22 Tex. Admin. Code § 291.127

Current through Reg. 49, No. 43; October 25, 2024
Section 291.127 - Emergency Remote Pharmacy License
(a) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. All other words and terms shall have the meanings defined in the Act.
(1) Emergency remote pharmacy--A pharmacy not located at the same Texas location as a home pharmacy at which pharmacy services are provided during an emergency situation.
(2) Emergency situation--An emergency caused by a natural or manmade disaster or any other exceptional situation that causes an extraordinary demand for pharmacy services.
(3) Home pharmacy--A currently licensed Class A (Community), Class C (Institutional), or Class D (Clinic) pharmacy that is providing emergency pharmacy services through an emergency remote pharmacy.
(b) Emergency remote pharmacy license. In an emergency situation, the board may grant a holder of a Class A (Community), Class C (Institutional), or Class D (Clinic) pharmacy license, the authority to operate a pharmacy and provide pharmacy services at an alternate location. The following is applicable for the emergency remote pharmacy.
(1) The emergency remote pharmacy will not be issued a separate pharmacy license, but shall operate under the license of the home pharmacy. To qualify for an emergency remote pharmacy license, the applicant must submit an application including the following information:
(A) license number, name, address, and phone number of the home pharmacy;
(B) name, address, and phone number of the emergency remote pharmacy;
(C) name and Texas pharmacist license number of the pharmacist-in-charge of the home pharmacy and of the pharmacist-in-charge of the emergency remote pharmacy; and
(D) any other information required by the board.
(2) The board will notify the home pharmacy of the approval of an emergency remote pharmacy license.
(3) The emergency remote pharmacy license shall be valid for a period as determined by the board not to exceed six months. The executive director of the board, in his/her discretion, may renew the remote license for an additional six months, if the emergency situation still exists and the holder of the license shows good cause for emergency remote pharmacy to continue operation.
(4) The emergency remote pharmacy shall have a written contract or agreement with the home pharmacy which outlines the services to be provided and the responsibilities and accountabilities of the remote and home pharmacy in fulfilling the terms of the contract or agreement in compliance with federal and state laws and regulations.
(5) The home pharmacy shall designate a pharmacist to serve as the pharmacist-in-charge of the emergency remote pharmacy.
(6) The emergency remote pharmacy shall comply with the rules for the class of pharmacy under which the home pharmacy is licensed. A Class A pharmacy shall comply with the rules under Subchapter B of this chapter titled Community Pharmacy (Class A). A Class C pharmacy shall comply with the rules under Subchapter D of this chapter titled Institutional Pharmacy (Class C). A Class D pharmacy shall comply with the rules under Subchapter E of this chapter titled Clinic Pharmacy (Class D).
(7) The records of services provided at the emergency remote pharmacy shall be:
(A) kept by the home pharmacy and be available, for at least two years from the date of provision of the service, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement agencies; and
(B) supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy. If the pharmacy maintains the records in an electronic format, the requested records must be provided in an electronic format if specifically requested by the board or its representative. Failure to provide the records set out in this section, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.

22 Tex. Admin. Code § 291.127

The provisions of this §291.127 adopted to be effective September 18, 2007, 32 TexReg 6352