(a) Purpose. The purpose of this section is to allow pharmacists to administer epinephrine through an auto-injector device to a patient in an emergency situation as authorized in Chapter 562 of the Act.
(b) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.
  (1) Act--The Texas Pharmacy Act, Chapter 551 - 569, Occupations Code, as amended.
  (2) Administer--The direct application of a prescription drug to the body of an individual by any means, including injection, by a pharmacist.
  (3) Anaphylaxis--A sudden, severe, and potentially life-threatening allergic reaction that occurs when a person is exposed to an allergen. Symptoms may include shortness of breath, wheezing, difficulty breathing, difficulty talking or swallowing, hives, itching, swelling, shock, or asthma. Causes may include, but are not limited to, an insect sting, food allergy, drug reaction, and exercise.
  (4) Epinephrine auto-injector--A disposable drug delivery system that contains a premeasured single dose of epinephrine that is used to treat anaphylaxis in an emergency situation.
(c) Administration requirements.
  (1) Pharmacists may administer epinephrine through an auto-injector to a patient in an emergency situation.
  (2) The authority of a pharmacist to administer epinephrine through an auto-injector may not be delegated.
  (3) Epinephrine administered by a pharmacist under the provisions of this section shall be in the legal possession of a pharmacist or the legal possession of a pharmacy which shall be the pharmacy responsible for drug accountability, including the maintenance of records of administration of the epinephrine.
(d) Limitation on liability.
  (1) A pharmacist who in good faith administers epinephrine through an auto-injector in accordance with this section and Chapter 562 of the Act is not liable for civil damages for an act performed in the administration unless the act is willfully or wantonly negligent.
  (2) A pharmacist may not receive remuneration for the administration of epinephrine through an auto-injector but may seek reimbursement for the cost of the epinephrine auto-injector.
  (3) The administration of epinephrine through an auto-injector to a patient in accordance with the requirements of this section and Chapter 562 of the Act does not constitute the unlawful practice of any health care profession.
(e) Notifications.
  (1) A pharmacist who administers epinephrine through an auto-injector to a patient shall report the use to the patient's primary care physician, as identified by the patient, as soon as practical, but in no event more than 72 hours from the time of administering the epinephrine.
  (2) Immediately, after administering the epinephrine auto-injector, the pharmacist shall ensure that 911 is called and the patient is evaluated by emergency personnel for possible transfer to the nearest emergency department for additional evaluation, monitoring, and treatment.
  (3) The notifications required in paragraph (1) of this subsection shall include the:
    (A) name of the patient;
    (B) age of the patient if under 8 years of age;
    (C) name and manufacturer of the epinephrine auto-injector;
    (D) date the epinephrine was administered;
    (E) name and title of the person administering the epinephrine; and
    (F) name, address, and telephone number of the pharmacy.
(f) Records.
  (1) The notification required to be made under this section shall be kept by the pharmacy and such records shall be available for at least two years from the date of such record, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement or regulatory agencies.
  (2) The notification may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided:
    (A) the records maintained in the alternative system contain all of the information required on the manual record; and
    (B) the data processing system is capable of producing a hard copy of the record upon request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.

Source Note: The provisions of this §295.16 adopted to be effective January 1, 2016, 40 TexReg 8788; amended to be effective December 19, 2016, 41 TexReg 9935