Number 2019-24, effective 11/25/2019

Amended by Utah State Bulletin Number 2020-22, effective 11/10/2020

Amended by Utah State Bulletin Number 2022-03, effective 1/27/2022