SECTION 97.123. Stocking, Issuing, and Returns

(a) Stocking. Anti-rabies biologicals may be procured and distributed by the Department of State Health Services (department). The department may enroll off-site depots for the storage and distribution of department-owned anti-rabies biologicals. The depot will be licensed as defined by the Texas Board of Pharmacy that allows for the storage and distribution of anti-rabies biologicals to individuals presenting a signed order from a medical practitioner licensed to practice in Texas. The products in each depot will remain under the ownership of the department until issued.

(b) Issuing.

(1) Anti-rabies biologicals may only be issued upon receipt of a signed order from a medical practitioner licensed to practice in Texas.

(2) The department has the right to refuse to provide anti-rabies biologicals if the incident in question does not warrant rabies post-exposure prophylaxis according to the recent ACIP's recommendations on human rabies prevention.

(3) Partial issuance. Issues may be less than the full regimen of treatment when:

(A) there is reason to believe that the treatment may be terminated before completion; or

(B) in the event of a biological shortage.

(4) For individuals who are declined anti-rabies biologicals, the department will provide a source from which biologicals may be purchased.

(5) At the time of issuance.

(A) A human rabies prophylaxis surveillance report will be completed by the person issuing the anti-rabies biologicals and forwarded to the appropriate health service region.

(B) An information sheet about rabies and rabies biologicals will be provided by the department for use by the attending medical practitioner to inform the patient of the risks and benefits of the anti-rabies treatment.

(C) The recent ACIP's recommendations on human rabies prevention will be provided to the attending medical practitioner.

(D) An information sheet will be provided to the patient or the patient's agent on the proper transport of the biologicals.

(E) The patient or patient's agent will receive and sign an information sheet pertaining to payment responsibilities.

(F) Anti-rabies materials may be obtained from the Department of State Health Services, Immunization Branch, 1100 West 49th Street, Austin, Texas 78765-3199, or by request by phoning, 1-800-252-9152.

(c) Return of anti-rabies biologicals. Once issued to a patient or patient's agent and removed from the depot storage area, no anti-rabies biologicals may be returned for credit or reimbursement.

Source Note: The provisions of this §97.123 adopted to be effective March 5, 1982, 7 TexReg 743; amended to be effective February 5, 1998, 23 TexReg 756; amended to be effective August 28, 2003, 28 TexReg 6855; amended to be effective September 6, 2007, 32 TexReg 5700