SUBCHAPTER A. ALL CLASSES OF PHARMACIES

The Texas State Board of Pharmacy proposes a new rule §291.12, concerning Delivery of Prescription Drugs. The new rule, if adopted, specifies requirements for the delivery of prescription drugs to a patient or patient's agent.

Julie Spier, R.Ph., President, has determined that, for the first five-year period the rules are in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule. Ms. Spier has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the proposed rule will be to improve the health, safety, and welfare of patients by ensuring the safety and efficacy of prescription drugs that are delivered to a patient or patient's agent by Class A, Class A-S, Class E, and Class E-S pharmacies. There is no anticipated adverse economic impact on large, small or micro-businesses (pharmacies), rural communities, or local or state employment. Therefore, an economic impact statement and regulatory flexibility analysis are not required.

For each year of the first five years the proposed rule will be in effect, Ms. Spier has determined the following:

(1) The proposed rule does not create or eliminate a government program;

(2) Implementation of the proposed rule does not require the creation of new employee positions or the elimination of existing employee positions;

(3) Implementation of the proposed rule does not require an increase or decrease in the future legislative appropriations to the agency;

(4) The proposed rule does not require an increase or decrease in fees paid to the agency;

(5) The proposed rule does create a new regulation concerning the delivery of prescription drugs;

(6) The proposed rule does not limit or expand an existing regulation;

(7) The proposed rule does not increase or decrease the number of individuals subject to the rule's applicability; and

(8) The proposed rule does not positively or adversely affect this state's economy.

Written comments on the proposed rule may be submitted to Eamon D. Briggs, Deputy General Counsel, Texas State Board of Pharmacy, 1801 Congress Avenue, Suite 13.100, Austin, Texas 78701-1319, FAX (512) 305-8061. Comments must be received by 5:00 p.m., July 24, 2023.

The new rule is proposed under §§551.002 and 554.051 of the Texas Pharmacy Act (Chapters 551 - 569, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act.

The statutes affected by the proposed rule: Texas Pharmacy Act, Chapters 551 - 569, Texas Occupations Code.

§291.12.Delivery of Prescription Drugs.

(a) Applicability. This section applies to the delivery of prescription drugs by a pharmacy licensed by the board as a Class A, Class A-S, Class E, or Class E-S pharmacy.

(b) Delivery by mail. A pharmacy may deliver prescription drugs by use of a common carrier or the U.S. Mail as provided in §291.9 of this title (relating to Prescription Pick Up Locations) on request of the patient or patient's agent.

(1) Standards. The pharmacy shall ensure that all prescription drugs are delivered to the patient or patient's agent in accordance with standards of the manufacturer or the United States Pharmacopeia.

(2) Packaging. The pharmacy shall ensure that prescription drugs are packaged in tamper proof and tamper evident mailers that are resistant to tearing and moisture.

(3) Temperature. The pharmacy shall ensure the integrity of any prescription drug requiring temperature control other than "room temperature" storage as defined in §291.15 of this title (relating to Storage of Drugs) that is delivered by mail. The pharmacy shall use temperature tags, time temperature strips, insulated packaging, gel ice packs, or a combination of these as necessary.

(4) Irregularity in delivery. The pharmacy shall provide a method by which a patient or patient's agent can notify the pharmacy as to any irregularity in the delivery of the patient's prescription, to include, but not be limited to:

(A) timeliness of delivery;

(B) condition of the prescription drug upon delivery; and

(C) failure to receive the proper prescription drug.

(5) Replacement. If a prescription drug is in any way compromised during delivery, the pharmacy shall replace the drug or arrange for the drug to be replaced, either by promptly delivering a replacement to the patient or by promptly contacting the prescriber to arrange for the drug to be dispensed to the patient by a pharmacy of the patient's or patient's agent's choice.

(6) Refusal to deliver. The pharmacy shall refuse to deliver by mail a prescription drug which in the professional opinion of a pharmacist may be clinically compromised by delivery by mail.

(c) Delivery by pharmacy employee. A pharmacy may deliver prescription drugs by means of its employee as provided in §291.9 of this title on request of the patient or patient's agent.

(1) Standards. The pharmacy is responsible for any problems in the delivery of the prescription drug. The delivery shall be on a continuous route from the pharmacy to the patient or patient's agent.

(2) Temperature. The prescription drug shall be maintained within the temperature range recommended by the manufacturer until the delivery has been completed.

(d) All deliveries. A pharmacy that delivers prescription drugs by mail or by pharmacy employee shall also comply with the following:

(1) Counseling information. The pharmacy shall comply with the requirements of §291.33(c)(1)(F) of this title (relating to Operational Standards).

(2) Notification of delivery. The pharmacy shall notify the patient or patient's agent of the delivery of a prescription drug. The notification shall provide information to the patient or patient's agent about the timeliness in addressing the proper storage of the prescription drug. The pharmacy shall document and maintain a record of the notification.

(3) Required signature. The pharmacy shall require the patient or patient's agent to sign for delivery if the prescription drug is reasonably likely to be compromised if left unattended. If the drug cannot be delivered with a signature, the package may not be left unattended and shall be returned to be held for pickup or redelivered on the request of the patient or patient's agent.

(4) Compromised delivery. The pharmacy shall include with the delivery the procedures for the patient or patient's agent to follow if the prescription drug does not arrive in a timely manner or if the integrity of the packaging or prescription drug has been compromised during delivery.

(5) Records. The pharmacy shall maintain records for two years on the following events:

(A) when a prescription drug was sent to the patient or patient's agent;

(B) patient complaints and audits regarding the timeliness of deliveries;

(C) prescription drugs that were compromised in delivery; and

(D) the failure of a patient to receive a prescription drug delivery.

(6) Controlled substances. A pharmacy shall comply with all state and federal laws and rules relating to the delivery of controlled substances.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on May 31, 2023.

TRD-202302009

Julie Spier, R.Ph.

President

Texas State Board of Pharmacy

Earliest possible date of adoption: July 16, 2023

For further information, please call: (512) 305-8026